Evaluation of specific and non-specific effects in homeopathy: Feasibility study for a randomised trial

Objective: To determine the feasibility, in terms of acceptability to patients, physicians and other staff; data return and statistical power of a study to elucidate the relative contributions of specific and non-specific effects in homeopathic treatment of dermatitis. Design: Randomised, controlled 4-arm trial, 2 arms double-blind. Setting: Outpatient clinic, Royal London Homoeopathic Hospital. Participants: Seventy-five adult patients with dermatitis. Interventions: Patients were randomly allocated to: 'fast track' open verum homeopathy, 'fast track' double-blind verum homeopathy, 'fast track' double-blind placebo homeopathy or waiting list control. Main outcome measures: One hundred millimeter visual analogue scale of overall symptom severity; 10 point digital scores of sleep, itching, skin condition; weekly 5-point Likert scale of topical steroid use; Dermatology Life Quality Index at entry and completion. Results: Recruitment was below target, but the study was acceptable to staff and feasible. Blinded patients were more likely to withdraw (P= 0.021, chi(2) test). After correction for baseline differences and multiple comparisons, no outcome measure showed statistically significant between group differences. Blindness appeared to have a negative effect, but this was confounded by differential withdrawal. Conclusions: A definitive trial of this design is unlikely to discriminate the relative contributions of the non-specific and specific effects to the outcome of homeopathic treatment of dermatitis, because of patient preference issues.