The placebo-controlled trial as a test of complementary and alternative medicine: observations from research experience of individualised homeopathic treatment

Abstract

The authors' experience of conducting clinical trials in homeopathy and analysing data from these has drawn attention to a fundamental problem with the interpretation of results from placebo controlled trials in homeopathy: It is not reasonable to assume that the specific effects of homeopathic medicine and the non-specific effects of consultations are independent of each other-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. 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. Only with such trials will the results be generalisable to homeopathic practice in the real world. The authors propose that comparative trials are a meaningful way of evaluating the effectiveness of homeopathic treatment.

The Context and Meaning of Placebos for Complementary Medicine

“…The process of identifying, choosing, and giving the homeopathic remedy appears to be specific to homeopathy as it has a central role in the homeopathic consultation and may therefore play an active part in promoting therapeutic benefit. My findings corroborate a previous theoretical explanation by Weatherley-Jones [41], in that the homeopathic remedy cannot be treated independently to the effect of the consultation, and hence it is meaningless to separate out the remedy from the consultation. This is consistent with the theoretical model of entanglement in homeopathy between the patient, the practitioner, and the remedy [47,48].…”

“…Additionally, the RCT has frequently not investigated homeopathy as it is practiced in a 'real world' situation, for instance the blinding of homeopaths participating in a trial interferes with their normal practice routine of an individualised patient response to a far greater extent than with a conventional medical prescription [41]. Furthermore, the use of isopathy is not a routine part of classical homeopathy [42,43].…”

“…of a therapy has been questioned. For example, it has been proposed in homeopathy that the specific and non-specific effects may interact rather than just being an additive effect of the homeopathic intervention [41]. This view is reiterated in Paterson and Dieppe's [44] observations on acupuncture research.…”

Under Pressure: Homeopathy UK and Its Detractors

“…Thus, applied to homeopathy, the remedy as an agent of therapeutic effect, is considered completely separate from case-taking, which provides context [50]. Only then can the results obtained from DBRCTs be statistically 'significant', which justifies separating therapy from context in the first place [51].…”

“…Then they were instructed to attribute any lack of patient response as due to a wrong choice of remedy; not to the more obvious reason that blinding and randomisation meant the practitioner was totally unaware whether the patient had received verum or placebo! As Weatherley-Jones et al have pointed out [50], this apparent 'collusion' with the randomisation protocol so impedes a practitioner's therapeutic abilities, it could virtually guarantee a negative trial result for homeopathy or any complex intervention. Perhaps a better way of gauging the efficacy and importantly the safety of a therapeutic modality might be to use long-term outcomes measurements (as has recently been done for homeopathy [56]), and more pragmatic trials that compare whole systems of care.…”