Bariatric bonus Bariatric surgery — the surgical therapy of morbid obesity — has more benefit than weight loss, say US authors. Most patients who undergo this kind of surgery will also benefit from the resolution or improvement of at least four life-shortening comorbid diseases — type 2 diabetes, hyperlipidaemia, hypertension and obstructive sleep apnoea. The authors conducted a systematic review and meta-analysis of 134 studies, including controlled trials and uncontrolled case series, involving a total of more than 22 000 obese patients. All forms of bariatric surgery reviewed had a marked effect on weight loss and all four comorbidities studied; however, resolution of diabetes was most likely after malabsorptive or mixed malabsorptive/restrictive procedures rather than purely restrictive gastroplasty and gastric banding. JAMA 2004; 292: 1724-1737 Ending with a CRASH The CRASH (Corticosteroid Randomisation After Significant Head injury) trial, a multi-centre international collaboration involving 239 hospitals in 49 countries, including Australia, has been stopped early because of an unexpected and alarming result.1,2 In CRASH, patients aged 16 years or older, with a head injury and a Glasgow coma score of 14 or less within 8 hours of injury (and who did not have a clear indication or contraindication for corticosteroid use) were randomised to receive an early 48-hour infusion of either methylprednisolone or placebo. It became apparent, when only halfway to the planned recruitment target of 20 000, that the corticosteroid group had an 18% increase in the relative risk of death from all causes in the first two weeks after treatment. The mechanism responsible for this increase in deaths was not known; however, it was not influenced by injury severity or time since injury. German commentators suggested that, during the 1980s and earlier, about 10 000 patients with brain injury could have lost their lives because of the then wide use of corticosteroid treatment.2 1. Lancet 2004; 364: 1321-1328 2. Lancet 2004; 364: 1291-1292 Stop the chocolate An Australian resident of two years’ standing has called for schools and education departments to take action to prevent school fund-raising campaigns that involve selling chocolates. Given the rapid increase in childhood obesity in our society, Gunatilaka suggests that, rather than promoting poor dietary habits, schools should instead use a child’s eagerness to support his or her school as an opportunity for promoting healthy food habits. Healthier alternatives to chocolate could include dried fruits and long-life milk packets. Aust N Z J Public Health 2004; 28: 494 Here, kitty kitty . . . Tasmanian authors say that empirical antibiotic therapy should be commenced for minor infections following cat bites of the hand, rather than waiting for microbiological results. Mitnovetski and Kimble reported a series of 41 patients treated for cat bites of the hand in which five required surgery, mainly for drainage of deep infection. The use of prophylactic antibiotics for small wounds following cat bites to the hand has previously been shown to reduce the infection rate from 28% to 2%. Aust N Z J Surg 2004; 74: 859-862 Tako-tsubo Emotional stress can trigger an acute myocardial infarction in the absence of significant coronary artery disease, say Australian authors. Connelly and colleagues reported three women, aged 40, 49 and 58 years, who had a myocardial infarct shortly after experiencing emotional distress related to a minor road crash, a heated meeting about a case of sexual harassment and an argument leading to a permanent family break-up, respectively. On angiography, none of the women had serious coronary heart disease, but all showed temporary left ventricular wall motion abnormalities. The angiogram pattern was first described by Japanese authors in 1991 as tako-tsubo, as it resembles the shape of the instrument used to trap octopuses in Japan (tako = octopus, tsubo = pot). Heart 2004; 90: e52 Cochrane report The Cochrane Collaboration has come a long way in its first 10 years, but has further to go, according to a Canadian expert. The Collaboration is a unique, worldwide, not-for-profit organisation that aims to help people make well-informed decisions about healthcare through its core business of producing systematic reviews which are regularly updated and published quarterly. The Cochrane Library (2004, Issue 3) presented 2074 systematic reviews authored by about 7000 volunteers worldwide, including reviews relevant to the top 10 causes of disability in both developed and developing countries. However, as the reviews are often interest-driven rather than priority-driven, the Collaboration has not been sufficiently responsive to the immediate needs of policy-makers; further, the reviews have not adequately assessed the potential harms of healthcare interventions. CMAJ 2004; 171: 747-749

Ann Gregory

Despite well publicised claims of the therapeutic value of dietary supplements and other new treatments, the evidence for their effectiveness is modest The distinction between conventional and alternative medicine is often based on the presence or absence of scientific evidence. However, this evidence is expensive to gather, and often difficult to interpret and reduce to practical advice. Age-related macular degeneration (ARMD), the dominant and rapidly increasing cause of permanent visual loss in Australia, is an important case in point. Its prevalence rises from 0.7% in the 65–74-years age group to 5.4% at 75–84 years and 18.5% in people over 85.1 Definitive treatment does not yet exist. While we have some knowledge of risk factors, this knowledge is imperfect and has recently been muddied by well publicised claims (discussed below) that, although evidence-based, are preliminary and need to be interpreted with caution. The early signs of ARMD include hypo- or hyperpigmentation of the retina and large yellow drusen (> 63 μm) or soft drusen with indistinct margins.2 A few small hard drusen can be found in almost everyone over 50 years of age, and, in contrast to large or soft drusen, do not appear to progress with age.1 Loss of vision from ARMD occurs either as a result of choroidal neovascularisation with exudation and haemorrhage (the “wet” form) or by slow atrophy of the retinal-pigment epithelium and overlying receptors (the “dry” form). Wet ARMD is twice as common as the dry type and causes rapid vision loss. About 10% of patients with wet ARMD who present early with distorted vision and an eccentric neovascular lesion can be treated successfully with laser photocoagulation.3 However, the recurrence rate is over 60%, and further vision is then usually lost. Another small proportion of patients can be treated with photodynamic therapy (involving low-intensity red laser treatment after intravenous verteporfin infusion), but the functional benefit is usually modest.4 There is no treatment yet for the dry form of ARMD. Elderly people fear blindness and the loss of independence greatly, and the prevalence of ARMD is rising dramatically. It is no surprise that recent studies of possible risk factors have attracted a lot of public interest. People with an ARMD-affected first-degree relative have a 50% lifetime risk of experiencing advanced ARMD and vision loss, and tend to develop it earlier.5 Smoking is associated with a fourfold increase in the risk of ARMD and visual loss and, again, tends to promote earlier occurrence.6 Weaker associations have been found with obesity, hypertension, macro-vascular disease, raised cholesterol and fibrinogen levels, cumulative light exposure and cataract surgery. Dietary associations have also been found both with the signs of ARMD and with progression to vision loss.7-9 In a well conducted, prospective study, dietary fat intake was systematically analysed after correcting for other risk factors.9 Vegetable fat intake had the strongest relationship with ARMD progression, with a relative risk of 3.82 for the highest fat-intake quartile compared with the lowest quartile. Higher intakes of total fat and of saturated, monounsaturated, polyunsaturated and transunsaturated fats all raised the relative risk of ARMD progression about twofold. Weekly fish intake and eating nuts two to three times a week were mildly protective. The implication is that a large shift away from vegetable oils, margarine and fat-containing processed foods might reduce this epidemic of blindness in the elderly. Some of these measures conflict with conventional advice on controlling cardiovascular conditions and need further research.10 Definitive evidence for the effectiveness of certain interventions might be obtained by randomly assigning those in the top quartile of risk to receive either a diet with low vegetable fat, fish, nuts and fruit, or a normal diet. There is also evidence from a randomised controlled trial that high-dose dietary supplements of the antioxidants vitamin C, vitamin E, beta-carotene and zinc can reduce the risk of progression from large or soft drusen to advanced ARMD and visual loss by about 20% compared with controls over 6 years.11 However, high-dose zinc can cause gastric irritation or anaemia, and beta-carotene may possibly be associated with an increased risk of lung cancer among smokers. Uncontrolled studies suggest the antioxidants selenium, lutein and zeaxanthin, which localise in the normal macula, may also help. There are as yet no studies to show whether dietary supplements are protective in patients with only small drusen or in the 20% of patients who are at genetic risk. It is not yet known whether major dietary adjustment and/or introduction of dietary supplements for large numbers of elderly people will be justified in terms of preventing blindness. On present evidence, we should identify people at increased risk of ARMD (ie, those with a family history, large or soft drusen, or vision loss in one eye from ARMD), encourage them to stop smoking, and promote a diet that includes vegetables, fish and nuts and reduces fatty foods laced with vegetable oils. Antioxidant supplements should be recommended if a fresh diet is impractical and if retinal signs of progression are present. For people of advanced age with a lower risk of ARMD, we might compliment them on reaching seniority and note that, in the dietary supplement study mentioned above,11 only 1.3% of patients with small drusen experienced ARMD progression over a 6-year period. Retinal images showing age-related macular degeneration (ARMD) A. “Dry” ARMD. Large soft macular drusen, signifying a high risk of progressive visual loss. B. “Wet” ARMD. Arrowed area delineates advanced wet macular degeneration with subretinal exudation and neovascular scar tissue. These changes result in blindness.

Ian J Constable FRANZCO, FRACS, FRCS

For most warfarin indications, the target maintenance international normalised ratio (INR) is 2–3. Risk factors for bleeding complications with warfarin use include age, history of past bleeding and specific comorbid conditions. To reverse the effects of warfarin, vitamin K1 can be given. Immediate reversal is achieved with a prothrombin complex concentrate (PCC) and fresh frozen plasma (FFP). Vitamin K1 is essential for sustaining the reversal achieved by PCC and FFP. When oral vitamin K1 is used for warfarin reversal, the injectable formulation of vitamin K1 is preferable to tablets because of its flexible dosing; this formulation can be given orally or injected. To temporarily reverse the effect of warfarin when there is a need to continue warfarin therapy, vitamin K1 should be given in a dose that will quickly lower the INR to a safe, but not subtherapeutic, range and will not cause resistance once warfarin is reinstated. Prothrombinex-HT is the only PCC approved in Australia and New Zealand for warfarin reversal. It contains factors II, IX and X, and low levels of factor VII. FFP should be added to Prothrombinex-HT as a source of factor VII when used for warfarin reversal. Simple dental or dermatological procedures may not require interruption to warfarin therapy. If necessary, warfarin therapy can be withheld 5 days before elective surgery, when the INR usually falls to below 1.5 and surgery can be conducted safely. Bridging anticoagulation therapy for patients at high risk for thromboembolism should be undertaken in consultation with the relevant experts.

Ross I Baker PhD, FRACP · Paul B Coughlin PhD, FRACP, FRCPA · Hatem H Salem MD, FRACP, FRCPA · Alex S Gallus FRACP, FRCPA, FRCP · Paul L Harper MD, FRACP, FRCPA · Erica M Wood FRACP, FRCPA

QuestionIn patients without diabetes, but with impaired renal function and proteinuria, does combination treatment with the angiotensin-converting enzyme (ACE) inhibitor trandolapril and the angiotensin-receptor blocker (ARB) losartan prevent deterioration of renal function more effectively than treatment with either agent used alone? Trial details Design: Randomised controlled trial. Setting: Outpatient clinics in Kisarazu, Kimitsu and Futtsu (Japan). Participants: 263 patients (mean age about 45 years; 54% men) with non-diabetic biopsy-proven renal disease, impaired renal function (creatinine clearance rate, 20–70 mL/min), persistent proteinuria > 0.3 g/24 h, and hypertension. Patients with proteinuria > 10 g/24 h, renovascular or malignant hypertension, urinary tract infection, heart failure or myocardial infarction, connective tissue disease, chronic hepatic or pulmonary disease, cancer and those pregnant or breastfeeding were excluded. Duration: 36 months. Main outcome measures: Combined endpoint of end-stage kidney disease (ESRD) or doubling of serum creatinine level, death and proteinuria. Main results: At 3 years’ follow-up, 10 (11%) of 85 patients receiving combination treatment reached the combined primary endpoint, compared with 20 (23%) of 85 taking trandolapril alone (hazard ratio, 0.38; 95% CI, 0.18–0.63) and 20 (23%) of 86 taking losartan alone (hazard ratio, 0.40; 95% CI, 0.17–0.69). Proteinuria decreased significantly in all treatment groups, but the effect was greatest with combination teatment; the maximum median change in daily urinary protein excretion was –42.1% with losartan, –44.3% with trandolapril and –75.6% with the combination treatment (P = 0.01). There was no significant difference in the mean fall in systolic blood pressure (losartan, – 5.1 mmHg [standard deviation, 1.6]; trandolapril, – 5.2 mmHg [SD, 1.3] mmHg; combination, – 5.3 mmHg [SD, 1.4]) and diastolic blood pressure (losartan, – 2.9 mmHg [SD, 0.9]; trandolapril, 22.9 mmHg [SD, 0.8]; combination, 23.0 mmHg [SD, 0.7]) among the three groups. Conclusion: Combining ACE inhibitors and ARBs reduces the incidence of the combined end-point of ESRD or doubling of serum creatinine in non-diabetic chronic kidney disease, with moderate reduction of renal function and moderate proteinuria by at least 30% compared with treatment with either drug alone. CommentaryRationale for the trialThe renin–angiotensin system has been implicated in the progression of non-diabetic renal disease, and ACE inhibitors and ARBs have independently been shown in randomised controlled trials to reduce proteinuria and the risk of end-stage kidney disease (ESRD) and doubling of the serum creatinine level. Proteinuria lies in the causal pathway to ESRD; therefore, the antiproteinuric effect of these agents is a component of renoprotection.1-6 What needed further exploration was whether the combination of ACE inhibitor and ARB was better than treatment with either agent alone. The COOPERATE triallists postulated an advantage of complete inhibition of the renin–angiotensin system with combination treatment of ACE inhibitor and ARB at maximum dosage.7 Trial methodsAfter an 18-week active run-in period, participants were randomly allocated to ACE inhibitor (trandolapril, 1–3 mg/day plus a lactose placebo), ARB (losartan, 12.5–100 mg/day plus a lactose placebo) or ACE inhibitor (trandolapril, 0.5–3 mg/day) plus ARB (losartan, 12.5–100 mg/day). Run-in was performed to establish safety, adherence and the maximum tolerable dose of ACE inhibitor. There was no run-in period for the ARB, and the maximum tolerable dose was chosen on the basis of a previous study.8 Information essential for assessing the quality of the trial was missing from the methods section. The triallists detailed their randomisation technique, but the methods by which the randomised intervention was allocated to the patients — such as use of sequentially labelled, sealed, opaque envelopes, or a central or pharmacy randomisation, which would guarantee concealment — was not specified. Patients and investigators were blinded by the drugs being dispensed in identical containers, but there was no mention of whether the capsules themselves were similar. There was also no indication of blinding of the outcome assessors. Analysis was reported as intention-to-treat, but six of 263 patients (who could have had outcomes measured) were actually excluded from the trial because of “protocol invalidation” or “discontinuation”, and so analysis was “per-protocol” and not intention-to-treat. Overall, seven of 301 (2.3%) patients were lost to follow-up, a small number which was unlikely to cause any differences in the final results of the trial. The authors performed a subgroup analysis to assess whether the effect of combination treatment compared with single therapy with ACE inhibitor or ARB was affected by the degree of baseline proteinuria. Their methods for this subgroup analysis and reporting of results were incorrect and misleading, although common. They analysed the three groups separately, and showed no statistically significant benefit of combination treatment in patients with low grade (< 1 g/24 h) proteinuria (hazard ratio, 0.69; 95% CI, 0.22–2.28), and statistically significant benefit in patients with moderate (1–3 g/24 h) proteinuria (hazard ratio, 0.33; 95% CI, 0.19–0.74) and heavy (> 3 g/24 h) proteinuria (hazard ratio, 0.40; 95% CI, 0.21–0.84). What they should have done was a formal test of interaction (a statistical assessment of differences in the proportion of an outcome [eg, ESRD] in the three treatment groups across patients with low-grade, moderate or heavy proteinuria).9 Given the overlapping confidence intervals in their separate analyses, it is very likely that the test of interaction would have been negative. The absence of demonstrable effect in the lowest-risk stratum is explainable on the basis of lower event rates in this group, and therefore lack of power to detect an effect in this group separately. Urinary protein excretion on a continuous scale in grams per 24 hours (rather than groups) could also have been used as the explanatory variable. This study may also have been relatively underpowered to detect the harms of treatments because of the relatively small sample size (263) and because of the active run-in phase, which would tend to exclude patients at risk of adverse effects from the intervention. Run-in periods are common and very useful for improving the efficiency of trials by selecting patients most likely to comply with treatment and fulfil follow-up requirements. However, if there is an active run-in when patients with adverse effects are not randomised, there may be a systematic underestimation of the true harms of an intervention. Also, only the dose of ACE inhibitor, but not ARB, was established by an active run-in, and the dose of ARB in the combination treatment was not reported clearly. The potential variability of doses makes it possible that outcome differences are related to dose rather than greater efficacy. However, blood pressure — probably the most important confounder — was equalised across the two groups. Finally, in this study, no account was taken of how the effect of ACE inhibitors, ARB, or their combination, may be influenced by histological types of renal disease with different rates of progression. New informationIt is likely that there is an advantage of complete inhibition of the renin–angiotensin system with combined ACE inhibitor and ARB treatment compared with therapy with either drug alone, at maximum doses, in patients without diabetes, but with moderate (1–3 g/24 h) and heavy (> 3 g/24 h) proteinuria and moderate to severe renal impairment (creatinine clearance rate, 20–70 mL/min). These findings of the COOPERATE trial are promising, but need to be further explored in light of some of the study’s limitations, and the fact that comparative findings in patients with cardiovascular disease are conflicting. In chronic heart failure, combined treatment has proven to be advantageous compared with individual treatment with ACE inhibitors or ARBs.10,11 This has not been confirmed in studies of post-myocardial infarction.12 Implications for clinical practiceIn patients without diabetes who have renal impairment (creatinine clearance rate, 20–70 mL/min; proteinuria, > 0.3 g/24 h), combination treatment with ACE inhibitors and ARBs at their maximum dose appears to be effective and well tolerated. Further studies are awaited to confirm the findings of the COOPERATE trial. In the meantime, combination therapy may prove a useful strategy in patients who continue to have high-grade proteinuria despite maximal doses of ACE inhibitor or ARB.

Giovanni FM Strippoli MD, MPH, MM(Epi) · Craig C Jonathan MB ChB, PhD

Many maternal deaths in Australia are still preventable The recently released report Maternal deaths in Australia 1997–1999 is the twelfth in a series of triennial reports, spanning over 35 years.1 The maternal mortality ratio (MMR) for this triennium was 8.2 per 100 000 confinements — one of the lowest national MMRs in the world. The MMR of a country reflects, in part, the overall health of women, the quality of the maternity services, and women’s access to those services. For comparison, the MMR per 100 000 confinements for the United Kingdom over this period was 11.4 and for the United States (for the year 2000), 17.0; Sweden had the lowest rate (2.0).2,3 There are huge differences in MMRs between developed and developing countries, with about 99% of global maternal mortality occurring in Africa, Asia and Latin America. The World Health Organization estimated that, in the year 2000, the MMR for Sierra Leone was 2000 per 100 000, or one death for every 50 confinements, compared with Australia’s one death for every 8500.3 While it is easy to see the magnitude and urgency of the problem of maternal mortality in developing countries, what, if anything, can be learned from analysing the rare maternal deaths in countries such as Australia? The answer lies in the fact that mortality represents the “tip of the iceberg” of severe morbidity; for every case of mortality directly or indirectly caused by pregnancy or its management, there are probably 50 women who experience a life-threatening complication but survive with varying degrees of short- and long-term sequelae. Improvements in obstetric care, which result from considering maternal mortality, can therefore be expected to apply to a broad population of childbearing women and their infants.4 Australia has witnessed a one-third reduction in the MMR over the past 30 years, from 12.7 per 100 000 confinements in 1973–1975 to 8.2 per 100 000 in 1997–1999. Higher rates of maternal mortality are seen for older women and for Indigenous women (Box). The highest risk of death was among women aged 40 years and older, who form an increasing proportion of the childbearing population, and who are more likely to use assisted reproduction techniques for conception, with higher multiple pregnancy rates. The inequity seen in all-cause mortality among Aboriginal and Torres Strait Islander women is reflected in the higher MMR for this population, who, in this triennium, represented about 3% of confinements, but 8% of deaths. There were no deaths in the triennium from terminations of pregnancy. If estimates are correct that over 80 000 termination procedures are performed in Australia annually, then these procedures carry exceptionally low risks of serious perioperative complications. Several conditions warrant special mention. Obstetric haemorrhage is still the major direct cause of maternal mortality (deaths directly caused by complications of pregnancy or its management). A recent report from Victoria supports the clinical impression of an increasing incidence of emergency hysterectomy for severe obstetric haemorrhage, possibly related to the increasing proportion of women embarking on pregnancy after one or more caesarean sections, with an increased risk of the more severe forms of abnormal placental implantation — placenta praevia, accreta and percreta.5 This is another change in the characteristics of the obstetric population which warrants close observation through systematic and comprehensive maternal mortality analysis. The Australian and UK reports encourage maternity institutions to rehearse the management of simulated cases of obstetric haemorrhage, which is happening in some, but not all, Australian institutions. Amniotic fluid embolism was responsible for seven deaths in Australia in the 1997–1999 triennium. Although small numbers are open to overinterpretation, it is noted that, in five of these cases, labour was induced. There is community and clinical concern about adverse consequences of induction of labour, especially when undertaken for non-clinical indications. We reiterate the need for maternity units (of all sizes) to have disaster plans for the immediate management of the rare and unpredictable cases of amniotic fluid embolism, which usually present with acute syncope and haemorrhage. Thromboembolism and severe hypertension continue to be major contributors to maternal mortality, with six deaths in each category. Some of these deaths were considered preventable, and, with the trend towards more obesity, higher caesarean rates and women delaying childbirth into their 40s, awareness of the indications for perioperative thromboprophylaxis is increasingly important. Adherence to clinical practice guidelines for severe hypertensive disorders, including earlier specialist referral, would have prevented at least some of the six deaths from hypertensive disorders. Deaths related to cardiac disease and psychiatric illness dominate the category of indirect maternal deaths (deaths in which the pregnancy was complicated by pre-existing disease). Eight deaths due to psychiatric causes mirrored what has been found in the UK, where increasing numbers of maternal deaths are reportedly due to psychiatric conditions. Clinicians and the community need to be reminded about not ignoring or dismissing symptoms of depression, especially suicidal intent, during and following pregnancy.2 There is an emerging group of women at risk of maternal death — those who have had surgery for major congenital heart disease as infants or children, and who are now attaining reproductive age. These women are at risk of severe cardiac complications during and after pregnancy, and require sophisticated and multidisciplinary management. Despite a very low risk of death associated with pregnancy, no-one should claim that, in a country like Australia, mere survival rates could serve as an indicator of the quality of maternity services. However, because of the implications for the broader population of women experiencing pregnancy and childbirth, maternal mortality warrants continuing systematic ascertainment, and high-level investigation and reporting, with reasonable timeliness, so that recommendations are relevant to current practice. Key findings of Maternal deaths in Australia 1997–19991 The 1997–1999 maternal mortality ratio (MMR) was 8.2 deaths per 100 000 confinements, compared with 9.1 per 100 000 in 1994–1996. There were 90 maternal deaths: 34 direct, 28 indirect, and 28 incidental deaths. The main causes of death were obstetric haemorrhage (8 deaths), psychiatric disease (8 deaths), amniotic fluid embolism (7 deaths), and cardiac disease (7 deaths). The highest risk of death was seen in women aged 40 years and older (MMR, 23.2 deaths per 100 000 confinements, compared with 4.0 deaths per 100 000 confinements for those aged 20–24 years). The MMR for Aboriginal and Torres Strait Islander women remains three times higher than the MMR for non-Indigenous women.

James F King MPH, FRANZCOG, FRCSC · Emma K Slaytor MPH, BMedSci(Hons) · Elizabeth A Sullivan MPH, MMed, FAFPHM

Melagatran is a synthetic, small-peptide direct thrombin inhibitor with anticoagulant activity. Ximelagatran, an oral prodrug, undergoes rapid enzymatic conversion to melagatran. Melagatran has rapid onset of action, fixed twice-daily dosing, stable absorption, apparent low potential for medication interactions, and no requirement for monitoring drug levels or dose adjustment. There is no specific antidote, but the drug has a short plasma elimination half-life (about 4 hours). In clinical studies, melagatran/ximelagatran is not inferior to warfarin for stroke prevention in patients with non-valvular atrial fibrillation, to heparin–warfarin for acute treatment and extended secondary prevention of deep vein thrombosis, and superior to warfarin for prevention of venous thromboembolism after major orthopaedic surgery. Major bleeding with melagatran/ximelagatran occurred at rates similar to those in patients treated with warfarin. 6%–12% of patients taking ximelagatran develop asymptomatic elevated liver enzyme levels (predominantly alanine aminotransferase) after 1–6 months of therapy; this usually resolves with cessation of therapy. Less than 1% of patients develop abnormal liver function while taking ximelagatran; this rarely persists or develops into clinical illness.

Timothy A Brighton FRACP, FRCPA, MD

The Victorian Doctors Health Program (VDHP) was established in November 2000 to provide a confidential and compassionate service for doctors and medical students with health concerns, including alcohol, other drug and mental health problems. Although funded by the Medical Practitioners Board of Victoria, the VDHP is completely independent of the Board. Its staff include a director with experience of North American Physician Health Programs and a case manager/psychologist. In its first 3 years of operation, the VDHP had 438 contacts: 218 requests for advice and information, and 220 contacts resulting in provision of services (to 92 doctors and students with alcohol or other drug problems, 82 with psychiatric problems, and 40 with stress-related or emotional problems). 99 participants received standard care (assessment, referral and up to two consultations with the program) and 56 extended care (three or more consultations with the program). 65 participants (most with substance use disorder) entered the more intensive Case Management, Aftercare and Monitoring Program (CAMP); 57 of these have had outcomes considered satisfactory, with 50 returned to work.

Naham (Jack) Warhaft MB BS, GradDipSustanceAbuse, FANZCA, FAChAM

Addiction is a treatable disease and patients can enjoy rather than endure recovery My work is regarded in various ways by my colleagues. Some see me as a quixotic figure ranting futilely against the impregnable world of alcohol and other drugs, as in the cartoon. Others see me as a sort of medical Mother Teresa on Sydney’s North Shore, devoted to a life of cleaning others’ mess. I think most simply shake their heads, believing that I am delusional and beyond help. This article seeks to define and refine this “delusion”: that addiction is a disease, that it is treatable, and that patients enjoy rather than endure recovery. Do addicted doctors need special treatment?I sometimes feel that all the hard work and inconvenience of gaining a medical qualification is worth it for one short sentence: “Doctor is busy.” As doctors, we have a wealth of privileges not afforded other members of the community. Not only are we excused for lateness, we also have access to a wide range of medicines (many of them dangerous, even in prescribed doses), and are permitted, even expected, to examine people’s bodies and to ask intrusive questions. With these privileges come ethical dilemmas that are not new to the profession — abortion, euthanasia, inappropriate relationships with patients, confidentiality, and commitment to training the next generation of practitioners. All rate a mention in the Hippocratic Oath. However, Hippocrates did not have a protocol for addicted colleagues. The saying that addicts and alcoholics are just like other people except more so is attributed to Sylvester Minogue, a psychiatrist influential in the introduction of Alcoholics Anonymous to Australia. I believe that alcoholic and addict doctors are just like other alcoholics and addicts, except more so. The issues of shame and guilt, of inability to believe that an intelligent person could perform such irrational and obviously unintelligent actions, still abound. Furthermore, colleagues who are patients know and have opinions about many interventions, reducing any chance of a placebo effect and virtually eradicating the impact of medical advice. They’re in the club, and they look carefully for any hint of superficiality in explanations and advice. Are addicts simply adults behaving very badly?Understandably, the moral stance has been the traditional first response by families, communities and medical boards when learning of a doctor’s addiction. Attempts to keep the community safe from addicted doctors have traditionally involved the law and lawyers, in a process that selected out, then deregistered, the “bad apples”. The problem is that addiction also occurs in undeniably “good” colleagues, whose work and track record make it both unacceptable and unhelpful to deal with them punitively (Anecdote 1 and Anecdote 2). Addiction is not “like” a disease — it is oneThis is the heart of my fortifying “delusion” and a debate in which I participated in the Journal in 1992. 1,2 Then, as now, I believed that addiction is a disease because it has definable clinical features, a substantial genetic influence, a reasonably predictable natural history, effective treatments, and even potential biological markers. More recently, others have compared addiction with medical conditions like asthma, diabetes and hypertension. 3 These comparisons have yielded remarkable similarities in genetic heritability, pathophysiology, role of personal responsibility, and treatment response. The effectiveness of drugs such as naltrexone4 and acamprosate5 in the short- and medium-term course of alcohol dependence, and methadone in opiate dependence,6 also argues strongly for medical involvement. The issue of hopelessnessEven more important than whether addiction is a disease is the fact that prognoses are not nearly as hopeless as most medical colleagues believe. The natural history of alcohol addiction can include remission, mostly through long-term abstinence, and often associated with attendance at Alcoholics Anonymous (Anecdote 3). 7 However, the fact that psychosocial interventions work (as they do for many medical conditions) does not render addiction a “non-medical” problem, as some have argued. Sustained abstinence is not an end in itself. If prolonged abstinence merely resulted in a desert of joylessness, as so many people in active addiction fear, then my job would indeed be difficult. In fact, real recovery takes off once abstinence becomes comfortable. New relationships are formed or old ones improved. Central issues, such as what constitutes meaning in life, are addressed. That common core belief of self-inadequacy begins to wither. If addiction is a disease and resetting one’s neural “reward” pathway from the ventral tegmental area to the nucleus accumbens of the brain is a key feature,8 then the treatment is only complete when ego-syntonic activities are fully rewarding — that is, previously enjoyed experiences, such as the joy of relationships, work and recreation, are fully enjoyed once more. Patients of mine in longer-term recovery do not continue to mourn for the moments of pleasure experienced at the end of a needle or a drinking binge. Instead, they are grateful for each sober day. Often, they gladly provide me with assistance with newer patients. Rehabilitation: a more enlightened attitudeThe progress made in treating doctors’ addiction is obvious over my 20 years of practice. Medical or licensing boards worldwide have come to recognise that the safety of the community is enhanced by having a rehabilitative attitude to alcohol and drug dependence. 9 Unidentified doctors still drinking or using drugs pose a greater danger to the community than those who have been identified, are seeking treatment, and are supervised by a stringent medical board program. Medical boards have also come to recognise that monitoring impaired doctors in a process independent of the treatment process is likely to be more beneficial for both doctors and the community. Both treatment and monitoring are important and neither should interfere with the other. The NSW Medical Board was at the vanguard of this movement in developing the Impaired Registrants Program (IRP). Under this program, doctors identified as having breached laws or regulations (such as the NSW Poisons and Therapeutic Goods Act 1966 through self-prescribing of drugs of addiction) make certain voluntary undertakings, such as to attend for assessment by a Board-appointed psychiatrist (whose only role is to provide detailed feedback for the Board’s use). 10 One of the conditions imposed by the IRP is for the practitioner to concurrently undergo treatment. Soon after the establishment of the IRP, I decided that I would be a treating psychiatrist and never a Board-appointed one. I have become much more disposed to referring my medical colleague patients to the IRP, as I have found that assessments by independent psychiatric colleagues can augment and monitor my own assessments and treatment. My other (non-medical) patients do not have the back-up of an independent assessment every 6 or 12 months. My involvement in this process also means I receive regular reports from the Medical Board about my patients and any changes to their conditions. My own frisson of anxiety at receiving an unexpected piece of mail from the Board reminds me of just how trying this process is for my patients. Issues of concern for doctors on monitoring programsMany problems can loom larger than usual for doctors in medical board monitoring programs. For instance, confidentiality is absolutely paramount (Anecdote 4), a drug test result that has gone astray may be misconstrued as a deliberately missed test, and false-positive test results can be especially trying for someone in recovery and working hard to comply with every condition of the IRP (Anecdote 5). All NSW doctors in the IRP are identified as such on their medical registration cards, which bear the word “conditional”. This can be a great source of agitation, and, as some suspect, of prolonged unemployment. Lest I be seen as advocating greater freedoms for doctors on the IRP, let me also say that some doctors may show enough change to satisfy their supervisors, but seem to gain little real insight into their problems. The NSW program is unable, in its present form, to deal with this issue of reluctant compliance. The futureTrends in the United States are for programs that manage identified addict and alcoholic doctors to be handled by systems outside medical boards. These newer programs (including one in Victoria) are called “Doctors Health Programs” (DHP). Most of these are funded in much the same way as medical boards, by medical registration fees, but these programs are independently involved in monitoring, often at four levels (individual, group, workplace and pathology), leaving the medical board to perform disciplinary functions. These programs are probably more intrusive than the ones run by the medical boards, but, while disciplinary procedures may still be imminent if compliance with the DHP is found wanting, many find it an advantage that the term “conditional” is not emblazoned across the registration papers of a doctor in early recovery. Anecdote 1 Dr A was a trainee physician who had been practising in another jurisdiction. He returned to Sydney, unregistered, and was referred by a senior specialist. A had developed an addiction to pethidine in the context of major social upheaval while working, and had been found diverting some from the hospital. His registration was suspended for 9 months, but no treatment was offered. On his return to Sydney and referral to my care, he was only able to gain the benefit of the NSW Impaired Registrants Program (IRP) after his suspension elsewhere ended. He responded to a regimen including counselling, urine testing and regular review by the IRP. Initially, he worked in unfashionable posts, but later returned to his previous level, passed his specialist exams, married and had children. Anecdote 2 Dr B was an influential specialist who referred himself, saying that his principal problem was migraines, but he had begun to self-medicate with a variety of opiates, including pethidine. Representatives of the Pharmaceutical Services Section of the Department of Health (which monitors the dispensing of Schedule 8 drugs in New South Wales) had visited him and informed him that it would be best if he voluntarily surrendered his right to prescribe S8 drugs. On taking a history, I discovered that, some 20 years before, he had been identified as having misused opiates, been reprimanded by the Medical Board, and been sent for treatment, which was unconventional, unmonitored, and, as his current presentation showed, ineffective. Anecdote 3 A 22-year-old medical student’s drinking habits and poor exam results were a source of concern to his supervisors. He was called before the warden of the clinical school and reprimanded. He resentfully disregarded this advice, but soon after was serendipitously placed as a medical student at a drug and alcohol treatment facility, where he identified himself as an alcoholic. He became a member of Alcoholics Anonymous and has remained sober and happy for many years without treatment. I know of his story because he sometimes helps me in supporting my medical patients. Anecdote 4 Dr C, a Resident Medical Officer from another hospital, rang to say that he desperately needed inpatient treatment under my care. I agreed, not learning until later that he was due to commence a term at Royal North Shore Hospital in the 12 months after his discharge. Subsequently, a colleague and rival of C was found to have enquired about gaining access to C’s inpatient medical records. C’s initial distress was well managed, he became a dedicated Narcotics Anonymous member, and has now graduated from the Impaired Registrants Program and been drug-free for more than 5 years. Anecdote 5 A colleague referred his patient, Dr D, who had been self-injecting benzodiazepines and lying about his alcohol use. After a brief negotiation, D informed the Impaired Registrants Program. He began urine testing, attending the Doctors Recovery Group and Alcoholics Anonymous. D became distressed when, despite a month of abstinence, his urine was still testing positive for benzodiazepines. He sought detailed quantitative analysis of his urine benzodiazepine levels allowing for the urine concentration, which subsequently showed an exponential decline consistent with abstinence. After only a year, his work, marriage, parenting, physical health and leisure pursuits have all improved dramatically.

Stephen M Jurd MB BS, FRANZCP, FAChAM

Objectives: To review the evidence for the effectiveness of complementary and self-help treatments for anxiety disorders.Data sources: Systematic literature search using PubMed, PsycLit, and the Cochrane Library.Data synthesis: 108 treatments were identified and grouped under the categories of medicines and homoeopathic remedies, physical treatments, lifestyle, and dietary changes. We give a description of the 34 treatments (for which evidence was found in the literature searched), the rationale behind the treatments, a review of studies on effectiveness, and the level of evidence for the effectiveness studies.Conclusions: The treatments with the best evidence of effectiveness are kava (for generalised anxiety), exercise (for generalised anxiety), relaxation training (for generalised anxiety, panic disorder, dental phobia and test anxiety) and bibliotherapy (for specific phobias). There is more limited evidence to support the effectiveness of acupuncture, music, autogenic training and meditation for generalised anxiety; for inositol in the treatment of panic disorder and obsessive-compulsive disorder; and for alcohol avoidance by people with alcohol-use disorders to reduce a range of anxiety disorders.

Anthony F Jorm PhD, DSc · Helen Christensen PhD · Kathleen M Griffiths PhD · Ruth A Parslow PhD · Bryan Rodgers PhD · Kelly A Blewitt BAppPsych

More than 170 clinicians from diverse healthcare backgrounds attended the National Institute of Clinical Studies (NICS) “Heart Failure Forum 2004: improving outcomes in chronic care”, held in Canberra, 7–8 June 2004. The purpose of the forum was to raise awareness of the growing burden of heart failure, engage with Australian and international experts in heart failure and chronic care management, and explore strategies for improving outcomes in chronic care. Successful models of careGeoffrey Tofler (Chair of the NICS Heart Failure Advisory Group and Professor of Preventive Cardiology, University of Sydney) set the scene by highlighting gaps in the current medical treatment of heart failure. These gaps are most notable in the use of evidence-based drug therapies, such as angiotensin-converting enzyme (ACE) inhibitors and β-blockers, that reduce symptoms and hospital admissions and improve survival.1 Chronic care expert Ed Wagner (Director, MacColl Institute for Healthcare Innovation, Group Health Cooperative, Seattle, Washington, US, and leader of the Robert Wood Johnson Foundation Improving Chronic Illness Care Program) argued that the current care system is not working adequately for either patients or healthcare professionals,2 and emphasised the importance of redesigning care systems around the needs of patients with chronic illnesses. He described the essential elements of the chronic care model (Box 1),3 and illustrated how the model, combined with the Institute of Healthcare Improvement collaborative improvement method, enabled over 1000 US healthcare organisations to improve quality of care for patients with asthma, diabetes and chronic heart failure.4 Peter Didsbury (Chairman, New Zealand Guidelines Group, and Deputy Head and Manager of Integration, ProCare Health Ltd, Wellington, NZ) reported increased prescribing of ACE inhibitors, β-blockers and spironolactones following multifaceted intervention strategies, such as improved access to echocardiography, rapid access to cardiology advice, funding for β-blocker titration, access to a cardiac nurse specialist and 24-hour telephone triage. The results of an unpublished randomised trial he conducted involving patients with chronic obstructive pulmonary disease led him to suggest that improving the effectiveness of patient adherence through more structured care processes (such as holistic assessments, education about the condition, lifestyle therapy, action plans and active follow-up) may have greater effect. The vital role played by nursing staff was highlighted by Simon Stewart (Chair, Cardiovascular Nursing, and Director of the Centre for Innovation in Health, University of South Australia). He presented evidence from a recent systematic review of randomised trials of multidisciplinary strategies for the management of patients with heart failure at high risk for admission. This review showed that programs that incorporate follow-up by a specialised multidisciplinary team (in either a clinic or a non-clinic setting) reduce mortality, heart failure hospitalisations and all-cause hospitalisations.5 Stewart emphasised the need for a more systematic implementation of specialist nurse-led, home-based, follow-up services after discharge for patients with heart failure. Such services are currently available to less than 10% of those needing them. Whether this form of care is applicable in rural and remote locations is not certain, according to Henry Krum (Director, NHMRC Centre of Clinical Research Excellence in Therapeutics, Monash University), who described the computerised, telephone-based patient support system (“Telewatch”) his research group is trialling in Australia. The system allows healthcare providers to closely monitor symptoms of patients with chronic heart failure and to track progress, respond to deterioration and make suggestions to improve overall management. Specific questions relate to diet, exercise, alcohol use, smoking, use of drugs for chronic heart failure, use of prescribed and over-the-counter medications unrelated to chronic heart failure, mood state and current coping. Results are expected by the end of 2005. The role of GPs in management of heart failureAlthough heart failure is a leading medical cause of hospital admissions in older people, Justin Beilby (Head, Department of General Practice, University of Adelaide) noted that patients with heart failure represent a low proportion of the total patients that each general practitioner treats. Of concern to GPs is the need to identify people with early heart failure, who would benefit from more aggressive intervention. This point was reinforced by Michael Feneley (Chair, Cardiac Society of Australia and New Zealand Echocardiography Working Group), who stressed that new shortness of breath with no other obvious cause is often a symptom of early heart failure and should trigger investigation. He believes echocardiography is the most useful investigation in confirming or ruling out heart failure and is critical for determining the underlying cause and guiding therapy.6 Mark Harris (Professor, General Practice, University of New South Wales) detailed the important role of Divisions of General Practice in providing support and feedback to practices in the collection and analysis of data and in the use of patient registries — key elements of proactive chronic care patient management. The forum heard from Judith Mackson (Prescribing Program Coordinator, National Prescribing Service [NPS]) that the NPS, the National Heart Foundation of Australia (NHFA) and the NICS have formed a collaboration to improve targeted elements of heart failure diagnosis and management in general practice. This joint program will deliver key messages on drug use for treating heart failure and will emphasise the importance of echocardiography to confirm the diagnosis and guide treatment. Current government initiatives in chronic careThe importance of adopting a more systematic approach to chronic care management in Australia was reinforced by Andrew Tonkin (Director, Health, Medical and Scientific Affairs, NHFA), who argued that the effective management of heart failure represents an excellent paradigm for improving the care of people with other chronic conditions. The value and cost-effectiveness of management programs that can support patients with heart failure in the home and community and prevent hospitalisation have been demonstrated. Programs and information systems for patients with heart failure, once established, could be easily adapted to the needs of other chronically ill patients. Jane Halton (Secretary, Australian Government Department of Health and Ageing) highlighted recent Budget initiatives. Funding is provided for 1600 more primary care nurses and a new Medicare Benefits Schedule item number linked to the Enhanced Primary Care multidisciplinary care plan for services provided by allied health professionals. Ms Halton outlined the government’s plans for a national chronic disease strategy, following development and consultations by the National Health Priority Action Council’s Chronic Disease Strategy Group. The forum heard about different state heart failure programs. Craig White (Deputy Chair, Victorian Hospital Admission Risk Prevention Program, and Executive Director, Clinical Services, Austin Health) and Kym Scanlon (Assistant Director, Chronic Care Program, NSW Health) presented figures showing encouraging reductions in hospital admissions for chronic heart failure since the commencement of statewide chronic care programs, such as the Victorian Hospital Admission Risk Prevention Program and the NSW Chronic and Complex Care Program.7,8 Clearly, more patients need to access these programs, with only an estimated 15% of eligible patients enrolled in Victoria (Andrea Driscoll, Deakin University). NSW Health is currently addressing implementation and spread of issues through a statewide chronic care collaboration that focuses on heart failure and chronic obstructive pulmonary disease. The change principles of the collaboration are based on the key elements of Wagner’s chronic care model, as well as policy components from the World Health Organization’s Innovative Care for Chronic Conditions Framework.9 Conclusion and the way forwardIn the concluding plenary session, Didsbury and Wagner suggested strategies that would facilitate implementation of the chronic care model in Australia. They emphasised the need to reward care planning, support efforts to encourage practice system change, and make patients a part of the planning. Using the patient journey as a framework, Geoffrey Tofler presented a matrix of key strategies and interventions that patients, clinicians and governments should consider to improve outcomes and quality of life for patients with heart failure (Box 2). The matrix indicates areas where best-practice models of care are known, such as cardiac nurse specialists for post-discharge heart failure patients, and areas where more research is needed, such as the best use of practice nurses in chronic diseases. Finally, the matrix suggests areas where enhanced government support is needed (such as in creating mechanisms for funding comprehensive care programs and in further funding for practice nurses). The range of participants at the forum reinforced the broad approach needed to improve outcomes in heart failure. Furthermore, strategies adopted successfully with heart failure could have major effects when extrapolated to other chronic conditions. The forum presentations and a more detailed report are available on the National Institute of Clinical Studies website (www.nicsl.com.au). 1 The chronic care model Source: Ed Wagner keynote address, NICS Heart Failure Forum 2004. Available at www.nicsl.com.au. For more information on the chronic care model, see reference 3. 2 Matrix of key strategies and interventions for a patient with heart failure Stage Prevention Early stage Acute exacerbation Ongoing care Palliative care Issues Identification of high-risk patients Recognition of early signs and symptoms, when and whom to refer for echocardiography Use and availability of echocardiography, particularly in rural areas Use of BNP in primary care to be further defined In-hospital initiation of appropriate therapy and discharge to community with management plan, including dose titration schedules Comorbidities, diagnostic issues, systematic patient education and support Need research on the education of practice nurses in chronic care management and effectiveness in improving patient outcomes Changing roles in general practice Need research on access to palliative care services and how to extend these to patients with heart failure Model Prevention and management of coronary artery disease and hypertension Consumer Education (NICS Online directory of quality information for patients with heart failure) Appropriate use of echocardiography in diagnosis and assessment of heart failure in primary care (NICS education module in preparation) Clinician-led quality improvement programs Heart failure nurse-led, home-based management programs (Alternatives include hospital-based rehabilitation, heart failure clinics) Chronic care management model Study and implement self-management models Targeted interventions aimed at implementing best practice management of heart failure in primary care (NICS, NPS and NHFA joint heart failure program) Need research on appropriate palliative care model and extrapolation of palliative care and nursing principles Consumer role Awareness of risk factors (SNAP) Awareness of early symptoms and precipitants, especially in high risk individuals Working in partnership with healthcare professionals Access to self-management education and support, particularly post-discharge Self-management education and support, ongoing monitoring, adherence to treatment Heart Failure Action plan Consider advance directives Access to self-management and support Provider role Identification and treatment of high-risk patients by GPs, cardiologists, general physicians Assessment of patients with early signs and symptoms by GPs Referrals to cardiologists or general physicians, where appropriate Emergency physicians, cardiologists, general physicians, geriatricians, cardiac nurses, hospital pharmacists GPs, practice nurses with training in chronic care and support from cardiac nurses, allied health, community nurses and pharmacists GPs, community nurses, palliative care teams Government role Heart failure health promotion campaign, and systems in place to support this Access to echocardiography, access to cardiologists Need heart failure prevalence study and minimum heart failure dataset Need initiatives for improved outcomes for cardiovascular disease in primary care Ongoing resourcing for cardiac nurse role in acute settings and post-discharge (state) Testing and implementation of chronic care model in general practice and system redesign issues (Commonwealth) Mechanism for funding comprehensive care programs More practice nurses Capacity building for quality improvement Extend palliative care entitlements to patients with heart failure (eg, access to medicines, oxygen and home nursing services) BNP = Brain natriuretic peptide. NICS = National Institute of Clinical Studies. NPS = National Prescribing Service. NHFA = National Heart Foundation of Australia. SNAP = Smoking, Nutrition, Alcohol, Physical activity.

Susan M Phillips DPhil · Janice M Davies PhD · Geoffrey H Tofler MB BS, MD