Complementary therapies

Objectives: To review the evidence for the effectiveness of complementary and self-help treatments for depression.Data sources: Systematic literature search using PubMed, PsycLit, the Cochrane Library and previous review papers.Data synthesis: Thirty-seven treatments were identified and grouped under the categories of medicines, physical treatments, lifestyle, and dietary changes. We give a description of each treatment, the rationale behind the treatment, a review of studies on effectiveness, and the level of evidence for the effectiveness studies.Results: The treatments with the best evidence of effectiveness are St John's wort, exercise, bibliotherapy involving cognitive behaviour therapy and light therapy (for winter depression). There is some limited evidence to support the effectiveness of acupuncture, light therapy (for non-seasonal depression), massage therapy, negative air ionisation (for winter depression), relaxation therapy, S-adenosylmethionine, folate and yoga breathing exercises.Conclusion: Although none of the treatments reviewed is as well supported by evidence as standard treatments such as antidepressants and cognitive behaviour therapy, many warrant further research.

Anthony F Jorm PhD, DSc · Helen Christensen MPsychol, PhD · Kathleen M Griffiths BSc, PhD · Bryan Rodgers MA, PhD

To fill this important gap in our knowledge would require collaboration between researchers from the manipulation disciplines and neurologists Manipulation of the spine is a popular treatment which is used frequently by chiropractors. In the past 25 years, its use has been evaluated by increasingly sophisticated randomised trials. In a recent review of the emergence of the chiropractic profession from "alternative" to more "mainstream",1 the results of 20 randomised controlled trials of cervical manipulation (for migraine and tension headache, cervicogenic headache or neck pain) were described: 11 were positive, and nine equivocal. Given this supporting evidence, as well as the frequency of use of manipulation2 and the health and social impact of the conditions treated, it is important to consider any suggestions that manipulation may do more harm than good with some care. In this issue of the Journal, Ernst (page 376)3 reviews case reports of serious adverse events associated with cervical spine manipulation. Although Ernst acknowledges the considerable doubt about a causal relationship between the manipulation and the adverse event, he is inconsistent in suggesting that the anecdotal and uncontrolled evidence of the case reports favours the adverse events, often strokes, being an effect of manipulation. Elucidating a causal relationship calls for greater clarity, less ambivalence and generally better science in the present evidence-based climate. Thus, the important question to be answered in the light of Ernst's article is whether the association between neck manipulation and stroke is actually causal and, if so, in what direction? The incidence of cerebrovascular accidents after neck manipulation has been estimated by various authors to range from 1 in 400 000 to between 3 and 6 per 10 million manipulations.1 Ernst's article suggests that the mechanism of the strokes associated with neck manipulation tends to be dissection of the vertebral or carotid arteries, an observation also made by others.4 However, dissection is not the only mechanism proposed in Ernst's review. Of the 42 cases tabulated, 20 were not attributed to dissection (although only two such cases appear to have been confirmed by angiography). Of these 20, nine seem to be either intracranial events or lesions such as cervical canal stenosis, intradural mass or cervical disc hernias, which are more likely to have been pre-existing conditions. Strokes following manipulation could also be linked to other pre-existing conditions, such as vasospasm, or kinking of the vertebral arteries and thrombus without dissection.5 Smith and Estridge, reporting two cases of stroke after manipulation, suggested that smaller forces than those used in neck manipulation may be all that is required to precipitate stroke in the presence of such pre-existing lesions.5 They proposed that some premanipulation testing of the neck in rotation and extension might warn of the presence of such lesions. However, a recent review of the literature6 and a study of patients with positive premanipulation tests7 failed to demonstrate such a link. In favour of neck manipulation causing stroke is the fact that it is a mechanical intervention. Particularly if a dissection were already in progress, a mechanical intervention might accelerate it. However, an argument can also be made that the dissection, before manifesting itself as a stroke, causes head or neck symptoms requiring treatment from a chiropractor, osteopath or other manipulation practitioner. The ensuing stroke could be the natural progression of the condition regardless of the manipulation. This hypothesis is further supported by recent evidence that the strain to the vertebral artery conferred by a high-velocity neck manipulation is almost an order of magnitude lower than that required to mechanically disrupt it.8 Both hypotheses are reasonable, but bring us no closer to answering the question of whether or not it is more likely that a stroke will follow neck manipulation than occur without manipulation, and, if it is more likely to occur after manipulation, which subgroups of patients are susceptible. If practitioners of manipulation are precipitating certain types of strokes then they must be made aware of how to recognise these. If, on the other hand, they are mere bystanders in an ongoing process, this also needs to be established. Either way, they may have an important role to play in detection. There are no high-quality data available to provide the denominator to enable us to calculate either the risk or the odds ratios of stroke following manipulation and to thereby assess causation. To fill this important gap in our knowledge would require collaboration between researchers from the manipulation disciplines and neurologists. Community-based studies could examine exposed and unexposed groups who have or have not been affected by strokes or transient ischaemic attacks. A stroke registry employing rigorous case-ascertainment methods could support this. Considerable care would be needed in selecting controls, matching for stroke risk as well as age and sex. Exposure data would need to be detailed for both cases and controls, including an account of the intervention itself. Careful consideration would need to be given to whether to examine the relationship between manipulation and all strokes, or limit studies to vertebral and carotid artery dissections in younger patients only. The latter subgroup approach would help to provide the statistical power needed to draw conclusions, but the case for dispensing with a more global approach would need to be made carefully. The increased use of spinal manipulation for its demonstrated benefits in healthcare means that, in the future, even without any causal link to stroke, more of the strokes that do occur will follow manipulation, just as they follow other common events. Given the expectation that has been generated, this is likely to increase public alarm unless this logical fallacy is appreciated and manipulation professionals come to be regarded as responsible partners instead of pariahs.

Alan Breen DC, PhD

Medicine and literature: The doctor's companion to the classics. John Salinsky. Abingdon, UK: Radcliffe Medical Press, 2002 (vi + 236 pp, $53.50). ISBN 1 85775 535 9. It is not easy, in a busy medical life, to find time to read literature. Spare time is devoted to reading medical journals and newspapers to try and keep abreast of medical developments and world events. Occasionally, we see a movie or read something frivolous, but serious books often remain unfinished on the bedside table. John Salinsky is a general practitioner from Middlesex, UK, who uses classical literature in teaching his registrars. He is responsible for the "Medicine and literature" column in the journal Education for primary care, and the present work includes 17 contributions from this column. Most pieces are by Salinsky himself, and he writes clearly and entertainingly, making it a joy to read. Salinksy's argument is that the classics are classics not just because of the quality of the writing, but because they describe human relationships in a manner that is both engaging and timeless. From these works of literature we can learn much about human behaviour, its strengths and frailties, and become better at the "art" of medicine. Some of the writers he talks about are doctors, like Mikhail Bulgakov, or were the sons of doctors, like Dostoyevsky or Flaubert. Others tell stories in which doctors play central roles, like Kafka, whose A country doctor contains the wonderful line, "To write prescriptions is easy, but to come to an understanding with people is hard". Salinsky's purpose is not to introduce us to stories by or about doctors, but rather to stories that contain characters that we will recognise in our practices. Our familiarity with and love of these personalities will increase our understanding of those of our patients who are excessively garrulous, who seem unable to take control of their lives or whose characters seem inherently flawed. If you already love good literature, this book will delight and inform you. If you have forgotten how much pleasure can be obtained from a great story, it may motivate you to return to a world that provides a wealth of entertainment and stimulation. Almost everybody will be introduced to something unfamiliar, but at just over $53 it is probably best borrowed from the library rather than added to one's own.

John Ward

Clinical question A 68-year-old woman diagnosed with osteoporosis attended a naturopath, who advised (a) exercise in the gym 2–3 times a week, because "walking wasn't good enough"; (b) natural progesterone cream applied to the skin; (c) oral boron supplements; (d) codliver oil 1000 mg daily; (e) chelated calcium (instead of her current calcium carbonate); and recommended that she stop drinking tea. The patient challenged her general practitioner for not giving the same advice as the naturopath, suggesting he was remiss. Her GP wondered if there was any empirical basis for these recommendations in osteoporotic patients. Search question The revised question was: Is there empirical evidence that the following interventions reduce fracture rates and improve bone mineral density (BMD) in postmenopausal women with osteoporosis?: exercise in the gym 2–3 times a week; natural progesterone cream; boron; codliver oil; chelated calcium supplement; abstaining from tea. The ideal studies for this would be randomised controlled trials (RCTs) comparing each of the recommendations with either placebo or no treatment (or, in the case of the last recommendation, drinking tea) for the outcomes of interest: fracture rate and BMD. Search We searched three online databases: PubMed Clinical Queries (<http://www.ncbi.nlm.nih.gov/entrez/query/static/clinical.html>), SUMSearch (<http://sumsearch.uthscsa.edu>) and the Cochrane Library, using the search terms "osteoporosis", "weight-bearing exercise", "walking", "progest", "natural progesterone cream", "boron", "bone", "cod liver oil", "caltrate", "calcium carbonate", "tea", "tannin" and "vitamin D". Summary of findings We identified a number of studies that used the primary outcome measure of BMD, but none that assessed fracture rate as the primary outcome. →Exercise Five meta-analyses were identified that demonstrated the effectiveness of aerobic and/or strength-training exercise in increasing BMD in different body regions,1 the lumbar spine,2-4 the hip,5 and femoral neck.4 The meta-analyses applied adequate eligibility criteria for the trials analysed and included either RCTs only1,3,5 or RCTs and non-randomised controlled trials.2,4 Four RCTs specifically evaluated the benefits of walking on BMD. The sample sizes were small in two of these trials but adequate in the other two. In a seven-month trial of 33 postmenopausal women, walking above (but not below) the anaerobic threshold (ie, sufficient to leave the subject panting) was found to significantly increase lumbar spine BMD in the walking women compared with controls, in whom BMD decreased.6 In a trial assessing the effects of walking and calcium supplementation on 36 postmenopausal women, those involved in a supervised one-year walking program showed a significant increase in trabecular BMD of the lumbar spine compared with sedentary women.7 In another trial,8 165 postmenopausal women with a history of fracture of an upper limb in the previous two years were randomly assigned to do upper-limb exercises or brisk walking: after two years, there was significantly greater loss of BMD in the femoral neck for women in the former group than the latter group, but no difference in lumbar spine BMD between the two groups. The dropout rate was high in this trial at 41%. In the largest trial assessing the benefits of walking, 255 women were randomly allocated to a walking group or a control group: after 3 years BMD changes in the cross-sectional dimensions of the radius did not differ significantly between the two groups.9 →Progesterone One controlled clinical trial assessed the efficacy of natural progesterone cream as an adjunct to percutaneous oestradiol in reducing postmenopausal bone loss in 57 women.10 Progesterone cream did not influence BMD. →Boron One RCT assessed the effect of boron supplements over one year on BMD.11 Subjects were grouped according to whether they were athletes (n = 17) or sedentary (n = 11). It was not possible to tell whether boron had an effect on BMD, as no results were reported that compared those who received supplements with those who did not. Moreover, this trial was conducted in female college students rather than postmenopausal women. →Codliver oil No trials were identified that examined the benefits of codliver oil for BMD. →Calcium In a randomised crossover controlled trial, three calcium supplements were assessed for their absorption ability.12 Thirty-five osteoporotic women received the three preparations on successive evenings: 1 g effervescent calcium, 1 g calcium carbonate or 1.2 g calcium carbonate. Urinary calcium excretion rose significantly and similarly for all three preparations, indicating similar levels of absorption. The effect that this had on BMD was not measured. Comment There is good evidence that exercise increases BMD in postmenopausal women with osteoporosis. Despite slight variations in the way different analyses defined each outcome measure, all five meta-analyses supported this conclusion. Although no trials specifically compared "just walking" with "exercise in the gym", there was reasonable evidence supporting the beneficial role of walking in this patient group, particularly above the anaerobic threshold. There is little good-quality empirical evidence to support the use of natural progesterone cream. One non-randomised controlled trial reported that its use had no effect on BMD. There is insufficient empirical evidence to support the use of boron, codliver oil or chelated calcium supplements (as opposed to calcium carbonate), or to suggest that drinking tea should be avoided. Outcome The GP discussed the available evidence with the patient, who then understood why he had not made the same recommendations as her naturopath. She was pleased to have avoided the unnecessary expense that she would have incurred if she had followed the alternative advice.

Christopher B Del Mar MD, FRACGP, FAFPHM · Paul P Glasziou MB BS, PhD, FRACGP, FAFPHM · Anneliese B Spinks BSc/Arts (Hons) · Sharon L Sanders BSc (Pod)

To the Editor: The EBM in Action article on laser treatment by Del Mar et al1 raises my anxiety about the reliability of evidence-based medicine (EBM) in general and, at the very least, the authors' assessment of the question they set out to answer. One is seldom, if ever, in a position to understand the breadth and depth of an issue unless it is the subject of particular study. Most of us can not challenge statements made in such articles without an intimate knowledge of the literature. As laser therapy is the topic of my PhD thesis, I am in a unique position to have much of the literature on the subject at my fingertips. The authors state in their conclusions that "low power laser therapy appears to be no more efficacious than placebo in relieving musculoskeletal pain". Several aspects of the analysis on which they base this conclusion cause me great concern. Firstly, they state that "The search report highlighted the high quality of evidence supporting the refined question". Quite the contrary. One of the two systematic reviews they cite2 has been criticised in the literature for its many inadequacies, not the least being that laser acupuncture and laser therapy are included in that review as if they were the same, which they are certainly not.3 In addition, the review by Beckerman et al concludes, with regard to musculoskeletal pain, that "the efficacy of laser therapy for musculoskeletal disorders seems, on average, to be larger than the efficacy of placebo treatment. More specifically, for rheumatoid arthritis, post-traumatic joint disorders and myofascial pain, laser therapy seems to have a substantial specific therapeutic effect".4 How can this fit with the conclusion of Del Mar et al? Furthermore, Gross et al state in their review, which consisted of three trials of laser therapy, that "In general, all therapies have not been studied in enough detail to adequately assess either efficacy or effectiveness".5 The choice of other articles by Del Mar et al is also somewhat mystifying in that, out of the nine references cited, one is in Russian and two in Danish. There are many other relevant articles in English that they have not cited.6,7 There is no doubt, as I myself have found, that it is difficult to search for this topic in the literature, as there are many terms used for laser therapy and the information comes from a broad range of sources. However, this is no excuse for a group that holds itself out to be "expert" in a field. It is very disappointing to see such an incomplete review with such an inappropriate conclusion based on such a poor sample of the literature. If this is an example of EBM in action, then I think we should be very concerned.

Roberta Chow MB BS (Hons), FRACGP, FAMAC, MApplSci(MedAcu)

In reply: Chow criticises us for not identifying all relevant trials. But is she willing to help others in the process of reviewing? We could not identify a systematic review of the area with her involvement, nor does she appear to have registered an appropriate protocol with the Cochrane Collaboration (instructions for which are available at <http://www.cochrane.de>). Systematic reviews are important to help clinicians make sense of a diversity of trials. If experts such as she, devoting years to the area, do not help us, who should? We were not attempting such a systematic review (which would probably take several months of work). Rather, we were trying to provide clinicians with the best obtainable answer in a 24–48-hour turnaround time.2 Given that clinicians might have one question per patient,1 attempting a systematic review with each question would give us a lifetime of work after only a fortnight of clinical work! We needed to balance the timely requirements of clinicians with the quality of the evidence obtained. As Chow points out, tracking down every last trial is difficult. Therefore, we first aimed to identify systematic reviews rather than attempting to find all trials ourselves. These reviews missed some relevant material — as indeed did Chow, who did not cite several recent studies,3,4 which makes us wonder if she has a strong prior belief that may bias her views. Would these missed trials have made any difference to the conclusions we reached previously? A systematic review published since our original literature report (January 2000) suggests not, although there may be some specific subgroups of patients and conditions for which laser therapy is effective.5 All of this highlights the need for a collective effort to sort out the mess of medical information. In seven years the Cochrane Collaboration has systematically reviewed less than 5% of more than 300 000 trials on the clinical trials registry. They are difficult to perform and maintain. Millions of dollars continue to pour into primary research that still remains inaccessible to us at the clinical frontline, the "great criticism" with which Archie Cochrane pricked the profession into action.6 Please, Dr Chow, abandon throwing bricks from the sidelines, and join us in trying to help clinicians access research evidence in the timely fashion needed for day-to-day practice!

Chris B Del Mar MD, FRACGP · Paul P Glasziou MB BS, PhD, FAFPHM

Clinical Practice A primer of complementary and alternative medicine commonly used by cancer patients Edzard Ernst MJA 2001; 174: 88-92 Abstract - Acupuncture - Diets - Aromatherapy - Chiropractic - Coffee enemas - Herbal medicinal products - Homoeopathy - Meditation - Ozone therapy - Shark cartilage - Spiritual healing - Comment - References - Author's details - - More articles on complementary medicine Abstract Complementary and alternative medicine (CAM) is frequently used by cancer patients, and many oncologists have limited knowledge of CAM. This article provides a brief, evidence-based introduction to several CAM treatments relevant in the context of cancer. "Alternative" diets, chiropractic, coffee enemas, ozone therapy, and shark cartilage seem to have little to offer cancer patients. The evidence for or against homoeopathy and spiritual healing is at present inconclusive. Acupuncture, aromatherapy, and meditation may be useful for nausea/vomiting, for mild relaxation, and for pain/anxiety, respectively. Herbal treatments offer no reasonable prospect of a cure (mistletoe), but could be useful as palliative treatments (eg, for depression [St John's wort] or anxiety [kava]). Our knowledge regarding the potential benefit and harm of CAM is insufficient. The prevalence of use of complementary and alternative medicine (CAM) for treating cancer is high: a systematic review of all surveys published by 1998 indicated an average prevalence of 34%,1 a figure which is close to that observed for Australia,2 but markedly lower than the 75% reported recently in the United States.3 Cancer patients generally report satisfaction with CAM1,2 and rarely inform their doctors about their CAM use.4 Consequently, many oncologists have limited knowledge of the subject.5My aim is to provide a brief introduction to those CAM modalities which have been identified as most relevant:1-5 acupuncture, "alternative" cancer diets, aromatherapy, chiropractic, coffee enemas, herbal medicinal products (HMPs), homoeopathy, meditation, ozone therapy, shark cartilage, and spiritual healing. Particular emphasis is placed on reliable evidence (eg, randomised clinical trials, or systematic reviews and meta-analyses of such studies) regarding safety and effectiveness. It is important to note that this article is not a systematic review of all available data. Acupuncture Acupuncture constitutes one of several elements of Traditional Chinese Medicine (TCM). Advocates of TCM view ill health as an imbalance of the life force "Qi", which is believed to flow in channels called meridians. To restore the balance (and thus health), the flow of Qi can be influenced by stimulating acupuncture points located along meridians. Typically, this is done by inserting needles, but heat (moxibustion), external pressure (acupressure), electrical currents (electroacupuncture), laser (laser acupuncture), and other stimuli are also used.6 Acupuncture is one of the best-known forms of CAM.7 Several hundred controlled clinical trials of acupuncture for a range of conditions have been published (for a review, see ref. 6). Such trials face formidable methodological challenges (eg, blinding or controlling for placebo effects), an issue that also applies to many other CAM treatments. Often the results of individual studies are contradictory. Thus, systematic reviews (including meta-analyses) of the totality of the trial data present the least-biased assessment. Box 1 provides an overview of the conclusions from all systematic reviews and meta-analyses of acupuncture currently available.6 There is good evidence for the use of acupuncture for non-specific back pain, dental pain, migraine, and nausea/vomiting. Of these conditions, only nausea and vomiting are directly relevant to cancer patients. There are many conditions for which substantial uncertainty remains (in spite of the availability of clinical trials) (Box 1), and future trials are required to define the effectiveness of acupuncture in these situations. Serious risks of acupuncture pertain mainly to tissue trauma (eg, pneumothorax) and infections (eg, hepatitis). They are usually avoidable and extremely rare.8 Less serious adverse effects (eg, pain of needle insertion or minor bleeding at the site of insertion) are much more common but transient.9 "Alternative" cancer diets More than 40 different cancer diets have been claimed to prevent and/or treat cancer.10 Several of these diets are an extension of conventional medicine, whereas others are considered more in the realm of CAM. The diets typically emphasise avoiding meat, and many are strictly vegetarian. Compelling evidence is largely absent. Two diets deserve particular mention. The Gerson diet is basically a vegan form of nutrition. Patients consume the juices of about 9 kg of fruit and vegetables per day (primarily carrots and apples). The diet is often supplemented with coffee enemas. The "Gerson Institute" offers anecdotal evidence of success in its promotional literature, and a retrospective analysis11 of 153 melanoma patients suggested an impressive prolongation of the five-year survival rates of Gerson patients compared with patients in orthodox care. This study was retrospective, its sample size was small, and about a third of all patients were lost to follow-up. Bias was further introduced by use of a self-selected sample, and through the use of non-randomised controls. The Macrobiotic diet is based on the belief that cancer is caused by an imbalance of yin and yang. It is assumed that imbalances can be corrected by eating foods with either yin or yang qualities. The Macrobiotic diet is composed primarily of whole-grain products (50%-60%) and fresh vegetables (20%-40%). Meat and milk are not allowed, but small amounts of fish are permitted. Macrobiotic diets allow few fluids but they require large amounts of salt intake (about 30 g/day). There is no clinical evidence to suggest that this diet prevents, alleviates or cures cancer.12 There are positive aspects to some cancer diets (eg, a reduction in red meat consumption, increase in intake of fruit, vegetables and fibre). However, dogmatic adherence to an unbalanced diet is clearly counterproductive and some CAM cancer diets (eg, Gerson, Macrobiotic, strict vegan) carry the risk of malnutrition. Aromatherapy Aromatherapy is the medicinal use of concentrated volatile oils extracted from plants.13 The term was first used in 1936 by the French chemist Gattefossé.14 Today it usually implies gentle massage therapy with a range of aromatic plant extracts known as essential (ie, volatile) oils.15 A recent systematic review summarised all randomised controlled trials (RCTs) testing the clinical effectiveness of aromatherapy.16 Twelve trials were found; six of them had no independent replication and six related to the relaxing effects of aromatic oils applied through gentle massage. These studies suggest that aromatherapy massage has mild and transient anxiolytic activity. Even though the effects are likely to be small, they may have benefits for cancer patients in terms of enhancing feelings of wellbeing. There are few risks associated with aromatherapy. Although some oils are potentially carcinogenic,17 the exposure rate for patients (but perhaps not for therapists) is probably too low to constitute a real danger. Chiropractic Chiropractic is "a system of health care founded in 1895 by Daniel David Palmer which is based on the belief that the nervous system is the most important determinant of a person's state of health; according to chiropractic theory, most diseases are the result of 'nerve interference', caused by spinal subluxations, which respond to spinal manipulation".13 Chiropractors employ spinal manipulation (eg, high-velocity thrusts), mobilisation (eg, low-velocity techniques), and other forms of natural medicine. A systematic review of conservative treatments for neck pain/headache failed to show convincingly that chiropractic is more effective than other interventions.18 A meta-analysis of chiropractic for low back pain published in 199219 suggested that chiropractic is effective for acute low back pain. For chronic low back pain, the evidence was less convincing. A more recent and more rigorous systematic review concluded that "the available randomised clinical trials provided no convincing evidence of the effectiveness of chiropractic for acute or chronic low back pain".20 Owing to lack of data, no firm conclusions are possible for the effectiveness of chiropractic for other conditions. One exception is asthma, where two rigorous, sham-controlled RCTs showed that chiropractic is no more effective than sham interventions.21,22 There is no evidence that chiropractic alleviates symptoms related specifically to cancer. About 50% of patients treated by chiropractors will experience mild and transient adverse effects, mostly local or distant pain lasting for one or two days.23,24 Serious complications of chiropractic are probably rare events that occur predominantly after manipulation of the cervical spine. A recent review described 32 fatalities associated with upper spinal manipulation.25 In addition, significant indirect risks are on record. Examples are the overuse of x-rays by some chiropractors26 and their tendency to advise against vaccination.27 Coffee enemas Coffee enemas are a derivative of colon therapy (ie, water enemas).28 As part of the Gerson diet,11 coffee enemas are usually administered on a four-hourly basis "to help relieve pain, nausea and other symptoms accompanying detoxification".29 Proponents claim that caffeine is absorbed in the colon, leading to vasodilatation of the liver, which in turn enhances the process of elimination of "toxins".29 These assumptions are unproven. There is no reliable evidence of the clinical efficacy of coffee enemas for any indication. Coffee enemas are regularly associated with adverse reactions (eg, electrolyte imbalances), some of which are severe.30 On balance, therefore, no reasons exist for recommending coffee enemas to cancer patients. Herbal medicinal products With many medicinal plants, it is not possible to define the principal active constituents; the clinical effects of most HMPs are produced by more than one active compound, and in many instances the full range has not been identified. Thus, the conventional pharmacological wisdom of isolation and synthesis of (single) active ingredients is often not a viable option. Several traditions of herbal medicine (eg, Traditional Chinese Medicine, Ayurveda) typically use complex, often individualised, mixtures of several (sometimes more than 20) medicinal herbs in one single prescription. However, most modern self-prescribed HMPs consist of one single herb. Several such HMPs have been submitted to relatively extensive clinical tests. Box 2 provides an overview of HMPs for which sufficient trial data as well as systematic reviews or meta-analyses exist (for a review, see ref. 31). It is obvious that each HMP (for each indication) has to be evaluated on its own merit -- generalisations regarding the efficacy (and safety) of HMPs are nonsensical. For other HMPs, efficacy remains uncertain. Mistletoe (Viscum album) is often recommended as a treatment for cancer. It gained widespread popularity in Europe, which now also extends to the US and Australia. Its proponents claim that it arrests or delays tumour progression and improves quality of life. Mistletoe lectins have been shown repeatedly to exhibit antineoplastic activity.32 However, a systematic review of all 11 controlled clinical trials yielded disappointing results.33 The average methodological quality of the primary studies was poor. The results of most trials favoured mistletoe, but the most rigorous study did not demonstrate efficacy. The authors therefore concluded that they "cannot recommend the use of mistletoe extracts in the treatment of cancer patients with an exception for patients involved in clinical trials".33 Since the publication of that report, several new studies have emerged, but the overall conclusion has not become more positive.34 Homoeopathy Homoeopathy is based on two highly controversial principles: the law of "similars" (ie, like cures like), and the notion that highly "potentised" (diluted) remedies can be effective, even though they are unlikely to contain a single molecule of the original substance. Scientists insist that where there is no molecule there can be no effect; all clinical effects of homoeopathy, they maintain, must therefore be due to placebo. A meta-analysis of all 123 randomised or placebo-controlled trials concluded that the clinical effects of homoeopathy are not entirely due to placebo.35 This meta-analysis has been criticised for pooling data relating to all types of indications and remedies. It may therefore be relevant to assess defined indications and remedies and see what evidence for or against homoeopathy emerges. The remedy that has been submitted to more controlled clinical trials than any other homoeopathic medicine is Arnica montana (a plant-based homoeopathic remedy often used for alleviating bruising and other tissue trauma). Two independent systematic reviews of all studies of homoeopathic arnica provided no conclusive evidence that it is clinically more effective than placebo.36,37 The condition most frequently employed for testing the efficacy of homoeopathic remedies is delayed-onset muscle soreness. A systematic review of all relevant trials produced no convincing evidence that homoeopathic remedies are superior to placebo in treating this condition.38 In their daily routine, homoeopaths are more likely to aim at alleviating ailments like asthma or headaches; systematic reviews found no good evidence to suggest that homoeopathic remedies are efficacious for either of these conditions.39,40 Most homoeopaths would claim that their approach can alleviate symptoms associated with cancer and therefore has a role in supportive/palliative care. Reliable evidence to substantiate this claim is lacking. Highly diluted homoeopathic drugs are obviously devoid of adverse effects, but low dilutions may cause adverse effects (eg, allergic reactions). Homoeopaths claim that, in about 20% of all patients, they would see an acute clinical deterioration ("homoeopathic aggravation") if the optimal remedy has been administered. Such aggravations might constitute a safety issue in their own right. Finally, some non-medically qualified homoeopaths advise their clients against vaccination,37 which clearly constitutes an indirect risk of homoeopathy. Meditation Meditation is a general term describing treatments in which a person empties his/her mind of extraneous thought with the intent of elevating the mind to a different level and transcending mundane concerns.13 A wide array of techniques exist which fall into two broad categories: emphasis on concentration (eg, Transcendental Meditation) and emphasis on mindfulness (eg, Vipassana). The techniques can be learned from experienced teachers during a series of tutored sessions. The physiological effects of meditation are those of deep relaxation. A typical relaxation response includes the cardiovascular (eg, decrease in blood pressure and heart rate) and the endocrine (eg, decrease in stress hormones) systems. There is evidence from controlled clinical trials suggesting that these effects can be used clinically to control cardiovascular risk factors, chronic pain and anxiety,41 which could be of benefit to cancer patients. Potential adverse effects of meditation include psychological symptoms such as tension, anxiety, depression, and confusion. A syndrome termed "meditation sickness" has been recognised.13 Meditation is contraindicated in patients with psychotic or borderline personality disorders.41 Ozone therapy Several techniques of administering ozone are being promoted as a treatment for cancer.42 The "optimal" system is apparently via the exposure ex vivo of up to 300 mL of freshly drawn blood to a gas mixture of oxygen and ozone, followed by reinfusion of this blood into the patient.43 Numerous mechanisms of action are quoted in support of ozone therapy. However, few rigorous clinical trials of the treatment exist. Those that have been published demonstrated no evidence of effect.44,45 The risks of ozone therapy are played down by its proponents.42,43 Yet, numerous reports of serious complications, including hepatitis, and at least five fatalities have been reported.46,47 Until more positive evidence emerges, ozone therapy should be avoided. Shark cartilage Shark cartilage is perhaps the most widely promoted CAM "cancer cure" in recent years. In 1995, the annual world market for shark cartilage products exceeded US$30 million.48 Two glycoproteins (sphyrnastatin 1 and 2) have been isolated from the cartilage of the hammerhead shark and were reported to have strong antiangiogenic activity inhibiting tumour neovascularisation,49 an effect which could be helpful in human cancer therapy. However, as macromolecules are not usually absorbed by the intestinal tract, it is questionable whether the sphyrnastatins ever reach the bloodstream in sufficiently high concentrations. To date, no controlled clinical studies testing the efficacy of shark cartilage have been published. Preliminary results have been reported from a US trial: 50% of cancer patients who took 100 mg dried cartilage powder daily reported improvements in quality of life, appetite and relief of pain.50 More recently, a well-documented trial was published.51 Sixty patients with various advanced cancers received 1 g/kg shark cartilage daily for 12 weeks. No complete or partial responses were noted, and the authors conclude that "shark cartilage as a single agent was inactive in patients with advanced-stage cancer and had no salutary effect on quality of life".51 Spiritual healing Spiritual healing has been defined as the direct interaction between one individual (the healer) and a patient, with the intention of improving the patient's condition or curing the illness.52 Treatment can occur through personal contact or at a (sometimes large) distance. Several variations exist (eg, therapeutic touch, Reiki, faith healing, intercessory prayer), and therapists of one group see themselves as distinct from other groups. Spiritual healers, who are usually not medically qualified, believe that the therapeutic effect results from the channelling of "energy" from an undefined source via the healer to the patient; there is no evidence that this energy actually exists. The central claim of healers is that they promote or facilitate self-healing and wellbeing, both of which could be relevant to cancer patients. The evidence from randomised controlled trials of all distant healing approaches on human patients is highly conflicting. A systematic review of 23 randomised and adequately controlled clinical trials found that about half of these trials suggested that healing is effective (ie, better than control interventions). Yet methodological shortcomings prevented firm conclusions.53 As long as it is not used as an alternative to effective therapies, spiritual healing should be virtually devoid of risks. Comment It has to be stressed again that this article is a mere primer and not an in-depth analysis of the existing evidence. CAM includes several hundred treatments. Because of the obvious constraints of space only 11 were discussed briefly. Inevitably, other important treatments (eg, osteopathy, hypnotherapy, naturopathy) had to be omitted. Much of the above evidence indicates that CAM, even though used frequently by cancer patients, is not supported by compelling data. This is particularly true for CAM as a cancer cure. The role of CAM as a palliative or supportive cancer treatment might be slightly different.54 Several CAM modalities have the potential to increase wellbeing with little potential for harm (eg, acupuncture, reflexology). This raises the complex question of what evidence is required for such therapies. Is it enough that individual patients desire CAM and feel better with it, or does one need to demonstrate that the CAM intervention in question is at least as effective and/or cost-effective as conventional palliative care? These questions require serious consideration and further, detailed discussion. The potential for harm is considerable for several of the CAM treatments (eg, chiropractic, coffee enemas, ozone therapy, HMPs). Ideally, one would want exact incidence figures of adverse events and conduct proper risk-benefit analyses. Unfortunately, for most forms of CAM, such data are not available. Future research should focus not merely on the efficacy but also on the safety of CAM. The ultimate question that needs answering is, does a given CAM intervention do more good than harm to cancer patients? In conclusion, cancer patients frequently use CAM. For most of these treatments the evidence is woefully incomplete. One challenge for the future is to adequately match CAM's popularity with an evidence base. References Ernst E, Cassileth BR. The prevalence of complementary/alternative medicine in cancer. Cancer 1998; 83: 777-782. Begbie SD, Kerestes ZL, Bell DR. Patterns of alternative medicine use by cancer patients. Med J Aust 1996; 165: 545-548. Morris KT, Johnson N, Homer L, Deb W. A comparison of complementary therapy use between breast cancer patients and patients with other primary tumor sites. Am J Surg 2000; 179: 407-411. Kao GD, Devine P. Use of complementary health practices by prostate carcinoma patients undergoing radiation therapy. Cancer 2000; 88: 615-619. Newell S, Sanson-Fisher RW. Australian oncologists' self-reported knowledge and attitudes about non-traditional therapies used by cancer patients. Med J Aust 2000; 172: 110-113. Ernst E, White A. Acupuncture: a scientific appraisal. Oxford: Butterworth Heinemann, 1999. Eisenberg DM, David RB, Ettner SL, et al. Trends in alternative medicine use in the United States, 1990-1997. JAMA 1998; 280: 1569-1575. Ernst E, White A. Life-threatening adverse reactions after acupuncture? A systematic review. Pain 1997; 71: 123-126. White A, Ernst E. survey of adverse events following acupuncture (SAFA). Forsch Komplementärmed 2000; 7: 56. Ernst E, Cassileth B. Cancer diets, fads and facts. Cancer Prevent Int 1996; 2: 181-187. Hildenbrand G. Five-year survival rates of melanoma patients treated by diet therapy after the manner of Gerson: a retrospective review. Altern Ther Health Med 1995; 4: 29-37. Bowman BB, Kushner RF, Dawson SC, Levin B. Macrobiotic diets for cancer treatment and prevention. J Clin Oncol 1984; 2: 702-711. Segen JC. Dictionary of alternative medicine. Stamford, US: Appleton Lange, 1998; 81. Gattefossè R-M. Aromatherapy. Paris: C W Daniel Co Ltd, 1993. Vickers A, Zollman C. ABC of complementary medicine massage therapies. BMJ 1999; 319: 1254-1257. Cooke B, Ernst E. Aromatherapy: a systematic review. Br J Gen Pract 2000; 50: 493-496. Tisserand R, Balacs T. Essential oil safety. Edinburgh: Churchill Livingstone, 1995. Aker PD, Gross AR, Goldsmith CH, Peloso P. Conservative management of mechanical neck pain: systematic overview and meta-analysis. BMJ 1996; 313: 1291-1296. Shekelle PG, Adams AH, Chassin MR, et al. Spinal manipulation for low back pain. Ann Intern Med 1992; 117: 590-598. Assendelft WJJ, Koes BW, van der Heijden GJMG, Bouter L. The effectiveness of chiropractic for treatment of low back pain: an update and attempt at statistical pooling. J Ther Physiol Ther 1996; 19: 499-507. Nielsen NH, Bronfort G, Bendix T, et al. Chronic asthma and chiropractic spinal manipulation: a randomized clinical trial. Clin Exper Allergy 1995; 25: 80-88. Balon J, Aker PD, Crowther ER, et al. A comparison of active and simulated chiropractic manipulation as adjunctive treatment for childhood asthma. New Engl J Med 1998; 339: 1013-1020. Leboeff-Yde C, Hennius B, Rudberg E, et al. Side effects of chiropractic treatment: a prospective study. J Manip Physiol Ther 1997; 20: 511-515. Senstad O, Leboeuf-Yde C, Borchgrevink C. Frequency and characteristics of side effects of spinal manipulative therapy. SPINE 1997; 22: 435-441. Di Fabio RP. Manipulation of the cervical spine: risks and benefits. Phys Ther 1999; 79: 50-65. Ernst E. Chiropractors' use of X-rays -- Correspondence. Br J Radiol 1998; 71: 897-900, 1107-1108. Ernst E. The attitude against immunisation within some branches of complementary medicine. Eur J Paediatr 1997; 156: 513-515. Ernst E. Colonic irrigation and the theory of autointoxication: a triumph of ignorance over science. J Clin Gastroenterol 1997; 24: 196-198. Petton R, Overholster L. Alternative cancer therapy. New York: Simon and Schuster, 1994. Green S. A critique of the rationale for cancer treatment with coffee enemas and diet. JAMA 1992; 68: 3224-3226. Ernst E. Herbal medicine. A concise overview for professionals. Oxford: Butterworth Heinemann, 2000. Beuth J. Clinical relevance of immunoactive mistletoe lectin-l. Anti-Cancer Drugs 1997; 8: S53-S55. Kleijnen J, Knipschild P. Mistletoe treatment for cancer: review of controlled trials in humans. Phytomedicine 1994; 1: 255-260. Ernst E. Mistletoe for cancer? Eur J Cancer 2001. In press. Linde K, Clausius N, Ramirez G, et al. Are the clinical effects of homoeopathy placebo effects? A meta-analysis of placebo-controlled trials. Lancet 1997; 350: 834-843. Ernst E, Pittler MH. The efficacy of homoeopathic Arnica. A systematic review of placebo-controlled clinical trials. Arch Surg 1998; 133: 1187-1190. Lüdtke R, Wilkens J. Klinische Wirksamkeitsstudien zu Arnica in homöopathischen Zubereitungen. In: Albrecht H, Frühwald M, editors. Jahrbuch Band 5 (1998) Karl und Veronica Carstens-stiftung. KVC Verlag Essen, 1999; 97-112. Ernst E, Barnes J. Are homoeopathic remedies effective for delayed-onset muscle soreness? A systematic review of placebo-controlled trials. Perfusion 1998; 11: 4-8. Linde K, Jobst KA. Homoeopathy for chronic asthma. Cochrane Library 1998; 1: 1-7. Ernst E. Homoeopathic prophylaxis of headaches and migraine? A systematic review. J Pain Symptom Manage 1999; 18: 353-357. Astin J, Shapiro SL, Schwartz GER. Meditation. In: Novey DW, editor. Clinician's complete reference to complementary and alternative medicine. St Louis: Mosby, 2000; 73-85. Beck EG, Wasser G, Viebahn-Hänsler R. Der aktuelle Stand der Ozontherapie -- Empirie und Grundlagenforschung. Forsch Komplementärmed 1998; 5: 61-75. Bocci V. Ozone: a mixed blessing. Forsch Komplementärmed 1996; 3: 25-33. Kraft K, Stenkamp E, Vetter H. Effect of autohemotherapy with ozone cardiovascular risk factors in mildly hypertensive patients. Forsch Komplementärmed 1995; 2: 352. Diehm C, Rechsteiner HJ. Wer heilt hat Recht? Munich: Zuckschwerdt, 1987; 8-39. Schmitt H. Zur Ozontherapie. Med dissertation. University of Marburg, 1982. Gabriel C. Transmission of hepatitis C by ozone enrichment of autologous blood. Lancet 1996; 347: 541. Holt S. Shark cartilage and neutriceutical update. Alt Compl Ther 1995; 1: 414-416. Lee A, Langer R. Shark cartilage contains inhibitors of tumor angiogenesis. Science 1983; 221: 1185-1187. Mathews J. Media feeds frenzy over shark cartilage as cancer treatment. J Natl Cancer Inst 1993; 85: 1190-1191. Miller DR, Anderson GT, Stark JJ, et al. Phase I/II trial of the safety and efficacy of shark cartilage in the treatment of advanced cancer. J Clin Oncol 1998; 16: 3649-3655. Hodges RD, Scofield AM. Is spiritual healing a valid and effective therapy? J R Soc Med 1995; 88: 203-207. Astin JA, Ernst E, Harkness EF. The efficacy of "Distant Healing": a systematic review of randomized trials. Ann Intern Med 2000; 132: 903-910. Ernst E, Cassileth BR. How useful are unconventional cancer treatments? Eur J Cancer 1999; 35: 1608-1613. Authors' details School of Postgraduate Medicine and Health Sciences, University of Exeter, Exeter, UK. Edzard Ernst, PhD, FRCP(Edin), Professor, Department of Complementary Medicine. Reprints: Professor E Ernst, Department of Complementary Medicine, School of Postgraduate Medicine and Health Sciences, University of Exeter, 25 Victoria Park Road, Exeter EX2 4NT, UK. E. ErnstATexeter.ac.uk Make a comment Back to text Back to text

Edzard Ernst

Changing Healthcare Complementary therapies: the appeal to general practitioners Heather L Eastwood MJA 2000; 173: 95-98 Abstract - Reasons for GPs' use of CAM - Clinical legitimacy - Ideological motivations - Postmodernisation - Postmodern values - References - Authors' details - - More articles on General practice and primary care Abstract Pragmatism -- among consumers seeking a cure and among general practitioners seeking clinical results and more patients -- is not a complete explanation for the burgeoning of complementary and alternative medicine (CAM) in Western societies. Instead, this growth is substantially a result of pervasive and rapid social change, alternatively termed 'globalisation' and 'postmodernisation'. Globalisation and postmodernisation are creating a new social reality, of which a prominent characteristic is the proliferation of consumer choice. GPs are enmeshed in this social change and subject to the trend to greater choice -- both their patients' and their own. On the one hand, GPs are reacting to social change as "economic pragmatists", responding to consumers' increasing demand for CAM. On the other hand, GPs themselves are acting as agents of social change by acknowledging the limitations of orthodox biomedical treatments and promoting CAM as part of their service delivery. Lack of scientific validation of CAM has not prevented GPs' use of such therapies. The phrase "clinical legitimacy" can be seen as a trump card that overrides "scientific legitimacy". It is the shibboleth of a postmodern movement among GPs towards healing and the "art" of medicine, as opposed to the "science" of medicine per se. Recent articles and editorials in the Journal1-3 have highlighted the increasing demand for complementary and alternative medicine (CAM) by Australians, and its provision by general practitioners (GPs). The findings of Pirotta et al that 1 in 5 Victorian GPs are using CAM in their practice1 support earlier data of the Royal Australian College of General Practitioners that 1 in 6 Australian GPs employed some form of CAM.4 A secondary analysis of Health Insurance Commission data indicates that about 1 in 7 GPs in Australia use acupuncture.5 CAM is a billion-dollar industry in Australia, and a multibillion-dollar industry globally.6-8 Pirotta and others have emphasised the need for further research into the reasons behind GPs' use of CAM. Reasons for GPs' use of CAM My research in this area -- a qualitative study involving GPs and alternative practitioners (see Box) -- produced two main explanations for the increasing use by GPs of CAM.9 The first is that GPs are responding to increasing consumer demand for these therapies because of their clinical success. The second and more contentious finding is that consumers are demanding, and GPs are using, these therapies because of factors beyond clinical success -- factors related to globalisation and the characteristics of the global market. These market characteristics include increased consumer choice,10 increased competition among providers, a resultant power shift from provider to consumer,11 and a return to and commercialisation of nature, history, and tradition.12The GPs I interviewed cited reasons for incorporating CAM into their practices that fall into three broad categories:13 Last resort: The use of or referral to practitioners of CAM to treat patients with chronic conditions unresponsive to orthodox medicine. Integrated approach: A considered choice to regularly incorporate CAM, in addition to orthodox biomedical therapies. Ideological conversion: The adoption of CAM as the main treatment practice. GPs who fall into this category also tend to use diagnostic techniques similar to those of alternative practitioners.13 The prevalence of the last two categories, at least among the GPs I have interviewed formally and conversed with informally, contradicts the conclusion by Bensoussan, in a Journal editorial,3 that simple pragmatism -- among both patients and doctors -- adequately accounts for the dramatic increase in the use of CAM. Clinical legitimacy Bensoussan, rightly and with apt humour, criticises recent articles that narrowly attribute patient demand for CAM to "postmodern" or "new age" values usurping scientific rationalism. He notes that a considerable segment of the medical profession has recognised this consumer demand, and that chronic sufferers and the elderly account for a large portion of the patients who request or accept CAM. He suggests that common sense indicates that medical practitioners, the elderly, and the chronically ill are not likely to embrace the naivety of "new age" thought or the jargonistic obscurity of postmodernism;3 instead, Bensoussan and others suggest that simple pragmatism among both doctors and patients provides a more satisfactory explanation for the dramatic increase in the use of CAM.3,14Other writers have coined the term "clinical legitimacy" (see Glossary) to explain the links among consumer demand, pragmatism, and increased GP provision of CAM. That is to say, CAM is effective, particularly in the treatment of chronic conditions, regardless of the lack of scientific explanation or validation. This clinical success, aside from gratifying both patient and doctor, ensures continuing consumer demand, and thereby increases the financial viability of GPs who incorporate CAM, whether directly or through referrals.14 Data from my research show that GPs acknowledge that, regardless of the deficit of scientific evidence for how or why, CAM does achieve clinical results. Ideological motivations GPs note that, in addition to being pragmatic, their patients want healthcare options, and some are indeed ideological in their increasing demand for "natural" therapies and their concomitant mistrust of pharmaceuticals and invasive surgery, a phenomenon described by one GP interviewed as the "greening of medicine".9GPs who offer CAM are keenly aware of this demand for "natural" therapy, and clearly do respond partly as pragmatists catering to consumer demand. However, my interviews reveal that GPs are not acting entirely as economic rationalists responding to market forces. GPs who resort to CAM, like their patients, are often ideological in their motivations. Many are genuinely disillusioned with their biomedical training and with the reality of general practice. They are genuinely seeking a more rewarding approach to primary healthcare, for themselves as well as their patients. For example, some GPs recommend CAM even to patients who prefer or expect synthetic drugs -- a practice described by one doctor interviewed as "good medicine", particularly in light of antibiotic overprescribing.13 Therefore, while my findings validate the roles of both therapeutic and market pragmatism in the increasing use of CAM by Australian GPs, these same findings suggest that this increase involves factors beyond simple pragmatism. The interview data support the sociological hypothesis that a broad cultural shift is occurring in late capitalist societies such as Australia, the United States, the United Kingdom and Western Europe, and GPs, like consumers, are not immune to this sweeping social change.15-17 Arguably, GPs who use CAM are not just influenced by this social change, they contribute to it. Postmodernisation Social scientists use the term postmodernisation -- which incorporates globalisation processes -- to designate fundamental changes occurring within Western societies, of which the inclusion of CAM into mainstream healthcare is a part. Bensoussan notes that factors in the globalisation processes include: increasing public access to information; increasing sensitivity towards traditional cultural practices; and increasing openness to traditional medicines, for example traditional Chinese medicine.3Another aspect of globalisation is concern about the ecological crisis, which has contributed to a "return to nature" within Western societies. Postmodernisation theorists point to this trend -- the return to nature -- as a key determinant in the historical shift from modernity to postmodernity. The return to "natural" medicines is a part of this trend and of globalisation processes generally.18 In Western societies, the effects of globalisation, along with the postmodernist movement, are creating a new social reality (ie, postmodernity), one that has created a greater awareness and, for some, greater appreciation of other cultures, which historically have used traditional medicines.12 Postmodernism has attacked the philosophical foundations that underpin the modernist worldview, including the belief that science, particularly medical science, holds the key to a utopian world "free of disease and inequality".19 All the GPs and alternative practitioners I interviewed advocated more scientific research into CAMs. However, the effects of globalisation processes and postmodernism are contributing to a new, relativistic, postmodernist worldview whereby both doctors and consumers see biomedicine as only one road to health and wellbeing -- not necessarily a dead-end road, but also not a freeway.9 Postmodern values Bensoussan rightly critiques facile resorts to postmodernism to portray increased consumer demand for CAM as a rejection of medical science in favour of individualist, "new age" values.3 Yet he and others fail to recognise adequately that the process of postmodernisation contributes to the rise of new values, values that are no longer an "alternative ideology" but are increasingly mainstream values. Moreover, CAM is being commercialised and aggressively marketed, an outcome predicted by globalisation and postmodernisation theory,12,18,20 and a far cry from a starry-eyed conversion to "new age" values.3 Benoussan notes that one does not have to adopt postmodern values to use CAM, but rather that we live in an age in which people shop around for healthcare services.3 No doubt this is true, but increased consumer choice -- the ability to shop around -- is itself a postmodern value. A fundamental premise of postmodernisation theory is that globalisation and the commercialisation of traditional culture, including healthcare, increases diversity in the market place and thereby increases consumer options.10,12,20 Market forces aside, a surprising number of the GPs interviewed were openly critical of their biomedical training and their perceived role in general practice as "technocrats" rather than "healers". As a result, GPs are seeking new avenues of specialisation and professional development. To reiterate, GPs who offer CAM are, like their patients, not only pragmatic but also ideological in their incorporation of CAM. Many of these GPs acknowledge the limitations of biomedical and synthetic pharmaceutical treatments. The lack of scientific evidence for CAM does not appear to have constrained these developments. In fact, my research revealed that GPs often legitimise their use of CAM -- in addition to citing clinical legitimacy -- by citing the history and tradition underlying these treatments.9 This return to tradition, history, and roots is a prominent aspect of postmodernisation.12,18 It is of considerable interest that the Australian Therapeutic Goods Administration has specified two major categories of evidence for complementary therapies: (1) scientific evidence, and (2) evidence based on traditional use of a substance or product.21 Despite the obvious weakness of much "postmodernist" literature on CAM, to dismiss postmodern theory outright is limiting and misleading. The following may serve to illustrate the effect of globalisation and postmodernisation upon Western health systems. Remarkably, these comments come from a GP who attended the Alternative Medicines Summit (organised by the Commonwealth Department of Health and Family Services) held in Canberra on 16 October 1996. This summit, the first of its kind, was attended by medical as well as alternative practitioners. In reporting events, the representative for the medical practitioners wrote: I felt the tone of the day's proceedings was one of "us versus them". Inasmuch as "natural and complementary practitioners" were seen as a distinct alternative to orthodox practitioners, particularly in cases of serious illnesses. Indeed, one speaker during the day indicated that as it was an Alternative Medicines Summit, orthodox doctors present should really be in only an observer capacity. There was no integration going on, rather the attitude was one of them seeking status as practitioners of the "new medicine", and control of their therapies.22 Note the dramatic contrast to the relationship between orthodox and alternative medical practice in modernity. Orthodox doctors are now concerned about being excluded from the "new medicine" practised by alternative practitioners rather than vice versa. The same doctor went on to conclude: There is a paradigm shift, occurring in health from within, that reflects a societal evolution, unstoppable by anyone. How to integrate all these practitioners, or even if it is desirable to, is a question that still perplexes me. There seems to be no one universal model, thus it becomes an exercise in lobbying for market share, and seeking, for example, inclusion in Medicare.22 With all due respect to common sense, simple pragmatism and clinical legitimacy, this type of sea change requires globally informed, forward-looking sophistication in the area of policy. For example, Duckett has noted that Australian health financing arrangements have not kept pace with a population that is embracing natural therapies. He opines that, as a society, "we may be over-investing in services for which there is a Medicare rebate and under-investing in other more effective or cost-effective services".23 Within the climate of evidence-based medicine, this observation invites the controversial question Based on evidence, who achieves the more cure-effective and cost-effective results: GPs who use exclusively orthodox treatments, GPs who incorporate CAM, or traditionally trained practitioners who use only CAM?. As things stand, any answer invites the truly urgent question Who regulates what, and how?. References Pirotta MV, Cohen MM, Kotsirilos V, Farish SJ. Complementary therapies: have they become accepted in general practice? Med J Aust 2000; 172: 105-109. Lewith G. Complementary and alternative medicine: an educational, attitudinal and research challenge [editorial]. Med J Aust 2000; 172: 102-103. Bensoussan A. Complementary medicine -- where lies its appeal? Med J Aust 1999; 170: 247-248. Services Division RACGP. Directory of RACGP Members and their Special Interests. Surry Hills: New Litho Pty Ltd. 1996. Easthope G, Beilby J, Gill G, Tranter B. Acupuncture in Australian general practice: practitioner characteristics. Med J Aust 1999; 169: 197-200. MacLennan AH, Wilson DH, Taylor AW. Prevalence and cost of alternative medicine in Australia. Lancet 1996; 347: 569-573. Eisenburg DM, Davis RB, Ettner SL, et al. Trends in alternative medicine use in the United States, 1990-1997. JAMA 1998; 280: 1569-1575. Complementary medicine is booming worldwide [news]. BMJ 1996; 313: 131-133. Eastwood H. Why are Australian general practitioners using alternative medicine? Postmodernisation, consumerism, and the shift towards holistic health. J Sociol 2000; in press. Featherstone M. Consumer Culture and Postmodernism. London: Sage, 1991. Commonwealth Department of Health and Aged Care. Reforming the Australian Health Care System. The Role of Government. Occasional papers: New Series No. 1. Canberra: Publications Production Unit, 1999. Robertson R. Globalization: Social Theory and Culture. New York: Sage Publications, 1992. Eastwood H. General Medical Practice, Alternative Medicine and the Globalisation of Health [unpublished doctoral thesis]. Brisbane: University of Queensland, 1997. Willis E. Complementary healers. In: Illness and Social Relations. Sydney: Allen and Unwin, 1994; 54-74. Fisher P, Ward A. Complementary medicine in Europe. BMJ 1994; 309: 107-311. Pietroni P. Beyond the boundaries: relationship between general practice and complementary medicine. BMJ 1992; 305: 564-565. Goldszmidt M, Levitt C, Duarte-Franco F, Kacorowski J. Complementary health care services: a survey of general practitioners' views. CMAJ 1995; 153: 29-35. Crook S, Pakulski J, Waters M. Postmodernisation: Changes in Advanced Society. London: Sage Publications, 1992. Chan JJ, Chan JE. Medicine for the millennium: the challenge of postmodernism. Med J Aust 2000; 172: 332-334. Waters M. Globalization. New York: Routledge, 1996. Complementary Medicines Evaluation Committee's guide to levels and kinds of evidence to support claims. Canberra; Commonwealth Department of Health and Aged Care, 2000. Available at <http://www.health.gov.au/tga/docs/pdf/ tgaccevi.pdf>. Integrative Medicine Association. IMA Newsletter, Issue 6, December. 1996. Duckett S. Policy challenges for the Australian Health Care system. Aust Health Review 1999; 22: 130-147. Authors' details Department of Social and Preventive Medicine, University of Queensland, Brisbane, QLD. Heather L Eastwood, PhD, BA(Hons), Lecturer. Reprints will not be available from the author. Correspondence: Dr H L Eastwood, Department of Social and Preventive Medicine, Herston Medical School, University of Queensland, QLD 4072. h.eastwoodATspmed.uq.edu.au Make a comment Summary of the study of why general practitioners (GPs) use complementary and alternative medicine (CAM)9,13 Participants: GPs (n=27); alternative practitioners without a medical degree (n=17); GPs and alternative practitioners who represent key educational and political organisations (n=16). All practitioners were located in Brisbane, QLD. Methods: Qualitative, telephone and face-to-face in-depth interviews, observation, and primary document analysis. Findings: Increased resort by GPs to CAM is not entirely pragmatic. It is partly due to factors beyond consumer demand, clinical effectiveness and financial reward. GPs attribute consumer demand for CAM to increased consumer wariness of synthetic drugs and invasive surgery, greater consumer choice, and a more educated public. GPs' own reasons for their provision of CAM include competition in the healthcare market; personal dissatisfaction with general practice; personal satisfaction gained through the clinical effectiveness of CAM; resistance to becoming "technocrats" rather than "healers"; recognition of the limitations of orthodox biomedical treatments; and concern, genuinely shared with patients, about over-reliance on synthetic drugs and invasive surgery. Back to text Glossary Clinical legitimacy: Validation conferred by the clinical effectiveness of a given treatment with or without scientific evidence as to why or how it works. Globalisation: The "shrinking planet" phenomenon, caused by dramatic advances in transportation and communications and by increasing ecological and economic interdependence, encouraging the concept that the whole world is but a single, albeit very large and complex, community. Globalisation processes: The many and varied inputs to social change in Western societies (ie, postmodernisation), which include (1) a "return to nature" arising from ecological concerns; (2) a return to tradition, history and "roots"; and (3) greater awareness and appreciation of other cultures. Postmodernisation: A sociological term denoting the broad social change occurring in Western societies. The term refers to those processes that are changing modern Western society and its values, organisation, and institutions (modernity) to a new social reality (postmodernity). Postmodernism: A confusing term, referring to the ideological movement that attacks the philosophical foundations of modernity and the modernist worldview based on the assumption that science, technology and reason will create the optimal society. Postmodernism can also refer to the creation, via contemporary social change (ie, postmodernisation), of a new mainstream culture and concomitant "postmodern" values, such as consumer choice (eg, shopping around for health services), independence from scientific and technological products (eg, rejection of, or concern about, genetically modified foods and synthetic drugs), and increased public access to information (eg, the Internet). Back to text

Heather L Eastwood

Editorials Complementary and alternative medicine: an educational, attitudinal and research challenge We need to understand more about these treatments, why they are being used, and what makes them effective MJA 2000; 172: 102-103 Complementary and alternative medicine (CAM) has become increasingly popular over the past decade. Out-of-pocket expenditure in the United States has doubled between 1990 and 1997, from $US14 billion to $US28 billion,1 a situation that is likely to be mirrored in Australia, both in the general population and among cancer patients.2,3CAM is difficult to define. The British Medical Association (BMA) has suggested that it encompasses treatments not taught as part of the medical undergraduate curriculum.4 The major CAM treatments are usually considered to be acupuncture, homoeopathy, herbal medicine, manipulative medicine (osteopathy and chiropractic) and nutritional medicine, although this is based on patient and practitioner use rather than on definitive evidence.5 Further, the use of CAM treatments varies regionally. For example, while homoeopathy is particularly popular among general practitioners in the United Kingdom and Holland,6,7 acupuncture seems to be the CAM treatment of choice in Australia.8 This is not necessarily related to evidence of efficacy, but correlates with a number of historical and cultural factors, including, in Australia, the enthusiasm of a small number of medically qualified acupuncturists in the late 1970s and early 1980s, which led to the reimbursement of acupuncture through Medicare. Patients may...not be seeking proof of efficacy of particular treatments, but meaning and context for their illness... In this issue of the Journal, articles by Pirotta and colleagues,9 and by Newell and Sanson-Fisher10 address doctors' knowledge and use of CAM in general practice and in cancer care. Both articles highlight extensive use of CAM among both doctors and patients. Pirotta et al found high levels of acceptance of acupuncture, hypnosis and meditation among GPs, and that considerable proportions of GPs had trained in, or expressed interest in training in, these and other CAM treatments, but that they still underestimate its use in the Australian population.9Newell and Sanson-Fisher show that Australian oncologists have very variable knowledge of the therapies that are being used by 22% of their patients,3,10 and that, while they appear to accept and understand meditation, acupuncture and chiropractic, they have very little knowledge of the widely available homoeopathic approaches used for cancer in Germany, such as Iscador. Newell and Sanson-Fisher suggest that Australian oncologists viewed this therapy as potentially dangerous,10 while preliminary evidence suggests that it may be both useful and safe.11 In the UK, doctors who practise CAM are predominantly GPs, and a similar situation seems likely in Australia. As GPs act as mediators between the public demand for treatment and the evidence-based provision of medical services,12 it is inevitable that economic and social pressures in a free market system such as Australia's will encourage the development of CAM in the general practice environment. Further, it is GPs who manage patients with chronic illnesses for which conventional medicine all too often offers inadequate solutions. Disenchantment with conventional medicine is not necessarily the reason why patients turn to CAM.13 One suggestion is that patients are increasingly knowledgeable about CAM and seek a more egalitarian process within the consultation.14 It has been confirmed that patients seek CAM because of an intuitive feeling that it could offer them a more appropriate medical model for their illness.15,16 Patients may therefore not be seeking proof of efficacy of particular treatments, but meaning and context for their illness, thus allowing them the freedom to benefit from therapeutic consultations within their chosen milieu.17 Why should we impose our medical model on patients? Their use of CAM may be their process of empowerment, which in turn allows them to contain and manage their chronic illness. It is perhaps difficult for those of us educated within the conventional medical system to allow our patients the freedom to make such journeys in a truly egalitarian manner. As physicians, we do, of course, have statutory and moral responsibilities. We are obliged to attempt to design and conduct studies for evaluating CAM treatments so that they can be safely integrated into medicine, and so that patients can make informed choices about the risks and benefits of particular treatments. Clinical trial work within CAM presents enormous challenges. How do we evaluate physical therapies such as acupuncture and individualised approaches such as homoeopathy?18 CAM research, like the development of general practice research in the 1970s, needs specific skills and teamwork. It requires proactive policies and, as Bensoussan suggests, a collegiate approach,13 whereby those involved in CAM and in conventional medicine genuinely communicate with each other to develop a research agenda. Such a process has recently been completed in the United Kingdom with the support of the Foundation for Integrated Medicine. A research agenda looking specifically at the problems of priority setting, research methods, research capacity and support, potential funding streams and the dissemination of CAM research has been established.5 Core funding for centres of excellence was considered an essential part of developing a specific academic discipline for CAM. It was envisaged that, once established with relatively small amounts of funding, such centres could compete equally for specific project grants. Bensoussan's vision of cooperative ventures13 could then inform all practice, both through original research and through access to appropriate databases and systematic reviews. The BMA has responded very clearly to the expansion of CAM by expressing a desire to expand both undergraduate and postgraduate CAM education.4 Over half the medical schools in the UK and nearly all those in the US now include some CAM familiarisation courses in their undergraduate curricula. The BMA, as well as Pirotta and Newell, indicate that such educational initiatives would also be of great value at the postgraduate level. CAM is clearly popular among patients in Australia and throughout the Western world, but it may be a mistake to read too much into the use of any particular therapeutic intervention. Patients may be using CAM largely to empower themselves in the management of their chronic illnesses. We certainly need to understand more about CAM, why patients choose it, why doctors provide it, and what is it within CAM that seems to be effective. On the other hand, while it may be easier to answer these questions than to conduct large, randomised controlled trials into complex therapeutic interventions, such research may usefully challenge many of our preconceptions about conventional medicine. Without adequate research funding and the establishment of a high quality research network, as well as a critical and evaluative approach to education and practice, it will be impossible for us to answer these vital questions about the increased use of CAM and its individual or combined therapeutic efficacy. CAM may have much to teach us about the practice of medicine and the increasing desire for patients to play an active part in the management of their own illness. George T Lewith Honorary Senior Research Fellow and Honorary Consultant Physician School of Medicine, University of Southampton, United Kingdom Eisenberg DM, Davis RB, Ettner SL, et al. Trends in alternative medicine use in the United States, 1990-1997. JAMA 1998; 280: 1569-1575. MacLennan A, Wilson D, Taylor A. Prevalence and cost of alternative medicine in Australia. Lancet 1996; 347: 569-573. Begbie SD, Kerestes ZL, Bell DR. Patterns of alternative medicine use by cancer patients. Med J Aust 1996; 165: 545-547. Integrated healthcare. A way forward for the next five years? Discussion document. The Foundation for Integrated Medicine on behalf of the Steering Committee for the Prince of Wales Initiative on Integrated Medicine, London: Foundation for Integrated Medicine, October 1997. British Medical Association. Complementary medicine: new approaches to good practice. Oxford: Oxford University Press, 1993. Lewith G, Reilly D. An examination of the effectiveness of complementary and alternative medicine in the UK NHS, with focus on homoeopathy. Health Matters in Prisons 1999; 6: 13-17. Visser G, Peters L. Alternative medicine and general practitioners in The Netherlands: towards acceptance and integration. Family Practice 1990; 7: 227-232. Easthope G, Gill GF, Beilby JJ, Tranter BK. Acupuncture in Australian general practice: patient characteristics. Med J Aust 1999; 170: 259-262. Pirotta MV, Cohen MM, Kotsirilos V, Farish SJ. Complementary therapies: have they become accepted in general practice? Med J Aust 2000; 172: 105-109. Newell S, Sanson-Fisher RW. Australian oncologists' self-reported knowledge and attitudes regarding non-traditional therapies used by cancer patients. Med J Aust 2000; 172: 110-113. Kiene H. Klinische Studien zur Misteltherapie karzinomatoser Erkrankungen. Eine Ubersicht. Therapeuticon 1989; 3: 347-353. Wharton R, Lewith G. Complementary medicine and the general practitioner. BMJ 1986; 292: 1498-1500. Bensoussan A. Complementary medicine -- where lies its appeal? Med J Aust 1999; 170: 247-248. Vincent C, Furnham A. Complementary medicine. A research perspective. Chichester, UK: John Wiley & Sons Ltd, 1997. Moore J, Phipps K, Marcer D, Lewith G. Why do people seek treatment by alternative medicine? BMJ 1985; 290: 28-29. Astin JA. Why patients use alternative medicine. JAMA 1998; 279: 1548-1553. Mitchell A, Cormack M. The therapeutic relationship in complementary health care. Edinburgh: Churchill Livingstone, 1998: 149-159. Lewith G, Vincent C. The evaluation of the clinical effects of acupuncture. A problem reassessed and a framework for future research. Pain Forum 1995; 4: 29-39. Make a comment

George T Lewith

Research Complementary therapies: have they become accepted in general practice? Marie V Pirotta, Marc M Cohen, Vicki Kotsirilos and Stephen J Farish MJA 2000; 172: 105-109 For related articles see Lewith and Newell Abstract - Methods - Results - Discussion - Acknowledgements - Disclosure - Authors' details - - More articles on complementary medicine Abstract Objectives: To describe Victorian general practitioners' attitudes towards and use of a range of complementary therapies. Design: A self-administered postal survey sent to a random sample of 800 general practitioners (GPs) in Victoria in July 1997. Participants: 488 GPs (response rate, 64%). Main outcome measures: GPs' knowledge; opinions about harmfulness and effectiveness; appropriateness for GPs to practise; perceived patient demand; need for undergraduate education; referral rates to complementary practitioners; and training in and practice of each therapy. Results: Acupuncture, hypnosis and meditation are well accepted by the surveyed GPs, as over 80% have referred patients to practitioners of these therapies and nearly half have considered using them. General practitioners have trained in various therapies -- meditation (34%), acupuncture (23%), vitamin and mineral therapy (23%), hypnosis (20%), herbal medicine (12%), chiropractic (8%), naturopathy (6%), homoeopathy (5%), spiritual healing (5%), osteopathy (4%), aromatherapy (4%), and reflexology (2%). A quarter to a third were interested in training in chiropractic, herbal medicine, naturopathy and vitamin and mineral therapy. General practitioners appear to underestimate their patients' use of complementary therapies. Conclusions: There is evidence in Australia of widespread acceptance of acupuncture, meditation, hypnosis and chiropractic by GPs and lesser acceptance of the other therapies. These findings generate an urgent need for evidence of these therapies' effectiveness. The past decade has seen a dramatic increase in the reported use of non-orthodox or complementary therapies by the public.1-4 In one year in Australia, almost half of a representative sample had used at least one non-medically prescribed complementary remedy and at least one in five had attended a non-medically trained complementary therapist.1 Further, Australians consume as much non-traditional medicine, vitamin and mineral supplements as prescription drugs.5There is evidence that the increasing public use of complementary medicine is paralleled by acceptance among family doctors. In one region of the United Kingdom in one week, 25% of general practitioners (GPs) referred patients for complementary therapies,6 while in Canada half7 to two-thirds8 of family doctors had at some time referred patients to alternative practitioners; these studies did not explore reasons for such referral. However, patient pressure is an acknowledged factor in medical referrals,9 so willingness of family doctors to refer their patients for these therapies may not be a good measure of their acceptance of them. Interest by GPs in training in and practising complementary therapies may give a better indication. In New Zealand, 54% of GPs were interested in further training in non-orthodox therapies,10 while in Israel 88% wanted training and 16% had trained.11 Estimates of practice of complementary therapies by GPs vary from around 16% in Canada8 and the UK,6,12 to 30% in New Zealand,10,13 47% in Holland (mainly homoeopathy)14 and up to 85% in Germany (mainly herbal medicine).15 Despite this degree of interest in and use of complementary therapies by family doctors, in the United States it has been estimated that 70% of people who attend non-medically trained complementary therapists do not inform their family doctor.3 The corresponding situation in Australia is largely unknown. At least 15% of Australian GPs practise acupuncture,16 the only non-orthodox therapy that attracts specific funding from Medicare. In this study, we describe Victorian GPs' attitudes towards and use of a range of complementary therapies. Methods We obtained a random sample of 800 Victorian GPs who had each seen at least 1500 patients in 1996 from the Health Insurance Commission, which administers the national health insurance scheme (Medicare). We designed an 11-page survey to investigate various aspects of GPs' interactions with the following complementary therapies: acupuncture, aromatherapy, chiropractic, herbal medicine, homoeopathy, hypnosis, meditation, naturopathy, osteopathy, reflexology, spiritual healing (eg, Reiki) and vitamin and mineral therapy. We developed the survey from the existing literature17 and by using a focus group of local GPs. After pilot testing, the survey was mailed to the 800 GPs with a reply paid envelope in July 1997. Non-responders were sent a reminder postcard and then a follow-up survey if necessary. Doctors who had left their clinic leaving no forwarding address, taken extended leave, were seriously ill, or had moved overseas, retired or died were excluded. The study received ethical approval from both the University of Melbourne and Monash University. The statistical analysis was performed using SAS.18 Responses were analysed to search for groupings of common levels of use/acceptance. (In all instances, for these data the 95% confidence intervals for percentages never exceed ± 4.5%.) Qualitative data from space left for comments were coded and classified by themes. Results Thirty-six GPs were excluded according to the exclusion criteria, leaving 764 GPs. Questionnaires were returned by 488, giving a response rate of 64%. The sample was representative of Australian GPs19,20 in terms of sex, age distribution, metropolitan or rural practice location and number of patients seen per week up to 199; doctors seeing more than 200 patients per week, however, were underrepresented. There was no significant difference in age or sex between responders and non-responders. Knowledge of complementary therapies At least 80% of GPs reported that they knew something of acupuncture, hypnosis, meditation and chiropractic; about half knew something of herbal medicine, naturopathy and vitamin and mineral therapy; while 60%-70% had only heard of osteopathy, homoeopathy, spiritual healing, reflexology and aromatherapy. Opinions on the harmfulness and effectiveness of complementary therapies Most GPs agreed that the well-known therapies (acupuncture, meditation, hypnosis and chiropractic) were moderately to highly effective (see Box 1); three-quarters also agreed that chiropractic was occasionally harmful. When given the opportunity to write comments, many doctors expressed concern that complementary therapies could be harmful if a diagnosis is delayed or missed or if a proven (orthodox) therapy is neglected. Complementary therapies were considered to have a strong placebo effect. Some respondents commented that, while some therapies were effective in certain conditions, one could not generalise and effectiveness may depend upon the training and competence of the therapist. General practitioners frequently differentiated between medical and non-medical practitioners and expressed greater confidence in medically trained colleagues who practised these therapies. Opinions on the appropriateness of GPs to practise complementary therapies and eligibility for Medicare subsidy Box 2 shows responses to the question of whether it is appropriate for general practitioners to practise these therapies. Although chiropractic was considered occasionally harmful by 75% of general practitioners surveyed, 55% considered it appropriate for trained GPs to practise. Doctors who agreed that it was appropriate to practise a therapy were asked whether GPs should be eligible for Medicare funding when practising these therapies. Nearly all GPs agreed that acupuncture should be funded. There was also strong support for specific funding for GPs practising hypnosis (91%), meditation (77%) and chiropractic (69%). Even the relatively unknown therapies had support from approximately a quarter of GPs for specific Medicare funding. Teaching in undergraduate curricula Most respondents (93%) agreed that there should be some education on complementary therapies in core medical undergraduate curricula. However, doctors were evenly divided over a five-point scale about the importance of this education for students. Patient demand Fifty-nine per cent of GPs reported that patient demand for complementary therapies was increasing, 29% reported demand was static, and 10% were unsure. A third of doctors estimated that less than 10% of their patients used complementary therapies and another third thought that 11%-30% did. Nearly half of the GPs reported that less than 5% of their patients had asked them about complementary therapies in the past month. Referrals for complementary therapies Box 3 summarises GPs' responses on referrals to complementary therapists, from how they would respond if a patient suggested consulting a complementary therapist to how often they themselves refer patients to these therapists. The question did not specify whether the therapists were medically trained. Most GPs (93%) had referred at least once and 82% had referred at least a few times a year for a complementary therapy. Just under half of the sample referred at least a few times per year for the best-known therapies -- acupuncture, meditation, hypnosis and chiropractic. While approximately two-thirds of the general practitioners would encourage a patient who suggested consulting a practitioner of acupuncture, meditation or hypnosis, only 29% would do so for chiropractic. In the remaining therapies, GPs were twice as likely to have actually referred a patient for these therapies than to endorse a patient's suggestion to consult a practitioner. Training and use of complementary therapies Box 4 shows that half of the GPs expressed an interest in training in acupuncture, meditation and hypnosis and a quarter to a third in chiropractic, herbal medicine, naturopathy and vitamin and mineral therapy. Nearly 20% of GPs practised one of the therapies, 8% used two therapies, 6% three, and 3% of general practitioners practised between 4 and 11 of these complementary therapies. For most of the complementary therapies, 80% or more of the GPs who trained in them practised them to some degree; exceptions were meditation (50%), hypnosis (56%), herbal medicine (62%) and vitamin and mineral therapy (64%). The practice of some complementary therapies, notably homoeopathy, vitamin and mineral therapy, naturopathy and herbal medicine, represented more than half of the clinical work for a small number of Victorian GPs. Discussion Our survey provides the first comprehensive description of the use of complementary therapies by GPs in Victoria. As the large sample is, in nearly all characteristics, similar to Australian GPs as a whole, our findings about GP attitudes and use of complementary therapies are likely to reflect the situation across the country. Nearly 20% of GPs had used acupuncture, meditation or hypnosis, and almost half had considered practising these therapies. Over 80% of GPs had referred patients to practitioners of these therapies. A quarter to a third were interested in training in chiropractic, herbal medicine, naturopathy and vitamin and mineral therapy. Further, around 5% of doctors use therapies, such as osteopathy, homoeopathy, aromatherapy and spiritual healing, which are relatively unknown to most of their colleagues. It is interesting to speculate on the discrepancy between the number of GPs who trained in meditation, hypnosis, herbal medicine and vitamin and mineral therapy and the number who actually practise these therapies (Box 4). Possible reasons may include GP or patient dissatisfaction with outcomes, poor acceptance by patients, lack of financial reward, or difficulty accommodating more time-consuming therapies in a busy clinic. The GPs we surveyed estimated a lower use of complementary therapies by their patients than indicated by population-based research. This may be because the portion of the population who do not attend GPs for their primary health care may attend complementary therapists, and because those who do attend GPs may be less likely to use complementary therapies. The interpretation of our findings is limited by several possible sources of bias. We have no information on non-responders, and the 64% who did respond may have been more likely to participate because they had particularly strong positive or negative views. The effects of self-report and recall bias are also unknown. Further, we did not define the therapies listed in the questionnaire and GPs may have different interpretations of the terms used, particularly vitamin and mineral therapy. Reviewing studies of various designs shows that Victorian doctors have similar levels of interest in training in, and of referral of patients for, complementary therapies as their colleagues in other Western countries, with the exceptions of Holland and Germany.6-8,10,12-15 However, the popularity of therapies varies. For example, the most popular therapy practised in Victoria was acupuncture, with 23% of respondents having trained, whereas only 8% of GPs in Canada8 and 4% in the UK12 had had acupuncture training. By contrast, homoeopathy, which has an established role in Europe,4 was the most popular complementary therapy practised by British GPs,6,12 but one of the least popular therapies in Victoria. Complementary therapies may well have something to offer, but it is of concern that therapies of unproven effectiveness are apparently being accepted in mainstream general practice. Many editorials, while acknowledging that randomised controlled trial evidence is lacking for many aspects of orthodox Western medical practice, have called for quality trials in complementary therapies.21,22 The Cochrane Library is coordinating a search for randomised controlled trials of complementary therapies and is undertaking systematic reviews of therapies for specific conditions.23 Meanwhile, other reviews have found some evidence of efficacy, for example St John's wort in treating mild to moderate depression,24 acupuncture for antiemesis,25 and also an overall greater than placebo effect for homoeopathy in a meta-analysis of trials for various conditions.26 There are diverse reasons for the lack of evidence for complementary therapies. Many therapies have not been challenged before because of their long history, "natural" origins or patients' or doctors' anecdotal reports of success. In this era of evidence-based medicine, there are difficulties applying the gold standard of randomised controlled trials to therapies which are based on different and varied paradigms of health and illness. Funding for trials in "natural" therapies is also lacking. Freely available herbs cannot be patented, so there is little incentive for research, particularly if the public is buying them regardless of evidence. Lewith et al suggest that lack of structure to enhance research in complementary therapies is a barrier in Britain.27 Our experience would suggest a similar situation in Victoria. Our findings show that general practitioners are actively using complementary therapies. Therefore, whatever the profession's attitude towards these therapies, well-designed trials, disseminated and accessible results and education are urgently needed to inform GPs' decision-making. Further research is also required into why GPs decide to practise these therapies and why they are less likely to endorse a patient's suggestion to consult a complementary therapist than to refer themselves. The problems of compliance with and interactions between orthodox and complementary therapies are also areas where much research is needed. As our findings support those of Eisenberg et al3 that GPs may not communicate sufficiently with their patients and are not aware of their widespread use of complementary therapies, the issues of communication between doctors and complementary therapists, as well as between doctors and their patients, also need to be addressed. Conclusions Acupuncture, meditation, hypnosis and, possibly, chiropractic may be considered to be well-accepted therapies in Victorian general practice, while herbal medicine, naturopathy, vitamin and mineral therapy, osteopathy and homoeopathy are accepted by a sizable minority of doctors. Doctors underestimate their patients' use of these therapies, which may contribute to compliance and medication interaction problems. There is an urgent need for well-designed trials to search for evidence of the effectiveness of these non-orthodox therapies, to inform doctors' and patients' use of them. Acknowledgements We thank Dr Jane Gunn and Dr Ngaire Kerse for advice, and Eleni Sita and Sue Vallance for assistance with data collection. Dr I Brighthope, Blackmores Ltd, Aveda, Nutrition Care Pharmaceuticals and the Australian Integrative Medicine Association contributed funding for this research. Disclosure Those who funded this trial had no input into its design, analysis, conclusions, writing of the manuscript or the decision to submit it for publication. References MacLennan A, Wilson D, Taylor A. Prevalence and cost of alternative medicine in Australia. Lancet 1996; 347: 569-573. Lloyd P, Lupton D, Wiesner D, Hasleton S. Choosing alternative therapy: an exploratory study of sociodemographic characteristics and motives of patients resident in Sydney. Aust J Public Health 1993; 17: 135-144. Eisenberg D, Davis R, Ettner S, et al. Trends in alternative medicine use in the United States, 1990-1997: results of a follow-up national survey. JAMA 1998; 280: 1569-1575. Fisher P, Ward A. Complementary medicine in Europe. BMJ 1994; 309: 107-111. Australian Bureau of Statistics. Australian social trends 1998. Canberra: ABS, 1998. (Catalogue No. 4102.0). White A, Resch K, Ernst E. Complementary medicine: use and attitudes among general practitioners. Fam Pract 1997; 14: 302-306. Verhoef M, Sutherland L. Alternative medicine and general practitioners. Can Fam Physician 1995; 41: 1005-1011. Goldszmidt M, Levitt C, Duarte-Franco E, Kaczorowski J. Complementary health care services: a survey of general practitioners' views. Can Med Assoc J 1995; 153: 29-35. De Marco P, Dain C, Lockwood T, Roland M. How valuable is feedback of information on hospital referral patterns? BMJ 1993; 307: 1465-1466. Hadley C. Complementary medicine and the general practitioner: a survey of general practitioners in the Wellington area. N Z J Med 1988; 101: 766-768. Schachter L, Weingarten M, Kahan E. Attitudes of family physicians to nonconventional therapies. Arch Fam Med 1993; 2: 1268-1270. Perkin M, Pearcy R, Fraser J. A comparison of the attitudes shown by general practitioners, hospital doctors and medical students towards alternative medicine. J R Soc Med 1994; 87: 523-525. Marshall R, Gee R, Israel M, et al. The use of alternative therapies by Auckland general practitioners. N Z J Med 1990; 103: 213-215. Visser G, Peters L. Alternative medicine and general practitioners in the Netherlands: towards acceptance and integration. Fam Pract 1990; 7: 227-232. Himmel W, Schulte M, Kochen M. Complementary medicine: are patients' expectations being met by their general practitioners? Br J Gen Pract 1993; 43: 232-235. Easthope G, Beilby J, Gill G, Tranter B. Acupuncture in Australian general practice: practitioner characteristics. Med J Aust 1998; 169: 197-200. Hopper I, Cohen M. Complementary medicine and the medical profession: a survey of medical students attitudes. Altern Ther Health Med 1998; 3(4): 68-73. SAS [computer program], version 6.12. Cary, NC: SAS Institute Inc, 1996. Australian Institute of Health and Welfare. Medical labour force 1995. Canberra: AIHW 1997. Commonwealth Department of Health and Family Services. General practice in Australia: 1996. Canberra: AGPS, 1996. Hensley M, Gibson P. Promoting evidence-based alternative medicine. Med J Aust 1998; 169: 573-574. Kerr D. In search of truth. J R Coll Physicians Lond 1996; 30: 405. The Cochrane Library Complementary Medicine Field. Oxford: Update Software, 1998. Linde K, Ramirez G, Mulrow C, et al. St John's wort for depression -- an overview and meta-analysis of the randomised clinical trials. BMJ 1996; 313: 253-258. Vickers A. Can acupuncture have specific effects on health? A systematic review of acupuncture antiemesis trials. J R Soc Med 1996; 89: 303-311. Linde K, Clausius N, Ramirez G, et al. Are the clinical effects of homoeopathy placebo effects? A meta-analysis of placebo-controlled trials. Lancet 1997; 350: 834-843. Lewith G, Kenyon J, Lewis P. Complementary medicine: an integrative approach. New York: Oxford University Press. 1996. (Received 13 May, accepted 5 Oct,1999) Authors' details Department of General Practice and Public Health, University of Melbourne, Carlton, VIC. Marie V Pirotta, MMed, FRACGP, Senior Lecturer. Stephen J Farish, BSc(Hons), MEd, Biostatistician and Senior Lecturer. Complementary Medicine Research Unit, Monash University, Melbourne, VIC. Marc M Cohen, PhD, MB BS(Hons), Senior Lecturer. Clayton, VIC. Vicki Kotsirilos, MB BS, General Practitioner. Reprints will not be available from the authors. Correspondence: Dr M V Pirotta, Department of General Practice and Public Health, University of Melbourne, 200 Berkeley Street, Carlton, VIC 3053. m.pirottaATgpph.unimelb.edu.au Make a comment 1: Attitudes among the 488 general practitioners on the harmfulness and effectiveness of complementary therapies* Harmful Effective FrequentlyOccasionallySeldomHighlyModeratelySeldomAcupuncture1 (0)76 (16%)395 (82%)93 (21%)294 (67%)41 (9%)Chiropractic32 (7%)362 (75%)82 (17%)48 (11%)306 (70%)61 (14%)Hypnosis1 (0) 141 (29%)305 (63%) 77 (18%)260 (60%)61 (14%)Meditation0 10 (2%)436 (90%)124 (29%)230 (53%)41 (10%)Osteopathy12 (3%)180 (37%)141 (29%)31 (7%)138 (32%)114 (26%)Herbal medicine20 (4%)262 (54%)144 (30%)14 (3%)128 (30%)199 (46%)Naturopathy16 (3%)200 (42%)165 (34%)19 (4%)125 (29%)191 (44%)Vitamin and mineral therapy11 (2%)214 (45%)182 (38%)22 (5%)94 (22%)224 (52%)Spiritual healing (Reiki)8 (2%)57 (12%)199 (41%)12 (3%)83 (19%)123 (28%)Homoeopathy13 (3%)143 (30%)188 (39%)10 (2%)72 (17%)217 (50%)Aromatherapy3 (1%)22 (5%)313 (65%)5 (1%)67 (16%)215 (50%)Reflexology12 (3%)47 (10%)198 (41%)4 (1%)31 (7%)207 (48%)*Many GPs offered no opinion, resulting in some missing values. Back to text 2: Opinions among general practitioners about the appropriateness of GPs to practise and charge Medicare for complementary therapies Appropriate for trained GPs to practise Should be eligible for Medicare rebates*Acupuncture97% (419/434)91% (384/422)Hypnosis92% (396/430)91% (364/399)Meditation80% (342/428)77% (282/367)Chiropractic55% (238/432)69% (207/301)Vitamin and mineral therapy44% (184/423)54% (137/254)Herbal medicine43% (183/427)53% (138/263)Naturopathy28% (117/424)42% (93/224)Osteopathy27% (113/423)44% (94/216)Homoeopathy23% (98/424)36% (77/213)Spiritual healing (Reiki)18% (74/422)27% (50/189)Aromatherapy17% (73/428)24% (47/197)Reflexology11% (48/426)22% (38/174)*Follow-on question answered only if the therapy was considered appropriate to practise. Back to text 3: Referral of patients for complementary therapies among general practitioners Those who ever referred patients Frequency of referrals Encourage a patient's suggestion to attend% (No.)RarelyFew times a yearAt least monthlyAt least weeklyMeditation74% (374/470)80% (379/476)31% (118)40% (153)20% (76)9% (32)Acupuncture71% (332/470)90% (424/473)24% (100)47% (199)19% (82)10% (43)Hypnosis62% (292/470)82% (386/473)44% (168)46% (179)10% (37)1% (2)Chiropractic29% (137/470)69% (326/476)37% (122)41% (135)17% (54)5% (15)Vitamin and mineral therapy17% (79/469)33% (157/472)57% (90)30% (47)8% (12)5% (8)Osteopathy16% (75/467)30% (141/476)55% (78)30% (42)11% (15)4% (6)Spiritual healing (Reiki)14% (66/469)20% (93/476)74% (69)20% (19)4% (4)1% (1)Naturopathy13% (62/470)30% (141/474)56% (79)26% (37)13% (18)5% (7)Herbal medicine12% (56/469)29% (138/474)63% (87)24% (33)9% (13)4% (5)Homoeopathy9% (43/470)20% (91/473)73% (66)18% (16)8% (7)2% (2)Aromatherapy9% (42/471)18% (83/475)70% (58)23% (19)6% (5)1% (1)Reflexology7% (22/470)10% (48/476)77% (37)17% (8)6% (3)0 Back to text 4: Training in and practice of complementary therapies among general practitioners Those who practise the therapy % Who practise Interest in trainingHave trained*No.5%6%-24%25%-50%>50%Meditation59% (283/477)34% (151/441)7567% (50)27% (20)5% (4)1% (1)Hypnosis52% (246/478)20% (89/442)5078% (39)20% (10)02% (1)Acupuncture49% (235/477)23% (102/441)9958% (59)34% (33)4% (4)3% (3)Herbal medicine36% (169/474)12% (53/438)3361% (20)27% (9)3% (1)9% (3)Vitamin and mineral therapy34% (160/470)23% (98/434)6346% (29)38% (24)3% (2)13% (8)Naturopathy25% (117/476)6% (26/439)2556% (14)24% (6)8% (2)12% (3)Chiropractic24% (112/475)8% (34/437)2976% (22)21% (6)3% (1)0Aromatherapy17% (83/477)4% (19/438)1883% (15)16% (3)00Homoeopathy16% (75/477)5% (23/440)2167% (14)19% (4)014% (3)Osteopathy13% (61/475)4% (17/437)†22†68% (15)18% (4)9% (2)5% (1)Spiritual healing (Reiki)12% (57/473)5% (21/439)1771% (12)24% (4)06% (1)Reflexology7% (33/475)2% (9/438)†12†100% (12)000*Includes self-taught. †These figures, which show that more doctors use osteopathy and reflexology than have actually trained in it, reflect inconsistencies in individual responses. Back to text

Marie V Pirotta · Marc M Cohen · Vicki Kotsirilos · Stephen J Farish

Abstract Objective: To assess Australian radiation and medical oncologists' self-reported knowledge about and attitudes towards a range of non-traditional therapies used by people with cancer. Design: Postal survey during May and June 1997 of all 265 radiation and medical oncologists practising in Australia. Participants: 161 oncologists returned surveys (61% response rate). Main outcome measures: Oncologists' own level of knowledge, and, for each known therapy, their perceptions of its likely harm or benefit in patients being treated curatively and palliatively, and of the prevalence of use among their patients. Results: Oncologists reported knowing most about acupuncture, antioxidant therapy and meditation and least about cellular therapy, magnetotherapy and psychic surgery. The therapies most likely to be considered helpful were meditation, acupuncture and hypnotherapy. Those most likely to be considered harmful were coffee enemas, psychic surgery, Iscador therapy and diet therapies. Perceptions of patients' use of most therapies varied widely, with herbal therapies, antioxidant therapy and meditation considered the most commonly used. Conclusions: These results indicate self-identified gaps in oncologists' knowledge about non-traditional therapies their patients may use; they suggest a need to consider including education about these therapies in oncologists' training. Introduction Recent studies have confirmed the popularity of non-traditional therapies among Australian cancer patients: 22%-52% of medical oncology patients,1,2 40% of those being treated palliatively3 and 46% of children with cancer4 report using at least one non-traditional therapy. Many of the most popular non-traditional therapies are psychosocial (eg, relaxation, meditation and visual imagery) and are unlikely to pose threats to patients' health.1-4 However, other popular therapies include dietary therapies, antioxidants, high dose vitamins and herbal therapies,1-4 many of which are poorly evaluated and could pose physical threats to patients, either directly, or by interfering with traditional therapies. Despite the lack of scientific evidence, 25%-73% of patients using non-traditional therapies expect them to cure their cancer or to prolong their lives,1-4 and 74%-86% expect them to assist their traditional therapies.2 Despite fairly high reported levels of satisfaction and perceived benefit with non-traditional therapies,1,2 17% of patients in one study reported negative side effects,4 10%-36% of patients reported no perceived benefit or feeling worse,1,2 and around 20% reported they would not take the therapy again or recommend it to other patients.2 Even if not harmful, many non-traditional therapies are expensive,1,2 and only 64% of patients felt the non-traditional therapies provided value for money.1 Recent guidelines highlight the need for oncologists to be aware of non-traditional therapies being used or considered by their patients, and to encourage patients to discuss them.5 This would require oncologists having at least a basic understanding of these therapies. We were able to identify only two relevant studies in this area -- a quantitative survey of 106 Italian oncologists6 and a qualitative study of 18 Canadian oncologists.7 They found limited knowledge about non-traditional therapies,6,7 relatively positive attitudes towards psychological therapies,6,7 more negative attitudes towards more invasive therapies,7 negative attitudes towards non-traditional therapy practitioners6 and more positive attitudes towards the use of non-traditional therapies by palliative patients.7 As there is a lack of data in this field, we explored Australian medical and radiation oncologists' knowledge of and attitudes to non-traditional therapies, and their perceptions of the frequency with which their patients used them. Given the increased tolerance among overseas oncologists of palliative patients using non-traditional therapies,7 we assessed attitudes to palliative and curative patients separately. We use the term "non-traditional therapies" to describe all therapies other than surgery, radiotherapy, chemotherapy and hormone therapy. Methods In May and June 1997, 273 questionnaires about 19 non-traditional therapies covering a wide range of psychosocial and physical therapies commonly discussed in the literature and media were mailed to all oncologists who practise in Australia. Non-responders received a written reminder after four weeks and a telephone reminder after six weeks. Ethical approval for this study was granted by the University of Newcastle's Human Research Ethics Committee. Sample identification We identified all medical and radiation oncologists practising in Australia through the Clinical Oncological Society of Australasia (COSA) and the Royal Australasian College of Radiologists' (RACR) Faculty of Radiation Oncology. The list of all the individuals registered with the Medical and Radiation Oncology Groups of COSA in late April 1997 comprised 155 Australian-based medical oncologists and 62 radiation oncologists. As the Medical Oncology Group of Australia advised they were aware of only 165 practising Australian-based medical oncologists, we considered the COSA list comprehensive for medical oncologists. However, the RACR advised they had 123 members currently practising in Australia, and, in line with its policy of not releasing members' contact details, they agreed to mail surveys to any of their members not on the COSA list -- an additional 56 radiation oncologists. The final sample of 273 thus comprised 155 medical and 118 radiation oncologists. The survey We designed a brief survey whereby oncologists rated, on a four-point scale ("none/never heard of it", "very little", "some" or "lots"), their own levels of knowledge about each of 19 non-traditional therapies; we provided no additional information about these therapies. Oncologists were also asked to rate each therapy they knew (also on a four-point scale: "very", "fairly", "neither" or "don't know"), according to how harmful or helpful they considered it for patients being treated palliatively and curatively. Finally, they were asked to estimate the proportion of their palliative and curative patients they believed were using, or had used, each known therapy. Copies of the survey may be obtained from the authors. Statistical analysis We report descriptive statistics on oncologists' knowledge and attitudes, including 95% confidence intervals around the proportion of oncologists knowing "lots" about each therapy. All analyses were conducted with the SAS statistical package;10 95% confidence intervals were calculated using Microsft Excel,11 based on the standard binomial approximation formula.12Results Of the 273 oncologists identified, four medical and two radiation oncologists were no longer practising and two radiation oncologists received surveys through both the COSA and RACR lists, leaving 265 eligible oncologists. Completed surveys were returned by 161 (61%) -- 60 radiation oncologists, 64 medical oncologists and 37 who could not be classified because they had destroyed the identifying number that allowed us to make this differentiation. Knowledge about non-traditional therapies Box 1 shows that meditation, relaxation and visual imagery were the therapies that most oncologists (about a quarter) reported knowing a lot about. Approximately a fifth of the oncologists surveyed also reported knowing a lot about antioxidant therapy and microwave, or Tronado, therapy. The least-known therapies were cellular therapy, magnetotherapy and psychic surgery. Perceptions of each therapy's potential harmfulness or helpfulness Box 2 shows that oncologists tended to consider the psychosocial therapies helpful for patients being treated both palliatively and curatively. Acupuncture was also considered helpful, especially for palliative patients. Many therapies were considered more likely to help palliative patients and, conversely, more harmful for curative patients. Not surprisingly, the less familiar, more physical or invasive therapies dominated those considered likely to be harmful. Perceptions of their patients' use of each therapy Box 3 compares the median proportion of their curative and palliative patients that oncologists believed were using or had used each non-traditional therapy with levels of use reported by Australian cancer patients.1-4 The oncologists showed a consistent trend to estimate higher use among palliative patients. The oncologists' estimates were within the ranges reported by Australian cancer patients for acupuncture, antioxidants, faith healing, hypnotherapy, iridology and meditation, relaxation and visual imagery. However, the oncologists overestimated patients' use of aromatherapy, coffee enemas, herbal therapies, naturopathy, homoeopathy, magnetotherapy and shark cartilage therapy. No patient data were available to compare cellular, mistletoe, microwave and ozone therapies or psychic surgery, and estimates for diet therapy were difficult to compare because of variation in the definitions used. Discussion As in the overseas studies,6,7 we found that oncologists identified gaps in their knowledge about many non-traditional therapies. It is interesting to note, however, that the therapies most patients reported using (meditation, relaxation and visual imagery and antioxidants) were also the therapies that most oncologists -- although still only up to a quarter -- reported knowing a lot about. Also consistent with the overseas studies,6,7 psychosocial therapies were viewed positively, and non-traditional therapies were considered more likely to be potentially helpful to patients being treated palliatively and potentially harmful to those being treated curatively. The more positive attitudes towards psychosocial therapies may reflect oncologists' awareness of some evidence of proven benefits from these therapies.8,9 Although our respondents tended to accurately estimate their patients' use of more commonly used non-traditional therapies, they tended to overestimate patients' use of more radical therapies, especially those with higher media profiles, such as coffee enemas and shark cartilage therapy. While the oncologists' and patients' estimates come from different surveys of different populations collected at different points in time, making some degree of variation inevitable, such variation is unlikely to explain the reasonably large differences for many of the lesser-used therapies. The trend for oncologists to estimate higher use of non-traditional therapies among palliative than curative patients is consistent with Australian and international data suggesting that patients with more advanced cancers are more likely to use non-traditional therapies.2,13-15 Our study has some other limitations. Firstly, for brevity, we sought no demographic information, thus prohibiting any assessment of the respondents' representativeness of Australian oncologists. However, as we targeted all Australian oncologists, and received responses from over 60% of the population, covering the full range of responses, we are confident that our data provide the first quantitative, reasonably representative overview of Australian oncologists' knowledge of and attitudes to non-traditional therapies. Secondly, we used self-report rather than an objective assessment of oncologists' actual knowledge about non-traditional therapies. As the oncologists are unlikely to have deliberately underestimated their knowledge levels, these estimates of how much they know should probably be interpreted as best-case scenarios. Also, we provided no definitions of "helpful" or "harmful", leaving individual oncologists to decide what constituted a harm or a help. This was done intentionally, as patients seek a range of benefits from non-traditional therapies, including physical, psychosocial and spiritual ones. Finally, while our results represent the first quantitative data on oncologists' knowledge and attitudes in this area, they cannot be generalised to other clinicians who treat people with cancer, such as surgeons, haematologists and general practitioners. Sceptics may question the need for oncologists to increase their knowledge about non-traditional therapies when the benefit of most remains unproven. However, without some basic knowledge of what is involved in each therapy, and of any demonstrated benefits or adverse reactions, oncologists may be unable to give adequate advice to patients. As outlined in the National Health and Medical Research Council guidelines, overly heavy-handed and dismissive attitudes are less likely to succeed in discouraging patients from using potentially harmful non-traditional therapies than more rational and considered discussions.5 Conclusions Research is needed to facilitate the production of evidence-based information summaries for oncologists in the area of non-traditional therapies, to compare oncologists' perceptions of use with their own patients' reported use of such therapies, and to establish the knowledge and attitudes of other clinicians treating cancer patients. Acknowledgements This research was funded by the NSW Cancer Council's Cancer Education Research Program. The views expressed are not necessarily those of the Cancer Council, which had no direct role in the design and/or analyses of this study or in the decision about publication of the results. We gratefully acknowledge the assistance of the Clinical Oncological Society of Australasia and the Royal Australasian College of Radiologists' (RACR) Faculty of Radiation Oncology for their assistance with identifying eligible oncologists, and the oncologists who completed the surveys. References Begbie SD, Kerestes ZL, Bell DR. Patterns of alternative medicine use by cancer patients. Med J Aust 1996; 165: 545-548. Miller M, Boyer MJ, Butow PN, et al. The use of unproven methods of treatment by cancer patients: frequency, expectations and cost. Supportive Care Cancer 1998; 6: 337-347. Yates PM, Beadle G, Clavarino A, et al. Patients with terminal cancer who use alternative therapies: their beliefs and practices. Sociol Health Illness 1993; 15: 199-216. Sawyer MG, Gannoni AF, Toogood IR, et al. The use of alternative therapies by children with cancer. Med J Aust 1994; 160: 320-322. National Health and Medical Research Council. Clinical practice guidelines: the management of early breast cancer. Sydney: The Stone Press; 1995. Crocetti E, Crotti N, Montella M, Musso M. Complementary medicine and oncologists' attitudes: A survey in Italy. Tumori 1996; 82: 539-542. Bourgeault IL. Physicians attitudes toward patients' use of alternative cancer therapies. Can Med Assoc J 1996; 155: 1679-1685. Meyer TJ, Mark MM. Effects of psychosocial interventions with adult cancer patients: a meta-analysis of randomized experiments. Health Psychol 1995; 14: 101-108. Devine EC, Westlake SK. The effects of psychoeducational care provided to adults with cancer: meta-analysis of 116 studies. Oncol Nurs Forum 1995; 22: 1369-1381. SAS [computer program], version 6.12. Cary, NC: SAS Institute Inc, 1998. Microsoft Excel [computer program], version 97. Seattle: Microsoft Corporation, 1997. Dobson AJ. Calculating sample size. Trans Menzies Found 1984; 7: 75-79. Risberg T, Lund E, Wist E. Use of non-proven therapies. Differences in attitudes between Norwegian patients with non-malignant disease and patients suffering from cancer. Acta Oncologica 1995; 34: 893-898. Sollner W, Zingg-Schir M, Rumpold G, Fritsch P. Attitude toward alternative therapy, compliance with standard treatment, and need for emotional support in patients with melanoma. Arch Dermatol 1997; 133: 316-321. Risberg T, Lund E, Wist E, et al. The use of non-proven therapy among patients treated in Norwegian oncological departments. A cross-sectional national multicentre study. Eur J Cancer 1995; 31A: 1785-1789. (Received 5 Jul, accepted 5 Nov, 1999) Authors' details NSW Cancer Council Cancer Education Research Program (CERP). Sallie Newell, PhD Research Academic (also Conjoint Lecturer, Discipline of Behavioural Science in Medicine, Faculty of Medicine and Health Sciences, University of Newcastle; currently Epidemiologist (Health Promotion Evaluation, Northern Rivers Institute for Health and Research, Lismore, NSW). Rob W Sanson-Fisher, PhD, Director (also Professor, Discipline of Behavioural Science in Medicine, Faculty of Medicine and Health Sciences, University of Newcastle; currently Dean of Faculty). Reprints will not be available from the authors. Correspondence: The Secretary, NSW Cancer Council Cancer Education Research Program, Locked Bag 10, Wallsend, NSW 2287. cherylmATmail.newcastle.edu.au Make a comment Back to text 2: Percentage of the 161 oncologists believing non-traditional therapies about which they reported at least some knowledge ("very little" or more) to be helpful or harmful Curative patients Palliative patients TherapyNo. reporting some knowledge of therapy*HelpfulHarmfulHelpfulHarmfulAcupuncture16025%1% 58%1%Antioxidants/high-dose vitamin C1605% 30%5%23%Aromatherapy1569%2% 21%1%Cellular therapy57029% 026%Coffee enemas1511%71% 1%70%Diet therapy (Gerson/macrobiotic)1422% 49%4%48%Faith healing/spiritualism15212%24% 23%15%Herbal therapies/naturopathy1598% 22%13%15%Homoeopathy1504%12% 8%6%Hypnotherapy15631%4% 46%3%Immune-enhancing therapy1313%27% 5%22%Iridology144 1%15%1%8%Iscador/mistletoe therapy1032%55% 2%45%Magnetotherapy695%8% 8%6%Meditation/relaxation/visual imagery15969% 3%82%2%Microwave/Tronado therapy1207%45% 7%37%Ozone therapy961%46% 2%37%Psychic surgery872%57% 2%56%Shark cartilage therapy1501%23% 1%17% *The remaining response options were "neither helpful nor harmful" and "don't know" - the balance of the oncologists with some knowledge of the therapy selected one of these options. Back to text 3: Perceptions among the 161 oncologists of their patients' use of non-traditional therapies compared with that reported by Australian cancer patients Oncologists' perceptions TherapyNo. reporting some knowledge of therapyMedian curative patientsMedian palliative patientsAcupuncture1606%10%Antioxidants/high-dose vitamin C16015%20%Aromatherapy1565%10%Cellular therapy573%3%Coffee enemas1513%5%Diet therapy (Gerson/macrobiotic)*14210%10%Faith healing/spiritualism1525%10%Herbal therapies/naturopathy15920%25%Homoeopathy15010%15%Hypnotherapy1565%5%Immune-enhancing therapy1315%8%Iridology1443%5%Iscador/mistletoe therapy1032%3%Magnetotherapy692%3%Meditation/relaxation/visual imagery15920%20%Microwave/Tronado therapy1201%1%Ozone therapy963%5%Psychic surgery871%1%Shark cartilage therapy1505%10% Reported use Therapy% Paediatric patients (n=48)4% Palliative patients (n=151)3% Medical oncology patients (n=319) 1% Medical oncology patients (n=156)2Acupuncture- 7%3%5%Antioxidants/high-dose vitamin C8%24%12%12%-16%Aromatherapy- --0.5%Cellular therapy----Coffee enemas---1%Diet therapy (Gerson/macrobiotic)*8%18%13%30%(diet therapy)(special foods)(diet therapy)(changed diet) 0.5% (Gerson)Faith healing/spiritualism6%9%7%3%Herbal therapies/naturopathy8%3%-8%6%5%-10%Homoeopathy2% 5%3%2%Hypnotherapy15%--3%Immune-enhancing therapy-3%4% -Iridology- --3%Iscador/mistletoe therapy----Magnetotherapy--- 0.5%Meditation/relaxtion/visual imagery4%-17%19%10%-13%12%-28%Microwave/Tornado therapy----Ozone therapy----Psychic surgery----Shark cartlilage therapy---4% *As diet therapies included those ranging from basic dietary changes through to very restricted diets (eg, Gerson diet), the actual wording used in each of the studies is included. Back to text

Sallie Newell · Rob W Sanson-Fisher

The Weight Debate The effectiveness of popular, non-prescription weight loss supplements Garry Egger, David Cameron-Smith and Rosemary Stanton MJA 1999; 171: 604-608 For editorial comment, see Caterson Abstract - Introduction - Methods - Results - Discussion - References - Authors' details - - More articles on Complementary medicine

Garry Egger · David Cameron-Smith · Rosemary Stanton

MJA Practice Essentials Psychosocial support, treatment of metastatic disease and palliative care Michael A Ashby, David W Kissane, Geoffrey F Beadle, Alan Rodger MJA 1996; 164: 43-49 Psychosocial support - Principles of oncological treatment of metastatic breast cancer - Complementary or alternative therapies - Palliative care - Conclusion - Acknowledgement - References - Further reading and reference material - Authors' details - - This article deals with four linked but distinct aspects of care for women with breast cancer, with an emphasis on the pivotal role of the general practitioner: Modern medicine is fast recognising the need for psychosocial support of patients; in fact, for an integrated approach to caring for the whole person at all stages of illness. Oncological treatment of metastatic disease needs to be individualised and based on realistic expectations of outcome balanced against side effects. An open dialogue about the role and appropriateness of so-called "alternative" or "complementary" therapies is needed. Despite significant improvements in palliative care quality and access in Australia in the last decade, many practitioners still require support and advice in this demanding area of care (particularly about difficult symptom control). Psychosocial support Women with breast cancer are likely to experience various psychosocial problems at different stages of their illness (Box 1). The most useful way of differentiating between a normal grief reaction and a classifiable psychiatric disorder is to assess the degree to which the distress is generating undesirable personal, family and social effects and to monitor intensity of symptoms. To assist with the diagnosis of depression in the presence of a medical illness, the Endicott9 criteria (depressed appearance, social withdrawal or decreased talkativeness, brooding, self-pity or pessimism, and a lack of appropriate responsiveness in situations that would normally be pleasurable) can be used in place of somatic symptoms like fatigue, anorexia, weight loss and poor concentration. Psychosocial morbidity can extend throughout the family. It has been shown that for those women who enter palliative care programs, substantial psychological morbidity is identifiable in half the patients, a third of spouses and a quarter of their offspring.10 Family-centred care that recognises family members not only as primary care providers but also as second-order patients is essential.7 There is a clear role for general practitioners in this process, as an integral part of good family medicine practice. The themes which need to be addressed are summarised in Box 2. Therapeutic interventions should be appropriate to the stage of the disease and the woman's personal situation (Box 3). Good clinical care requires that medical, surgical and nursing staff provide opportunities for patients to express their concerns, anxieties and preoccupations throughout routine management. Coping skills and cognitive behaviour therapies11 may be more applicable to early stage disease, while supportive psychotherapies which encourage the sharing of feelings about existential concerns are more suited to patients with metastatic cancer.12 Another approach utilises the central concept of loss. Women with breast cancer grapple with many losses -- their health, breast, sense of femininity, confidence, dreams and belief in the future. A primary goal, therefore, is to facilitate adaptive grieving. So-called grief therapy13 can be pivotal in much cancer counselling, particularly in the light of the pervasive pressure on women "to think positively". It is also important to deal with the possibility of death. Education and clarification of fears can help promote a sense of realism-based mastery. Group therapies are cost-effective, provide a supportive network and are acceptable to about two-thirds of women. Pharmacological treatments complement psychotherapeutic approaches (see Box 4). Major tranquillisers and benzodiazepines can allay anxiety, assist in crises and help to contain distressing features of delirium. Tricyclic antidepressants and selective serotonin reuptake inhibitors help in depressive disorders. They are prescribed for major depression, when sleep disturbance or other depressive symptoms are moderate in degree and when poor coping and chronic grief are persisting. Reduced sex drive2 and reduced frequency of intercourse invariably follow the initial diagnosis. Open communication about intimacy and sexuality is desirable and may need to be initiated by clinicians. The general practitioner should be approachable for first contact on these issues. Clarification of the role of altered body image, grief, depression, the nature of the relationship and adjustment of both partners is necessary before endocrine assessment is considered. Although at present psychological interventions are usually offered only to those who have become symptomatic or are perceived to be particularly at risk, recent studies suggesting an association between psychological wellbeing and survival compel us to consider whether such therapies should be offered routinely.12,14,15 The experience of stressful life-events, loss of hope, helplessness, social isolation and failure to share negative emotions have all been associated with poorer outcome.16 Large multicentre replication studies of group therapy for women with both early stage and metastatic breast cancer are currently proceeding in the United States, Canada and Australia, in the hope of clarifying how critical this role of support and coping is to overall survival. Principles of oncological treatment of metastatic breast cancer Metastatic breast cancer is incurable, but effective palliative treatment is possible for most patients. The five-year survival is about 5%-10%. In view of the variable natural history, treatment plans have to be tailored to the needs of each patient. Surgery, radiotherapy and systemic treatments have important and varying roles during the course of the disease. The relative value of each treatment is influenced by the dominant site(s) and distribution of metastastic spread, the severity of symptoms, the general condition of the patient, rate of progression of the disease and response to previous treatments. It is crucial with all forms of palliative therapy -- local or systemic -- that the benefits in terms of symptom control are weighed against the expected toxicities of treatment. The patient must be involved in these decisions as expectations, tolerances and wishes will vary. Advice and support of general practitioners and palliative care staff may be useful to complement the input of the oncologist. Systemic therapies Approximately 30%-35% of patients with metastatic breast cancer respond to endocrine treatment and 60%-70% to cytotoxic drug treatment. Box 5 summarises the principles of selection of these treatments. The therapeutic effect of endocrine treatment is mediated through the oestrogen and progesterone receptors, and the most important single characteristic predicting response to hormone therapy is the original tumour receptor status (rate of response 50%-60% if receptors are present, 10% if absent). Resistance to initial endocrine treatment is associated with a very small chance of a response to subsequent hormone manipulation, but progression after a good initial response is an indication to continue with second and even third line endocrine therapy until the disease becomes hormone resistant. In practice, patients rarely respond to more than two sequential endocrine treatments. Endocrine therapy: For premenopausal patients ovarian ablation (by oophorectomy or radiation) may be replaced by medical treatment with the luteinising hormone-releasing hormone agonists (e.g., goserelin and leuprorelin acetate). For postmenopausal women the antioestrogen tamoxifen and oral progestogens (medroxyprogesterone acetate and megestrol acetate) are the most commonly prescribed treatments. Aromatase inhibitors (e.g., aminoglutethimide and formestane [4-hydroxy androstenedione]) have replaced adrenalectomy for those postmenopausal patients who have exhibited protracted responses to initial endocrine treatment. Chemotherapy: The initial high response rate of metastatic breast cancer to cytotoxic drugs and the eventual development of resistance raise several important issues in management. Combinations of cytotoxic drugs offer a better chance of response than single agents, but do not yield substantially better survival for most patients. The exception is those patients with life threatening visceral metastases (normally in liver and lung). Regimens including anthracyclines (doxorubicin, epirubicin) are the most effective and are useful for aggressive or life threatening disease. Less aggressive disease may be treated with less toxic regimens, frequently based on mitozantrone, although there are a considerable number of alternative options. Second and even third line regimens are indicated when disease progresses after an initial response, but response rate and duration are usually less with each subsequent regimen. All treatments must be presented to patients as a balance between a potentially beneficial tumour response and unwanted cytotoxic effects. Studies of dose intensification of cytotoxic drugs suggest higher rates of response but only a minor improvement in survival. The logical extension of these observations is the application of very high doses of cytotoxic drugs followed by bone marrow rescue, in an attempt to achieve maximum tumour control. Initial results indicate high rates of response, but the ultimate worth of these treatments awaits further evaluation and their use should be confined to assessment in randomised controlled trials. Alternative approaches include constant infusional chemotherapy, such as fluorouracil given over many weeks, often with low toxicity. Newer agents such as taxol have been extensively researched and are likely to be approved for second or third line treatments. The sensitivity of metastatic breast cancer to both cytotoxic and hormonal treatments and their different mechanisms of action make combined treatments attractive. However, the results of a trial comparing sequential and concurrent administration of tamoxifen and cytotoxic drugs (doxorubicin and cyclophosphamide) failed to demonstrate better survival with combined modality treatment.17 One Australian study comparing standard (continuous) and less intensive (intermittent course) cytotoxic drug treatment showed that the control of symptoms and quality of life were superior in the group receiving continuous chemotherapy, with a longer time to progression of cancer and better survival in this group.18 A follow-up study evaluating the physician's assessment of quality of life showed that those patients assessed as having better quality of life at the time of entry into the study also had better survival.19 It remains to be determined at what point dose intensity and better survival in metastatic breast cancer will be offset by unacceptable quality of life, and the study should not be interpreted as justifying the routine use of chemotherapy for advanced disease in the absence of defined symptoms. It is also possible that the patients receiving the more intensive treatment believed (despite information to the contrary) that they had a better chance of cure or remission. Patients' beliefs about treatment goals certainly require more research and understanding, for both standard and alternative therapies. Radiotherapy: Radiotherapy plays a major part in the palliation of a variety of localised symptoms. Box 6 lists the role of palliative radiotherapy, which can generally be given in one to five (daily) fractions, frequently on an outpatient basis, with the reasonable expectation of a significant impact on symptom control for most patients. A randomised study of bone pain palliation has confirmed that short courses are as effective and non-toxic as longer courses of two weeks or more.20 Complementary or alternative therapies Interventions such as massage, relaxation, aromatherapy, hypnotherapy, acupuncture and homoeopathy have gained widespread acceptance. The use of alternative therapies (such as naturopathy, nutritional, immunological or physical treatments) is also common, and may set the patient and clinician on a direct path of conflict which can be difficult to resolve. Consequently, many patients do not tell their clinicians that they are using them.21,22The need for patients to participate in decisions about treatment should be emphasised at all times. Doctors should recognise the limitations of modern oncological treatment, and be prepared to acknowledge the patient's need to explore other avenues. It is often helpful for doctors to offer to comment on this issue and such an offer is rarely rejected. There may be times when doctors feel that they must advise patients of a dangerous or futile treatment, with the occasional possibility of real harm being caused, and it should be pointed out that many therapies are completely untested. Sometimes it is helpful to differentiate between therapies which patients believe might cure them and those that help them to live more comfortably with their disease. Gentle exploration of patients' beliefs about potential curability of their disease may be important. Positive thinking strategies which obstruct appropriate care delivery for a dying patient may also need skilful addressing. Palliative care Modern palliative medicine offers a model of care which focuses on the whole person, within their social and emotional context. There is a difference between the adoption of a palliative approach and the delivery of holistic, multidisciplinary care appropriate to the individual patient's needs and wishes. It is not simply a matter of knowing when to stop oncological treatment, nor of a "cookbook" style of symptomatic management. The focus must be on the person rather than the disease, although a good knowledge of the natural history of the disease and relevant oncological practice is essential. Active oncological intervention is often required for malignant bone pain, fungating chest-wall disease or liver, lung or brain metastases, and can be of value until a very late stage in the disease process. About 10% of patients with metastatic breast cancer will develop symptomatic hypercalcaemia (symptoms include nausea, vomiting, polyuria, drowsiness) and should be treated with intravenous rehydration, diuretics and a bisphosphonate infusion. Pleural effusions may require aspiration if symptomatic. If they recur, pleurodesis with talc, tetracycline or BCG may be required for control of breathlessness. Meningitic carcinomatosis is very rare and may respond to intrathecal cytotoxic agents or craniospinal irradiation. It is important that the general practitioner be fully informed of the patient's management and condition. During a long disease course, often with multiple oncological events, it is all too easy (and understandable) for patients and families to become attached to a hospital oncology service and its staff. This may pose problems for palliative and terminal care at home, as a hitherto relatively uninvolved general practitioner may have to suddenly take over care. See Box 7 for definition of palliative care. Early referral to a specialised palliative care source should be considered for most patients with metastatic disease, to introduce future options in palliative care. Although sometimes confronting for patients and their oncological caring team, a commitment of future support and proper care planning is of real value in allowing patients to plan to live until they die. The general practitioner should be actively involved in this process of communication to ensure the smoothest possible transitions from curative to palliative and terminal care. In psychosocial support, emphasis is often required on issues of family history (anxieties about daughters developing the disease), body image and loss of femininity, although concerns about the latter may be less pronounced than at initial diagnosis. For younger women with children, death will leave the children without a mother, which is probably the hardest aspect for a woman to bear. Work on helping to hand over present and future parenting roles is required. The proper and appropriate use of opioid drugs is an essential skill for control of pain and shortness of breath. Nearly 30 years of safe international clinical experience has led the World Health Organization to recommend morphine as the opioid of first choice in cancer pain management.23 Other drugs (either alone or in combination with morphine) are usually required for deep somatic pain caused by bone metastases or liver capsule inflammation (non-steroidal anti-inflammatory drugs and corticosteroids), and neurogenic pain (antidepressants, anticonvulsants, membrane stabilising agents). Specialist help is nearly always required for neurogenic pain, often with the additional involvement of an anaesthetist with a special interest in cancer pain management. The regular oral administration of the right dose of an appropriate drug or drug combination is the cornerstone of modern cancer pain management. The dose of morphine is adjusted according to the patient's top-up (or "breakthrough") requirements. The management of cancer pain with morphine is somewhat unusual in that there is no absolute upper dose limit. Most patients will achieve initial pain control on an oral 24-hour morphine dose in the range of 100-200 mg, but there is very wide individual variation and if the dose continues to rise without response the cause of the pain and the drug choice should be reassessed. Advice about anticipated side effects and their prompt and effective management is essential, together with frequent review of pain control and analgesic dose. Intermittent subcutaneous injections or infusions may be used if the oral route is not possible (e.g., because of nausea and vomiting), or not effective. Shortness of breath, anxiety, acute delirium and so-called terminal restlessness may be managed with anxiolytic drugs such as diazepam, midazolam or clonazepam (after looking for a specific treatable underlying cause). Antiemetics also require regular administration in adequate doses, and may need to be used in combination (e.g., prochlorperazine 25 mg rectally 3-4 times daily with metoclopramide 30-90 mg per 24 hours by subcutaneous infusion). Bowel care is important (and often neglected) throughout the illness, but particularly towards the end of life. Most patients taking morphine will require a regular prophylactic aperient. Intensification of supports and symptomatic treatment will usually be required as death approaches, particularly if the patient and family have chosen for this to occur at home with the help of a domiciliary palliative care team (Box 8). Conclusion Doctors are being challenged to focus on the needs of the whole person and to work collaboratively with colleagues from other disciplines. Psychosocial support may be required from the time of diagnosis and should be an intrinsic part of caring throughout the course of the illness. It is also now widely accepted that there is more to the management of incurable disease than tumour regression alone, and therapeutic interventions need to be critically assessed on the basis of their impact on palliative endpoints, quality of life and psychological well-being. Acknowledgement We thank Dr Angela Rutherford, General Practitioner, East Brunswick Medical Centre, Victoria, for her comments and assistance. References Walker LG, Cordiner CM, Gilbert FJ, et al. How distressing is attendance for routine breast screening? Psycho-Oncology 1994; 3: 299-304. Fallowfield LJ, Hall A, Maguire GP, et al. Psychological outcomes of different treatment policies in women with early breast cancer outside a clinical trial. BMJ 1990; 301: 575-580. Silberfarb PM, Maurer LH, Crouthamel CS. Psychological aspects of neoplastic disease: 1. Functional status of breast cancer patients during different treatment regimens. Am J Psychiatry 1980; 137: 450-455. Dean C. Psychiatric morbidity following mastectomy: preoperative predictors and types of illness. J Psychosom Res 1987; 31: 385-392. Bukberg J, Penman D, Holland JC. Depression in hospitalised cancer patients. Psychosom Med 1984; 46: 199-212. Maguire P. The repercussions of mastectomy on the family. Int J Fam Psychiat 1981; 6: 485-503. Kissane DW, Bloch S, Burns WI, et al. Perceptions of family functioning and cancer. Psycho-Oncology 1994; 3: 259-269. Massie MJ, Holland J, Glass E. Delirium in terminally ill cancer patients. Am J Psychiatry 1983; 140: 1048-1050. Endicott J. Measurement of depression in patients with cancer. Cancer 1984; 55: 2243-2248. Kissane DW, Bloch S, Burns WI, et al. Psychosocial morbidity in the families of patients with cancer. Psycho-Oncology 1994; 3: 47-56. Moorey S, Greer S. Psychological therapy for patients with cancer. A new approach. Oxford: Heinemann, 1989. Spiegel D, Bloom JR, Kraemer HC, et al. Effect of psychosocial treatment on survival of patients with metastatic breast cancer. Lancet 1989; 1: 888-891. Worden JW. Grief counselling and grief therapy. 2nd ed. New York: Springer, 1991. Fawzy FI, Fawzy NW, Hyun CS, et al. Effects of an early structured psychiatric invention, coping, and affective state on recurrence and survival 6 years later. Arch Gen Psychiatry 1993; 50: 681-689. Greer S, Morris T, Pettingale KW, et al. Psychological response to breast cancer and 15-year outcome. Lancet 1990; 335: 49-50. Mulder CL, Van der Pompe G, Spiegel D, et al. Do psychosocial factors influence the course of breast cancer? A review of recent literature, methodological problems and future directions. Psycho-Oncology 1992; 1: 155-167. ANZ Breast Cancer Trials Group. A randomised trial of post-menopausal patients with advanced breast cancer comparing endocrine and cytotoxic therapy given sequentially or in combination. J Clin Oncol 1982; 4: 186-193. Coates A, Gebski V, Bishop JF, et al. for the ANZ Breast Cancer Trials Group. Improving the quality of life during chemotherapy for advanced breast cancer. A comparison of intermittent and continuous treatment strategies. N Engl J Med 1987; 317: 1490-1495. Coates A, Gebski V, Signorini D, et al. for the ANZ Breast Cancer Trials Group. Prognostic value of quality-of-life scores during chemotherapy for advanced breast cancer. J Clin Oncol 1992; 10: 1833-1838. Price P, Hoskin PJ, Easton D, et al. Prospective randomised trial of single and multifraction radiotherapy schedules in the treatment of painful bony metastases. Radiother Oncol 1986; 6: 247-255. Downer SM, Cody MM, McCluskey P, et al. Pursuit and practice of complementary therapies by cancer patients receiving conventional treatment. BMJ 1994; 309: 86-89. Eisenberg DM, Kessler RC, Foster C, et al. Unconventional medicine in the United States. Prevalence, costs and patterns of use. N Engl J Med 1993; 328: 246-252. World Health Organization. Cancer pain relief. Geneva: WHO, 1986. Further reading and reference material Woodruff R. Palliative medicine. Symptomatic and supportive care for patients with advanced cancer and AIDS. Melbourne: Asperula, 1993. Raphael B. The anatomy of bereavement. A handbook for the caring professions. London: Routledge, 1984, reprinted 1990. Dunlop RJ, Hockley JM. Terminal care support teams. The hospital-hospice interface. Oxford: Oxford University Press, 1990. Buckman R. I don't know what to say. How to help and support someone who is dying. Sydney: Sun, 1990. Derek Doyle. Caring for a dying relative. A guide for families. Oxford: Oxford University Press, 1994. Doyle D, Hanks GWC, Macdonald N, editors. Oxford textbook of palliative medicine. Oxford: Oxford University Press, 1993. Trevelyan J, Booth B. Complementary medicine for nurses, midwives and health visitors. London: Macmillan, 1994. Spiegel D. Living beyond limits. New York: Times Books, 1993. Authors' details Palliative Care Centre, McCulloch House, Monash Medical Centre, Clayton, VIC. Michael A Ashby, FRCR, FRACP, Professor of Palliative Care, Department of Medicine, Monash University. Department of Psychiatry, Monash Medical Centre, Clayton, VIC. David W Kissane, FRACGP, FRANZCP, Senior Staff Specialist, and Senior Lecturer, Department of Psychological Medicine, Monash University. Wesley Medical Centre, Auchenflower, QLD. Geoffrey F Beadle, FRACP, FRACR, Medical Oncologist. William Buckland Radiotherapy Centre, The Alfred Health Care Group, Alfred Hospital, Prahran, VIC. Alan Rodger, FRCS, FRACR, Director and Professor, Department of Radiation Oncology, Monash University. No reprints will be available. Correspondence: Professor M A Ashby, McCulloch House, Monash Medical Centre, Clayton, Vic 3168. 1: Frequency of psychosocial problemsPsychosocial problemsPhase of illnessFrequencyGriefAll phasesUniversalAnxiety disordersMammography1 20%Diagnosis240%Adjuvant therapies233%Recurrence315%Palliative careCommonDepressive disordersMammography5%Diagnosis226%Adjuvant therapies4Minor 20%;major 5%Recurrence315% Palliative care542%Sexual disordersRemission/survival2 38%Family relationship problemsRemission633%Palliative care746% Back to text 2: Themes covered in psychological therapies for patients with breast cancer Multiple losses Death anxiety Fear of recurrence Living with uncertainty Understanding treatment regimens Body and self-image Sexuality Relationships with partner, family and doctors Surgical reconstruction Lifestyle review Future goals Back to text 3: Range of psychosocial supportsPsychotherapeutic techniqueIndicationsEarly stage group therapyGroup therapy is being assessed as an adjuvant to initial medical therapyAdvanced breast cancer group therapyDistress and poor coping; anxiety and depression; routine supportIndividual supportive psychotherapySymptomatic anxiety and depressionFamily therapyFamily distress and poor copingCouple therapyMarital and sexual difficultiesCommunity-based self-help groupsGeneral supportBack to text 4: Useful psychotropic agentsDepressiondothiepin75-300 mg at nightmianserin20-120 mg at nightsertraline50-200 mg dailyparoxetine20-40 mg dailymoclobemide150-900 mg divided into two daily dosesAnxietydiazepam2-40 mg divided into two or three daily dosesclonazepam0.5-8 mg divided into two daily dosesAgitation/deliriumhaloperidol1.5-10 mg divided into two or three daily dosesmidazolam1-5 mg single doses by intravenous injection, as required Back to text 5: Guidelines for selecting systemic treatmentInitial systemic treatmentEndocrine treatmentCytotoxic drug treatmentClinically indolent diseaseAggressive diseaseLong disease-free intervalShort disease-free intervalSlow progressionRapid progressionPositive tumour hormone receptor statusNegative tumour hormone receptor statusLow tumour bulk/few sitesHigh tumour bulk/many sitesSpecial site(s): bone marrow, liver, lung (lymphangitis carcinomatosa)Second and subsequent systemic treatmentsEndocrine treatmentCytotoxic drug treatmentPrior good response to endocrine treatmentProgression after first endocrine treatment requiring more intensive therapy Minimal or no response to previous endocrine treatments Good response to previous cytotoxic drugs Back to text 6: Indications for palliative radiotherapy Locoregional recurrence: ulceration, bleeding supraclavicular or axillary nodes Metastases:bone pain- localised: external beam localised fields- widespread: hemibody irradiationbase of skull/orbital diseaseimpending or pathological fractures- internal fixation and postoperative radiotherapybrain metastasescord compression- surgical decompression and stabilisation rarely indicatedmediastinal nodesBack to text 7: Definition of palliative care Hospice and palliative care is defined as a concept of care which provides coordinated medical, nursing and allied services for people who are terminally ill, delivered where possible in the environment of the person's choice, and which provides physical, psychological, emotional and spiritual support for patients and for patients' families and friends. The provision of hospice and palliative care services includes grief and bereavement support for the family and other carers during the life of the patient, and continuing after death. From: Australian Association for Hospice and Palliative Care Inc. Standards for Hospice and Palliative Care Provision, March 1994. Back to text 8: Clinical and practical issues in planning the palliative care of a person dying at home Pain and symptom control Place of care and death (home, hospice, hospital, nursing home) Role of the team members (who to call for help and when) Aids and equipment Distressing events (expected and unexpected, such as terminal confusion, vomiting or haemorrhage) The actual dying process (explaining to family how death usually occurs) What to do at time of death What to do after death (funeral arrangements, death certificates) Back to text

Michael A Ashby · David W Kissane · Geoffrey F Beadle · Alan Rodger

Healthcare Acupuncture in Australian general practice: patient characteristics Gary Easthope, Gerard F Gill, Justin J Beilby and Bruce K Tranter MJA 1999; 170: 259-262 For editorial comment, see Bensoussan See also Acupuncture in Australian general practice: practitioner characteristics Abstract - Introduction - Methods - Results - Discussion - Acknowledgements - References - Authors' details - - More articles on Complementary medicine Abstract Objective: To ascertain the incidence of acupuncture claims and the characteristics of patients claiming for acupuncture. Design: Secondary analysis of Health Insurance Commission data on claims for acupuncture performed by a medical practitioner. Participants: A summary of all Medicare acupuncture claims for financial years 1984-85 to 1996-97 and a random sample of patients claiming a Medicare rebate in calendar year 1996. Main outcome measures: Claims for acupuncture by patients' State, sex, age, and the socioeconomic disadvantage index of patients' residences. Results: Between 1984-85 and 1996-97 the number of acupuncture claims increased, but declined as a proportion of total Medicare claims. In 1996, 1.16% of patients claimed for acupuncture, which constituted 0.5% of all Medicare claims. Adjusting for age and socioeconomic disadvantage, women were more likely than men to claim for acupuncture (odds ratio, 1.40; 95% confidence interval, 1.36-1.45). This sex difference is proportionately greater than that for all medical services. Propensity to claim for acupuncture increased with age, peaking at 65-69 years, then declining. Acupuncture claims were more likely in areas just above those assessed as having the greatest social disadvantage. Conclusion: The number of acupuncture claims has increased since 1984. As a proportion of all Medicare claims, acupuncture has remained stable since declining in 1991-92. This suggests that acupuncture is now an established complementary medical practice. Introduction People in the United States,1,2 Canada,3,4 the Netherlands,5,6 the United Kingdom7,8 and Australia9 are increasingly using medicines that are not part of the conventional pharmacopoeia and seeking therapies that are not taught in the conventional medical undergraduate curriculum. A South Australian community study reported that 48.5% of respondents had used such alternative medicines and 20.3% had visited a non-medical practitioner of alternative therapies.10Some general practitioners, as well as non-medical practitioners, provide alternative therapies. Such provision ranges from 16% of general practitioners in Australia,11 Britain12,13 and Canada14 to 30% in New Zealand.15,16 In addition, the proportion of doctors who refer patients to non-medical therapists ranges from 59%-72% in Britain12,13 to 60% in the United States,17 68% in Canada,14,18 80% in New Zealand15,16 and 90% in Holland.6 In Australia one such therapy, acupuncture, is of particular interest in that, although it is used by doctors as part of their normal general practice in many countries, including the UK,13 Canada14 and Holland,6 it is used most extensively by doctors in New Zealand15,16 and Australia.11 Acupuncture is not part of the standard medical curriculum in Australia, but it is recognised as a standard medical therapeutic technique in that it attracts a Medicare rebate (as item 173) when it is performed by a medical practitioner. Other alternative therapies do not attract a rebate or are not so clearly specified. Given this level of government recognition and its use by one in seven Australian general practitioners,11 acupuncture can be considered an addition to general practice in Australia -- a complementary, rather than an alternative, therapy. In this article we examine the characteristics of patients claiming for acupuncture provided by general practitioners, as an extension of our previous report on the characteristics of general practitioners using acupuncture.11 Methods The Health Insurance Commission provided two datasets on the claims submitted by patients involving acupuncture, where those services were provided by medical practitioners. The first dataset was time-series data for the financial years 1984-85 to 1996-97. It includes the number of services and benefits claimed for acupuncture (1984-1990, item 980; 1991-1997, item 173) by State/Territory, age and sex. The second dataset consisted of all Medicare services claimed by patients in the calendar year 1996 -- each case representing an individual patient. We analysed a 1:10 systematic random sample of these data, which included 1 575 173 patients. The data included five variables that measured the frequency of acupuncture claims, frequency of non-acupuncture items, sex, age groupings and postcode. Postcodes were reclassified into 62 categories (consolidated to 12 for presentation) derived from an Australian Bureau of Statistics socioeconomic disadvantage index (SDI).19 SDI groupings were used as proxy measures of socioeconomic status. The 1996 data were analysed using the SAS procedure proc logistic.20 A logistic regression model was fitted to the data to analyse a dichotomous dependent variable (1 = acupuncture service claims, 0 = other service claims). Models were also fitted to four dependent variables representing acupuncture use as quartiles of total service use (ie, 0-25%, 26%-50%, 51%-75%, 76%-100%). Logistic regression odds ratios adjusted for sex, age and SDI were calculated. The University of Tasmania Ethics Committee (Human Experimentation) approved the study. Results Time-series data Between 1984 and 1996, claims for acupuncture rose in all States and Territories except South Australia, where claims began to decrease in 1989, and the Northern Territory, where they began to decrease in 1990. However, in proportion to total Medicare claims, there has been decreased relative demand for acupuncture (Figure). This general Australian decline is echoed in all States and Territories except New South Wales, where demand has fluctuated at a low level. Of particular interest is the order of States and Territories in use of acupuncture throughout the whole time period, with consistently high proportions of claims in Tasmania and South Australia and low levels of claims in the Northern Territory and New South Wales. Separate analyses (not shown) indicate that women make about two-thirds of all claims, except in the Northern Territory, where women make only 55% of claims. When age is examined by sex the picture is more complex. In 1996-97, boys aged 14 years or younger (51.6%; 95% CI, 50.5%-52.7%) were slightly more likely than girls (48.5%; 95% CI, 47.3%-49.5%) to make claims for acupuncture, whereas among older people the pattern was 35% men (95% CI, 34.9%-35.1%) and 65% women (95% CI, 64.9%-65.1%). From 1984 to 1987 claims for both men and women increased with age, peaking at age 55-64 years. However, from 1988 the peak age for women shifted to 45-54 years. There has also been an increase in claims among people 70 years or older, from 7.25% in 1984 to 18% in 1996. 1996 sample data In 1996, acupuncture claims accounted for about 0.5% of all HIC claims for medical services. Of the 1 575 173 patients in our sample, 18 219 (1.16%) claimed for acupuncture. Most patients (16 039; 88.0%) claimed for 10 acupuncture services or fewer, but a small proportion (519; 2.8%) claimed for more than 20 services. High use of acupuncture is only weakly associated with high use of other Medicare services (Pearson's r = 0.07; P < 0.0001). Analyses of the 1996 data (not shown) suggest that, while women (52.7%; 95% CI, 52.6%-52.8%) are more likely than men (47.3%; 95% CI, 47.2%-47.4%) to claim for all types of medical services, their claims for acupuncture are proportionately higher, with 61.7% of those claiming for acupuncture being women (odds ratio [OR], 1.45). These sex differences remain after adjusting for age and SDI (Box). However, acupuncture claims expressed as quartiles (ie, 0-25%, 26%-50%, 51%-75%, 76%-100%) by sex show a different pattern. Sex-based differences tend to decrease as the proportion of acupuncture claims rises. From a logistic regression model (not shown) controlling for age and SDI, no sex-based differences were found for acupuncture claims in the group claiming acupuncture as 76%-100% of all claims (OR, 1.03; 95% CI, 0.91-1.16). As a proportion of all claims, acupuncture claims increased linearly with age (Box), peaking for the 65-69 years age group, then declining. Acupuncture claims tend to be highest in the areas just above the most socioeconomically disadvantaged. Patients in SDI area 2 are 1.7 times (95% CI, 1.58-1.85) more likely to have claimed for acupuncture than those in the area 6 reference group, although the odds ratios for other SDI categories do not exceed 1.3 (Box). Discussion Acupuncture was claimed for by about one in every 100 patients in 1996 and in 1996-97 constituted about 0.5% of all Medicare claims. Although the number of acupuncture claims has increased in the past 13 years, such claims have decreased as a proportion of total Medicare claims. The consistent State/Territory differentials in acupuncture claims are difficult to explain. One possible factor may be ease of access to providers because of the small size of Tasmania and the concentration of the South Australian population in Adelaide. Another may be that these two States have high unemployment, and Medicare-funded acupuncture, unlike medication or physiotherapy, does not require patients to pay for treatment. Acupuncture claims are made more by women than men, and are age-related. The differential between claims made by women and men is greater than the usual disproportion for medical-service claims. This finding appears to lend support to previous research that suggests women are more receptive to alternative techniques.9,10,21 However, this apparent receptiveness varies by age, with boys more likely than girls to receive acupuncture. Further, the peak age for acupuncture claims by women has varied, shifting in 1988 from 55-64 years to 45-54 years. These age variations suggest that the decision to use acupuncture is not solely a function of women's receptiveness to alternative therapies, but is a function of either sex/age-based differences in presenting complaints or doctors' changing willingness to use acupuncture. The increase in claims for acupuncture by middle-aged and elderly patients is also likely to relate to the presenting complaints of patients, or perhaps the lack of success of conventional treatment in alleviating their problems. However, the very weak relationship between high Medicare claims and high acupuncture claims suggests that acupuncture is being used as an alternative to, rather than in conjunction with, other treatments. Whether acupuncture is used after other treatments have failed, as suggested by American2 and Canadian21 research, cannot be ascertained from these HIC data. However, focus groups conducted by one of us (G E) with general practitioner users of acupuncture suggest that it is seen by family doctors as most useful for chronic pain, a symptom more likely to present in middle-aged and elderly patients.22 The higher rate of claims for acupuncture in areas in the lower levels of the SDI scale is contrary to most previous research on alternative therapies,9,10,21 which suggests they are used predominantly by wealthier segments of the community. The fact that these data relate to a Medicare-funded complementary procedure is important in considering this divergence from previous findings. Differences in the rate of acupuncture claims by SDI are not related to the proportion of doctors providing acupuncture in different SDI areas.11 This suggests either that the use of acupuncture is demand-driven rather than supply-driven or that doctors providing acupuncture in low-SDI areas do so to a greater extent through Medicare funding than their colleagues in other SDI areas. However, we recognise that a degree of caution is necessary when interpreting the SDI results, as postcode-based SDI measures may be subject to misclassification error.23 The funding system for Australian healthcare (Medicare and the Health Insurance Commission) provided data which are not available anywhere else in the world. This, coupled with the fact that acupuncture attracts a Medicare rebate if performed by a doctor, enabled us to produce this study, the only national-level study of the characteristics of patients treated with acupuncture. However, the advantages of this dataset are also its disadvantages. The data do not include acupuncture services provided by doctors conducted privately or for insurance companies. Nor do they include the provision of acupuncture by non-medical practitioners. Therefore, these results are not representative of overall acupuncture use or alternative therapies in general. Nevertheless, our results are important at the national level. Acupuncture, a therapy not taught in the standard undergraduate medical curriculum, has been adopted by doctors and used as a complementary therapy throughout Australia. The current Medicare rebate for acupuncture is $18.45, $2.55 less than a standard consultation. Doctors choosing acupuncture are not doing so for monetary reasons. For some doctors it is now an established complementary therapy, apparently chosen for clinical reasons, and a therapy used more frequently with women and elderly patients than with men or young adults and children. Acknowledgements The authors wish to thank the Government Employees Medical Research Fund, which provided funds to conduct the research. References Eisenberg DM, Kessler RC, Foster C, et al. Unconventional medicine in the United States. Prevalence, costs and patterns of use. N Engl J Med 1993; 328: 246-252. Astin JA. Why patients use alternative medicine: results of a national study. JAMA 1998; 279: 1548-1553. Northcott HC, Bachynsky JA. Concurrent utilization of chiropractic, prescription medicines, nonprescription medicines and alternative health care. Soc Sci Med 1993; 37: 431-435. Blais R, Maiga A, Aboucar A. How different are users and non-users of alternative medicine? Can J Public Health 1997; 88: 159-162. Menges LJ. Regular and alternative medicine: the state of affairs in the Netherlands. Soc Sci Med 1994; 39: 871-873. Visser GJ, Peters L. Alternative medicine and general practitioners in The Netherlands: towards acceptance and integration. Fam Pract 1990; 7: 227-232. Thomas KJ, Carr J, Westlake L, Williams BT. Use of non-orthodox and conventional health care in Great Britain. BMJ 1991; 302: 207-210. Vincent C, Furnham A, Willsmore M. The perceived efficacy of complementary and orthodox medicine in complementary and general practice patients. Health Education Research 1995; 10: 395-405. Lloyd P, Lupton D, Weisner D, Hasleton S. Choosing alternative therapy: an exploratory study of sociodemographic characteristics and motives of patients resident in Sydney. Aust J Public Health 1993; 17: 135-144. MacLennan AH, Wilson DH, Taylor AW. Prevalence and cost of alternative medicine in Australia. Lancet 1996; 347: 569-573. Easthope G, Gill GF, Beilby JJ, Tranter BK. Acupuncture in Australian general practice: practitioner characteristics. Med J Aust 1998; 169: 197-200. Anderson E, Anderson P. General practitioners and alternative medicine. J R Coll Gen Pract 1987; 37: 52-55. Wharton R, Lewith G. Complementary medicine and the general practitioner. BMJ 1986; 292: 1498-1500. Verhoef MJ, Sutherland LR. Alternative medicine and general practitioners. Opinions and behaviour. Can Fam Physician 1995; 41: 1005-1011. Hadley CM. Complementary medicine and the general practitioner: a survey of general practitioners in the Wellington area. N Z Med J 1988; 101: 766-768. Marshall RJ, Gee R, Israel M, et al. The use of alternative therapies by Auckland general practitioners. N Z Med J 1990; 103: 213-215. Borkan J, Neher JO, Anson O, Smoker B. Referrals for alternative therapies. J Fam Pract 1994; 39: 545-550. Goldszmidt M, Levitt C, Duarte-Franco E, Kaczorowiski J. Complementary health services: a survey of general practitioners' views. CMAJ 1995; 153: 29-35. Castles I. Information paper: 1991 census. Socio- economic indexes for areas. Canberra: AGPS, 1994. (Catalogue no. 2912.0.) SAS for Windows [computer program]. Version 6.12. Cary, North Carolina: SAS Institute, 1996. Kelner M, Wellman B. Health care and consumer choice: medical and alternative therapies. Soc Sci Med 1997; 45: 203-212. Astin M, Lawton D, Hirst M. The prevalence of pain in a disabled population. Soc Sci Med 1996; 42: 1457-1464. Hyndman JCG, Holman CDJ, Hockey RL, et al. Misclassification of social disadvantage based on geographical areas: comparisons of postcodes and collectors district analyses. Int J Epidemiol 1995; 24: 165-176. (Received 28 Aug, accepted 11 Dec, 1998) Authors' details School of Sociology and Social Work, University of Tasmania, Hobart, TAS. Gary Easthope, MA, PhD, Associate Professor; Bruce K Tranter, BA, PhD, Lecturer. Division of Community and Rural Health, University of Tasmania, Launceston, TAS. Gerard F Gill, MAE, FRACGP, Clinical Senior Lecturer. Department of General Practice, University of Adelaide, SA. Justin J Beilby, MPH, FRACGP, Senior Lecturer. Reprints will not be available from the authors. Correspondence: Dr G Easthope, School of Sociology and Social Work, University of Tasmania, GPO Box 252-17, Hobart, TAS 7001 Email: Gary. EasthopeATutas.edu.au Journalists are welcome to write news stories based on what they read here, but should acknowledge their source as "an article published on the Internet by The Medical Journal of Australia <http://www.mja.com.au>". <URL: http://www.mja.com.au/> Acupuncture claims (Medicare Benefits Schedule item 980 from 1984 to 1990; item 173 after 1990) by State and Territory (A), and as a proportion of all claims (B), from financial year 1984-85 to 1996-97. Back to text Characteristics of patients who claimed for acupuncture provided by general practitioners in 1996 (Medicare Benefits Schedule item 173)Number (%) Odds ratio* (95% CI) Sex (n = 18219)Women11233 (61.7%) 1.40 (1.36-1.45) Men6986 (38.3%) 1 Age (n=18219)0-4 years85 (0.5%) 0.08 (0.06-0.10) 5-9 years133 (0.7%) 0.13 (0.11-0.15) 10-14 years263 (1.4%) 0.28 (0.24-0.32) 15-19 years474 (2.6%) 0.49 (0.44-0.54) 20-24 years758 (4.2%) 0.69 (0.63-0.75) 25-34 years2314 (12.7%) 1 35-44 years3438 (18.9%) 1.55 (1.47-1.63) 45-54 years3672 (20.2%) 1.98 (1.88-2.09) 55-64 years3016 (16.6%) 2.36 (2.23-2.49) 65-69 years1447 (7.9%) 2.51 (2.35-2.68) 70-74 years1168 (6.4%) 2.39 (2.23-2.57) 75-79 years818 (4.5%) 2.33 (2.15-2.53) > 80 years633 (3.5%) 1.34 (1.23-1.47) Socioeconomic disadvantage index of claimants (n = 17961) High socioeconomic disadvantage1 300 (1.7%) 1.33 (1.18-1.50) 2 844 (4.7%) 1.71 (1.58-1.85) 3 1047 (5.8%) 1.33 (1.24-1.43) 4 1640 (9.1%) 1.23 (1.16-1.31) 5 2650 (14.8%) 1.27 (1.20-1.34) 6 2283 (12.7%) 1 7 2512 (14.0%) 1.20 (1.13-1.26) 8 2136 (11.9%) 1.20 (1.13-1.27) 9 1734 (9.7%) 1.29 (1.21-1.37) 10 1350 (7.5%) 1.25 (1.17-1.34) 11 864 (4.8%) 1.22 (1.13-1.32) 12 601 (3.3%) 1.34 (1.22-1.46) Low socioeconomic disadvantage * Multiple logistic regression odds ratios adjusted for sex, age and socioeconomic disadvantage index score dummy variables (model chi-squared, 12797.77; df, 25; P < 0.001). Dichotomous dependent variable (1 = acupuncture service claims, 0 = other service claims). CI = confidence interval. Source: Health Insurance Commission 1996. Back to text

Gary Easthope · Gerard F Gill · Justin J Beilby · Bruce K Tranter

Alternative Medicine Chinese herbal medicines in the treatment of acute respiratory infections: a review of randomised and controlled clinical trials Chaoying Liu and Robert M Douglas MJA 1998; 169: 579-582 For editorial comment see Hensley & Gibson Abstract - Introduction - Methods - Results - Discussion - References - Authors' details Make a comment - - - More articles on Complementary medicine Abstract Objective: To review clinical trials of Chinese herbal medicines (CHMs) in the management of acute respiratory infections (ARIs). Data sources: MEDLINE, the Cumulative Index to Nursing and Allied Health Literature, the Cochrane Library and three Chinese medical journals available in Australia. Study selection: Studies in which a control group was used in comparing CHMs with a placebo or "Western medicine" (usually antibiotics) for treating ARIs were included. Data synthesis: 27 of 46 studies identified in the search of the databases and the Chinese journals fulfilled the inclusion criteria. Twenty-six of these were published in Chinese, and one in English. Twenty were randomised controlled trials and seven were "controlled clinical trials". Although most of the studies reported that CHMs are better than antibiotics for the treatment of ARIs, the quality of the studies was generally poor when evaluated for patient allocation, treatment description, outcome measurement and data analysis. Conclusions: Because the trial methodology of these studies was often inadequate or insufficiently documented, it is difficult to recommend the use of CHMs in ARIs. However, Shuang Huang Lian does appear to be useful for treating lower respiratory tract infections. More rigorous evaluation of CHMs is needed, as they are becoming popular treatments in many countries, including Australia. Introduction Acute respiratory infection (ARI) is the most common illness in childhood and is the leading cause of death in children younger than five years.1,2 In Western medicine, although ARIs are most commonly caused by viral infection, antibiotic agents are widely used in their treatment, despite evidence that the clinical benefits of antibiotics may be slight.3-5 In China, many physicians believe that traditional agents are effective in alleviating symptoms of ARIs, shortening the course of disease, helping recovery from severe illness, and minimising potential long term consequences of lung infections (Box 1).6-8 Chinese herbal medicines (CHMs) are not only routinely used for most respiratory ailments in hospitals in China, but are also commonly used by many Chinese people in the community. The effort to integrate Western and traditional approaches has resulted in a number of publications comparing the benefits of CHMs with Western medicine. Our aim was examine the available evidence in order to explore the generalisability of the traditional Chinese approach to clinical management and determine whether CHMs might be advocated in Australia, where CHMs are now widely marketed.9 Methods Data extraction MEDLINE (1966 to May 1997), the Cumulative Index to Nursing and Allied Health Literature (1982 to May 1997) and the Cochrane Library (1995 to May 1997) were searched for all studies in which CHMs were used to treat ARIs. We also performed a search of three Chinese publications available in Australia: Chung Kuo Chung Hsi I Chieh Ho Tsa Chih (the Chinese Journal of Integrated Traditional and Western Medicine) (1982 to 1996), Chinese Traditional Patent Medicine (1991 to 1996) and Chung Huo I Hsueh Tsa Chih (Taipei) (the Chinese Medical Journal of Taipei) (1986 to 1996). The search keywords were CHMs and acute respiratory infections (or bronchiolitis, pneumonia or viral infections); random allocation; treatment group/control group; CHMs group/Western medicine group. Inclusion criteria Studies were included in our review if they had used a control group to compare CHMs with a placebo or Western medicine. We assessed the quality of these studies from four perspectives: patient allocation, treatment description, outcome assessment, and data analysis. Results Of the 46 studies identified from the search, 27 fulfilled our inclusion criteria.10-36 Ten studies involved upper respiratory tract infections (URTI) (Box 2), and 17 involved lower respiratory tract infections (LRTI) (Box 3). Twenty-six studies were published in Chinese, and one in English.29 Only the article written in English was found in the databases. Treatment Most studies used a herbal tea or patent medicine, although six used parenteral preparations and one study36 used a topical herbal preparation. Treatment duration was three to seven days for URTIs, and more than seven days for LRTIs. The control treatment was antibiotics in 18 studies, antiviral agents in five, symptomatic and supportive therapy in three, and a placebo in one. Clinical outcomes Various methods of reporting outcome were described; a common approach was to report an "effect rate" from less effective to significantly effective. CHMs were reported to have a significantly higher effect rate in 15 of 22 studies (Box 4). Generally, CHMs were reported to produce greater improvement in clinical symptoms and physical signs and a shorter hospital stay. Five out of seven studies testing Maxingshigangton20-24,28,32 and all studies using Shuang Huang Lian29,31,34 reported better treatment effects on bronchiolitis and pneumonia. Assessment of study quality We rated only two studies as of high methodological quality. Both examined the efficacy of intravenous Shuang Huang Lian for LRTIs.29,34 Patient allocation: Twenty studies reported a randomisation strategy, but only three21,30,35 described the allocation method. Three studies29,30,36 reported using single- or double-blind methods in the study. Treatment description: Most studies provided information about the main herbs included in the formulation, dose, course and treatment approach. Information on safety or side-effects of the herbal medicines tested was provided in only four studies.11,17,23,29 In eight studies11,12,14,16,18,21,23,31 the treatment applied to the control group was not described or was manifestly not identical to that of the experimental group in manner of administration. Outcome assessment: Twenty-two studies used a rate to assess the outcome. Eight of these14,15,19,22,23,28,30,36 did not provide adequate information on what constituted the degree of effect or on the defined time point for outcome measures. Satisfactory outcome measures were identified in only eight studies.11,12,22,26,27,29,32,34 Data analysis: Thirteen studies reported baseline data about the participants; only one29 tabled the baseline comparison. Six studies11,17,20,21,29,34 presented statistical results such as mean and standard deviation. Two studies18,28 drew a conclusion regarding efficacy without any reference to statistical analysis. Discussion Although CHMs are the subject of many Chinese research publications, definitive conclusions about their efficacy are difficult to draw. There are perceived ethical constraints about conducting rigorous randomised controlled trials in China, and placebo and double-blind methods are not generally accepted in clinical research, especially for time-honoured and widely used treatments. The inadequate methods of most studies make it difficult to transfer the Chinese confidence in CHMs to other settings. In the articles we reviewed, there was insufficient information on randomisation and baseline comparisons, outcome measures were either complicated or of doubtful validity, and terms were poorly defined or explained. Data analysis and presentation were generally too limited to enable us to assess the adequacy of the statistical analysis. Most of the studies failed to deal with potential confounding factors, and for several reports the timing of outcome measures was inappropriate. Nevertheless, in Chinese practice these traditional approaches are seen as appropriate treatment for ARIs. They are often used as life-saving remedies in preference to antibiotics. From this review, we have been impressed by the "clinical effects" of Maxingshigantong and intravenous Shuang Huang Lian for treating bronchiolitis and pneumonia. On the evidence provided, Shuang Huang Lian appears to be a promising remedy worthy of further study. Interestingly, no studies evaluated the herbs and formulas most widely used in the community for treating the common cold and other common URT infections in China. Perhaps the most widely used herbal medicines, such as Banlangen Chong Ji (tea) and Ganmaoqingre Chong Ji, are so firmly trusted by both clinicians and the community that evaluation is not considered necessary. The one trial published in English was carried out collaboratively between the University of Newcastle, Australia, and the Harbin Medical University, China, and used rigorous procedures to conclude that bronchiolitis was better treated with Shuang Huang Lian than with antibiotics.29 More studies of this calibre are needed. In our view, the scientific evidence that CHMs are more effective than antibiotics in ARIs is inadequate. Our analysis indicates the need for more rigorous evaluation of CHMs, including descriptions of their derivation, preparation, standardisation, potency, safety, and efficacy, if they are to meet modern Western criteria for their use. We suggest that, acknowledging the difficulty in conducting randomised controlled trials in China, the following approaches may be needed: further studies should examine herbs and formulas that are widely used and accepted by Chinese practice as well as those that show promise in treating ARIs; further international collaborations should be encouraged; protocols for studies in which CHMs are tested in clinical settings outside China should be developed; and training for Chinese doctors in clinical trial methodology should be supported through the International Clinical Epidemiology Network, with a view to more rigorously testing the clinical value of CHMs. References BOSTID Researchers. The epidemiology of acute respiratory tract infection in young children: comparison of findings from several developing countries. Rev Infect Dis 1990: 12 Suppl 8: S870-S888. Garcia J. Epidemiology of acute bronchopulmonary infections in children [abstract]. Rev-Prat 1996; 46: 2056-2061. Del Mar CB, Glasziou PP. Antibiotics for the symptoms and complications of sore throat. In: Douglas R, Bridges-Webb C, Glasziou P, et al, editors. Acute respiratory infections module of the Cochrane database of systematic reviews, 3 June 1997. The Cochrane Library [database on disk and CDROM]. Oxford: Update Software; 1997. Glasziou PP, Hayem M, Del Mar CB. Treatments for acute otitis media in children: antibiotic versus placebo. In: Douglas R, Bridges-Webb C, Glasziou P, et al, editors. Acute respiratory infections module of the Cochrane database of systematic reviews, 3 June 1997. The Cochrane Library [database on disk and CDROM]. Oxford: Update Software; 1997. Randolph AG, Wang EEL. Ribavirin for respiratory syncytial virus lower respiratory tract infection. In: Douglas R, Bridges-Webb C, Glasziou P, et al, editors. Acute respiratory infections module of the Cochrane database of systematic reviews, 3 June 1997. The Cochrane Library [database on disk and CDROM]. Oxford: Update Software; 1997. Wen ZY. [TCM-WM diagnosis and treatment of paediatric pneumonia.] Chung Kuo Chung Hsi I Chieh Ho Tsa Chih 1983; 3: 44-45. Chinese. Zhang ZJ. [TCM-WM diagnosis and treatment of severe pneumonia in children.] Chung Kuo Chung Hsi I Chieh Ho Tsa Chih 1987; 7: 112-114. Chinese. Zhang ZJ. [Recent development on treatment of repeated respiratory infection in children.] Chung Kuo Chung Hsi I Chieh Ho Tsa Chih 1996; 17: 571-573. In Chinese. Shenfield G, Atkin P, Kristoffersen S. Alternative medicine -- an expanding health industry. Med J Aust 1997; 166: 516-517. Yu RH. [Investigation on preliminary therapeutic effect of combined Chinese and Western medicine for treatment of acute tonsillitis.] Chung Kuo Chung Hsi I Chieh Ho Tsa Chih 1984; 4: 750. Chinese.* Luo H, Zou DW, Qie JR, et al. [Treatment of upper respiratory tract infection with a mixt 716 compound.] Chung Kuo Chung Hsi I Chieh Ho Tsa Chih 1993; 13: 730-732, 709. Chinese. Chang GZ, Li QC, Li M, et al. [Investigation on therapeutic effect of Yanholer powder in treatment of 220 cases of acute tonsillitis.] Chung Kuo Chung Hsi I Chieh Ho Tsa Chih 1994; 14: 309-311. Chinese.* Gao JF, Ma YX, Lin HP. [A report of 112 children with herpes simplex treated with Jiaweiyinxiao powder.] Chung Kuo Chung Hsi I Chieh Ho Tsa Chih 1994; 14: 620. Chinese.* Yang LP. [Treatment of 60 children with herpes simplex with Qingkailing injection.] Chung Kuo Chung Hsi I Chieh Ho Tsa Chih 1995; 15: 119. Chinese.* An ZY. [Investigation on treatment of 329 cases of acute tonsillitis with Yinma powder.] Chung Kuo Chung Hsi I Chieh Ho Tsa Chih 1995; 15: 428. Chinese.* Zhou ZQ, Xu J, Ding YF. [Clinical investigation on treatment of acute pharyngitis with Shangdogen liquor.] Chinese Traditional Patent Medicine 1995; 17: 20-21. Chinese.* Liu H, Ding PL, Li HC, et al. [Investigation of clinical therapeutic effect of Kanggantuireling tea for treating 301 patients with wild cold.] Chinese Traditional Patent Medicine 1995; 17: 25-27. Chinese.* Lo GQ, Tang WY. [Clinical investigation on children with upper respiratory tract infections treated with Qingjie decoction.] Chinese Traditional Patent Medicine 1996; 18: 26-27. Chinese.* Wang GX, Ho HX. [Investigation on therapeutic effect of Yanhouwan in treatment of pharyngitis.] Chung Kuo Chung Hsi I Chieh Ho Tsa Chih 1996; 16: 43. Chinese.* Hu J. [A clinical study on curative effect of 529 cases of pneumonia in children.] Chung Kuo Chung Hsi I Chieh Ho Tsa Chih 1984; 4: 672. Chinese. Zhang HC, Li FX, Zhu XD. [Therapeutic effects of febrifugal and detoxicant drugs in treating pneumonia in adults: an analysis of 118 cases.] Chung Kuo Chung Hsi I Chieh Ho Tsa Chih 1985; 5: 537-539, 515. Chinese. Xue D, Cheng SH, Wu XF. [Treatment of severe infantile pneumonia with traditional Chinese medicine and herbs.] Chung Kuo Chung Hsi I Chieh Ho Tsa Chih 1988; 8: 234. Chinese.* Yan CR, Shen W, Zhang DS, Zheng JX. [A report of 38 cases of infantile pneumonia treated with Chinese herbal aerosol.] Chung Kuo Chung Hsi I Chieh Ho Tsa Chih 1988; 8: 748. Chinese.* Sun XD. [A report of 94 cases of paediatric bronchopneumonia treated with combined Chinese and Western medicines.] Chung Kuo Chung Hsi I Chieh Ho Tsa Chih 1988; 8: 749. Chinese.* Zhang DY, Yang WW, Gao XC. [Comparison of Chinese medicine with Western medicine for treatment of paediatric bronchitis.] Chung Kuo Chung Hsi I Chieh Ho Tsa Chih 1989; 9: 30. Chinese.* Pang JC. [Clinical investigation on 50 cases of severe paediatric pneumonia treated with Danshi (Salviae miltiorrhirae) injection.] Chung Kuo Chung Hsi I Chieh Ho Tsa Chih 1990; 11: 566. Chinese.* Zhu CY. [A report of 56 cases of paediatric pneumonia with heart failure treated by combined Chinese and Western medicine.] Chung Kuo Chung Hsi I Chieh Ho Tsa Chih 1991; 11: 56. Chinese.* Hu RS, Li YQ, Yuan W, Zhang SL, et al. [Clinical and experimental study of Xiao Er Ke Chaun Ling oral liquid in treating infantile bronchopneumonia.] Chung Kuo Chung Hsi I Chieh Ho Tsa Chih 1992; 12: 719-737. Chinese. Kong XT, Fang HT, Jiang GQ, et al. Treatment of acute bronchiolitis with Chinese herbs. Arch Dis Child 1993; 68: 468-471. Wu KH, Hu TC, Liu XF. [Clinical investigation on 119 cases of paediatric pneumonia treated with Jieduling (defebrile and detoxication) injection.] Chung Kuo Chung Hsi I Chieh Ho Tsa Chih 1994; 14: 116-117. Chinese.* Li MZ, Lu S, Tong QM, et al. [Investigation on therapeutic effect of Shuang Huang Lian injection for treatment of paediatric pneumonia.] Chung Kuo Chung Hsi I Chieh Ho Tsa Chih 1994; 14: 232-233. Chinese.* Li YX, Zhang YH. [Investigation on therapeutic effect of Chinese medicine in treating paediatric pneumonia.] Chung Kuo Chung Hsi I Chieh Ho Tsa Chih 1994; 14: 573. Chinese.* Hong JX, Xie T, Gao YW, et al. [Clinical and experimental study on oral liquor night-cough tranquiller in treating infantile cough.] Chung Kuo Chung Hsi I Chieh Ho Tsa Chih 1995; 15: 25-27. Chinese. Yu JE, Zheng Y, Tang WY, et al. [Analysis of curative effect of Shuang Huang Lian powder for injection for paediatric pneumonia in 110 cases.] Chinese Traditional Patent Medicine 1996; 15: 24-25. Chinese. Shi YM, Zhang YQ, Fang SQ. [Clinical and experimental studies of Zhenkeling Oral Liquor on treatment of infantile cough.] Chung Kuo Chung Hsi I Chieh Ho Tsa Chih 1996; 16: 390-393. Chinese. Weng CX, Li G, Zheng SL. [Application of modified therapeutic system in treatment of upper respiratory viral infection in childhood with Chinese medicine.] Chung Kuo Chung Hsi I Chieh Ho Tsa Chih 1996; 16: 693. Chinese.* * Title translated by C L. (Received 24 Feb, accepted 23 Jul, 1998) Authors' details National Centre for Epidemiology and Population Health, The Australian National University, Canberra, ACT. Chaoying Liu, MB BS, PhD, Visiting Fellow; Robert M Douglas, MB BS, MD, Director. Reprints will not be available from the authors. Correspondence: Dr C Liu, National Public Health and Planning Branch, Public Health Division, MDP 16, Commonwealth Department of Health and Aged Care, Woden, ACT 2601. Email: chaoying.liuAThealth.gov.au Journalists are welcome to write news stories based on what they read here, but should acknowledge their source as "an article published on the Internet by The Medical Journal of Australia <http://www.mja.com.au>". <URL: http://www.mja.com.au/> We appreciate

Chaoying Liu · Robert M Douglas

Alternative Medicine Hypericum perforatum (St John's wort) in depression: pest or blessing? Joseph M Rey and Garry Walter St John's wort (SJW) was introduced into Australia during the 1880s for medicinal purposes, but was subsequently declared a noxious weed. There is now a resurgence of interest in the therapeutic properties of this herb. In particular, use of SJW as an antidepressant has increased in recent months owing to reports of its effectiveness and safety. Nevertheless, the controlled trials available have limitations. Increasing use of SJW in the community poses a variety of questions. For example, should medical practitioners become more knowledgeable about the effects and interactions of alternative remedies? What are the ethical and medical implications of "antidepressant" prescribing by non-medical persons? Who is to fund further research and treatment studies? How can quality of SJW preparations be guaranteed? (MJA 1998; 169: 583-586) Introduction - Botany - Active constituents - Antidepressant? - Mechanism of action - "First, do no harm" - Other health claims - Preparations - Precautions - Implications - Acknowledgements - References - Authors' details - - More articles on Complementary medicine "What is a weed? A plant whose virtues have not been discovered" - Ralph Waldo Emerson, Fortune of the Republic. Introduction Although a considerable proportion of the Australian population uses herbal medicines regularly,1,2 most medical professionals distrust herbal remedies and know little about them.3 This scepticism may be related to the perception that many of the claims of herbalists are unproven or fanciful. One of the current health crazes in Europe and the United States concerns Hypericum perforatum, more commonly known as St John's wort (SJW). Used to treat a range of ailments for more than 2000 years, and said to have been prescribed by Hippocrates himself,4 it is the apparent value of SJW as an antidepressant that has captured most recent attention, and been the subject of a recent meta-analysis.5In the past year alone, 10 books extolling the antidepressant effects of SJW were published. The titles are eloquent enough, among them St John's wort: nature's blues buster6 and The natural Prozac program: how to use St John's wort, the antidepressant herb.7 There have also been many review articles published in botanical and herbal medicine journals.8 An article in Time9 in 1997 elevated the herb to superstar status in the United States, and sales of SJW in that country skyrocketed. In Germany, SJW is used more extensively than conventional antidepressants for treating depression.10 In Australia, SJW has been attracting increasing media attention. Undoubtedly, consumption of this herb will become more prevalent. Are assertions about the antidepressant effects of SJW justified? The fact that the National Institute of Mental Health (NIMH) in the United States recently funded a US$4 million trial gives some credence to the claims. The NIMH study is testing whether SJW is more effective than a placebo or a selective serotonin reuptake inhibitor in the treatment of depression. If SJW does reduce depressive feelings, should we recommend its use? Are the extracts from SJW safe for human consumption? In this article, we seek to answer these questions and to inform clinicians about this herbal treatment, particularly in relation to depression. Botany The genus Hypericum contains more than 300 species. Hypericum perforatum is the species most often used in herbal remedies. It is an upright bush, growing to a metre tall, with oblong, perforated leaves and bright yellow flowers (see Figures). The leaves are dotted with translucent glands. There are many explanations for the appellation "St John's wort" (wort means "plant" in Old English); one is that the plant was named after St John the Baptist because the flowers were said to bloom on the anniversary of his execution. SJW is native to Europe, Asia and Africa, but not Australia. It has been introduced to parts of Queensland, New South Wales, Victoria, South Australia and Tasmania. The original introduction has been traced to the Ovens Valley in Victoria during a gold boom in the 1880s, when a German woman imported seed of the plant and established it for medicinal purposes.11 It soon overran her garden and spread to the nearby racecourse, from where it attracted the local name of "racecourse weed". As the goldminers moved out seeking new fields, the plant went with them, mainly in chaff for their horses. SJW has been declared a noxious weed in most areas; however, in some quarters the attitude towards the herb has changed and it is beginning to be seen as a cash crop. Earlier this year, the St John's Wort Landholders' Association was launched in Bathurst, NSW, to encourage harvesting of the weed.12 Australia expects to provide up to 20 per cent of the 7000 tonnes of SJW used worldwide each year.12 Active constituents Many constituents with potential biological activity have been extracted from the flowers and leaves, the parts of the plant used for medicinal purposes.4,8 These include naphthodianthrones, flavonoids, phloroglucinols and xanthones. Hypericin, one of the naphthodianthrones, has traditionally been considered the main active ingredient, but it is not known whether it is the antidepressant compound. The amount of hypericin varies widely in different parts of the plant, under different growth conditions, and at different times of the year.4,8 Is St John's wort antidepressant? Most of the research on SJW has been performed in Germany and published in Continental journals. There have been numerous open trials of SJW in depression and 24 double-blind studies: eight randomised, double-blind studies comparing SJW to other active medications (desipramine,13 imipramine,14,15 amitryptiline,16,17 diazepam18,19 and maprotiline20) and 16 randomised, double-blind studies comparing SJW to placebo. In two studies13,21 SJW was used in combination with valerian. There have been no head-to-head trials with newer antidepressants. As noted, an NIMH study is currently comparing SJW with a selective serotonin reuptake inhibitor and a placebo. A meta-analysis assessing 23 of the double-blind trials was published recently,5 and will not be replicated in this article. In summary, most patients in the reports had mild to moderately severe depression. (In mild depression the patient is distressed by depressive symptoms but will probably be able to perform most activities; symptoms are more numerous and intense when depression is of moderate severity, and the patient is likely to have significant difficulty in continuing with ordinary activities.)22 Three trials included patients with severe depression. Most trials lasted four to eight weeks. Across all reports, 50%-80% of patients improved with SJW, a rate similar to that achieved with conventional antidepressants. Patients with mild to moderate depression fared best. Vorbach et al found SJW superior to imipramine (75 mg/day) in severe depression,15 but the dose of imipramine was inadequate. SJW was found to be as effective as phototherapy in patients with seasonal affective disorder.23 A field of St John's wort. Declared a noxious weed in most areas of Australia, St John's wort is now being seen as a cash crop. Inset: Details of the flower. Photos courtesy of NSW Agriculture. Linde et al concluded that these studies had significant limitations.5 Most of the trials were small and used heterogeneous patient groups. Classification of depression was not uniform and none of the studies lasted longer than 12 weeks. Dosages of antidepressant in the comparison trials were subtherapeutic or in the low therapeutic range. Mechanism of action Although the exact mechanism of action remains obscure, substances contained in SJW extracts have been found to interact with a number of neurotransmitter systems implicated in depression and in psychiatric illness generally. SJW inhibits uptake of serotonin, noradrenaline and dopamine. Crude extract of SJW has a potent affinity for g-aminobutyric acid (GABA) receptors and inhibits monoamine oxidase.24 Recently, it has been postulated that the antidepressant effect of SJW may be due to its effect on interleukin-6.25 It is also of interest that the plant has high concentrations of melatonin,26 increases nocturnal production of melatonin,4 and increases deep sleep.27 Melatonin is thought to play a role in the aetiology of seasonal affective disorder and sleep.28 "First, do no harm" The popular belief that "natural products are safe" has not always been vindicated, as the tragic experience with royal jelly revealed.29 However, SJW has not been associated with serious adverse events in humans and appears well tolerated. The rates of adverse events with placebo (4.8%) and SJW (4.1%) in placebo-controlled trials are comparable.5 Fewer than 2% of patients in studies have stopped taking SJW.30 In an open trial of 3250 patients taking hypericum, side effects were reported by 2.4% of subjects.30 The most commonly noted adverse events were gastrointestinal symptoms (0.6%), allergic reactions (0.5%), fatigue (0.4%) and restlessness (0.3%). Other adverse reactions reported were emotional vulnerability, pruritus, weight gain and dizziness.4 Severe phototoxicity has been reported in cattle and sheep grazing on the plant8 (the veterinary term is "hypericism"), but not in humans taking therapeutic (antidepressant) doses. However, photosensitivity does appear to be a common problem for AIDS patients treated with high doses of hypericum in studies of the antiviral properties of SJW.4During the past 25 years there have been three reports, all in the past few months, to the Australian Adverse Drug Reactions Advisory Committee (ADRAC) relating to SJW (Dr Patrick Purcell, Acting Head, ADRAC, personal communication). These comprised hyperaesthesia in a 38-year-old woman; a combination of dyspnoea, flushing, headache, hyperventilation, mydriasis, nausea, pain, palpitations, rhinitis and tremor in a 47-year-old woman; and a fall in cyclosporin levels to 25% of previous levels in a woman in her mid-twenties (enzyme induction?). The low rate of reports to ADRAC may be due to under-reporting, insufficient identifying information about many of the herbs reported, uncommon use (until recently), or a low actual rate of adverse effects.31 Other health claims SJW is being promoted as a treatment for a range of other ailments besides depression, including anxiety and "stress", sleep problems, nocturnal enuresis, bacterial and viral infections, respiratory conditions, peptic ulceration, inflammatory arthritis, cancer, and skin wounds.4 It is also said to increase libido, an application dating from the Middle Ages: Take the ash of starlizard, civet oil and St John's wort oil. Smeared on the toe of the left foot and on the loins, the ointment will serve to reinvigorate.32 Tradition further had it that the herb would be most effective for stimulating sexual desire when picked at night while the picker was naked!32 Preparations, dosage and administration SJW is available as tablets, capsules, drops and teas and is produced by many manufacturers. An oil form is available for external use but has no place in treating depression. The optimum adult dose of SJW for treating depression, based on available studies, appears to be 300 mg of plant extract orally three times daily. However, doses used varied considerably among studies, and there are no systematic studies on the minimum therapeutic dose. Furthermore, the amount of active substances might vary depending on factors such as the extraction process, season, and plant part used. As with prescription antidepressants, there is a lag in onset of action. If side effects are intolerable, or if at six weeks SJW is deemed to be ineffective, the patient can be weaned off SJW and another antidepressant considered. Unfortunately, there are no data about "washout periods" following discontinuation of SJW. A conservative approach is to wait two weeks after ceasing SJW before commencing another agent. Precautions Because SJW may potentiate monoamine oxidase inhibitors (MAOIs), its combination with these compounds is best avoided. At this stage, combining SJW with other antidepressants is strongly discouraged for the same reasons. To our knowledge, there are no reports of dietary interactions with SJW, similar to those found with MAOIs, and no empirical studies dealing with this issue. Uterotonic activity has been reported in animal experiments,33 and for this reason SJW is not recommended in pregnancy. SJW has not been evaluated in children and adolescents. Because of the potential risk of phototoxicity, it has been suggested that patients should be advised not to sunbathe (naturally or artificially) while taking SJW and not to concurrently use photosensitising drugs such as chlorpromazine or tetracyclines. Implications for practice, research and policy Over the past few years the physical treatment of depression has been bolstered by the emergence of a number of new classes of antidepressant (such as selective serotonin reuptake inhibitors, reversible inhibitors of monoamine oxidase type A, serotonin and noradrenaline reuptake inhibitors, and 5-HT2 antagonists). A variety of augmenting agents are available and electroconvulsive therapy retains a place for more severe cases. Cognitive-behaviour therapy is also effective. Nevertheless, not all patients benefit from "standard" treatments and some people experience troublesome side effects. Further, antidepressant drugs are yet to meet with uniform community acceptance. A recent national survey found that, for depression, conventional antidepressants were perceived as helpful by 29% of respondents and harmful by 42%.34 In contrast, the treatment category that included vitamins, minerals, tonics and herbal medicines was considered helpful by 57% of respondents and harmful by 3%. Clearly, there is scope for alternative antidepressants if they can be shown to be safe and effective. SJW is the best known of several herbs being touted as antidepressant.24 However, available evidence for SJW is insufficient at this stage. Indeed, one of the aims of treating depression, the prevention of suicide, could be compromised by using a treatment that is yet to be fully investigated. If SJW is to consolidate a place in the medical armamentarium, several issues relating to clinical practice, research and policy will need to be addressed: Acknowledgement by medical practitioners of the existence of an alternative treatment system. The presence of another therapeutic system cannot be ignored.3,34,35 We need to routinely ask our patients about their use of SJW and other herbal preparations. This is particularly important as concurrent use of SJW and other antidepressant drugs may be harmful. Quality control of SJW preparations. The Register of Therapeutic Goods currently categorises SJW and most herbal preparations as "listed drugs", which are subject to fewer checks than "registered drugs". Apart from having to satisfy less-rigorous efficacy and safety criteria compared with registered drugs, listed drugs lack standardised preparation and are more prone to contamination, substitution, adulteration, incorrect packaging, wrong dosage, and inappropriate labelling and advertising.31 For example, in the case of SJW there is presently no way of knowing that the correct species of Hypericum is used, that the plant is harvested at the right time of year, that appropriate plant parts are chosen, dried and stored properly, and that the extraction process is uniform. All of these are known to affect biological activity. Funding of further research. Several breakthroughs in therapeutics have resulted from the study of natural substances,24 and SJW also promises to be rewarding in this area. However, further research into SJW will need to be funded from outside the pharmaceutical industry, by the National Health and Medical Research Council or other institutions. Herbal treatments cannot be patented, so the financial incentives for research that drive the pharmaceutical market are limited. Determination of the antidepressant component. SJW has many biologically active components. Determination of which of these are antidepressant may, in turn, contribute to the development of more refined preparations of SJW and further antidepressants, as well as increase our knowledge about the aetiology of depression. New treatment studies. To date, duration of trials has ranged from two to 12 weeks. Longer-term studies should be done to assess long term effects and the effectiveness of SJW in preventing relapse. Patient populations need to be described better and therapeutic doses of comparison antidepressants need to be used. Evaluation of SJW in certain subgroups. SJW has mainly been studied in adults with mild to moderate depression. There is a need to evaluate the herb in severely depressed patients. There is also a growing realisation that major depression is not uncommon in young people. Adult data cannot necessarily be generalised to the young, as the experience with tricyclic antidepressants has shown.36 Trials with children and adolescents are therefore necessary. The current situation in which treatment of depression with SJW is initiated by non-medical persons is fraught with danger. Suicide risk has been mentioned already. Non-medical prescription and supervision may preclude patients from receiving antidepressant treatments of demonstrated effectiveness. This has ethical implications, particularly in the case of children.37 Also, medical conditions that mimic depression, some of them common (eg, hypothyroidism), may remain unidentified and untreated. On the other hand, access to an over-the-counter antidepressant might be useful for patients with subclinical depression who are unlikely to be treated otherwise.38 For these reasons, a wider debate about who should prescribe SJW may be necessary. We find ourselves in the midst of an era in which new, better-tolerated therapeutic agents are being regularly introduced. Paradoxically, patients are turning to herbal remedies. Time will tell whether, in Australia, SJW is allowed to blossom in medicine as a bona fide antidepressant, or whether it should be weeded out. Acknowledgements Con Spiliopoulos, Glenda Schaffer, Susie Freeman, Rachel Rees, Patrick Purcell and Helen Cameron are thanked for their assistance. References MacLennan AH, Wilson DH, Taylor AW. Prevalence and cost of alternative medicine in Australia. Lancet 1996; 347: 569-573. Kristoffersen SS, Atkin PA, Shenfield GM. Uptake of alternative medicine [letter]. Lancet 1996; 347: 972. Thompson A. 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J Geriatr Psychiatry Neurol 1994; 7 Suppl 1: S24-S28. Ditzler K, Gessner B, Schatton WFH, Willems M. Clinical trial on Neuropas versus placebo in patients with mild to moderate depressive symptoms: a placebo- controlled, randomised double-blind study. Complement Ther Med 1994; 2: 5-13. World Health Organization. The ICD-10 classification of mental and behavioral disorders. Clinical descriptions and diagnostic guidelines. Geneva: World Health Organization, 1992; 121-122. Martinez B. Hypericum in the treatment of seasonal affective disorder. J Geriatr Psychiatry Neurol 1994; 7 Suppl 1: S29-S33. Cott J. Natural product formulations available in Europe for psychotropic indications. Psychopharmacol Bull 1995; 31: 745-751. Thiele B, Brink I, Ploch M. Modulation of cytokine expression by Hypericum extract. J Geriatr Psychiatry Neurol 1994; 7 Suppl 1: S60-S62. Murch SJ, Simmons CB, Saxena PK. Melatonin in feverfew and other medicinal plants. Lancet 1997; 350: 1598-1599. Schulz H, Jobert M. Effects of hypericum extract on the sleep EEG in older volunteers. J Geriatr Psychiatry Neurol 1994; 7 Suppl 1: S39-S43. Wirz-Justice A. Biological rhythms in mood disorders. In: Bloom FE, Kupfer DJ, editors. Psychopharmacology: the fourth generation of progress. New York: Raven Press, 1995; 999-1018. Bullock RJ, Rohan A, Straatmans JA. Fatal royal-jelly induced asthma [letter]. Med J Aust 1994; 160: 44. Woelk H. Benefits and risks of the hypericum extract L1 160: drug monitoring study with 3250 patients. J Geriatr Psychiatry Neurol 1994; 7 Suppl 1: S34-S38. Drew AK, Myers SP. Safety issues in herbal medicine: implications for the health professions. Med J Aust 1997; 166: 538-541. Fletcher K. Themes for herbal gardens. Ringwood, Victoria: Viking, 1996; 16. Shiplochliev T. Extracts from a group of medical plants enhancing the uterine tonus. Vet Med Nauki 1981; 18: 94-98. Jorm AF, Korten AE, Jacomb PA, et al. Mental health literacy: a survey of the public's ability to recognise mental disorders and their beliefs about the effectiveness of treatment. Med J Aust 1997; 166: 182-186. Shenfield GM, Atkin PA, Kristoffersen SS. Alternative medicine: an expanding health industry. Med J Aust 1997; 166: 516-517. Hazell P, O'Connell D, Heathcote D, et al. Efficacy of tricyclic drugs in treating child and adolescent depression: a meta-analysis. BMJ 1995; 310: 897-890. Komesaroff PA. Use of complementary medicines: scientific and ethical issues. Med J Aust 1998; 169: 180-181. Cott JM, Fugh-Berman A. Is St John's wort (Hypericum perforatum) an effective antidepressant? J Nerv Ment Dis 1998; 186: 500-501. Authors' details Rivendell Unit, Concord West, NSW. Joseph M Rey, PhD, FRANZCP, Director, and Clinical Professor, Department of Psychological Medicine, University of Sydney; Garry Walter, FRANZCP, Inpatient Director, and Clinical Lecturer, Department of Psychological Medicine, University of Sydney. Reprints will not be available from the authors. Correspondence: Dr J M Rey, Rivendell Unit, Hospital Road, Concord West, NSW 2138. E-mail: jreyATmail.usyd.edu.au ©MJA 1998 Journalists are welcome to write news stories based on what they read here, but should acknowledge their source as "an article published on the Internet by The Medical Journal of Australia <http://www.mja.com.au>". <URL: http://www.mja.com.au/>

Joseph M Rey · Garry Walter

Use of complementary medicines: scientific and ethical issues We need to address questions of effectiveness, safety and regulation MJA 1998; 169: 180-181 This article has been cited in Rey JM, Walter G. Hypericum perforatum (St John's wort) in depression: pest or blessing? MJA 1998; 169: 583-586. The widespread acceptance of complementary medicines in Australia raises important scientific, social and ethical issues. The expression "complementary medicines" covers a diverse range of practices, from historically well-established therapies, such as traditional Chinese medicine, to more exotic forms, such as colour therapy and psychic healing.1 Taken together, the precise extent of their use is unknown. Certainly, the industry is a very large one: in the United States and Australia about one-fifth of the population visit alternative practitioners each year, and in Australia up to half the population have visited them at some stage.2-4 In the United States, expenditure on complementary therapies in 1990 was about $14 billion;3 for Australia, precise data are not available, but the figure is likely to be in the hundreds of millions of dollars.2,4 The use of complementary medicines is increasing. Again, data are scanty. However, over the last five years the number of raw medicinal substances imported for use in Australia has increased fourfold, and there are now about 300-400 individual medicines available.5 Since the introduction of a Medicare rebate for acupuncture in 1984, use of acupuncture by medical practitioners has increased greatly. By analysing one of the few reliable sources of data available, Health Insurance Commission records, Easthope et al,6 in this issue of the Journal, show that the number of Medicare claims for acupuncture services by general practitioners grew by nearly 50% in 12 years, to almost one million in 1996-97. Medicare reimbursements to doctors for acupuncture increased during this period from $7.7 million to $17.7 million, and in 1996 about 15% of general practitioners presented Medicare claims for acupuncture. Evidence regarding the clinical effectiveness of most complementary treatments, and the risks associated with them, is extremely limited.7,8 Randomised clinical trials have been few; indeed, it has been argued that complementary therapies in general, and traditional Chinese practices in particular, are in principle not susceptible to assessment using randomised-trial designs.7 In the case of acupuncture, significant insights have been achieved into physiological mechanisms of action; however, the few clinical studies that have been performed have often been flawed by poor design, inadequate measures and statistical analysis, and lack of follow-up data.7,8 Notwithstanding this, rigorous trials are possible, as has been shown by studies that support the use of acupuncture in the treatment of pain and nausea, and suggest possible applications in other areas, such as hypertension and asthma.7,8 It is important to recognise that complementary medicines, like orthodox ones, are not without risk. There is the possibility that use of complementary treatments might lead to withdrawal from appropriate medical therapy or to delays in diagnosis or treatment of underlying conditions. In addition, physical treatments can cause adverse effects, and herbal therapies can be either intrinsically toxic or contaminated with toxic substances. As recent discussions in the Journal have highlighted, serious reactions and even death can occur.8-11 Complications of acupuncture have included pneumothorax and puncture of other vital organs, spinal cord lesions, and infections (including HIV and hepatitis B),12,13 again associated with possible death.14 A National Health and Medical Research Council working party in 1989 found that complications occurred most frequently with acupuncturists without medical training.14 The widespread use of complementary medicines, and especially the application of acupuncture by general practitioners demonstrated by Easthope et al, raises some interesting social and ethical questions: It is widely accepted that individuals should be free to make their own choices with respect to healthcare; however, are not claims of cures matters of public interest affecting public health? Should the application of public funds be directed by consumer demand, or should it be limited to practices -- orthodox or complementary -- for which reasonable evidence of effectiveness and safety can be provided? Should the training and right to practise of complementary therapists -- at present largely unrestricted -- be subject to a formal system of regulation? Does the community have an obligation to protect vulnerable citizens from exploitation by practitioners holding uncertain qualifications, who apply practices with dubious benefits and unknown risks? Should special measures be introduced to protect children, especially from practices that may lead to their being denied conventional therapies of proven efficacy?15 Why have risk and lack of evidence not deterred potential patients and practitioners? The question of why people use complementary therapies is an important one which may have ethical implications of its own. There is evidence that people turn to alternatives because they are disillusioned with orthodox medicine. This may include dissatisfaction with doctor-patient interactions or dissatisfaction with medicine in general.16 Declining public support for hospitals and the introduction of economic practices such as managed care, which promote cost-saving at the risk of reducing the quality of service, may well exacerbate this process. Some form of regulation of complementary medicines seems to be necessary, but a delicate balance needs to be struck between control and consumer choice. A possible model, referred to as "protection of title", is presently under consideration in Victoria, following a government-sponsored inquiry into the practice of traditional Chinese medicine. It is believed that legislation will be introduced to limit the use of the titles "acupuncturist" and "practitioner of traditional Chinese medicine" to individuals who have been accredited by specified registration bodies. This approach would contribute to the establishment of standards of practice and training and provide avenues for aggrieved consumers to have their complaints addressed. Unregistered therapists could continue to practise as long as they did not claim to hold specific qualifications to do so. It is quite likely that some form of protection of title will eventually be adopted as a general approach to the regulation of various forms of complementary therapy throughout Australia. This approach, however, represents only a partial solution. It will still be necessary to consider whether therapies work and are safe -- and, indeed, whether this question can be answered at all. It will still be necessary for us to understand the cultural meaning of complementary medicines and what they have to teach orthodox practitioners. For these questions to be addressed, detailed research will be needed into not just the scientific but also the sociological, ethical and philosophical aspects of complementary medicines. It is to be hoped that such research will be undertaken, and that it will promote much-needed dialogue between practitioners of orthodox and complementary medicine. Paul A Komesaroff Associate Professor, Department of Medicine, Monash University and Director, Eleanor Shaw Centre for the Study of Medicine Society and Law Baker Medical Research Institute, Melbourne, VIC Eagle R. Alternative medicine. London: Futura, 1978. MacLennan AH, Wilson DH, Taylor AW. Prevalence and cost of alternative medicine in Australia. Lancet 1996; 347: 569-573. Eisenberg DM, Kessler RC, Foster C, et al. Unconventional medicine in the United States: prevalence, costs and patterns of use. N Engl J Med 1993; 328: 246-252. Ban E. Australian alternatives. Nat Med 1998; 4: 8. Myers S, Bensoussan A. Towards a safer choice: the practice of Chinese medicine in Australia. Sydney: Faculty of Health, University of Western Sydney, Macarthur, 1996. Easthope G, Beilby JJ, Gill GF, Tranter BK. Acupuncture in Australian general practice: practitioner characteristics. Med J Aust 1998; 169: 195-198. Vincent C, Furnham A. Complementary medicine: a research perspective. London: Wiley, 1997; 181-182. National Institutes of Health. Acupuncture. NIH Consensus Statement, April 1998. Mullins RJ. Echinacea-associated anaphylaxis. Med J Aust 1998; 168: 170-171. Kelly S. Aconite poisoning [letter]. Med J Aust 1990; 153: 499. Drew AK, Myers SP. Safety issues in herbal medicine: implications for the health professions. Med J Aust 1997; 166: 538-541. Halvorsen TB, Anda SS, Naess AB, Levang OW. Fatal cardiac tamponade after acupuncture through congenital sternal foramen [letter]. Lancet 1996; 345: 1175. Norheim AJ, Fønnebø V. Adverse effects of acupuncture [letter]. Lancet 1995; 345: 1576. National Health and Medical Research Council, Acupuncture Working Party. Acupuncture. Canberra: NHMRC, 1989. Neeley GS. Legal and ethical dilemmas surrounding prayer as a method of alternative healing for children. In: Humber JM, Almeder RF, editors. Alternative medicine and ethics. New Jersey: Humana Press, 1998; 163-194. Siahpush M. Postmodern values, dissatisfaction with conventional medicine and popularity of alternative therapies. J Sociology 1998; 34: 58-70. - Readers may print a single copy for personal use. No further reproduction or distribution of the articles should proceed without the permission of the publisher. For permission, contact the Australasian Medical Publishing Company Journalists are welcome to write news stories based on what they read here, but should acknowledge their source as "an article published on the Internet by The Medical Journal of Australia <http://www.mja.com.au>". <URL: http://www.mja.com.au/>

Paul A Komesaroff

Alternative medicine: an expanding health industry As many Australians are using alternative medicines, it is essential for doctors to ask their patients about such use MJA 1997; 166: 516-517 This article has been cited in Easthope G, et al. Acupuncture in Australian general practice: practitioner characteristics. MJA 1998; 169: 197-200. Rey JM, Walter G. Hypericum perforatum (St John's wort) in depression: pest or blessing? MJA 1998; 169: 583-586. ©MJA1997 What form of therapy is used by at least 50% of Australian patients, costs them more than $900 million a year and is increasingly being supported by health insurance funds? Is it antibiotics, prescribed at 15.1% of all general practice encounters1 and targeted by the Pharmaceutical Benefits Branch of the Department of Health and Family Services as overused? No. Is it non-steroidal anti-inflammatory drugs, which are subject to prescribing restrictions, and are taken by an estimated minimum of 630 000 Australians at any one time (Peter McManus, Secretary, Drug Utilisation Sub-Committee, 1997, personal communication)? No. The form of therapy is something not included in the medical curriculum and rarely considered by most medical practitioners -- described by various terms, it is collectively referred to as "alternative medicine". If 50% of Australians are using alternative treatments each year, it is essential that doctors recognise this fact A South Australian survey of more than 3000 people aged 15 or older found that 48.5% used at least one non-medically prescribed alternative medication annually (excluding calcium, iron and medically prescribed vitamins), and 20.3% of those in the survey had visited at least one alternative practitioner during the year.2 Extrapolated to the Australian population, the overall out-of-pocket costs were almost three times the patient contributions for all classes of pharmaceutical drugs purchased during 1992-1993.2 Our own smaller survey of the use of alternative medicine by people attending a Sydney teaching hospital emergency department revealed remarkably similar results in a predominantly white middle-class population.3 It is perhaps not surprising to learn of the high usage of alternative therapies in children4 and adults5 with cancer, or in people with chronic rheumatoid arthritis.6 However, the high usage in generally "healthy" populations cannot be attributed to desperation about an incurable disease or to reliance on traditional remedies by certain ethnic groups. Other reasons given in our study (apart from consultations for specific conditions) for consulting alternative therapists were to "feel better", "clean up the system", or other, general, reasons. In both the Sydney and the South Australian surveys, consumers of alternative medicine were more likely to be female, better educated and employed.2,3 If these statistics are of concern to the medical profession, then the profession should be even more disturbed to learn that fewer than 50 per cent of both our study population3 and parents of children with cancer4 had informed their doctors of their use of alternative therapies -- yet many were simultaneously taking prescribed medications for the same indications. The startling usage figures are for therapies for which there is, in most cases, no evidence of efficacy beyond "traditional use". Moreover, there are numerous documented problems with the safety of alternative preparations -- their content is uncontrolled, and hence very variable;7 they may be adulterated, as with the Chinese medicines for arthritis that contain corticosteroids;8 and the substances themselves may be intrinsically toxic.9 In Australia, there have been reports of acute hepatitis due to ingestion of chaparral,10 and deaths caused by anaphylactic reactions to royal jelly11 (as summarised by Drew and Myers in this issue of the Journal). The popular perception that alternative medicines are harmless may be true of many preparations, but the more extensive their use, the greater the potential for toxicity. What is being done about this situation? Should more controls be introduced? Prescribed drugs go through an extensive and exhaustive evaluation of their efficacy and safety, but this is not the case for most alternative medicines. Under the Therapeutic Goods Act 1989 (Cwlth) they can be "listed" for a small fee, without evaluation, provided that no specific claim is made for efficacy and there is no available evidence of problems with quality or safety. More than 4500 "herbal" preparations are on this list. Those substances which have been registered as a result of a full evaluation of safety and efficacy may be counted on the fingers of one hand. It is unlikely that the Government will increase its vigilance. The recent review of the Therapeutic Goods Administration (TGA) included the investigation of "approval processes for alternative medicines with a view to ensuring any inappropriate existing impediments are removed."12 The final report has been submitted and, while some recommendations have not been accepted, it is hard to see how these medicines can be any less restricted than they are at present. In his media release in response to the recent TGA review, Senator Christopher Ellison (Parliamentary Secretary to the Federal Minister for Health and Family Services) stated that, with a new range of initiatives, "the Federal Government has ensured that patients can have confidence that their [alternative] medicines will work in the way they are intended to". It is difficult to see how this can be the case when in the same document he states that the approval processes of the TGA should not prevent people obtaining alternative medicines "where the intrinsic safety of the product is not in doubt but the therapeutic effectiveness is unproven". These products should be scientifically assessed so that patients do not unwittingly delay their own access to proven effective therapy. We believe it is up to doctors and other health professionals to address the situation as a matter of urgency. In our survey, the main reasons given for not telling medical practitioners about the use of alternative therapies were the perception that doctors would probably reject the therapies, and a belief that individuals were "in charge of their own health". If 50% of Australians are using alternative treatments each year, it is essential that doctors recognise this fact and be prepared to discuss such use with their patients in a non- judgemental manner. As a minimum step, questions about alternative treatments must be included as a routine part of history-taking. Eliciting the reasons for their use might indicate where conventional medicine is perceived to be failing, and allow supportive discussion with patients. In addition, any unusual or unexplained symptom or sign should raise the possibility of an adverse reaction to, or interaction with, an alternative medication, and if there is a suggestive temporal association the event should be reported to the Australian Adverse Drug Reactions Advisory Committee (Commonwealth Department of Health and Family Services). We need to acknowledge what is happening in the community. It has been suggested that the normal doctor-patient encounter lacks "time, empathy, personalisation, expectation of a cure in chronic disease states, counselling and a general emphasis on health rather than disease".2 While this is not always the case, it is time for us to recognise that a complementary system for trying to achieve a state of well-being exists in Australia and is widely used by our patients. We cannot ignore it and should record and collect objective data about its use. Gillian M Shenfield Clinical Professor in Clinical Pharmacology Philip A Atkin Research Associate in Clinical Pharmacology Sean S Kristoffersen Honours Student, Department of Clinical Pharmacology, Royal North Shore Hospital, Sydney, NSW. Bridges-Webb C, Britt H, Miles DA, et al. Morbidity and treatment in general practice in Australia 1990-1991. Med J Aust 1992; 157 (suppl): 1S-56S. MacLennan AH, Wilson DH, Taylor AW. Prevalence and cost of alternative medicine in Australia. Lancet 1996; 347: 569-573. Kristoffersen SS, Atkin PA, Shenfield GM. Uptake of alternative medicine [letter]. Lancet 1996; 347: 972. Sawyer MG, Gannon AF, Toogood IR, et al. The use of alternative therapies by children with cancer. Med J Aust 1994; 160: 320-322. Begbie SD, Kerestes ZL, Bell DR. Patterns of alternative medicine use by cancer patients. Med J Aust 1996; 165: 545-548. Kestin M, Miller L, Littlejohn G, Wahlqvist M. The use of unproven remedies for rheumatoid arthritis in Australia. Med J Aust 1985; 143: 516-518. Myers SP, Smith AJ. Cardioprotection and garlic. Lancet 1997; 349: 131-132. Huxtable RJ. The harmful potential of herbal and other plant products. Drug Saf 1990; 5: 126-136. Pillans PI. Toxicity of herbal products. NZ Med J 1995; 108: 469-470. Smith BC, Desmond PV. Acute hepatitis induced by ingestion of the herbal medication chaparral. Aust N Z J Med 1993; 23: 526. Harmless herbals? ADRAC Bull 1993; 12: 11. KPMG Management Consulting. Review of Therapeutic Goods Administration on behalf of the Department of Health and Family Services. Canberra: AGPS, Jan 1997 p2. ©MJA 1997 <URL: http://www.mja.com.au/> © 1997 Medical Journal of Australia.

Gillian M Shenfield · Philip A Atkin · Sean S Kristoffersen

Safety issues in herbal medicine: implications for the health professions Anna K Drew and Stephen P Myers The use of herbal medicines in Australia is widespread. A number of factors make assessment of adverse effects associated with these products more complex than for pharmaceuticals. Problems have resulted from contamination with heavy metals and adulteration with prescription drugs in overseas herbal products. A classification is proposed for adverse effects associated with herbal medicines, and medical practitioners are encouraged to include use of these preparations in a patient's drug history and in reports of suspected adverse drug reactions. It may be necessary to develop a separate database to promote adverse drug reaction reporting for herbal medicine and the wider field of complementary and alternative medicine. (MJA 1997; 166: 538-541) For editorial comment see Shenfield et al. Introduction - Regulation of herbal medicines in Australia - Safety of herbal medicines - Proposed classification of adverse effects of herbal medicines - Adverse drug reaction (ADR) reporting - Conclusion - References - Authors' details - ©MJA1997 Introduction The World Health Organization estimates that 65%-80% of the world's population use traditional medicine as their primary form of health care.1 The use of herbal medicine, the dominant form of medical treatment in developing countries, has been increasing in developed countries in recent years.2 Assessment of the safety and efficacy of these medicines is an important issue for the health professions. We focus here on the safety of these preparations; the issue of their efficacy is not addressed. A classification of potential adverse effects associated with these preparations is proposed, and we encourage the reporting of any adverse drug reactions (ADRs). Herbal medicine, in which plants (dried or in extract form) are used as therapeutic substances, is one of a number of practices encompassed by the term "complementary and alternative medicine" (CAM). Recent studies have highlighted the extent to which CAM is used in Australia. A 1993 survey of 3004 South Australians by MacLennan et al.3 found that, in the previous year, 48.5% had used at least one form of CAM preparation and 20.3% of all respondents had visited at least one alternative practitioner. Herbal medicine accounted for approximately 26% of CAM use in this survey. Estimates of the national cost of both CAM preparations and practitioner visits were about one billion dollars when extrapolated to the Australian population. Results for the use of CAM were similar in a survey of 325 patients attending a Sydney teaching hospital emergency department in 1994,4 and only 35.5% of users had informed their medical practitioner about any use of CAM. Of the women who had borne children, 12 (14.5%) had taken one to 18 herbal preparations during pregnancy, and eight of 34 (23.5%) patients under 16 had been given between one and eight herbal preparations. Evidence suggests that CAM preparations or therapies are used for conditions such as cancer, high blood pressure and allergies, as well as for general wellbeing.3,5,6 Regulation of herbal medicines in Australia In Australia, products for human medicinal use must be placed on the Register of Therapeutic Goods [Therapeutic Goods Act 1989 (Cwlth)] in one of two categories -- "listed" or registered. Formulations can be listed for a small fee if they contain substances regarded by the Therapeutic Goods Administration (TGA) as being of low public health concern and comply with the Therapeutic Goods Advertising Code. This restricts wording of claims to "assist" rather than "treat" and limits indications to minor self-limiting conditions. The products have to be manufactured by a TGA-licensed manufacturer following a recognised code of Good Manufacturing Practice. Labelling requirements are the same as those for registered products. Efficacy data have to be held by the manufacturer/distributor of such products and can be called on at any time by the TGA or the Australian Competition and Consumer (formerly, the Trade Practices) Commission. About 4500 plant-based products are listed; these are given an "AUST L" number, indicating their listing on the register and that they can be sold legally in Australia. Registered products, which bear an "AUST R" number, contain herbs that are either restricted by the federal Standards for the Uniform Scheduling of Drugs and Poisons, those for which efficacy claims are more substantial, or those which are specified by the TGA as being of some health concern. For registration, which is more costly, appropriate documentation outlining clinical trial work must be submitted to the Traditional Medicines Evaluation Committee (established in 1991 -- soon to be replaced by the Complementary Medicines Evaluation Committee) which advises the TGA. Fewer than five CAM products have been evaluated in this way. Although Australia has more regulatory controls than many other countries for CAM preparations, including herbals,7 most of these preparations are not exposed to the premarketing evaluation process that prescription and scheduled proprietary medicines undergo. Few CAM preparations can be patented, so they are not subject to the financial incentive that drives the pharmaceutical market. Safety of herbal medicines Although it is widely perceived that "natural" products are safe, the evidence suggests that CAM use is not without risk. Of 90 patients with rheumatoid arthritis, 82% had tried more than one form of alternative medicine or therapy, including dietary modification, and 31% of these patients had experienced at least one adverse effect.8 Of 1701 consecutive patients admitted to the Prince of Wales Hospital, Hong Kong, three (0.2%) had had adverse effects attributed to traditional Chinese medicines and 75 (4.4%) to "Western" medications.9 A review of 5563 enquiries received by the National Poisons Unit, London, showed that 77.7% involved vitamin preparations and 19.3%, herbal extracts, royal jelly, hormonal products and other natural products. Exposure was linked to adverse effects in 49 (0.9%) of these cases.10 In ascertaining whether a substance is associated with an adverse effect, the medical literature may be of limited help -- there may be no previous report of such an event, as was the case for fatal anaphylaxis which occurred in an 11-year-old child with asthma after her third exposure to royal jelly.11 Prior to this event, contact dermatitis had been documented with royal jelly (which contains proteins, carbohydrates, amino acids, vitamins, lipids and fatty acids), but the allergen had not been identified.12 At the time of the child's death, the Adverse Drug Reactions Advisory Committee (ADRAC) of the Commonwealth Department of Health and Family Services had three reports of adverse reactions to royal jelly on file: one of anaphylaxis and two of bronchospasm (Dr Ian Boyd, Adverse Drug Reactions Advisory Committee, Canberra; data, 1972-May 1993; personal communication). Raised awareness of this problem resulted in the TGA advising manufacturers to label royal jelly products to warn of their potential to cause severe allergic reactions in people who suffer from asthma or allergies.13 ADRAC have now received a total of 18 reports of allergic reactions to royal jelly, including two fatalities (Dr Ian Boyd, Adverse Drug Reactions Advisory Committee, Canberra; data, 1972-February 1997; personal communication). Proposed classification of adverse effects of herbal medicines Adverse effects of herbal medications may be intrinsic or extrinsic (Box 1). The patient's age, genetic constitution, nutritional state, concomitant diseases and concurrent medication may affect the risk and severity of adverse events, as can consumption of large amounts or a wide variety of herbal preparations, or long-term use.15,16 Intrinsic effects Intrinsic effects are those of the herb itself and are characterised, as for pharmaceuticals, as type A (predictable, dose-dependent) and type B (unpredictable, idiosyncratic) reactions.17 Yohimbine, an alkaloid found in Pausinystalia yohimbe bark that has α2 -adrenoceptor antagonist activity, is taken for male impotence, and can cause hypertension and anxiety in a predictable, dose-related manner (type A reaction); it has also been associated with the serious idiosyncratic reactions of bronchospasm and increased mucus production when taken in normal doses by a patient with severe allergic dermatitis (type B).18,19 Type A reactions with herbal preparations also include effects with deliberate overdose or accidental poisoning and interactions with pharmaceuticals. Extrinsic effects Extrinsic effects are not related to the herb itself, but to a problem in commercial manufacture or extemporaneous compounding. Potential failures to adhere to a code of Good Manufacturing Practice, while not specific to herbal medicine, can occur, particularly in developing countries where such a code is not in place. This makes it more difficult for medical practitioners and other health professionals to assess the adverse effects of herbal preparations compared with pharmaceuticals. Misidentification: It is difficult to track and identify adverse effects of herbal ingredients, as the plants can be named in four different ways -- the common English name, the transliterated name, the latinised pharmaceutical name, and the scientific name.20 It is essential that plants are referred to by their binomial Latin names for genus and species; misidentification can occur when other names are used. For example, the scientific name of the Chinese herb that is variously transliterated as "dong quai", "dong guai", "danggui" and "tang kuei" is Angelica polymorpha (formerly sinensis). The common English name "angelica" and the latinised name "Radix Angelica" could refer either to this species, which is used in Australia, or to the European species Angelica archangelica, depending on the country of origin. Misidentification can result in erroneous associations being made, with potential clinical implications. Plant material can be misidentified at the time of the manufacturer's bulk purchase or when wild plants are picked. Lack of standardisation: The therapeutic/toxic components of plants vary depending on the part of the plant used, stage of ripeness, geographic area where the plant is grown, and storage conditions. Therefore, batch-to-batch reproducibility of plant material should be assessed in the production of marketed products, but, in practice, product variation in herbal medicines can be significant. The content of ginsenoside, the glycosylated steroid to which most of the biological activity of ginseng (Panax ginseng) has been ascribed, was examined in 50 commercial brands of ginseng sold in 11 countries.21 In 44 of these products, the concentration of ginsenoside ranged from 1.9% to 9% w/w; six products contained no ginsenoside, and one of these six contained large amounts of ephedrine (for which a Swedish athlete was accused of doping). Contamination: During growth and storage, crude plant material can become contaminated by pesticide residues, microorganisms, aflatoxins, radioactive substances and heavy metals;22 lead, cadmium, mercury, arsenic and thallium have been reported as contaminants of some overseas herbal preparations.23-25 In a case series of five patients in the United Kingdom with lead poisoning from Asian traditional remedies, the preparations implicated contained 6%-60% w/w lead by weight.26 The Australian Code of Good Manufacturing Practice specifies detection of microorganisms and leaves estimation of other contaminants (not specified in internationally recognised pharmacopoeial standards) to the discretion of manufacturers.14 Substitution: A report of nine cases of rapidly progressive interstitial nephritis in young women taking a Belgian slimming treatment27 led to the discovery that Aristolochia fangchi, containing the nephrotoxic component aristolochic acid, had been introduced in place of Stephania tetrandra.20 Eighty cases have now been identified and more than half of these patients developed terminal renal failure.28,29 Adulteration: The intentional use of pharmaceutical adulterants has been reported. Cases of acute interstitial nephritis, reversible renal failure, loss of blood pressure control and peptic ulceration have been reported with a product called "Tung Shueh" pills, taken for arthritic complaints.30-32 The product contained mefenamic acid and diazepam, neither of which was included on the label. Adulterants can also be added by unethical herbalists compounding preparations for individual patients. In a recent Victorian court case, a Chinese herbalist was prosecuted for adding a steroid cream to a herbal preparation, which produced severe facial erythema in a patient. 33 Incorrect preparation/dosage: The processing of crude plant material carried out by a manufacturer, CAM practitioner or the patient is a major determinant of the pharmacological activity of the finished product. A Western Australian patient had a heart attack when he failed to follow a herbalist's instructions to boil aconite (a restricted plant in Australia) in three pints of water for one hour and take the decanted liquid; the patient increased the dose and shortened the boiling time. 34 Boiling changes the alkaloid composition, rapidly reducing the plant's toxicity, 35 and can substantially reduce microorganism contamination. 36 Another point to consider is that the activity of crude plant material may differ from that of the purified constituents, as some constituents may modify the toxicity of others. 35 Inappropriate labelling/advertising: In early 1996, a direct-mailing campaign to individuals who had purchased exercise bicycles included information on seaweed (Fucus vesiculosus) patches for weight loss. Seaweed, or kelp, contains iodine, and it was claimed that the patches would reverse hypothyroidism by releasing iodine into the body, speeding up the body's metabolism, resulting in weight loss. This claim was unproven. Hyperthyroidism has been reported in people who take kelp products orally,36 and if iodine were to be absorbed transdermally it could lead to hyperthyroidism in susceptible individuals. The TGA became aware of the product promptly and secured a promise that no further supplies would be imported, but keeping abreast of potentially unsafe products is a mammoth task. Adverse drug reaction (ADR) reporting ADR reporting is as essential for CAM products as it is for pharmaceuticals in providing postmarketing surveillance. In Australia, reporting of adverse effects of any medication, whether alternative or conventional, is usually undertaken by a medical practitioner, pharmacist or dentist, who completes and forwards a "blue card" to ADRAC. Although the person reporting need not assess the association between the medication and the adverse effect, this process enables trends to be spotted. ADRAC has received 154 reports relating to CAM in 25 years (Dr Ian Boyd, Adverse Drug Reactions Advisory Committee, Canberra; data, 1972-February 1997; personal communication). Given the widespread use of CAM, this low number of reports suggests that CAM has either a low risk of adverse effects or that such effects are significantly under-reported. Although limited evidence suggests that CAM products may be associated with a lower risk than conventional medicines, 9 under-reporting is likely, as: ADRAC does not actively encourage the reporting of adverse effects by practitioners and consumers of alternative medicine; CAM use is not routinely included in patients' drug histories or in reports of adverse effects; The public perception that "natural" products are safe biases against an association being made between CAM products and adverse effects. Conclusion The incidence of adverse effects of CAM products requires further study, and more education about CAM is needed. Medical practitioners should be encouraged to routinely ask for information about CAM use when they take a drug history and to include CAM products in ADR reports (Box 2, below). It is also important to promote an avenue for alternative practitioners and consumers to report adverse effects to CAM products, as a large proportion of alternative medicines are sold through health food outlets, supermarkets and by direct marketing (including via the Internet). Development of a separate or parallel database could fulfil this purpose. The Government response to recommendations arising from the recent TGA review accepts the need to extend the coverage of ADRAC to complementary and alternative medicines. 37,38 As there is increasing pressure to regulate CAM products to pharmaceutical industry standards of quality and safety, 7 the challenge for the Government and the CAM industry is to provide a level of postmarketing surveillance at least equivalent to that in place for pharmaceuticals. References Anonymous. Program Profile: international liaison brings global vision to OAM. Complementary and Alternative Medicine at the NIH 1996; 3: 3 . British Medical Association. Complementary medicine. New approaches to good practice. Oxford: Oxford University Press, 1993: 9-36. MacLennan AH, Wilson DH, Taylor AW. Prevalence and cost of alternative medicine in Australia. Lancet 1996; 347: 569-572. Kristofferson SS, Atkin PA, Shenfield GM. Uptake of alternative medicine [letter]. Lancet 1996; 347: 972. Sawyer MG, Gannoni AF, Toogood IR, et al. The use of alternative therapies by children with cancer. Med J Aust 1994; 160: 320-322. Eisenberg DM, Ronald CK, Foster C, et al. Unconventional medicine in the United States; prevalence, costs, and patterns of use. New Engl J Med 1993; 328: 246-252. De Smet PAGM. Should herbal medicine-like products be licensed as medicines [editorial]? BMJ 1995; 310: 1023-1024. Kestin M, Miller L, Littlejohn G, Wahlqvist M. The use of unproven remedies for rheumatoid arthritis in Australia. Med J Aust 1985; 143: 516-518. Chan TYK, Chan AYW, Critchley JAJH. Hospital admissions due to adverse reactions to Chinese herbal medicines. J Trop Med Hyg 1992; 95: 296-298. Perharic L, Shaw D, Colbridge M, et al. Toxicological problems resulting from exposure to traditional remedies and food supplements. Drug Saf 1994; 11: 284-294. Bullock RJ, Rohan A, Straatmans, J-A. Fatal royal jelly-induced asthma [letter]. Med J Aust 1994; 160: 44. Takahashi M, Matsuo I, Ohkido M. Contact dermatitis due to honeybee royal jelly. Contact Dermatitis 1983; 9: 452-455. Anonymous. Royal jelly: warning label required. TGA News 1994; 16: 4. Bensoussan A, Myers SP. Towards a safer choice. The practice of traditional Chinese medicine in Australia. Sydney: Faculty of Health, University of Western Sydney (Macarthur), 1996: 54. De Smet PAGM. Health risks of herbal remedies. Drug Saf 1995; 13: 81-93. Huxtable RJ. The harmful potential of herbal and other plant products. Drug Saf 1990; 5 (Suppl 1): S126-S136. Rawlins MD, Thompson JW. Pathogenesis of adverse drug reactions. In: Davies DM, editor. Textbook of adverse drug reactions. Oxford: Oxford University Press, 1977: 44. Landis E, Shore E. Yohimbine-induced bronchospasm. Chest 1989; 96: 1424. De Smet PAGM, Smeets OSNM. Potential risk of health food products containing yohimbe extracts. BMJ 1994; 309: 958. But P P-H. Need the correct identification of herbs in herbal poisoning [letter]. Lancet 1993; 341: 637. Cui J, Garle M, Eneroth P, Bjorkhem I. What do commercial ginseng preparations contain? [letter] Lancet 1994; 344: 134. Bisset NG, editor. Herbal drugs and phytopharmaceuticals. Stuttgart: Medpharm Scientific Publishers, 1994. Schaumburg HH, Berger A. Alopecia and sensory polyneuropathy from thallium in a Chinese herbal medication [letter]. JAMA 1992; 268: 3430-3431. Kew C, Morris C, Aihie A, et al. Arsenic and mercury intoxication due to Indian ethnic remedies. BMJ 1993; 306: 506-507. Wu M-S, Hong J-J, Lin J-L, et al. Multiple tubular dysfunction induced by mixed Chinese herbal medicines containing cadmium. Nephrol Dial Transplant 1996; 11: 867-870. Bayly GR, Braithwaite RA, Sheehan TMT, et al. Lead poisoning from Asian traditional remedies in the West Midlands -- report of a series of five cases. Hum Exp Toxicol 1995; 14: 24-28. Vanherweghem J-L, Depierreux M, Tielemans C, et al. Rapidly progressive interstitial renal fibrosis in young women: association with slimming regimen including Chinese herbs. Lancet 1993; 341: 387-391. Vanhaelen M, Vanhaelen-Fastre R, But P, Vanherweghem J-L. Identification of aristolochic acid in Chinese herbs [letter]. Lancet 1994; 343: 174. van Ypersele de Strihou C, Vanherweghem JL. The tragic paradigm of Chinese herbs nephropathy [editorial]. Nephrol Dial Transplant 1995; 10: 157-160. Diamond JR, Pallone TL. Acute interstitial nephritis following use of tung shueh pills. Am J Kidney Dis 1994; 24: 219-221. Abt AB, Oh JY, Huntington RA, Burkhart KK. Chinese herbal medicine induced acute renal failure. Arch Intern Med 1995; 155: 211-212. Gertner E, Marshall PS, Dean Filandrinos, et al. Complications resulting from the use of Chinese herbal medications containing undeclared prescription drugs. Arthritis Rheum 1995; 38: 614-617. Adams D. Herbal tea made woman's face "stop light", court told. The Age (Melbourne ) 12 December 1995; 7. Dean A. Herbalist's patient had heart attack. The Sydney Morning Herald 21 July 1994; 4. De Smet PAGM, Tognoni G. Drugs used in non-orthodox medicine. In: Dukes MNG, editor. Meyler's side effects of drugs. 12th edition. Amsterdam: Elsevier, 1992: 1209-1232. De Smet PAGM. Toxicological outlook on the quality assurance of herbal remedies. In: De Smet PAGM, Keller K, Hansel R, editors. Adverse effects of herbal drugs, I. Heidelberg: Springer-Verlag, 1992: 1-72. Therapeutic Goods Administration. Government response to recommendations arising from the Therapeutic Goods Administration Review. Canberra: AGPS, April 1997: 37-38. KPMG Management Consulting. Review of Therapeutic Goods Administration on behalf of the Department of Health and Family Services. Canberra: AGPS, January, 1997: 126-127. (Received 11 September 1996; accepted 18 February 1997) Authors' details Hunter Drug Information Service, Department of Clinical Toxicology and Pharmacology, Newcastle Mater Misericordiae Hospital, Newcastle, NSW. Anna K Drew, BPharm(Hons), Director. School of Natural and Complementary Medicine, Southern Cross University, Lismore, NSW. Stephen P Myers, BMed, ND, Head. Medical Doctoral Student, Discipline of Clinical Pharmacology, Faculty of Medicine and Health Sciences, University of Newcastle. No reprints will be available. Correspondence: Anna Drew, Director: Hunter Drug Information Service, Locked Bag 7, Hunter Region Mail Centre, NSW 2310. E-mail: oudanATcc.newcastle.edu.au Make a comment - - To top of article - ©MJA 1997 <URL: http://www.mja.com.au/> © 1997 Medical Journal of Australia. We appreciate your comments.

Anna K Drew · Stephen P Myers

Alternative cancer treatments We must let patients know we are on their side and make every effort to ascertain and deliver what it is they seek from treatment MJA 1996; 165: 536 Readers may print a single copy for personal use. No further reproduction or distribution of the articles in whole or in part should proceed without the permission of the publisher. For copyright permission, contact the Australasian Medical Publishing Company Journalists are welcome to write news stories based on what they read here, but should acknowledge their source as "an article published on the Internet by The Medical Journal of Australia <http://www.mja.com.au/>". - - ©MJA1996 In this issue of the Journal, Begbie and colleagues show once again the continued attraction of alternative medicine or unproved remedies. In many developed countries, a large proportion of the general public (nearly half over 12 months, according to a recent survey in South Australia 1 ) attend alternative practitioners, use unconventional therapies, or both. It seems not to matter whether the country has a universal health scheme or not; the public is prepared to spend large sums on alternative treatment, as shown in studies from both the United States 2 and the United Kingdom. 3 Several of the surveys have shown that among users of alternative practitioners and alternative remedies there is a bias towards younger, fitter people, towards women and towards the better educated. However, it is not just the healthy who turn to alternatives. As the paper by Begbie and colleagues, and others, 4 shows, among cancer patients the use of alternative therapy is widespread. Why is this so and what can the medical profession learn from this? Some of the attractions of alternative treatments for cancer are perhaps self-evident. When faced with an illness incurable by medical science, patients and their families understandably turn to those who claim that their remedies are effective, "natural" and harmless. Thus, alternative therapies abound not only for cancer but also for conditions such as multiple sclerosis and rheumatoid arthritis. These therapies do, however, come and go. Where now is copper ointment for rheumatoid arthritis? Where now is ozone treatment for HIV? For cancer, where now Krebiozen (a treatment popular in the 1950s), Milan Brych's secret remedy (of the 1970s) and Laetrile (from the 1980s)? Although these have gone, others have replaced them. In Australia, the most popular currently are diets, and psychological measures such as relaxation and meditation. As quoted by Begbie et al., there are "no unproven treatments for universally curable diseases". 5 It might also be relevant that there are few unproven treatments for conditions that can be more readily understood than cancer, such as pneumonia, bone fractures and venous thrombosis. When medical science has an effective treatment, even if it's not a cure, the alternative industry has little to offer. An important message is that the profession should use its available treatments to best advantage. The current trend to "evidence-based medicine" will strengthen our hand, and guide doctors to the most effective treatments. For example, the publications on early breast cancer distributed by the National Breast Cancer Centre 6,7 should provide an effective answer to many patients' questions and may limit their need to seek help from the un qualified. Patients may not necessarily seek a "cure" -- effective symptom relief, using modern palliative care, may fulfil the needs of many. It is also important for medical practitioners to gain patients' confidence so that they do not feel inhibited about discussing alternative treatments. The discussion may reveal that the patient feels pressured into trying some alleged cure by a well-meaning, but ill-informed, friend or relative. Straightforward scientific information about the lack of evidence of the "remedy" in question may be all that the patient is seeking. If the doctor is unfamiliar with the particular treatment, a Cancer Council will provide the information needed. The discussion may reveal that what patients really seek is something that may be as readily available through orthodox channels as the unorthodox. All of the State and Territory Cancer Councils run their own support and self-help groups, or can refer patients to those organised by approved organisations and institutions. Meditation, social support and a sympathetic ear can also be found, if not through the Cancer Councils, then the oncology department of the local hospital should be able to point patients in the appropriate direction. Should we be concerned? That so many patients seek "alternatives" not only indicates certain failings in the services provided by the profession, it actually exposes patients to potential harm. 8-10 Many so-called cancer diets are nutritionally inadequate, the costs may be substantial and "natural" does not necessarily equate to "harmless". Some natural substances that are far from harmless include snake venom, strychnine, toadstools, potato leaves and tobacco. Laetrile and comfrey, previously recommended for the treatment of cancer, carry their own dangers. Some allegedly natural herbal medications conceal their real ingredients. 11 There is also the danger that patients may forgo proven effective treatments for cancer, and their only chance of cure. None of this discussion denies the many shortcomings of orthodox medicine nor the potential dangers of our own prescriptions. Nor does it lessen the need for the scientific study of folk remedies in the hope of finding new effective "natural" treatments to follow, for example, aspirin (from willow bark) or paclitaxel (from the Pacific yew tree). It is important for the public to know that we are on their side. With treatments for cancer, cure is the aim whenever possible, but always and above all else the aims are comfort and relief of suffering. The medical profession must ensure that a wide range of treatments and support services is available to cancer patients. Their needs can best be met by a doctor-patient partnership, by free discussion, and by use of measures of proven effectiveness. Raymond M Lowenthal Director of Medical Oncology, Royal Hobart Hospital, TAS MacLennan AH, Wilson DH, Taylor AW. Prevalence and cost of alternative medicine in Australia. Lancet 1996; 347: 569-573. Lerner IJ, Kennedy BJ. The prevalence of questionable methods of cancer treatments in the United States. CA Cancer J Clin 1992; 42: 181-191. Downer SM, Cody MM, McClusky P, el al. Pursuit and practice of complementary therapies by cancer patients receiving conventional treatment. BMJ 1994; 309: 86-89. Sawyer MG, Ganom AF, Toogood IR, et al. The use of alternative therapies by children with cancer. Med J Aust 1994; 160: 320-322. Cassileth BR. The social implications of questionable cancer treatments. CA Cancer J Clin 1989; 39: 311-316. Clinical practice guidelines. The management of early breast cancer. Canberra: National Health and Medical Research Council, 1995. A consumer's guide. Early breast cancer. Canberra: National Health and Medical Research Council, 1995. Lowenthal RM. On eye of newt and bone of shark. The dangers of promoting alternative cancer treatments. Med J Aust 1994; 160: 323-324. Lowenthal RM. Can cancer be cured by meditation and "natural therapy"? A critical review of the book You can conquer cancer by Ian Gawler. Med J Aust 1989; 151: 710-715. Abbot NC, White AR, Ernst E. Complementary medicine. Nature 1996; 381: 361. Bayly GR, Braithwaite RA, Sheehan TMT, et al. Lead poisoning from traditional remedies in the West Midlands -- report of a series of five cases. Human Exp Toxicol 1995; 14: 24-28. - - To top of article - ©MJA 1996 <URL: http://www.mja.com.au/> © 1996 Medical Journal of Australia.

Raymond M Lowenthal

Patterns of alternative medicine use by cancer patients Stephen D Begbie, Zoltan L Kerestes and David R Bell MJA 1996; 165: 540 For editorial comment, see Lowenthal Readers may print a single copy for personal use. No further reproduction or distribution of the articles in whole or in part should proceed without the permission of the publisher. For copyright permission, contact the Australasian Medical Publishing Company Journalists are welcome to write news stories based on what they read here, but should acknowledge their source as "an article published on the Internet by The Medical Journal of Australia <http://www.mja.com.au/>". Abstract - Introduction - Methods - Results - Experiences of conventional treatment - Alternative treatment - Patient characteristics and alternative therapy use - Discussion - Acknowledgements - References - Authors' details - - ©MJA1996 Abstract Objective: To assess the patterns of alternative medicine use in patients of a public hospital oncology unit, and to compare patients' experience of alternative with conventional medicine. Design and setting: Self-administered questionnaire survey of cancer patients attending specialist consulting rooms at the Royal North Shore Hospital and the Oncology Outpatient Clinic at Port Macquarie Base Hospital during August 1995. Participants: 507 patients attended the clinics; 335 (66%) returned questionnaires, of which 319 (62%) were sufficiently complete for analysis. Main outcome measures: Expectations of and satisfaction with both conventional and alternative treatment, use of alternative treatment, and patient characteristics associated with this use. Results: Expectations of and satisfaction with both conventional and alternative treatment were very high. Alternative treatments (most commonly dietary and psychological methods) were used by 21.9% of patients. Median annual cost of alternative therapy was $530, with most patients reporting "value for money". Younger age and being married were positively associated, and satisfaction with conventional treatment was negatively associated, with alternative medicine use; 40% of patients did not discuss alternative medicine with their physician. Conclusions: A significant proportion of cancer patients use one or more forms of alternative therapy. The use of alternative therapy may reflect on deficiencies in the current standard of care. MJA 1996; 165: 545-548 Introduction Rapid developments in the conventional management of cancer have been accompanied by an increased consumer-driven move toward choice and individual control. While alternative (or complementary) medicine has always existed, its availability and variety are growing and its use increasing. 1 Cancer patients use alternative therapies despite arguments such as lack of scientific validity, proven ineffectiveness of some treatments and reliance on the placebo effect. It may be helpful for Australian doctors to know the range of alternative therapies used by cancer patients, and to have an understanding of the reasons why they use such therapies, as this may cast some light on deficiencies in the current standard of conventional care. We aimed to investigate the range of alternative therapies used by cancer patients attending outpatient clinics conducted by a teaching hospital clinical oncology unit, and to assess the level of satisfaction with these therapies and with conventional therapy. Methods Our subjects were all patients who attended the specialist consulting rooms of three medical oncologists at Royal North Shore Hospital (RNSH) in Sydney, and the Oncology Outpatient Clinic at Port Macquarie Base Hospital (PMBH), New South Wales, during August 1995. Reception staff offered each patient a self-administered questionnaire, with a covering letter from the chief investigator encouraging participation, and assuring confidentiality. Response to the questionnaire was voluntary, and patients were not asked to give explanations for not responding. The questionnaire sought demographic data, and the following information about their conventional treatment: understanding of diagnosis and treatment, expectations before treatment, impressions at the conclusion of treatment, and overall satisfaction. All questions were multiple choice, with the exception of diagnosis. Those who had used alternative medicine were asked (in multiple-choice questions, but with space for comments) to outline their reasons for doing so, as well as the treatments chosen. The questionnaire did not seek details of the chosen therapies. The same questions that were used to assess their conventional medicine experience were used to assess their alternative medicine experiences. In addition, they were asked about the reaction of family and friends to their use of alternative therapy, whether they had discussed alternative treatment with their medical oncologist, to estimate the financial cost, and whether they felt they had received value for money. Data were analysed using the Statistical Package for the Social Sciences 2 to determine associations between patient characteristics and alternative medicine use; significance was measured by the odds ratio. Logistic regression analysis was used to analyse all variables which may affect use of alternative therapy. Approval for this study was received from the Royal North Shore Hospital Ethics Committee, and from Port Macquarie Base Hospital. Results Five hundred and seven patients attended, of whom 335 (66%) responded (271 from RNSH, 64 from PMBH). Sixteen questionnaires were excluded from assessment (the alternative medicine question was unanswered in 12, no demographic details were given in 3, and one was returned blank), leaving 319 (62%) to be assessed. Demographic details for the 319 patients are shown in Box 1. It is noteworthy that in our study women, married people, and those with high levels of education and private health insurance predominate. Only 22.9% of the 319 patients were in paid employment, and median household income was in the $20 000-$40 000 range. A wide variety of diagnoses were represented; breast cancer was the single most common diagnosis. Experiences of conventional treatment Most respondents had received chemotherapy, and many had undergone other kinds of cancer therapy (Box 1). When asked about their expectations at the beginning of treatment, 85.6% believed that it would cure them or prolong their lives. By contrast, at the end of conventional treatment 63.0% felt that they had been cured or that their life had been prolonged, while 8.2% felt that their treatment had been of no benefit, or had made them worse. Most respondents (75.3%) were either satisfied or very satisfied with their experience of conventional therapy, while only 3.1% were either unsatisfied or very unsatisfied. Alternative treatment Seventy patients of the 319 assessed (21.9%) indicated that they were using alternative therapy. The most frequently given reasons were a preference for natural therapy, and seeing the alternative therapy as another source of hope (Box 2). Box 3 shows the alternative therapies chosen; dietary and psychological methods were most prevalent, followed by herbalism. Seventy-five per cent of patients tried more than one therapy (median, 3; range, 1-8). Most of the patients had learnt of alternative therapies through friend or family recommendation (37; 52.9%), and personal research (32; 45.7%), while doctor's recommendation (11; 15.7%) and media reports (6; 8.6%) were less common (some patients cited more than one source). In addition, family and friends were overwhelmingly supportive, with those of 64 patients (91.4%) being either encouraging or tolerant of the use of alternative therapies. At the beginning of alternative treatment 51 patients (72.9%) expected it would cure them or prolong their lives, while at the completion 34 (48.6%) felt that they had been cured, or that their lives had been prolonged. Only seven (10%) had the impression that alternative treatment was of no benefit, or had made them worse. Overall, 49 patients (70%) were satisfied or very satisfied with alternative treatment, and only one (1.4%) was unsatisfied. Forty-five patients gave an estimate of the annual cost of their alternative therapy; the median annual cost was $530 (range, 0-$20 000). Of the 70 patients who had alternative therapy, 45 (64.3%) felt they were getting value for money, five (7.1%) did not, and the remainder did not answer this question. Importantly, 37 (52.9%) felt that they could discuss their alternative treatment with their physician, while 28 (40%) felt they could not. Patient characteristics and alternative therapy use Being young and being married were significantly associated with use of alternative medicine, with marital status significant at P = 0.02. Logistic regression analysis showed that age and satisfaction with conventional therapy are the key predictors for a decision to use alternative therapy. Overall, younger patients used more alternative therapy (odds ratio, 1.67; P < 0.0001; 95% CI, 1.32-2.13), and those who were very satisfied with their conventional treatment used less alternative therapy (odds ratio, 0.55; P < 0.0001; 95% CI, 0.38-0.79). Sex, level of education, employment status, income, private health insurance, diagnosis, expectations at beginning of treatment or impressions at the end of treatment were not significantly associated with use of alternative therapy. Discussion Any discussion of alternative medicine is complicated by arguments about terminology. The most commonly used terms in the literature are "alternative", "complementary" or "unproven". Some have suggested that the term "alternative" is spurious, because it suggests equally valid options, 3 but we have chosen to use it because it is in common use in describing treatments outside conventional medicine. "Complementary" may seem an appropriate term for a study of patients attending a hospital, but it suggests therapies that are valuable when combined with conventional medicine. "Unproven" is the American Cancer Society's preferred term and relates to methods that are "on the basis of careful review by scientists and/or clinicians, not deemed proven, nor recommended for current use". 4 It has also been suggested that "There are no unproven treatments for universally curable diseases" 5 -- the very fact that this issue is so controversial in cancer medicine suggests that conventional treatment has a long way to go in optimising management of malignant disease. Previous studies have shown that between 9% and 54% of adult cancer patients use some form of alternative medicine, 6-10 while a recent Australian study reported a 46% rate of alternative therapy use in a paediatric oncology population. 11 The rate of alternative medicine use in our study (21.9%) is within this range. It may not be an accurate reflection of alternative therapy use in cancer patients as our patients' response to the questionnaire was voluntary, creating a potential selection bias. Nevertheless it does indicate that a significant proportion of cancer patients use some form of alternative therapy, and gives some idea of the current range of therapies. Several features of our study population should be considered when relating our results to other populations. Royal North Shore Hospital services the northern Sydney area, where the population is characterised by being relatively wealthy, and having high levels of education and private health insurance. Port Macquarie Base Hospital serves a community with a large retired population and relative wealth (by rural standards). The high prevalence of breast cancer managed by this unit explains the predominance of women in the group studied. There was a high level of optimism at the outset of both conventional treatment and alternative therapy (85.6% v. 63.0% belief in cure/life-prolongation), which fell modestly by completion of treatment (72.9% v. 48.6%). As most patients were receiving palliative chemotherapy, it seems that many patients had an unrealistic expectation about the goals of treatment. This reinforces the need for clear communication with patients. However, most patients were highly satisfied with both conventional and alternative treatments (75.3% v. 70.0%), and dissatisfaction was almost non-existent (3.1% v. 1.4%). This high level of satisfaction, often in the absence of objective benefit, has been described in studies of conventional 12 and alternative 6,11 medicine, and may be related to a hope engendered by the intervention of a clinician. 13,14 As in other studies which report that patients will frequently try multiple alternative therapies, 6,11 we found that over 75% of patients used two or more therapies. Alternative therapies available in Australia appear to be a mixture of the British and United States experience. Psychological methods such as relaxation, imagery and healing, which are prevalent in the United Kingdom, 6 and interventional methods, such as diet and megavitamins, more common in the US, 7 are used with similar frequency. The predominance of friend and family recommendation (52.9%) as the source of information on alternative medicine may partially explain the significantly increased use by married patients. The contribution of recommendation by doctors is comparatively low, but it must be remembered that these patients were attending an oncology service. Of course, some cancer patients may not seek conventional care, and consultations with alternative practitioners, or with medical practitioners who combine conventional and alternative therapies, are becoming more common. 15,16 In the US there are currently more referrals to alternative practitioners than to primary care physicians. 17 Many studies report the significant financial costs of alternative medicine. 5,9,18-20 There is a wide variation in the cost of various therapies, with psychological methods usually far less expensive than interventions such as metabolic therapy, Laetrile and high-dose vitamin C. In one US study, the median annual outlay was US$262, and the mean was US$3492, suggesting enormous expense in some cases. 7 Our findings are similar, with expenditure ranging from nothing to $20 000 per year. However, nearly all of those using alternative medicine felt they were getting value for money. Previous studies have reported that users of alternative therapy tend to be young, female, of higher social class and more highly educated, while income, increased time since cancer diagnosis, increased number of people in a household, and tumour site may be associated with alternative therapy use. 6,7,9 We found that being young and being married were significantly associated with increased use, and that those who were very satisfied with conventional therapy used less alternative therapy. The finding that being married is associated with increased use of alternative therapy may be related to having increased numbers in a household, 9 and perhaps greater access to ideas and support for trying new things. Many patients in our study did not discuss their use of alternative therapy with their physicians, possibly because they were afraid of getting a negative response. This may reflect a need to improve doctor-patient communication. If a proportion of patients are going to use alternative therapies, it is important that their doctors are informed: firstly, so that possible interactions and complications can be avoided, and, secondly, to enable doctors to provide informed opinion on the alternative choices available. Acknowledgements We thank Professor John A Levi and Dr Helen R Wheeler for contributing their patients to the study. References MacLennan AH, Wilson DH, Taylor AW. Prevalence and cost of alternative medicine in Australia. Lancet 1996; 347: 569-573. SPSS: Statistical package for the social sciences [computer program], version 5. Chicago, Ill: SPSS inc, 1990. McGinnis LS. Alternative therapies, 1990. An overview. Cancer 1991; 67: 1788-1792. Pamphlet number 3028-REV. Atlanta, Ga.: American Cancer Society, 1990. Cassileth BR. The social implications of questionable cancer therapies. CA Cancer J Clin 1989; 39: 311-316. Downer SM, Cody MM, McCluskey P, et al. Pursuit and practice of complementary therapies by cancer patients receiving conventional treatment. BMJ 1994; 309: 86-89. Cassileth BR, Lusk EJ, Strouse TB, Bodenheimer BA. Contemporary unorthodox treatments in cancer medicine. A study of patients, treatments and practitioners. Ann Intern Med 1984; 101: 105-112. Harris L and associates. Health information and the use of questionable treatments: a study of the American Public, 1987. Washington DC: Department of Health and Human Services, 1987. Lerner IJ, Kennedy BJ. The prevalence of questionable methods of cancer treatments in the United States. CA Cancer J Clin 1992; 42: 181-191. Miller MJ, Boyer MJ, Dunn SM, et al. Why do Australian cancer patients use unproven therapies? Proc Clin Oncol Soc Aust 1995; 22: 78. Sawyer MG, Gannom AF, Toogood IR, et al. The use of alternative therapies by children with cancer. Med J Aust 1994; 160: 320-322. Coates A, Gebski V, Bishop JF, et al. Improving the quality of life during chemotherapy for advanced breast cancer. N Engl J Med 1987; 317: 1490-1495. Stoll BA. Can unorthodox cancer therapy improve quality of life? Ann Oncol 1993; 4: 121-123. Kodish E, Post SG. Oncology and hope. J Clin Oncol 1995; 13: 1817-1822. Borkan J, Neher JO, Anson O, Smoker B. Referrals for Alternative therapies. J Fam Prac 1994; 39: 545-550. Paterson C, Peacock W. Complementary practitioners as part of the primary health care team: evaluation of one model. Br J Gen Pract 1995; 45: 255-258. Burke C, Sikora K. Complementary and conventional cancer care: the integration of two cultures. Clin Oncol 1993; 5: 220-227. Guzley GJ. Alternative cancer treatments: impact of unorthodox therapy on the patient with cancer. South Med J 1992; 85: 519-523. Cassileth BR, Lusk EJ, Guerry D, et al. Survival and quality of life among patients receiving unproven as compared with conventional cancer therapy. N Eng J Med 1991; 324: 1180-1185. Ernst E. Complementary medicine: common misconceptions. J R Soc Med 1995; 88: 244-247. (Received 24 Jan, accepted 5 Aug 1996) Authors' details Department of Clinical Oncology, Royal North Shore Hospital, Sydney, NSW. Stephen D Begbie, MB BS, Oncology Registrar; Zoltan L Kerestes, PhD, Computer Scientist; David R Bell, MB BS, FRACP, Medical Oncologist. Reprints: Dr D R Bell, Department of Medical Oncology, Royal North Shore Hospital, St Leonards, NSW 2065. - To top of article - ©MJA 1996 <URL: http://www.mja.com.au/> © 1996 Medical Journal of Australia.

Stephen D Begbie · Zoltan L Kerestes · David R Bell