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FACT
Focus on Alternative and Complementary Therapies

Are the therapeutic effects of homoeopathy attributed to the consultation, the homoeopathic remedy, or both? Protocol for an exploratory randomised controlled trial in rheumatoid arthritis patients

Brien S1, Lachance L2, Lewith G1
1Complementary Medicine Research Unit, Royal South Hants Hospital, Brintons Terrace, Off St Mary’s Road, Southampton, SO14 0YG, UK
2M5071 School of Public Health, University of Michigan, 109 South Observatory Street, Ann Arbor, MI 48109-2029, USA

Objective

Four randomised, controlled trials assessed homoeopathy in rheumatoid arthritis; three using classical homoeopathy and one complex homoeopathy (without consultation). A meta-analysis indicates that homoeopathy is more effective than placebo (OR 2.0). The positive effects from homoeopathy are unexplained; they may be attributed to the specific (remedy) and/or to the contextual effects of the consultation process. The aim of this protocol is to provide a model to identify where the therapeutic effects of homoeopathy lie, provide data on the contextual effects of the consultation and provide evidence for the plausibility of homoeopathy for rheumatoid arthritis.

Materials and methods

An exploratory randomised, controlled pilot trial in rheumatoid arthritis patients. Patients (n = 100) will be randomised into five groups: (1) consultation with individualised treatment; (2) consultation with homoeopathic RA complex; (3) consultation with placebo; (4) homoeopathic complex without consultation; (5) placebo without consultation. Outcome measures include Outcome Measures for Arthritis Clinical Trials (OMERACT), quality of life (SF-36), and analgesic use. The primary outcome will be achievement of a 20% reduction in rheumatoid symptoms. Covariates/predictors of outcome will include patient’ expectations, sense of enablement, attitudes to, and beliefs in, complementary medicine, and perceived practitioner empathy.

Results and conclusion

We anticipate the most favourable outcomes in the consultation groups, with enhanced outcome in the classical homoeopathy group.

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