A research model for the scientific investigation of homoeopathy

Homoeopathy is a controversial form of medicine that is governed by the premise that highly diluted substances that can a defined set of symptoms in a healthy person can cure a similar set of symptoms in a non-healthy person. The use of highly diluted homoeopathic substances that may no longer be expected to contain any trace of the original substance is contrary to accepted pharmacological theory. In addition to serial dilution, homoeopathic “potentisation” of substances also includes violent agitation of the substance at each dilution step, a process known as “succussion”. The role of this process is not understood. The fact that the mechanism of action of homoeopathic substances is unknown adds to the controversial nature of this therapy. A review of the literature demonstrated that a more rigorous approach to the research of homoeopathy was needed in order to investigate whether homoeopathy could be investigated within a scientifically appropriate context. It was initially proposed that, through the successful replication of an existing trial, a series of clinical trials based on this replication could be conducted to test fundamental questions of homoeopathy. For pragmatic reasons, this initial approach was abandoned. A novel protocol that was subsequently designed to scientifically evaluate the effects of homoeopathy, in particular, the homoeopathic treatment of osteoarthritis of the knee and hip, was subsequently developed. A description of homoeopathy, its development, its placement within the scientific paradigm and its role in the treatment of various clinical conditions is reviewed in Chapter 1. From this literature review, hypotheses were generated to test the effect of the homoeopathic treatment of osteoarthritis. Chapter 2 describes the selection process and proposed replication of a prior clinical trial with a successful outcome upon which to base a further series of clinical trials to test fundamental questions in homoeopathy. The selected study was a randomised, double-blind clinical trial designed to compare the effects of a complex homoeopathic preparation with the effects of paracetamol in the treatment of osteoarthritic knee pain. The study was prematurely terminated when another study presented evidence that the analgesic effect of paracetamol was no better than placebo. The uncertainty that paracetamol was no better than placebo raised doubts as to the validity of any outcome had the trial proceeded. The proposal to develop a series of clinical trials replicating the protocol of this study was postponed as a consequence. Chapter 3 describes the subsequent formation of a ‘think tank’ consisting of epidemiologists, biostatisticians, clinical researchers in complementary medicine and homoeopaths and the subsequent development of a rigorous research protocol for the investigation of homoeopathy within the scientific paradigm. This homoeopathic research model and is described in detail. Chapter 4 describes a randomised, double-blind, placebo-controlled trial with five arms designed to evaluate both the research model and the homoeopathic treatment of osteoarthritis of the hip and knee. Chapter 5 details the results of this clinical trial. No significant difference was demonstrated between individualised homoeopathic treatment, generic complex homoeopathic treatments or placebo. Furthermore, no positive effect on treatments was demonstrated by the inclusion of a full homoeopathic consultation. Chapter 6 provides a discussion of the clinical trial. Possible reasons for the discrepancy between the hypothesised outcomes and the results of the clinical trial are explored and directions for future research are suggested