Letters

Paul J Gow,* Nathan J Connelly,† Richard L Hill,‡ Peter Crowley,§ Peter W Angus¶ * Gastroenterologist, † Gastroenterology Registrar, ¶ Director, Department of Gastroenterology and Liver Transplantation, § Pathologist, Department of Anatomical Pathology, Austin and Repatriation Medical Centre, Studley Road, Heidelberg, VIC 3084; ‡ Medical Officer, Adverse Drug Reactions Unit, Therapeutic Goods Administration, Canberra. paul.gowATarmc.org.au In reply: Thomsen et al raise several points regarding our recent report of a death following ingestion of a preparation containing kava.1 The first is that the results of their analysis of the herbal preparation differ from those of the Therapeutic Goods Administration (TGA). The TGA found Passiflora incarnata in the tablets, whereas Thomsen and colleagues did not. The explanation for this lies in the fact that different batches of the product were analysed by the two laboratories. The analysis we reported relates to batch 13861, which was the source of the patient’s tablets. Thomsen and colleagues have analysed material from a different batch that may have contained different components. Thomsen et al also raise the possibility that Teucrium, a known adulterant of Scutellaria, may have been present in the preparation. With respect to this issue, the TGA tested for both T. chamaedrys and T. canadensis and found none present. They also tested for the presence of the chemicals teucreoside and verbascoside, both of which are found in many Teucrium species. Neither was present. The raw materials used to make the tablets were also analysed, and no evidence of Teucrium substitution or contamination could be found. The next point raised is whether the association between kava use and hepatotoxicity is causal, and they quote an analysis published in the journal Phytomedicine, in which the authors claimed that kava was the probable cause in only two of 68 reviewed cases. In marked contrast, the Journal of Hepatology, in July 2003, published an analysis of 36 cases of hepatitis associated with the use of kava.2 The review concluded that kava was the certain or probable cause of the hepatitis in 24 of the 36 cases. Worryingly, eight of these patients required liver transplantation. Thomsen and colleagues then point to a lack of evidence of hepatotoxicity in studies in rats administered kavalactones.3 We believe it is inappropriate and misleading to suggest that a study of this kind could rule out the possibility that kava preparations cause life-threatening but uncommon idiosyncratic hepatotoxic reactions in humans. Finally, Thomsen et al wonder whether the patient’s illness may have been due to chromium toxicity. However, the illness was not suggestive of chromium poisoning.4 There is no reason to believe that chromium was present at other than normal background levels.

Paul J Gow · Nathan J Connelly · Richard L Hill · Peter Crowley · Peter W Angus

Colin L Crawford Retired physician, 23 Grafton Road, London, W3 6PB, UK clcraw13AThotmail.com To the Editor: The Australian Drug Evaluation Committee (ADEC) has recommended that thalidomide be approved for the management of erythema nodosum leprosum. This recommendation has now been accepted by the Therapeutic Goods Administration. Was ADEC unaware that the World Health Organization no longer recommends thalidomide in the management of this complication of lepromatous leprosy?1,2

Colin L Crawford

Martin H N Tattersall Chairman, Australian Drug Evaluation Committee; and Professor of Cancer Medicine, Blackburn Building D06, University of Sydney, Sydney, NSW 2006 mtattATmed.usyd.edu.au In reply: When it considered thalidomide for registration for management of erythema nodosum leprosum (ENL) and another indication (myeloma), the Australian Drug Evaluation Committee (ADEC) was not aware that the World Health Organization (WHO) does not recommend the drug for this indication. ADEC bases its recommendations on review of the scientific and clinical evidence submitted concerning the efficacy and safety of products submitted for registration. In the case of thalidomide in the management of ENL, ADEC reviewed the results of several randomised studies, together with additional published reports. Data from the US Public Health Service analysing the entire experience of thalidomide use in ENL in the United States from 1978 to 1994 were also reviewed. The committee concluded that the efficacy of thalidomide in acute ENL is beyond dispute. Moreover, thalidomide was also shown to be useful in patients with ENL already treated with corticosteroids and dapsone. ADEC discussed the side-effect profile of thalidomide in the ENL studies and concluded that skin rashes, sometimes with eosinophilia, were somewhat more common than in the myeloma studies that were also reviewed. In regard to safety concerns relating to thalidomide’s teratogenicity, the committee was informed of the sponsor’s proposed risk management program, which is based on mandatory registration of prescribing doctors, patients and dispensing pharmacists. This program is based on an effective program in the US, where the Food and Drug Administration has registered thalidomide for treatment of ENL. ADEC felt that the risk–benefit ratio favoured registration for ENL (and myeloma). However, the committee resolved that a boxed warning should be included stating: Thalidomide has caused severe birth defects when taken during pregnancy. Thalidomide should never be used by women who are pregnant or who could become pregnant whilst taking the drug, or could become pregnant within four weeks after stopping the drug. Even a single dose can cause severe birth defects. I have reviewed the WHO documents referred to by Crawford,1,2 and consulted Medline. I have also had access to a review article in press in the Lancet.3 I believe the evidence indicates that thalidomide is superior to steroids in controlling ENL. Britton and Lockwood state that thalidomide is the drug of choice for men with ENL;3 however, they comment that using thalidomide in women with ENL is a difficult decision for a woman and her doctor. The WHO documents emphasise that any benefit from thalidomide must be balanced against its known toxicity, and conclude that experience has shown that it is virtually impossible to develop and implement a foolproof surveillance mechanism to combat thalidomide toxicity. ADEC concludes that thalidomide is an effective and useful drug in the management of ENL, and that the risk management program which is to be established in Australia, together with the inclusion of a boxed warning, will ensure that the risk–benefit profile of thalidomide use in ENL is favourable.

Martin H N Tattersall

Lynne M Roberts,* Lucy Bowyer,† Caroline S Homer,‡ Mark A Brown§ * Research Midwife [corresponding author], † Senior Lecturer in Obstetrics (University of New South Wales), ‡ Midwifery Consultant, Department of Women’s and Children’s Health, St George Hospital, Research Building, St George Hospital, Kensington Street, Kogarah, Sydney, NSW 2217; § Professor of Medicine (University of New South Wales), Department of Renal Medicine, St George Hospital. RobertslyATsesahs.nsw.gov.au To the Editor: The obstacles presented by Human Research Ethics Committees (HRECs) have caused a significant delay in commencing a valuable research project. We are currently conducting a multicentre study investigating the outcomes of hypertensive pregnancies in a cohort of 1620 women. It is a retrospective review of medical records and does not entail any participation of the women. Ethics approval was sought and gained from the New South Wales Health Department and one other NSW area health service (AHS) involved in the study. The bulk of the medical records (85%) are held by this AHS and a smaller proportion by eight other AHSs in NSW. Despite these prior approvals, the process of gaining ethics approval from the eight AHSs was fraught with obstacles at every stage. After 8 months’ work, we have received approval from the HREC of each of the AHSs. Our experience has revealed many inconsistencies in the requirements of the HRECs in the different AHSs, as summarised in the Box 1. These inconsistencies highlight discordances with the guidelines to support researchers and HRECs drawn up by the National Health and Medical Research Council (NHMRC). The NHMRC’s National Statement on Ethical Conduct in Research Involving Humans1 clearly outlines that, once approval has been gained from one HREC, other sites should accept that approval. Unfortunately, it seems that the HRECs involved in giving approval for our study did not follow the guidelines relating to multicentre projects. Other researchers have reported similar problems. 2-4 Breen and Hacker2 suggest that HRECs are slow to adopt a simplified review process because this interferes with traditional practices of each committee making its own assessment. It is indisputable that ethics considerations are a vital component when undertaking human research. It is also crucial to have a reliable and trustworthy process that evaluates research proposals in order to protect participants from physical and psychological harm. However, it has taken the research midwife (who is on a 1-year non-renewable grant) 8 months to secure ethical approval at all sites. This process is cumbersome and counterintuitive to the principles and guidelines for multicentre research in this country. 1: Summary, by area health service (AHS, coded S to Z), of different requirements for gaining ethics approval for a multicentre study Area health service S T U V W X Y Z No. of pages of application form 19 20 19 20 12 23 2 11 No. of copies of form required 1 1 17 15 20 16 1 14 No. of hospitals in AHS covered by approval 2 2 4 1 3 5 3 5 Approval covered private hospitals in AHS also na na Yes No No na No na No. of contacts made (phone/letter/email) to gain approval 20 15 20 15 20 30 10 20 Time taken to gain approval 3 months 5 months 4.5 months 8 weeks 6 weeks 6 weeks 1 week 3 weeks Special requests during approval process A F A, B, C, E A A, D A G, H Approved after first submission Yes No No Yes Yes Yes Yes Yes na = not applicable. A = Asked for local researcher to be a contact person for the study. B = Charged a $33 fee to submit application. C = Requested scientific protocol with references. D = Requested budget form. E = Reviewed by scientific advisory committee before human research ethics committee (HREC). F = Requested consent and subject information forms. G = University HREC’s approval as well as approval of area health service HREC required. H = Final approval required from chief executive officer of major hospital in that AHS.

Lynne M Roberts · Lucy Bowyer · Caroline S Homer · Mark A Brown

Gautam Ramnath,* Peter Bampton† * Gastroenterology Registrar, † Head of Endoscopy, Department of Gastroenterology and Hepatology, Flinders Medical Centre, Bedford Park, SA 5042. peter.bamptonATflinders.edu.au To the Editor: Reflux oesophagitis is an increasingly common medical condition, and up to 10% of all patients with reflux oesophagitis have associated columnar-lined oesophagus, or Barrett’s oesophagus (Box 1).1 This is associated with an increased risk of adenocarcinoma in Australian data of 1 in 176 patient-years.2 Current surveillance guidelines for Barrett’s oesophagus recommend second-yearly endoscopy with quadrantic biopsies at 2–3 cm,3,4 although recent reviews have suggested that the time interval can be extended.1 No prospective study has demonstrated that screening for Barrett’s oesophagus improves survival in the screened population. All the evidence is based on retrospective reviews. If, however, screening is to be of benefit, then adequate tissue sampling is required, otherwise the screening test provides false reassurance and is a poor use of endoscopy resources. We retrospectively audited the endoscopies performed for Barrett’s oesophagus (with intestinal metaplasia) surveillance at our institution over 5 years (1996–2001). In this period, 253 endoscopies were performed as surveillance procedures for Barrett’s oesophagus. We reviewed the endoscopy and histopathology reports to determine whether an adequate number of biopsies had been taken. We found that quadrantic biopsies (defined as four biopsies per 2 cm or less) at every 2–3 cm were performed in 27 of 72 (38%) short-segment, 27 of 150 (25%) long-segment (3–10 cm), and 1 of 13 (8%) extensive (> 10 cm) Barrett’s oesophagus. An acceptable number of biopsies were taken from 40% of patients. The number of biopsies taken per centimetre of Barrett’s oesophagus was inversely proportional to the length of Barrett’s oesophagus. The median interval between surveillance procedures was 12 months. In most surveillance procedures (137/217; 63%) the endoscopy was performed following medical review in the outpatient department rather than because of planned call-back, although in only a few cases did it appear to be due to alarm symptoms such as dysphagia or weight loss. There was little consistency in recommendations among the medical staff. Only one cancer was identified through surveillance in this period, with another presenting in a patient previously on the call-back system who had been lost to follow-up. Three high-grade dysplasias were found. Our retrospective audit revealed that the endoscopists were not following biopsy guidelines, and revealed significant variances in practice. Previously, we found a similar picture with post-polypectomy surveillance; with re-education and development of a prospective review of all cases, we have been able to greatly improve this aspect of practice.5 We were surprised at the result of our audit, and invite other endoscopy units to perform a similar audit of their own practice. It has encouraged us to develop a process similar to the one we have adopted to improve post-polypectomy surveillance. This should improve our practice and enable more efficient utilisation of the endoscopy facility. 1: Barrett’s oesophagus

Gautam Ramnath · Peter Bampton

Mark R Nelson NHMRC Research Fellow, Department of Epidemiology and Preventive Medicine, Monash University, Commercial Road, Prahran, VIC 3181. mark.nelsonATmed.monash.edu.au To the Editor: The lessons from the introduction of COX-2-selective non-steroidal anti-inflammatory drugs (NSAIDs), related by Kerr et al,1 have a corollary in the introduction of angiotensin-II-receptor antagonists 2 years previously. Both cases involved common conditions (osteoarthritis and hypertension), with extensive prescribing of newly developed and marketed agents, which blocked an enzyme further down the cascade of reactions to avoid adverse outcomes — the gastrointestinal upset and bleeding associated with non-selective NSAIDs, and the cough and angioedema caused by angiotensin-converting enzyme inhibitors. In both conditions, off-patent, low-cost alternative drug therapies were available — paracetamol and acetylsalicylic acid, and thiazide diuretics and β-blockers, respectively. My quantitative investigation of general practitioners’ perceptions of newer versus older antihypertensive agents suggested that they thought newer agents were more efficacious, and were safer in the short term and long term, but were more expensive.2 These beliefs were held despite the lack of long-term safety data. Younger doctors were more likely to hold these beliefs. It is possible that the experience of using older medications permitted older doctors to maintain a healthy scepticism towards the marketing claims of medical representatives. It may be interesting for Kerr and colleagues to look at the demographics of GPs in the General Practice Research Network to see if these findings hold true for this cohort.

Mark R Nelson

Ian D Coombes,* Danielle A Stowasser,† Charles A Mitchell,‡ Paul Varghese§ * Leader, Adverse Drug Event Prevention Project, Queensland Health Medication Management Services, ‡ Associate Professor of Medicine, § Director of Geriatric Medicine, Princess Alexandra Hospital, Ipswich Road, Woolloongabba, QLD 4102; †Manager, Queensland Health Medication Management Services, Royal Brisbane Hospital, Brisbane, QLD. Ian_coombesAThealth.qld.gov.au To the Editor: We would like to add our perspective to the discussion on computerised prescribing.1 Electronic prescribing with appropriate decision support is recognised by the Medication Safety Taskforce of the Australian Council for Safety and Quality in Health Care as a key initiative to prevent patient harm.2 Such systems reduce the opportunity for prescribing errors and improve patient safety.3 The widely espoused benefit of the clarity and legibility associated with electronic prescribing appears to have led many to assume that electronic prescribing is an essential component of medication safety systems whether or not it includes a decision support system. In fact, electronic prescribing without decision support has been associated with an increase in the incidence of error4 and inappropriate use of medications.1 A computer-generated discharge summary was developed at a tertiary referral teaching hospital in Brisbane. With this system, a discharge prescription was generated using information entered from the database by the medical officer. As part of standard practice, a pharmacist reviews all discharge prescriptions and compares them with the inpatient medication chart, discussing any apparent errors with the medical officer. We conducted an audit of 200 consecutive medical discharge prescriptions (100 generated by computer and 100 handwritten) in mid-2001. The errors detected are summarised in the Box. The same medical staff were responsible for both types of prescriptions. Significantly more errors in prescribing were noted for the computer-generated prescriptions than for the handwritten scripts (P < 0.001). The proportion of errors with potential for harm was similar in both groups. Three specific types of error occurred more frequently with electronic prescribing. We can speculate that dosing errors occurred when previous discharges were copied and the previous dose was continued, duration errors occurred as a result of a computer default to 10 days’ therapy, and the continuation of drugs not required for discharge resulted from copying previous medication records and not reviewing the current drugs prescribed. This uncontrolled observational audit demonstrated that electronic prescribing without decision support in busy medical wards can significantly increase the risk of patient harm when compared with the handwritten system. The discharge prescription component of this system was withdrawn on the basis of this audit, and the paper-based system reinstituted until a safer alternative becomes available. 1: Comparison of error rates with electronic and handwritten discharge prescribing systems Examples of prescribing errors Computer Handwritten Number of prescriptions 100 100 Number of drugs 700 605 Omissions Warfarin and irbesartan omitted 12 16 Duplications Spironolactone and atorvastatin duplicated 2 0 Dosing errors Prednisolone 50 mg in the morning for 10 days ordered: should have been reducing by 10 mg every second day 25 5 Drug errors Diltiazem oral 60 mg three times a day ordered: should have been diltiazem slow release 180 mg in the morning 4 4 Drug name unclear Fluticasone inhaler: no strength 6 0 Duration error Antibiotics intended for 3 or 5 days: ordered for 10 days (default quantity) 13 1 Drug not required on discharge Frusemide 80 mg twice daily was continued: the drug had been stopped during admission 15 4 Route error Glyceryl trinitrate 5 mg oral ordered: patch was the intended form of drug 3 0 Frequency error Carvedilol ordered for mornings: had been twice daily in hospital 1 0 Total number of errors 81 30 Error rate per item 11.6% 5.0%

Ian D Coombes · Danielle A Stowasser · Charles A Mitchell · Paul Varghese

Jane Turner,* Brian McAvoy,† Karen Luxford,‡ Jane Fletcher§ * Senior Lecturer, Department of Psychiatry, University of Queensland, Herston, QLD; † Deputy Director, § Senior Project Officer, National Cancer Control Initiative, Carlton, VIC; ‡ Program Director, National Breast Cancer Centre, Camperdown, NSW. jane.turnerATuq.edu.au To the Editor: The Supplement on palliative care (15 Sep 2003) provided a welcome overview of this critical area of clinical practice. 1 Many of the articles emphasised the generalist nature of palliative care and the importance of multidisciplinary care and teamwork. Recently published guidelines2 now provide evidence-based information on psychosocial aspects of care for health professionals working in the field, as well as surgeons, radiation oncologists, medical oncologists, general practitioners, nurses, social workers, psychologists, psychiatrists, physiotherapists and occupational therapists. These are the world’s first comprehensive, evidence-based guidelines on the social, psychological and economic impacts of cancer and how these can be better prevented, managed and treated by health professionals. They cover the whole spectrum of cancer care, from diagnosis through to treatment and palliation. The guidelines are based on comprehensive and systematic reviews of the international research literature and an extensive consultative process to ensure their clinical relevance. Developed by the National Breast Cancer Centre and the National Cancer Control Initiative (NCCI) and funded by the Federal Government, the guidelines were approved by the National Health and Medical Research Council (NHMRC) in April 2003. The guidelines cover the most commonly occurring cancers: colorectal, breast, gynaecological, head-and-neck, lung, pancreatic, prostate and urogenital cancers, and melanoma and non-Hodgkin’s lymphoma. Recommendations for clinical practice are rated according to NHMRC levels of evidence.3 Four main areas are addressed by the guidelines: understanding the challenges of cancer and how people react; provision of care by the treatment team to all patients with cancer; referral for specialised care; issues requiring special consideration — culture, age, geography and sexual orientation. The guidelines were developed to assist health professionals in supporting adult cancer patients. This includes providing information and choice to patients, helping them deal with procedures and treatments, providing emotional and social support, ensuring continuity of care, and dealing with specific concerns that may arise, including anxiety and depression. The guidelines can be accessed at the NCCI’s website (www.ncci.org.au), or hard copies can be obtained from the National Breast Cancer Centre.

Jane Turner · Brian McAvoy · Karen Luxford · Jane Fletcher

David J Blacker Neurologist and Stroke Physician, Sir Charles Gairdner Hospital, Hospital Avenue, Nedlands, WA 6009. davidblackermdAThotmail.com To the Editor: I respect the opinion of Hoffman1 and others who have recently expressed concerns about the use of tissue plasminogen activator (tPA) in patients with ischaemic stroke. However, it is critical that these views do not dampen the enthusiasm for better stroke treatments. The Therapeutic Goods Administration recently approved tPA for ischaemic stroke patients with symptoms of less than 3 hours’ duration. This approval has catalysed collaboration between stroke units around Australia and may provide benefits to patients who do not receive tPA, by improving clinical pathways, as well as a more coordinated approach to treatment. Internationally acclaimed Australian stroke experts have already rebutted the arguments of opponents of the National Institute of Neurological Disorders and Stroke (NINDS) trial, 2,3 and an independent reanalysis of the NINDS data showed tPA to be more effective than originally reported.4 It is time to stop bickering about the NINDS trial5 and move forward, by focusing on a collaborative effort between emergency departments and stroke teams. In the near future, there will surely be better data on new-generation thrombolytics and other agents; all will operate on similar “time is brain” protocols, as did the NINDS trial. Obviously, more data would be useful, but when clinicians are faced with patients with acute stroke today they must give the patients and their families the facts about tPA, regardless of their personal opinion. These are best expressed in terms of the absolute risk reduction for disability seen in the NINDs trial. It is interesting to note the widespread discomfort with the 6.4% risk of intracerebral haemorrhage (half of which were fatal) in this trial of a “medical” therapy. Surgeons quote similar morbidity and mortality risks every day to patients undergoing procedures such as coronary artery bypass grafting. Additionally, many surgical procedures became established on much less solid evidence than the NINDs trial, and yet there is no outcry. For example, many thousands of carotid endarterectomies were performed before the publication of controlled-trial data. In properly selected patients in expert hands, we now have a treatment that works. Its risks should not be underestimated, but should also be placed into context when compared with other powerful therapies for serious illnesses. Patients presenting with acute ischaemic stroke in Australia today have the chance to benefit from tPA, but future patients will benefit even more, partly because of the process that is being undertaken to institute pathways for using this drug.

David J Blacker

Jerome R Hoffman Professor of Medicine and Emergency Medicine, UCLA School of Medicine, Los Angeles, California, USA. jrhATucla.edu In reply: I agree with Blacker that enthusiasm generated by thrombolytic therapy could lead to benefit for stroke patients, independent of whether the therapy is actually useful, or even whether they receive it. However, I believe there are better ways to encourage rational stroke care. I also acknowledge that some experts believe thrombolysis is proven to be beneficial if used in accordance with NINDS (National Institute of Neurological Disorders and Stroke) guidelines. Others believe the question is not yet settled and are concerned that widespread adoption of the guidelines will lead to more harm than good. It is one thing to enthuse about possible benefits of a treatment, particularly for a devastating disease for which we have traditionally had little to offer. It is entirely different to embrace this therapy, even though it may be harmful overall, simply out of this frustration. I disagree with Blacker that the best way to inform patients about thrombolysis is “in terms of the absolute risk reduction for disability seen in the NINDS trial”. Regardless of concerns about the trial itself, it is always foolhardy to accept data from one small study as “the truth”. Many other trials have found far worse results — it would be equally inappropriate to base all estimates on their worst outcomes. Finally, there is strong evidence that, even if NINDS-like “success” could be achieved under optimal circumstances, routine use in the community might well lead to overall harm. I am also cautious about Blacker’s comparison of thrombolysis and some surgical procedures in terms of adverse effect rates. No single adverse effect rate is or is not acceptable for all interventions — a 90% rate of intracerebral haemorrhage could be acceptable in a disease with 100% mortality, while a 2% rate would be completely unacceptable in a disease with no long-term morbidity. Furthermore, the adoption of many surgical interventions in the absence of persuasive evidence does not justify repeating this mistake. Of course we must routinely make decisions without definitive evidence, based on our best estimates of benefits and harms. We should never take such decisions lightly, and should in general embrace the precautionary principle, which tells us not to adopt new therapies without reasonable evidence of their safety (especially when any benefit is likely to be extremely small). Although some advocates support thrombolysis based on current knowledge, my reading of available evidence is far less sanguine. That is why I continue to argue that this treatment should not be introduced into routine practice until far better evidence of its benefit outweighing its harm becomes available. Given the possibility that this treatment will harm stroke patients overall, and the likelihood that any potential benefit is very limited for the stroke population as a whole, I ask once again, why is so much being made of so little?

Jerome R Hoffman

Matthew T Naughton,* Darren R Mansfield,* David M Kaye,† Peter Bergin,† Meroula Richardson† * Respiratory Physician, † Cardiologist, Alfred Hospital, PO Box 315, Prahran, VIC 3181. m.naughtonATalfred.org.au To the Editor: We were surprised that Campbell’s recent article on heart failure1 made no mention of sleep apnoea. This is despite the fact that about 50% of heart failure patients have sleep apnoea (either central or obstructive) and that quite a large body of literature now supports a causative relationship between obstructive sleep apnoea and congestive heart failure, supported by recent authoritative reviews. 2-4 Canine studies have shown that, in the absence of any other variable, obstructive sleep apnoea results in left ventricular systolic and diastolic dysfunction. Importantly, the impact of continuous positive airway pressure (CPAP) in acute cardiogenic pulmonary oedema and subacute pulmonary oedema (central sleep apnoea) and heart failure in the setting of obstructive sleep apnoea are not mentioned. Identification and treatment of sleep apnoea in people with heart failure is supported by a trial we have recently conducted in which significant improvements in quality of life and objective markers of cardiac function were seen in patients treated with nasal CPAP.5

Matthew T Naughton · Darren R Mansfield · David M Kaye · Peter Bergin · Meroula Richardson

Duncan J Campbell Senior Research Fellow, St Vincent's Institute of Medical Research, 41 Victoria Parade, Fitzroy, VIC 3065. J. CampbellATmedicine.unimelb.edu.au In reply: I am grateful to Naughton and colleagues for their contribution to the debate about how we might prevent the epidemic of heart failure. I agree that both obstructive and central sleep apnoea are frequently associated with heart failure and that treatment of sleep apnoea can improve cardiac function. However, as indicated by its title, my article focused on how we might prevent heart failure. Central sleep apnoea in heart failure is usually the consequence of the heart failure.1 Heart failure may contribute to obstructive sleep apnoea as well,2 and obstructive sleep apnoea may, in turn, be an important contributor to heart failure pathogenesis. Epidemiological evidence links obesity with hypertension and obstructive sleep apnoea.3 Significant sleep apnoea is present in about 40% of obese people, and about 70% of people with obstructive sleep apnoea are obese.3 Obesity and obstructive sleep apnoea may each contribute to one another, and both may contribute to hypertension. The need to prevent obstructive sleep apnoea is an argument for more effective prevention of obesity. In addition to reducing its metabolic consequences, preventing obesity is likely to reduce the incidence of hypertension and obstructive sleep apnoea, and to thereby decrease the incidence of heart failure. For people with obstructive sleep apnoea not caused by obesity, alternative strategies will be required to prevent and treat the sleep apnoea and thus prevent its consequences.

Duncan J Campbell

Balakrishnan R Nair,* Brendan Flynn† * Director, † Medical Registrar, Division of Geriatric Medicine, John Hunter Hospital, New Lambton, NSW 2291. knairATmail.newcastle.edu.au To the Editor: We refer to the recent article by Parslow and Jorm1 and the editorial by Headey2 on the link between pet ownership and health outcomes. There is no evidence that pet ownership per se confers cardiovascular benefits. Indeed, the findings of the study were that pet owners were more likely to smoke, had a higher diastolic blood pressure and a higher body mass index than the non-pet owners. The editorial points out that, based on sociological studies, it is likely that pet ownership does have a positive effect on health, but the medical data demonstrating how this is achieved are lacking.2 Might there be other negative effects of pet ownership on health outcomes? A patient under our care recently demonstrated the potential risks involved in pet companionship for elderly people. An 81-year-old woman who was living independently was admitted after a fall caused by tripping over her delightful Himalayan Persian cat. Her presenting symptom was severe back pain exacerbated by weight bearing. However, no bony abnormality was identified. She had difficulty mobilising initially, and the outcome of her fall was significant morbidity with some loss of her previous mobility, even on discharge. She stayed in hospital for 12 days. A follow-up phone call revealed that the patient was still experiencing difficulty mobilising some 2 weeks after discharge. This case raises the possibility that the risks may outweigh the benefits of pet ownership in elderly people who are already at risk of falls. A MEDLINE search, using the terms elderly, trauma, cat, pet and fall (and combinations of these), did not reveal any relevant literature. A recent case report highlighted other cardiovascular issues relating to cat ownership.3 It described a patient who had recurrent episodes of syncope whenever her cat slept on the right side of her neck. The underlying mechanism was carotid sinus hypersensitivity. She required a single-lead ventricular pacemaker and for the cat to lie on her left side. Anecdotal evidence from colleagues highlighted the danger of “dogs taking elderly patients for walks”, resulting in rotator cuff injuries. Additionally, older patients with peripheral vascular disease and fragile skin have presented with non-healing ulcers from dog scratches. Pet ownership for the purpose of modifying cardiovascular risk factors would seem to be unwise in this population. However, the benefits of companionship and the pleasure derived from pets may outweigh the risk of falls for many elderly patients. Should we be doing more “cat scans” or “pet scans” in older patients?

Balakrishnan R Nair · Brendan Flynn

Michael McDonnell General Practitioner, and owner (with his wife) of Daisy and Cashew, 1/4 Mylne Street, Toowoomba, QLD 4350. To the Editor: Having read the article by Parslow and Jorm,1 I dashed to my surgery — praise the Lord, my diastolic blood pressure was 70 mmHg. So, I raced home again and reassured our labradors that they would not have to be shot. Let’s leave elderly pet owners and their blood pressures alone. Pet ownership is all about companionship, friendship, trust, care for your friend — the really important things in life — not your diastolic blood pressure!

Michael McDonnell

Alan E Dugdale Principal Honorary Research Fellow, Department of Paediatrics and Child Health, Medical School, University of Queensland, Herston, QLD 4006. A. DugdaleATuq.edu.au To the Editor: Chronic suppurative otitis media (CSOM) is a long-term problem which often has serious effects on hearing, speech and learning. Couzos and colleagues have shown that local treatment with ciprofloxacin (CIP) eardrops clears episodes of purulent discharge more efficiently than the commonly used framycetin, gramicidin and dexamethasone (FGD) eardrops.1 This hardly ranks as a “cure” as suggested by the authors. The natural history of CSOM is known2-4 (see Box). The disease commonly starts in infancy with painless perforation of the ear drum and purulent discharge. The perforation is usually central and often large. It remains for several years. During this time there are episodes of painless discharge of foul-smelling pus associated with a blocked ear canal and poor hearing. Between these episodes, the perforation remains, but the ear is usually dry and hearing can be normal or at least adequate. By mid-childhood the perforation often closes spontaneously. In some children this leaves a scarred retracted eardrum, but, in others, fluid collects behind the now intact drum, and this chronic serous otitis media decreases hearing. Eventually, this chronic serous otitis media clears, leaving a scarred, retracted eardrum. Hearing then improves and is often functionally normal. Cholesteatoma and other medical complications are uncommon, but the loss of hearing during childhood has severe social and educational effects on the child. Attempts to hasten closure of the perforation and limit the episodes of purulent discharge have had incomplete success.5,6 Any treatment that hastens recovery is welcome, but we should ask: Does local CIP treatment retain its effectiveness in repeated episodes of purulent discharge? (The most common organisms are Pseudomonas spp which rapidly develop resistance to antibiotics); Does CIP treatment alter the interval between purulent episodes compared with other treatments?; and Is there any evidence that local CIP treatment alters the natural history of the disease or lessens the hearing loss? (it is probably too early to detect this). CSOM is a disease of poverty and overcrowding, but the mechanism leading from social disadvantage to ear disease is not clear. In Cherbourg Aboriginal Community where I work, social and living conditions have improved and CSOM is now much less common than reported by Stuart and co-workers more than 25 years ago.2 I hope that treatment with local CIP eardrops will maintain its promise as a significant improvement in the management of this disease in children who have already acquired it, while we work towards eliminating the disease in the long term. Changes in the incidence of ear disease with age in an Aboriginal community (from Dugdale et al3)

Alan E Dugdale

David R Brewster Clinical Dean, Northern Territory Clinical School, Royal Darwin Hospital, PO Box 41326, Casuarina, NT 0811. david.brewsterATnt.gov.au To the Editor: Although the study by Couzos et al1 is important, I have serious concerns about (i) the lack of “intention-to-treat” analysis and (ii) the implication that the use of ototopical aminoglycosides is unethical and could lead to litigation. The CONSORT statement indicates that analysis by intention-to-treat (ITT) is a key measure of methodological quality in reporting of randomised trials.2,3 Of 147 children randomly allocated to the two treatments in this trial, the primary outcome (resolution of otorrhoea) is only reported for 111 children (75.5%), and the secondary outcomes of healed tympanic membrane perforation in 64 (43.5%), and of improved hearing in 49 (33.3%). In addition, although the difference in cure rates is indeed 24.6% if drop-outs are ignored, the authors report incorrect 95% confidence intervals (15.8%–33.4%, instead of 7.3%–41.8%). Analysis by intention-to-treat means that the 36 children lost to follow-up are assumed to still have ear discharge, so 33 of 75 in the ciprofloxacin group and 43 of 72 in the combined framycetin, gramicidin and dexamethasone group would not have “clinical cure”. This reduces the absolute difference to 15.7% (95% CI, 0–32%; P = 0.07), which is no longer a significant difference. It is also unlikely that the clinical cure rates of 50%–70% in the study can be replicated in the real world of remote Top End Aboriginal communities with a high prevalence of chronic suppurative otitis media (CSOM). Cleaning ears twice a day with gentle syringing with 0.5% povidone-iodine, followed by ototopical ciprofloxacin for 10–14 days is not a feasible intervention among the competing priorities in most Aboriginal communities in the Northern Territory. The really important clinical outcomes for CSOM are the two secondary outcomes of healed perforations and improved hearing, but these outcomes were not significantly improved by ciprofloxacin compared with combined framycetin, gramicidin and dexamethasone. Couzos and colleagues conclude that the use of aminoglycosides in CSOM is unethical and could lead to litigation on the basis of potential ototoxicity. Were this true, it would make this trial unethical. This misuse of ethics and law in the medical literature must be denounced. Nearly all drugs have potential side effects which have to be measured against their potential benefits. The potential ototoxicity of ototopical aminoglycosides (and other antibiotics) is not an absolute contraindication to their use, and has not been documented in any of the randomised controlled trials that have measured hearing before and after use of topical aminoglycosides.4 Couzos and colleagues misinterpret the strength of evidence for changing to ototopical ciprofloxacin. Although it is probably true that ciprofloxacin is superior to combined framycetin, gramicidin and dexamethasone in eradicating Pseudomonas aeruginosa, and for the short-term resolution of ear discharge, it is still unclear whether this transient benefit will be maintained in the long term, or whether resistant organisms will emerge in the middle ear, mitigating any benefit from the new drug. Haphazard use of ototopical ciprofloxacin in Top End Aboriginal communities is likely to result in resistance (indeed there is already anecdotal and unpublished evidence of this), so I believe that its use should currently be restricted to studies and programs whose outcomes are healed perforations and improved hearing (rather than only transient resolution of ear discharge).

David R Brewster

Sophie Couzos,* Traven Lea,† Margaret Culbong,‡ Reinhold Mueller,§ Richard Murray¶ * NACCHO Public Health Officer, National Aboriginal Community Controlled Health Organisation, PO Box 927, Broome, WA 6725; † Former Clinical Project Officer, ‡ Chair, NACCHO Research Subcommittee, National Aboriginal Community Controlled Health Organisation, Deakin, ACT; § Senior Biostatistician and Epidemiologist, School of Public Health and Tropical Medicine, James Cook University, Townsville, QLD; ¶ Medical Director, Kimberley Aboriginal Medical Services Council, Broome, WA, and Associate Professor, School of Public Health and Tropical Medicine, James Cook University, Townsville, QLD. scouzosATtpgi.com.au In reply: Dugdale correctly refers to the natural history of chronic suppurative otitis media (CSOM), and the spectrum of endpoints. The primary endpoint chosen in our trial after ototopical treatment was a dry ear1 (commonly referred to as a “clinical cure” by other trials2), an outcome to be expected after short-term follow-up. Surgical closure of the tympanic membrane (TM) has also been defined as “curing” CSOM. Attaining a dry ear is essential to TM healing, and is therefore a functionally important outcome. Brewster seems to confuse intention-to-treat (ITT) analysis with sensitivity analysis. Patients for whom there is no data after random allocation to study groups fall into the “missing” category, and may be included as “failures” in a sensitivity analysis. This may reveal additional information if missing data occurred differentially (ie, in some way associated with the treatments). However, in an ITT analysis, patients (with recorded data) are analysed in the group to which they were randomly allocated, irrespective of the actual treatment they received.3 Our analysis followed this principle and included all children, irrespective of the completeness of their treatment regimen.1 A sensitivity analysis revealed no new information, which was not surprising as the missing data were lost for (ascertained) reasons exclusively unrelated to the treatment, and double-blinding excluded any differential follow-up efforts by the healthcare workers. Consequently, the missing values occurred randomly and our analysis not only follows the ITT principle but is also unbiased (ie, valid with respect to “missing” patients). We are surprised that our treatment regimen is not feasible in the Northern Territory given that it has been used for years in remote Aboriginal communities in Western Australia. We also confirmed the effectiveness of twice-daily use of ototopical medications, which is simpler than current four-times daily schedules. In 1996, the World Health Organization recommended that topical aminoglycosides (AG) not be used for CSOM because of ototoxicity.4 Such use is also contraindicated by manufacturers.1 Given the availability of a safer alternative, healthcare professionals face potential medicolegal challenges if they choose ototopical AG to treat CSOM. The relative superiority of ototopical fluoroquinolones (FQ) over AGs in effecting a dry ear is likely to persist with repeated treatments, as the risk of bacterial resistance generated in CSOM pathogens appears to be very small,5 and is far outweighed by the risks of resistance found with oral or parenteral FQs. In our trial, bacterial resistance to ciprofloxacin in ear isolates was not demonstrated in the short term. Systemic absorption of FQ through ototopical use is also negligible.5 In Japan, ototopical ofloxacin has been used as treatment for CSOM since 1992. Based on repeated nationwide surveys from 1995, increased FQ resistance attributed to ototopical use has not been seen in chronic otitis media isolates (Professor K Suzuki, Department of Otolaryngology, The Second Hospital, Fujita Health University School of Medicine, personal communication).6 Whether antibiotics can affect the interval between purulent episodes of CSOM is predicated on host and environmental factors, as well as the duration of effective drug therapy. A multifaceted approach to the problem of CSOM, requiring the political will to improve the living conditions of Aboriginal families, access to appropriate primary healthcare, ototopical FQs, and surgery will see a reduction in the rate of this disabling disease.

Sophie Couzos · Traven Lea · Margaret Culbong · Reinhold Mueller · Richard Murray

Terry J Coyne,* Michael G Findlay,† Torukiri I Ibiebele,‡ David W Firman§ * Senior Lecturer, School of Population Health, University of Queensland, Public Health Building, Medical School, Herston Road, Herston, QLD 4029; † Acting Senior Analyst, ‡ Assistant Analyst, Epidemiology Services Unit, Queensland Health, Brisbane; § Team Leader, Surveys and Social Statistics, Office of Economic and Statistical Research, The Treasury, Queensland Government, Brisbane.t.coyneATsph.edu.au To the Editor: While the rates of overweight and obesity among Australian adults, as determined by the Australian Diabetes, Obesity and Lifestyle Study (AusDiab),1 may be alarming to some, they may in fact be underestimates of the true prevalence of overweight and obesity. The AusDiab study design2 and its low response rates indicate that the results will need to be interpreted with caution. Firstly, the AusDiab study design excluded rural and predominantly Indigenous census collection districts (CDs). In Queensland, all CDs selected were capital city or other major urban centres (Rural and Remote Areas Classification, categories 1 and 2);3 thus, people living in major rural centres (such as Rockhampton or Bundaberg) or major remote centres (such as Mt Isa) were excluded (ie, in Queensland, about 20% of the population were excluded). Secondly, another potential bias may have been introduced by the Socio-Economic Indexes for Areas (SEIFA) scores of the CDs sampled in the AusDiab study. For example, the overall SEIFA score for the CDs included in Queensland was 1035 (73rd percentile), well above the state average. Finally, the response rates in the AusDiab study were low: only 29% of those estimated to be eligible, and only 52% of those invited, actually completed the study. Our analysis of risk factors of Queensland-AusDiab participants suggests that these participants may have been more health conscious than the general Queensland population. Rates of smoking reported for men and women were considerably lower in the Qld-AusDiab cohort compared with those in the Queensland phase of the 2001 National Health Survey4 (17.3% and 14.5% v 28.4% and 19.8%, respectively). Compared with results of a Queensland Omnibus telephone survey5 conducted at about the same time, higher proportions of Qld-AusDiab participants reported greater intakes of vegetables (≥ 4 serves/day: 27.4% Qld-AusDiab v 16.4% Omnibus) and fruit (≥ 2 serves/day: 28.9% v 24.3%), and less frequent consumption of fast foods (> 1 day/week: 37.3% v 49.5%). Given the low response rate and possible selection bias in the AusDiab study, we suggest that the overweight and obesity data should be interpreted with caution. Several indicators suggest that these data could be underestimates of the true prevalence of overweight and obesity, and that the AusDiab population may have been of higher socioeconomic status, more health conscious (lower rates of smoking, better dietary intake), and more willing to participate in a lengthy examination than the general Australian population. These factors may all be associated with lower rates of overweight and obesity, and therefore future national surveys will need to take these factors into consideration to obtain more accurate estimates of important determinants of health.

Terry J Coyne · Michael G Findlay · Torukiri I Ibiebele · David W Firman

Adrian J Cameron,* Paul Z Zimmet,† David W Dunstan,‡ Jonathan E Shaw§ * Epidemiologist, † Director, ‡ Research Fellow, § Physician in Diabetes, and Director, Clinical Research; Epidemiology Department, International Diabetes Institute, 250 Kooyong Road, Caulfield, VIC 3162. acameronATidi.org.au In reply: Coyne suggests that, based on comparisons within Queensland, the national prevalence of obesity in our article1 is an underestimate. It should be noted that the Australian Diabetes, Obesity and Lifestyle Study (AusDiab) was designed primarily to produce national, not state-specific, data. Forty-two census collection districts (CDs) were selected Australia-wide, with only six CDs selected within each state. The primary objective of this sample selection was to obtain a nationally representative population, not necessarily one representative of each state. Coyne states that none of the Queensland CDs were in major provincial centres. Of the six Queensland CDs, four were outside Brisbane. From the national sample, 17 of 42 CDs (40.5%) were outside capital cities. As a comparison, 36% of the Australian population lives outside capital cities.2 Regarding selection of CDs, we excluded only those in Statistical Local Areas defined as 100% rural, and those where the Indigenous population made up 10% or more of the overall population.3 This excluded only 5.8% of the total eligible population. If the prevalence of obesity among this group was double the overall prevalence, this would not significantly alter the national rate. While the smoking rates in AusDiab were lower than reported elsewhere, the prevalence of obesity, hypercholesterolaemia and hypertension were in line with trends in a series of surveys over the past 20 years.4 In an extensive analysis of food consumption between AusDiab and the 1995 National Nutrition Survey, the rates of fruit and vegetable consumption were within 4% between the surveys for those most commonly eaten. Since our conclusion was that obesity has increased, the possibility of an underestimate only reinforces our message.

Adrian J Cameron · Paul Z Zimmet · David W Dunstan · Jonathan E Shaw

Johan H A Janssen,* David Henshaw† * Cardiologist, † General Physician, Kalgoorlie Regional Hospital, PO Box 8035, Hannans, Kalgoorlie, WA 6433. Johan. JanssenAThealth.wa.gov.au To the Editor: We read with interest the article by Hung on aspirin for cardiovascular disease prevention,1 and would like to alert readers to the fact that, from the same studies Hung discussed, it is clear aspirin fails to prevent 80% of recurrent serious vascular events, and that one in eight high-risk patients will suffer from another “event” in the next 2 years while taking aspirin.2 Recent studies have triggered discussion about the concept of aspirin resistance and competitive binding issues as possible causes for the observed failure of aspirin, or indeed the increased risk of all-cause mortality when aspirin is used in combination with ibuprofen.3,4 Although it may still be premature to recommend routine testing for aspirin resistance, the possibility that testing might lead to improved strategies for reducing the risk of thrombotic complications means that it should be considered. Another point for consideration is whether primary prophylaxis with aspirin might induce aspirin resistance, thereby nullifying the effect of taking it in the first place. We agree with Hung that the current main alternative to aspirin is clopidogrel, and that this agent could be used in cases in which there is any doubt about the efficacy of aspirin.

Johan H A Janssen · David Henshaw

Joseph Hung Associate Professor, School of Medicine and Pharmacology, University of Western Australia, and Head of Department, Cardiovascular Medicine, Sir Charles Gairdner Hospital, Verdun Street, Nedlands, WA 6009. jhungATcyllene.uwa.edu.au In reply: Janssen and Henshaw are correct to point out that aspirin fails to prevent 80% of recurrent serious vascular events among high-risk patients. However, to put this into perspective, simple treatment with aspirin produces about the same relative risk reduction as treatment with a statin or the angiotensin-converting enzyme inhibitor, ramipril, among patients at high risk of vascular events.1-3 Janssen and Henshaw raise the concept of aspirin resistance and the role of a screening test. However, aspirin resistance is a poorly defined term, and could mean the clinical inability of aspirin to protect individuals from arterial thrombotic events, or laboratory measures indicating the failure of aspirin to inhibit platelet activity. There is currently no specific, accurate, and reproducible measure of the antiplatelet effects of aspirin, nor are there methods that can reliably predict the clinical efficacy of aspirin.4 For now, with high-risk patients, doctors should: ensure that patients comply with aspirin therapy along with other proven preventive treatments; avoid regular concomitant use of non-steroidal anti-inflammatory drugs with aspirin because of the potential for competitive inhibition;5 and consider the addition of clopidogrel to therapy with aspirin, so as to block other pathways of platelet activation not blocked by aspirin, particularly in patients who experience thrombotic complications during aspirin therapy.1

Joseph Hung

Bruce Hadden President, Royal Australian and New Zealand College of Ophthalmologists, Eye Institute, 125 Remuera Road, Auckland, 1005, New Zealand. bruceATeyeinstitute.co.nz To the Editor: The article by Brooks contains valuable forward-thinking for future healthcare management of the increasing burden of chronic illness.1 However, Brooks’s suggestion that non-medical practitioners might perform cataract extraction shows his lack of knowledge of the complexity and potential complications of modern cataract surgery. Modern cataract surgery is the most commonly performed major operation, and one of the most rewarding in lifestyle improvement. It is done under local anaesthetic with almost no discomfort, and recovery is rapid. Thus, the patient sees it as being simple. However, it is far from simple for the surgeon. The small-incision, phacoemulsification technique has made the operation more demanding than ever before. The learning curve is both long and steep. Posterior capsule rupture during phacoemulsification is an ever-present threat, and if it occurs, the sight-threatening complications of cystoid macular oedema, retinal detachment and endophthalmitis all become more likely. The modern, highly technical procedure that Australians demand and deserve is comparable with coronary artery bypass and joint replacement surgery in terms of the skill required. There are three reasons that non-ophthalmologists think cataract surgery is simple. First, it is simple from the patients’ perspective. Secondly, cataract extraction can be done relatively cheaply in developing countries. However, the operation done in those countries is a different procedure, and comparisons are not valid. Thirdly, some unscrupulous ophthalmologists themselves have trivialised the procedure as a means of self-promotion. Brooks and others would pay the operation much more respect if they took the trouble to view a few procedures in real life.

Bruce Hadden

R Frank Gorman Medical Ophthalmologist, PO Box 211 Marrickville, NSW, 1475. rfgormanAThotmail.com To the Editor: Ernst raises the matter of obstacles to research in complementary and alternative medicine. With respect to spinal manipulation therapy as an alternative medical approach to constitutional ailments, such as migraine, the key evidence is the recovery of vision, which occurs with spinal manipulation in appropriately ill patients. These data have not been acknowledged by this Journal because randomised controlled trials have not been performed. Ernst says, “Randomisation is only ethical if there is substantial uncertainty about the best treatment for that patient.”1 Applied to the recovery of vision with spinal manipulation, this ethical principle prevents any randomised trials from being performed in studying that phenomenon. In 1992, I sent 12 consecutive patients demonstrating constricted visual fields to four senior fellows of the then Royal Australian College of Ophthalmologists. The patients were examined by those consultant scrutineers, who agreed that the visual fields were constricted in all occasions. The patients were seen at independent locations, and I was present only on one occasion. The patients were then treated by spinal manipulation under anaesthesia, with immediate recovery of the visual fields being noted on wakening from anaesthesia.2 This recovery of vision merely reiterated many earlier anecdotal demonstrations.3-5 In every case, the scrutineers agreed that the vision had recovered when, at an independent location subsequent to the treatment, they saw the patients. Further, when Stephens and his associates, including me, treated 17 patients by outpatient chiropractic spinal adjustments, that entire group showed immediate improvement in the visual fields, as measured by computerised static perimetry.6 Sletteberg and his associates found that 55% of patients with constricted visual fields of the type under discussion still had the visual disability on re-examination on a mean review period of 7 years after orthodox treatment.7 Kathol and his associates also found that 55% of these patients still had the visual disability at a mean review period of 4 years.8 When the 100 per cent improvement obtained by spinal manipulation is compared with results of orthodox medical treatment (45% improvement at mean review periods of 7 and 4 years), it is clear that spinal manipulation is more effective than orthodox medical treatment, so much so that to repeat the experiment would be unethical. In my personal experience, the main obstacle to research of complementary medicine precepts has been the censorship of dissenting data from orthodox medical literature. The most blatant example of this is the studied neglect of the “tunnel vision information”: the knowledge that vision improves in appropriately ill patients when the spine is manipulated.

R Frank Gorman

Edzard Ernst Director, Complementary Medicine, Peninsula Medical School, Universities of Exeter and Plymouth, UK. Edzard. ErnstATpms.ac.uk In reply: Gorman’s story is characteristic of complementary/alternative medicine (CAM): someone makes an observation inconsistent with current medical teaching, and subsequently becomes convinced that therapy X is “100 per cent” effective. Yet clinical trials are never conducted and therapy X assumes somewhat of a cult status. Its proponents name various reasons why clinical trials are unavailable. In some instances (not in the case of spinal manipulation for recovery of vision), clinical trials do eventually emerge. These show that therapy X does not work. Proponents view this as a confirmation of their conspiracy theory. Eventually the cult status of therapy X becomes established. This dangerous scenario would be avoidable if CAM proponents understood the role of science in testing emerging treatments. It is, of course, not unethical to conduct a randomised trial on spinal manipulation for recovery of vision. Sure, randomisation is only ethical if there is uncertainty, but to deny that uncertainty exists is unreasonable — as is the notion of “censorship of dissenting data from orthodox medical” journals. Gorman’s reference list shows that even CAM journals have resisted publishing the effects of spinal manipulation on vision recovery. My conclusion is simple: science and medical publishing follow certain rules for good reasons. CAM should learn to follow them.

Edzard Ernst

Vivian Lin President, Chinese Medicine Registration Board of Victoria, PO Box 5088, Alphington, VIC 3078. adminATcmrb.vic.gov.au To the Editor: The Chinese Medicine Registration Board of Victoria would like to provide updated information relevant to the debate on the article by Parker.1 All practitioners of acupuncture and Chinese herbal medicine in Victoria are now legally required to register. The Chinese Medicine Registration Act 2000 (Vic) specifically includes transitional arrangements, and the Board has developed a “grandparenting policy” for assessing registration applications until 31 December 2004. There are six key assessment areas for all applicants: adequacy of qualification (minimum requirements); recency of practice; competence; good character; fitness to practise; and having the required professional indemnity insurance, first aid and effective communication arrangements. Details are available at www.cmrb.vic.gov.au. To date, 740 practitioners have become registered, and 11.5% of applicants have had a registration refusal or conditions imposed. After the grandparenting period, new applicants will be required to complete an approved course or pass an examination set by the Board. The Board will consider advanced diploma courses for approval up until December 2007, after which the minimum level will be a bachelor degree. Complaints are handled according to the Act, which is modelled on the medical (and other health) practice Acts. The current Victorian model dictates that the Board include two non-practitioners, one legally qualified member and six practitioners with a minimum of 5 years practice experience. Very specific steps must be taken in dealing with complaints, and 28 complaints have already been investigated. The issues of concern include infection control, advertising, professional ethics and communication with patients. Other boards (not medical practitioners) have asked us to assist with endorsement of their registrants, mainly for acupuncture. The Medical Practitioners Board of Victoria plans to ask medical practitioners seeking endorsement for Chinese herbal medicine to register directly with us. We hope this information will help contribute to informed debate on the regulation of complementary and alternative medicine.

Vivian Lin