Letter to the Editor (matters arising)

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Jun 17, 2011 - Comment 2 on: Homeopathy has clinical benefits in rheumatoid arthritis patients that are attributable to the consultation process but not the ...

Rheumatology Advance Access published June 17, 2011

RHEUMATOLOGY

Letter to the Editor (matters arising)

Comment 2 on: Homeopathy has clinical benefits in rheumatoid arthritis patients that are attributable to the consultation process but not the homeopathic remedy: a randomized controlled clinical trial

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SIR, We read with interest the article by Brien et al. [1] published recently in this Journal. The authors conclude that homeopathic consultations, but not homeopathic remedies, are associated with clinically relevant benefits for patients with active but relatively stable RA. In the same edition, Ernst in his editorial [2] suggests that we should take these results at face value; that homeopathic remedies are ineffective and empathetic therapeutic encounters are helpful. Brien et al. [1] sought to assess whether any benefits from adjunctive homeopathic treatment in patients with RA are due to the homeopathic consultation, homeopathic remedies or both. Participants in the trial were randomly allocated to consultation [further randomized to either individualized homeopathy (Group 1) or the complex homeopathic medicine Rheumaselect (Group 2) or placebo (Group 3)] or to no consultation [further randomized to Rheumaselect (Group 4) or placebo (Group 5)]. Secondary, but not primary, outcomes detected a significant improvement over time and for current pain in Groups 1–3 when compared with Groups 4 and 5. This trial therefore suggests that homeopathy can be effective in the treatment of RA. However, the authors and Ernst [2] are premature in their assumption that homeopathic remedies themselves are ineffective. There are a number of obvious problems with this trial, some of which the authors themselves identified. First, it was underpowered: 110 participants (22 in each arm, allowing for a drop-out of 20%) were required to detect a significant difference in the primary outcome measure. Only 77 participants began the treatment and only 56 completed the treatment. The trial was underpowered to detect any difference between individualized treatment and complex (Group 1 vs Group 2), for either primary or secondary measures, where only 12 and 10 participants, respectively, completed the follow-up in these arms. The trial was also underpowered to detect any difference between individualized treatment and placebo (Group 1 vs Group 3) where only 12 and 11 participants, respectively, completed the follow-up. Hence, the conclusion cannot be drawn from this study that the individualized remedies prescribed did not have an effect. Secondly, an intention-to-treat analysis was undertaken in an attempt to reduce bias. However, the drop-out rate was higher than anticipated (27% as opposed to 20%) and the total numbers of participants at follow-up across the groups was low (n = 56). For those who

dropped out, their last known data were carried forward for analysis, which can only lead to an underestimation of any treatment effect. Thirdly, the authors base their conclusion that improvements were not due to homeopathic treatment solely upon comparison between the two groups receiving the homeopathic complex medicine Rheumaselect (Groups 2 and 4) and the two groups receiving placebo (Groups 3 and 5). Rheumaselect was chosen as it had previously been reported as efficacious for RA [3, 4]; it is unlikely, however, that all patients in a sample will be responsive to this particular standardized remedy. In addition, for this comparison, data have been pooled from those in the consultation and no consultation arms. There are problems with this approach as those in the consultation arm received a very different intervention, and a difference between placebo and complex remedy would only be fully revealed by comparison with the no consultation arm. No conclusions can be drawn for Group 4 vs Group 5 (no consultation plus homeopathic complex vs no consultation plus placebo) as the trial was underpowered to detect any significant difference between these groups (9 and 10 completers, respectively). In order to answer the question of whether or not Rheumaselect complex is more effective than placebo, a further trial would be needed with no consultation for either arm and a much larger sample size. Hence, the conclusion cannot be drawn from this study that the Rheumaselect complex did not have an effect over and above placebo. Fourthly, a frequent occurrence in complementary and alternative medicine research is that both verum and placebo arms produce a positive response, with the consequence that the treatment is dismissed as being of no greater value than placebo. This so called double positive has been observed on numerous occasions. Reilly [5] argues that the problem stems from the fact that the specific efficacy of the intervention may be small in comparison with the overall effectiveness. The smaller the specific efficacy in relation to the effectiveness, the greater the number of participants needed in a trial to detect it. If the homeopathic consultation is truly of high therapeutic value in RA, then the numbers of participants needed to demonstrate specific effects of homeopathic remedies in a trial may be much larger than the numbers in this trial. Finally, and importantly, the model validity of the individualized prescribing is impossible to assess from this report. It is only stated that the prescribing homeopaths had 15 years of experience but not whether they had experience in the treatment of RA. The homeopathic remedies were only prescribed in 50 millesimal potencies, a procedure that would not be standard practice for most homeopaths. It is a fundamental principle of any scientific report that the work should, in principle, be repeatable on

L ET T E R

doi:10.1093/rheumatology/ker120

Letter to the Editor

the basis of the report, and that is not the case here. It is not possible to judge the appropriateness of the individualized treatment in this trial: patients might have received inappropriate remedies throughout the trial, with the consequence that placebo was not compared with active treatment for that individual. The only legitimate conclusion from this trial is that there is some evidence that homeopathy may be effective in the treatment of RA. It is not possible to make conclusions about the relative effects of the consultation or the remedy itself; more research is clearly needed. It is therefore surprising that, in his editorial, Professor Ernst comes to the sweeping conclusion: ‘The authors demonstrate that homeopathic remedies are placebos and show that the benefits of homeopathy are attributable to the consultation’ [2]. Such overstated conclusions do not assist an objective and constructive approach to research development in homeopathy. Disclosure statement: The authors have declared no conflicts of interest.

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School of Health, University of Central Lancashire, Preston, 2 British Homeopathic Association, Luton and 3Royal London

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References 1 Brien S, Lachance L, Prescott P, McDermott C, Lewith G. Homeopathy has clinical benefits in rheumatoid arthritis patients that are attributable to the consultation process but not the homeopathic remedy: a randomized controlled clinical trial. Rheumatology 2010;50:doi:10.1093/rheumatology/keq234. 2 Ernst EE. Homeopathy, non-specific effects and good medicine. Have we lost core medical values?. Rheumatology 2010;50:doi:10.1093/rheumatology/ keq265. 3 Kohler T. Proof of efficacy of homeopathy against rheumatoid arthritis. A randomised double blind trial by independent doctors. Der Kassenarzt 1991;13:48–52. 4 Wiesenauer M, Gaus W. Proof of efficacy of homeopathy against rheumatoid arthritis. A randomised, double blind trial by independent doctors. Aktuelle Rheumatologie 1991;16:1–9. 5 Reilly D. When is useful improvement a waste of time? Double positive paradox of negative trials. Br Med J 2002; 325:42.

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Kate Chatfield1, Robert T. Mathie2 and Peter Fisher3

Hospital for Integrated Medicine, London, UK Accepted 17 February 2011 Correspondence to: Kate Chatfield, School of Health, University of Central Lancashire, Preston PR5 4RL, UK. E-mail: [email protected]