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Randomized Controlled Trial
. 2009 Nov-Dec;16(6):1156-66.
doi: 10.1097/gme.0b013e3181ace49b.

Safety and efficacy of black cohosh and red clover for the management of vasomotor symptoms: a randomized controlled trial

Stacie E Geller  1 , Lee P Shulman, Richard B van Breemen, Suzanne Banuvar, Ying Zhou, Geena Epstein, Samad Hedayat, Dejan Nikolic, Elizabeth C Krause, Colleen E Piersen, Judy L Bolton, Guido F Pauli, Norman R Farnsworth
Affiliations
Randomized Controlled Trial

Safety and efficacy of black cohosh and red clover for the management of vasomotor symptoms: a randomized controlled trial

Stacie E Geller et al. Menopause. 2009 Nov-Dec.

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.

Trial registration: ClinicalTrials.gov NCT00066144.

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Figures

FIGURE 1
FIGURE 1
Study design and profile
FIGURE 2
FIGURE 2
Change in vasomotor symptoms, by study group: A) average number of vasomotor symptoms, hot flashes plus night sweats; B) average number of hot flashes; and C) average intensity of hot flashes
See this image and copyright information in PMC

References

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