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Summary and Commentary on “A randomised, controlled, triple-blind trial of the efficacy of homeopathic treatment for chronic fatigue syndrome.” (Weatherley-Jones E, Nicholl JP, Thomas KJ, Parry GJ, McKendrick MW, Green ST,Stephen T. Stanley,Philip J, Lynch,Sean PJ. Journal of Psychosomatic Research 2004;56:189-97.)
There is no management regime for chronic fatigue syndrome (CFS) that has been found to be universally beneficial and no treatment can be considered a “cure”. Patients with CFS may use complementary and alternative medicine (CAM). Our aim was to evaluate homeopathic treatment in reducing subjective symptoms of CFS.
Using a triple-blind design (patient and homeopath blind to group assignment and data analyst blind to group until after initial analyses to reduce the possibility of bias due to data analyst), we randomly assigned patients to homeopathic medicine or identical placebo. One hundred and three patients meeting the Oxford criteria for CFS were recruited from two specialist hospital out patient departments. Patients had monthly consultations with a professional homeopath for 6 months. Main outcome measures were scores on the subscales of the Multidimensional Fatigue Inventory (MFI) and proportions of each group attaining clinically significant improvements on each subscale. Secondary outcome measures were the Fatigue Impact Scale (FIS) and the Functional Limitations Profile (FLP).
Ninety-two patients completed treatment in the trial (47 homeopathic treatment, 45 placebo). Eighty-six patients returned fully or partially completed post-treatment outcome measures (41 homeopathic treatment group who completed treatment, 2 homeopathic treatment group who did not complete treatment, 38 placebo group who completed treatment, and 5 placebo group who did not complete treatment).
Seventeen of 103 patients withdrew from treatment or were lost to follow-up. Patients in the homeopathic medicine group showed significantly more improvement on the MFI general fatigue subscale (one of the primary outcome measures) and the FLP physical subscale but not on other subscales. Although group differences were not statistically significant on four out of the five MFI subscales (the primary outcome measures), more people in the homeopathic medicine group showed clinically significant improvement. More people in the homeopathic medicine group showed clinical improvement on all primary outcomes (relative risk = 2.75, P = .09).
Conclusions: There is weak but equivocal evidence that the effects of homeopathic medicine are superior to placebo. Results also suggest that there may be nonspecific benefits from the homeopathic consultation. Further studies are needed to determine whether these differences hold in larger samples.
There are two questions addressed by this study:
- Is homeopathy a useful treatment for CFS/ME?and
- Are the effects of homeopathic treatment due only to placebo?
Although the results are equivocal, the study had a very rigorous design and aimed to find a strong clinically significant effect. An independent reviewer[i] commented: “the effect of a small significant difference in the main outcome criterion is worth noticing” (p 211) and concluded that the “homeopathic therapy for chronic fatigue patients is at least one option that should be considered in light of the fact that chronic fatigue is very difficult to treat with any method.” (p. 211).
The reviewer also concluded that although the study did not conclusively answer the question of whether the effects of homeopathic remedies are due solely to placebo, “it has shown in a carefully designed, rigorous trial that the placebo hypothesis is less likely to hold true than the specificity hypothesis.”
Since completing and reporting on this study, I have reflected on and researched the relevance and appropriateness of the design of this study for investigating homeopathic treatment. It is important in homeopathic research, as in any medical research, to apply rigorous scientific methods to address questions about efficacy and effectiveness and in designing this study this principle was applied. Nevertheless it is important that whatever methods are used permit homeopathic practice to be studied without interference in its essential principles. At the time of designing this trial, I believed the triple/double-blind placebo randomized controlled trial fit these criteria.
In retrospect, however, it is clear that the presence of a placebo arm in a study of homeopathic treatment can compromise the practice of homeopathy. In a further paper[ii], colleagues and I conclude that “It is not reasonable to assume that the specific effects of homeopathic medicine and the non-specific effects of consultations are independent of each otherâ€”specific effects of the medicine (as manifested by patients’ reactions) may influence the nature of subsequent consultations and the non-specific effects of the consultation may enhance or diminish the effects of the medicine.” and that “For clinical trials of homeopathy to be accurate representations of practice, we need modified designs that take into account the complexity of the homeopathic intervention.”.
It is probably the case that the results of the CFS/ME homeopathic treatment trial were influenced by the existence of a placebo arm in the study. We concluded from this observation and those of colleagues researching homeopathic treatment for other conditions[iii] that the “search for efficacy of individualized homeopathy is flawed if done in placebo-controlled RCTs. They are also a possible explanation why only small effects are seen in placebo-controlled trials of homeopathy. The distinction between (1) the academic aim of distinguishing whether homeopathy is a placebo effect, albeit with therapeutic value, and (2) whether homeopathy is of clinical benefit, should be made and reflected in distinct research aims. Furthermore, these observations support the idea that research of individualized homeopathy and other individualized therapies should be focused on answering questions about whether it is a useful tool for health care, which is often a question of relevance to patients, health-care providers and purchasers.
Whilst placebo-controlled trials of specific homeopathic remedies are valid, it is time to halt the misguided task of conducting placebo-controlled RCTs to test efficacy of individualized treatments; to redirect our energies to analyses of whole-systems healthcare and to design more relevant and meaningful pragmatic studies of comparative effectiveness, where untested treatments are compared to those where there is evidence of effectiveness.”
A Report of the CFS/ME Working Group. Report to the chief medical officer of an independent working group: Department of Health, 2002.
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