Randomized trial of black cohosh for the treatment of hot flashes among women with a history of breast cancer

Purpose: Most breast cancer survivors experience hot flashes; many use comp lementary or alternative remedies for these symptoms. We undertook a random ized clinical trial of black cohosh, a widely used herbal remedy for menopa usal symptoms, among breast cancer patients. Patients and Methods: Patients diagnosed with breast cancer who had complet ed their primary treatment were randomly assigned to black cohosh or placeb o, stratified on tamoxifen use. At enrollment, patients completed a questio nnaire about demographic factors and menopausal symptoms. Before starting t o take the pills and at 30 and 60 days, they completed a 4-day hot flash di ary. At the final visit, they completed another menopausal symptom question naire. Follicle-stimulating hormone (FSH) and luteinizing hormone (LH) leve ls were measured in a subset of patients at the first and final visits. Results: Of 85 patients (59 on tamoxifen, 26 not on tamoxifen) enrolled in the study, 42 were assigned to treatment and 43 were assigned to placebo; 6 9 completed all three hot flash diaries. Both treatment and placebo groups reported declines in number and intensity of hot flashes; the differences b etween the groups were not statistically significant. Both groups also repo rted improvements in menopausal symptoms that were, for the most part, not significantly different. Changes in blood levels of FSH and LH also did not differ in the two groups. Conclusion: Black cohosh was not significantly more efficacious than placeb o against most menopausal symptoms, including number and intensity of hot f lashes. Our study illustrates the feasibility and value of standard clinica l trial methodology in assessing the efficacy and safety of herbal agents. (C) 2001 by American Society of Clinical Oncology.