A pilot, randomized, double-blinded, placebo-controlled trial of individualized homeopathy for symptoms of estrogen withdrawal in breast-cancer survivors.
OBJECTIVE
To pilot an investigation of individualized homeopathy for symptoms of estrogen withdrawal in breast cancer survivors.


METHODS
Randomized, double-blinded, placebo-controlled trial.


METHODS
Outpatient department of a National Health Service (NHS) homeopathic hospital.


METHODS
Fifty-seven (57) women met inclusion criteria and 53 were randomized to the study.


METHODS
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.


METHODS
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.


CONCLUSIONS
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.
Thompson
Elizabeth A
EA
Bristol Homeopathic Hospital, Bristol, UK. Elizabeth.Thompson@ubht.swest.nhs.uk
Montgomery
Alan
A
Douglas
Diane
D
Reilly
David
D
D000328:Adult; D001943:Breast Neoplasms / Q000628:therapy; D016001:Confidence Intervals; D004311:Double-Blind Method; D004967:Estrogens / Q000172:deficiency*; D005260:Female; D006705:Homeopathy / Q000379:methods*; D006801:Humans; D008875:Middle Aged; D016017:Odds Ratio; D010865:Pilot Projects; D011788:Quality of Life; D012107:Research Design; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires; D017741:Survivors; D016896:Treatment Outcome
D004967:Estrogens