Randomized trial of black cohosh for the treatment of hot flashes among women with a history of breast cancer.
OBJECTIVE
Most breast cancer survivors experience hot flashes; many use complementary or alternative remedies for these symptoms. We undertook a randomized clinical trial of black cohosh, a widely used herbal remedy for menopausal symptoms, among breast cancer patients.


METHODS
Patients diagnosed with breast cancer who had completed their primary treatment were randomly assigned to black cohosh or placebo, stratified on tamoxifen use. At enrollment, patients completed a questionnaire about demographic factors and menopausal symptoms. Before starting to take the pills and at 30 and 60 days, they completed a 4-day hot flash diary. At the final visit, they completed another menopausal symptom questionnaire. Follicle-stimulating hormone (FSH) and luteinizing hormone (LH) levels 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; 69 completed all three hot flash diaries. Both treatment and placebo groups reported declines in number and intensity of hot flashes; the differences between the groups were not statistically significant. Both groups also reported 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.


CONCLUSIONS
Black cohosh was not significantly more efficacious than placebo against most menopausal symptoms, including number and intensity of hot flashes. Our study illustrates the feasibility and value of standard clinical trial methodology in assessing the efficacy and safety of herbal agents.
Jacobson
J S
JS
Herbert Irving Comprehensive Cancer Center and Joseph L. Mailman School of Public Health, Columbia University, and Weill-Cornell Medical College, New York, NY 10032, USA.
Troxel
A B
AB
Evans
J
J
Klaus
L
L
Vahdat
L
L
Kinne
D
D
Lo
K M
KM
Moore
A
A
Rosenman
P J
PJ
Kaufman
E L
EL
Neugut
A I
AI
Grann
V R
VR
D018931:Antineoplastic Agents, Hormonal / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy; D003131:Combined Modality Therapy; D004311:Double-Blind Method; D005260:Female; D005640:Follicle Stimulating Hormone / Q000097:blood; D019584:Hot Flashes / Q000188:drug therapy*; D006801:Humans; D007986:Luteinizing Hormone / Q000097:blood; D008875:Middle Aged; D010936:Plant Extracts / Q000627:therapeutic use*; D013629:Tamoxifen / Q000009:adverse effects / Q000627:therapeutic use*
D018931:Antineoplastic Agents, Hormonal; D010936:Plant Extracts; D013629:Tamoxifen; D007986:Luteinizing Hormone; D005640:Follicle Stimulating Hormone