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Focus on Alternative and Complementary Therapies 2012 The Author FACT 2012 Royal Pharmaceutical Society DOI 10.1111/j.2042-7166.2012.01160.x ISSN 1465-3753

A critique of the Swiss report Homeopathy in Healthcare

Edzard Ernst

Keywords Cost effectiveness health technology assessment homeopathy safety

Introduction The Swiss report Homeopathy in Healthcare: Effectiveness, Appropriateness, Safety, Costs,1 which was recently published in English, is important mainly for one reason: it is being cited by proponents of homeopathy the world over as the ultimate proof that homeopathy works. These proponents tend to claim that it is a report by the Swiss government that rigorously evaluates the evidence for and against homeopathy and arrives at an indisputable positive conclusion. It is through this article that I intend to critically analyse the value of this document. Background In 1998, the Swiss government added homeopathy to the list of services covered by the Swiss health insurance system, but for a limited period of time. In parallel, a literature study was commissioned, which took the shape of a Health Technology Assessment (HTA). The report Homeopathy in Healthcare: Effectiveness, Appropriateness, Safety, Costs,1 is the English translation of this HTA. It is would be incorrect to claim that this document is a report of the Swiss government; it is in fact a pamphlet written by 13 proponents of CAM. The authors of the report explain in some detail their research agenda. For instance, they dedicate much space to a critique of the RCT methodology, which they believe is ethically questionable, and claim that the method that is best suited to prove homeopathic effectiveness . . . is the single-case observation. Unbiased methodologists would disagree with that view, and I might add that any scien-

tific method is misused when it is employed to prove rather than test a hypothesis. Method of the health technology assessment Consistent with their exotic views on research methodology, the authors of the report include all types of study designs in the HTA. The authors make it clear that methods that involve no experimental change in the medical intervention (such as case studies) are considered preferable, as they are better able to reflect the healthcare reality. The findings of such methods are given the term real-world effectiveness, and it is such results that form the focus of the authors attention. More critical thinkers might point out that, by adopting this bizarre strategy, the authors effectively create their own standard. This evaluation of homeopathy thus significantly deviates from the rigour generally expected of HTAs. The assessment proper is focused on four areas: (1) an overview of systematic reviews of the clinical efficacy of homeopathy, (2) clinical studies on the effectiveness of homeopathy for upper respiratory tract infections and allergic reactions, (3) the safety of homeopathic use, and (4) the cost-effectiveness of homeopathy. Results of the health technology assessment For the overview of systematic reviews (SRs), the authors included 22 articles. It was unclear why certain SRs were excluded, however. Interestingly, the excluded SRs24 tended to report negative outcomes. The results of each included SR were not fully assessed but only outlined in a short paragraph. Here

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we find puzzling inconsistencies and contradictions. This is illustrated in the following examples where the report covered my own systematic reviews. In an SR of homeopathic aggravations,5 it was claimed that the results suggest an effectiveness of homeopathic medicine that differs from placebo. Yet, our SR did not assess effectiveness and concluded that this systematic review does not provide clear evidence that the phenomenon of homeopathic aggravations exists.5 An SR of homeopathy for postoperative ileus6 was reported to have generated results in favour of homeopathy. Yet, the authors of the HTA failed to mention that, in our conclusions, we stated that several caveats preclude a definitive judgement.6 An SR of homeopathy for osteoarthritis7 was depicted as positive by the authors of the report.1 However, the SR actually stated that the evidence did not allow a firm conclusion . . . [to be made] . . . as to the effectiveness of homeopathic remedies.7 Reporting on the results on an SR of homeopathic arnica,8 the authors stated that five of eight RCTs showed a trend in favour of homeopathy. The authors failed to mention that the conclusions of this SR were squarely negative: On balance, they [the RCTs] do not suggest that homeopathic arnica is more efficacious than placebo. The results section of the report ends with a table, which shows that, in total, 10 of the 22 included reviews were judged more positively by the authors of the HTA than by the authors of the original SR. This section of the HTA thus arrives at a positive overall conclusion by transforming the negative SRs into positive evidence. Similarly bewildering interpretations could be found in the following section where clinical studies were evaluated. As previously mentioned, the authors also included uncontrolled observations. Therefore, it is hardly surprising that the overall conclusion was positive: the trials that were examined . . . do not . . . put the effectiveness of homeopathic treatment in general in doubt. A further criticism of this section was that it covered only two indications. As such, it represented only a small part of the body of clinical studies of homeopathy. The most perplexing section of the report, in my view, was the section on safety. This section was only three pages long and concluded that homeopathy is free from toxic and unexpected organ effects. Here, the authors quote just one case report. Considering that the authors had previously made a point of including case-studies in their HTA, this omission is difficult to understand. There is no mention of the risks associated with using ineffective treatments for serious conditions or the harm done by replacing

effective interventions with homeopathy; for example, using homeopathic vaccination instead of conventional immunisation.9 The section on cost analyses stated that the use of homeopathy has the potential to lower pharmaceutical spending. The authors also cited an unpublished paper, which concluded that available data suggest potential cost savings due to the use of homeopathy. However, critical reviewers would point out that firstly, no good published evidence exists in this area,10 and secondly, there can be no costeffectiveness in the absence of effectiveness. Most of the authors of the HTA were homeopaths, and none of the many critics of homeopathy had contributed to this report. The evidence was also highly selective. Critical texts were systematically omitted, and issues such as the biological implausibility of homeopathy11 were almost entirely excluded. The authors stated that nobody involved in the compilation had any financial or other conflicts of interest. But this is demonstrably incorrect. Being homeopaths themselves, they clearly had a strong interest in producing a report that might motivate the Swiss government to rule that homeopathy will in future be covered by the Swiss health insurance system. Conclusion This brief, critical analysis of Homeopathy in Healthcare: Effectiveness, Appropriateness, Safety, Costs,1 discloses this report as methodologically flawed, inaccurate and biased. Hence, its conclusions are not reliable. Conflict of interest None declared. References
1 Bornhft G, Matthiessen PF. Homeopathy in Healthcare: Effectiveness, Appropriateness, Safety, Costs. Berlin: Springer, 2012. 2 Altunc U, Pittler MH, Ernst E. Homeopathy for childhood and adolescence ailments: systematic review of randomized clinical trials. Mayo Clin Proc 2007; 82: 6975. 3 Ernst E. A systematic review of systematic reviews of homeopathy. Br J Clin Pharmacol 2002; 54: 57782. 4 Ernst E. Homeopathy: what does the best evidence tell us? Med J Aust 2010; 192: 45860. 5 Grabia S, Ernst E. Homoeopathic aggravations: a systematic review of randomised, placebo-controlled clinical trials. Homeopathy 2003; 92: 928. 6 Barnes J, Resch KL, Ernst E. Homeopathy for postoperative ileus. J Clin Gastroenterol 1997; 25: 62833. 7 Long L, Ernst E. Homeopathic remedies for the treatment of osteoarthritis a systematic review. Br Homeopathic J 2001; 90: 3743.

8 Ernst E, Pittler MH. Efficacy of homeopathic arnica. A systematic review of placebo-controlled clinical trials. Arch Surg 1998; 133: 118790. 9 Schmidt K, Ernst E. Welcome to the lions den CAM therapists and immunisations. Focus Altern Complement Ther 2005; 10: 98100. 10 Ernst E, Pittler MH, Wider B, Boddy K. The Desktop Guide to Complementary and Alternative Medicine, 2nd edn. Edinburgh: Elsevier Mosby, 2006. 11 Ernst E. Testing the water. Biologist 2012; 59: 1921.

Edzard Ernst, MD, PhD, FMedSci, FSB, FRCPEd, Editor-inChief of FACT, Laing Chair in Complementary Medicine, Peninsula Medical School, University of Exeter, Veysey Building, Salmon Pool Lane, Exeter EX2 4SG UK. E-mail: