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

2009-11
Menopause (New York, N.Y.) 16(6)
- Stacie E Geller
- 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

PubMed: 19609225
DOI: 10.1097/gme.0b013e3181ace49b

Study Design

Type: Randomized Controlled Trial (RCT)
Sample size: n = 89
Population: 89 participants (women with menopausal vasomotor symptoms)
Methods: 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)
Blinding: Double-blind
Duration: 12 months
Funding: Unclear

Highly Cited

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.

Research Insights

Black Cohosh→Improved Quality of Life
In general, there were no improvements in other menopausal symptoms.
Effect
Neutral
Effect size
Small
Dose
standardized extract, dose not specified
Black Cohosh→Reduced Somatic Symptom
In general, there were no improvements in other menopausal symptoms.
Effect
Neutral
Effect size
Small
Dose
standardized extract, dose not specified
Black Cohosh→Reduced Vasomotor Symptom
Reductions in number of vasomotor symptoms after a 12-month intervention were as follows: ... red clover (57%), placebo (63%)... 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.
Effect
Neutral
Effect size
Small
Dose
standardized extract, dose not specified
Black Cohosh→Relieved Sexual Dysfunction
In general, there were no improvements in other menopausal symptoms.
Effect
Neutral
Effect size
Small
Dose
standardized extract, dose not specified
Red Clover→Improved Quality of Life
In general, there were no improvements in other menopausal symptoms.
Effect
Neutral
Effect size
Small
Dose
standardized extract, dose not specified
Red Clover→Reduced Somatic Symptom
In general, there were no improvements in other menopausal symptoms.
Effect
Neutral
Effect size
Small
Dose
standardized extract, dose not specified
Red Clover→Reduced Vasomotor Symptom
Reductions in number of vasomotor symptoms after a 12-month intervention were as follows: ... red clover (57%), placebo (63%)... 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.
Effect
Neutral
Effect size
Small
Dose
standardized extract, dose not specified
Red Clover→Relieved Sexual Dysfunction
In general, there were no improvements in other menopausal symptoms.
Effect
Neutral
Effect size
Small
Dose
standardized extract, dose not specified

Adverse Events Reported

Red Clover→Overall tolerability
Secondary measures indicated that both botanicals were safe as administered.
Finding
No significant difference
Significant
No
Black Cohosh→Overall tolerability
Secondary measures indicated that both botanicals were safe as administered.
Finding
No significant difference
Significant
No
Red Clover→Overall tolerability
Safety monitoring indicated that chemically and biologically standardized extracts of black cohosh and red clover were safe during daily administration for 12 months.
Finding
Reported
Black Cohosh→Overall tolerability
Safety monitoring indicated that chemically and biologically standardized extracts of black cohosh and red clover were safe during daily administration for 12 months.
Finding
Reported