Research: FISHER and SCOTT,

Listed in Issue 72

Abstract

FISHER and SCOTT, Royal London Homoeopathic Hospital, Great Ormond Street, London, UK, investigated whether a homeopathic medicines series was effective in reducing the symptoms of joint inflammation in rheumatoid arthritis (RA).

Background

Methodology

This 6-month, randomized, cross-over design, double-blind, placebo-controlled, single-centre clinical trial involved 112 patients with definite or classical RA who were seropositive for rheumatoid factor and were receiving either stable doses of single non-steroidal anti- inflammatory drugs (NSAIDs) for up to 3 months or single disease- modifying antirheumatic drugs (DMARDs) with or without NSAIDs for up to 6 months. Patients were excluded if they were severely disabled, had taken systemic steroids in the previous 6 months or had withdrawn from DMARD therapy in the previous 12 months. Trial subjects received either a series of 42 homeopathic medicines used to treat RA in 6cH (10(-12)) and/or 30cH (10(-30)) dilutions (a total of 59 preparations) manufactured to French National Pharmacopoeia standards, or a series of identical matching placebos, for 3 months, after which they were 'crossed over' to the opposite treatment series for a further 3 months. Main outcome measures were: visual analogue scale (VAS) pain scores; Ritchie articular index; duration of morning stiffness; and erythrocyte sedimentation rate (ESR).

Results

58 patients (51.8%) completed the trial. 54 withdrew before completing the trial. 31 changed to conventional medicine, 10 had serious intercurrent illness or surgery, 12 failed to attend, and 3 withdrew consent. For those patients who completed, mean pain scores, articular indices and ESRs decreased significantly over the 6-month trial period by 18%, 24% and 11% respectively (p<0.01, Wilcoxon rank sum tests). Mean pain scores were significantly lower after 3 months' placebo therapy than after 3 months' homeopathic treatment (p=0.032, Wilcoxon rank sum test). Articular index, ESR and morning stiffness were similar with placebo and homeopathic treatment.

Conclusion

There was no evidence that the series of homeopathic medicines used in this trial improved symptoms of RA over 3 months in patients attending a routine clinic who were stabilized on NSAIDs or DMARDs.

References

Comment from Dr Peter Fisher: This clinical trial was essentially an attempt to replicate two clinical trials of homeopathy for rheumatoid arthritis, reported by Robin and Sheila Gibson of the Glasgow Homoeopathic Hospital, in the early 1980s. The 3-month treatment period and crossover design were the same as in their work. The trial ran into serious problems, in particular that nearly half the patients were withdrawn from the study, mostly because their conventional medication was changed or because of other illnesses. Both the active treatment and placebo groups seemed to improve, but this probably reflects the fact that the patients who were deteriorating had their medication changed and were withdrawn. The main conclusion is that, for us at least, the trial design simply did not work. Given the short treatment period, the large proportion of withdrawals and cross-over design, very little can be said about the effectiveness of homeopathy for rheumatoid arthritis. In retrospect, perhaps we should have abandoned it. But having done the study it was important to publish it, if only to prevent others from making the same mistakes. It is by no means the end of the road; we have done other, positive studies of homeopathy in rheumatic conditions, and are planning more, much better designed trials. Certainly we have learned some important lessons about trial design, if not about homeopathy!

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