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Safety and efficacy of black cohosh and red clover for the management of vasomotor symptoms: a randomized controlled trial.
Menopause. 2009 Nov-Dec; 16(6):1156-66.M

Abstract

OBJECTIVE

The aim of this study was to evaluate the safety and efficacy of black cohosh and red clover compared with placebo for the relief of menopausal vasomotor symptoms.

METHODS

This study was a randomized, four-arm, double-blind clinical trial of standardized black cohosh, red clover, placebo, and 0.625 mg conjugated equine estrogens plus 2.5 mg medroxyprogesterone acetate (CEE/MPA; n = 89). Primary outcome measures were reduction in vasomotor symptoms (hot flashes and night sweats) by black cohosh and red clover compared with placebo; secondary outcomes included safety evaluation, reduction of somatic symptoms, relief of sexual dysfunction, and overall improvement in quality of life.

RESULTS

Reductions in number of vasomotor symptoms after a 12-month intervention were as follows: black cohosh (34%), red clover (57%), placebo (63%), and CEE/MPA (94%), with only CEE/MPA differing significantly from placebo. Black cohosh and red clover did not significantly reduce the frequency of vasomotor symptoms as compared with placebo. Secondary measures indicated that both botanicals were safe as administered. In general, there were no improvements in other menopausal symptoms.

CONCLUSIONS

Compared with placebo, black cohosh and red clover did not reduce the number of vasomotor symptoms. Safety monitoring indicated that chemically and biologically standardized extracts of black cohosh and red clover were safe during daily administration for 12 months.

Authors+Show Affiliations

Department of Obstetrics and Gynecology, Center for Research on Women and Gender, College of Medicine, University of Illinois at Chicago, Chicago, IL 60612, USA. sgeller@uic.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, N.I.H., Extramural

Language

eng

PubMed ID

19609225

Citation

Geller, Stacie E., et al. "Safety and Efficacy of Black Cohosh and Red Clover for the Management of Vasomotor Symptoms: a Randomized Controlled Trial." Menopause (New York, N.Y.), vol. 16, no. 6, 2009, pp. 1156-66.
Geller SE, Shulman LP, van Breemen RB, et al. Safety and efficacy of black cohosh and red clover for the management of vasomotor symptoms: a randomized controlled trial. Menopause. 2009;16(6):1156-66.
Geller, S. E., Shulman, L. P., van Breemen, R. B., Banuvar, S., Zhou, Y., Epstein, G., Hedayat, S., Nikolic, D., Krause, E. C., Piersen, C. E., Bolton, J. L., Pauli, G. F., & Farnsworth, N. R. (2009). Safety and efficacy of black cohosh and red clover for the management of vasomotor symptoms: a randomized controlled trial. Menopause (New York, N.Y.), 16(6), 1156-66. https://doi.org/10.1097/gme.0b013e3181ace49b
Geller SE, et al. Safety and Efficacy of Black Cohosh and Red Clover for the Management of Vasomotor Symptoms: a Randomized Controlled Trial. Menopause. 2009 Nov-Dec;16(6):1156-66. PubMed PMID: 19609225.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Safety and efficacy of black cohosh and red clover for the management of vasomotor symptoms: a randomized controlled trial. AU - Geller,Stacie E, AU - Shulman,Lee P, AU - van Breemen,Richard B, AU - Banuvar,Suzanne, AU - Zhou,Ying, AU - Epstein,Geena, AU - Hedayat,Samad, AU - Nikolic,Dejan, AU - Krause,Elizabeth C, AU - Piersen,Colleen E, AU - Bolton,Judy L, AU - Pauli,Guido F, AU - Farnsworth,Norman R, PY - 2009/7/18/entrez PY - 2009/7/18/pubmed PY - 2010/1/15/medline SP - 1156 EP - 66 JF - Menopause (New York, N.Y.) JO - Menopause VL - 16 IS - 6 N2 - OBJECTIVE: The aim of this study was to evaluate the safety and efficacy of black cohosh and red clover compared with placebo for the relief of menopausal vasomotor symptoms. METHODS: This study was a randomized, four-arm, double-blind clinical trial of standardized black cohosh, red clover, placebo, and 0.625 mg conjugated equine estrogens plus 2.5 mg medroxyprogesterone acetate (CEE/MPA; n = 89). Primary outcome measures were reduction in vasomotor symptoms (hot flashes and night sweats) by black cohosh and red clover compared with placebo; secondary outcomes included safety evaluation, reduction of somatic symptoms, relief of sexual dysfunction, and overall improvement in quality of life. RESULTS: Reductions in number of vasomotor symptoms after a 12-month intervention were as follows: black cohosh (34%), red clover (57%), placebo (63%), and CEE/MPA (94%), with only CEE/MPA differing significantly from placebo. Black cohosh and red clover did not significantly reduce the frequency of vasomotor symptoms as compared with placebo. Secondary measures indicated that both botanicals were safe as administered. In general, there were no improvements in other menopausal symptoms. CONCLUSIONS: Compared with placebo, black cohosh and red clover did not reduce the number of vasomotor symptoms. Safety monitoring indicated that chemically and biologically standardized extracts of black cohosh and red clover were safe during daily administration for 12 months. SN - 1530-0374 UR - https://www.unboundmedicine.com/medline/citation/19609225/Safety_and_efficacy_of_black_cohosh_and_red_clover_for_the_management_of_vasomotor_symptoms:_a_randomized_controlled_trial_ L2 - https://doi.org/10.1097/gme.0b013e3181ace49b DB - PRIME DP - Unbound Medicine ER -