Are the therapeutic effects of homeopathy attributed to the consultation, the homeopathic remedy, or both? A protocol for a future exploratory feasibility trial in patients with rheumatoid arthritis.

Systematic reviews suggest that homeopathy has a greater effect than placebo, however, the mechanisms of its action are unknown. The clinical effects of homeopathy could be attributed to the specific effects of the remedy and/or to the contextual effects of the consultation process; these factors have not been critically evaluated. We have developed a model that attempt to separate the consultation effects from the specific effects because of the remedy. We propose to investigate this design in a chronic condition, rheumatoid arthritis, for which previous research has evaluated both classical and complex homeopathic interventions. The following protocol describes the study design. The aims of this exploratory trial are to assess the feasibility of the study design, identify effect sizes of the consultation, the complex treatment, and the individualized remedy, as well as possibly efficacy, for the two types of homeopathic treatment and the homeopathic consultation. Data collection will take place in 2004.