A Pilot, Randomized, Double-Blinded, Placebo-Controlled Trial of Individualized Homeopathy for Symptoms of Estrogen Withdrawal in Breast-Cancer Survivors

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Abstract
Objective: To pilot an investigation of individualized homeopathy for symptoms of estrogen withdrawal in breast cancer survivors. Design: Randomized, double-blinded, placebo-controlled trial. Setting: Outpatient department of a National Health Service (NHS) homeopathic hospital. Participants: Fifty-seven (57) women met inclusion criteria and 53 were randomized to the study. Intervention: After 2 weeks of baseline assessment, all participants received a consultation plus either oral homeopathic medicine or placebo, assessed every 4 weeks for 16 weeks. Outcome measures: The primary outcome measures were the activity score and profile score of the Measure Yourself Medical Outcome Profile (MYMOP). Results: Eighty-five percent (85%) (45/53) of women completed the study. There was no evidence of a difference seen between groups for either activity (adjusted difference =–0.4, 95% confidence interval CI –1.0 to 0.2, p = 0.17) or profile scores (adjusted difference = –0.4, 95% CI –0.9 to 0.1, p = 0.13) using this trial design, although post hoc power calculations suggests that 65–175 would be needed per group to detect differences of this magnitude with sufficient precision. Clinically relevant improvements in symptoms and mood disturbance were seen for both groups over the study period. Conclusion: Improvements were seen for symptom scores over the study period. However, presuming these improvements were caused by the individualized homeopathic approach, the study failed to show clearly that the specific effect of the remedy added further to the nonspecific effects of the consultation. Future trial design must ensure adequate power to account for the nonspecific impact of such complex individualized interventions while pragmatic designs may more readily answer questions of clinical and cost effectiveness.