Safety and efficacy of black cohosh and red clover for the management of vasomotor symptoms: a randomized controlled trial.
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.
Geller
Stacie E
SE
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.edu
Shulman
Lee P
LP
van Breemen
Richard B
RB
Banuvar
Suzanne
S
Zhou
Ying
Y
Epstein
Geena
G
Hedayat
Samad
S
Nikolic
Dejan
D
Krause
Elizabeth C
EC
Piersen
Colleen E
CE
Bolton
Judy L
JL
Pauli
Guido F
GF
Farnsworth
Norman R
NR
D015992:Body Mass Index; D015519:Bone Density; D031885:Cimicifuga / Q000009:adverse effects / Q000737:chemistry*; D004311:Double-Blind Method; D004966:Estrogens, Conjugated (USP) / Q000008:administration & dosage; D005260:Female; D019584:Hot Flashes / Q000188:drug therapy*; D006801:Humans; D017258:Medroxyprogesterone Acetate / Q000008:administration & dosage; D008593:Menopause; D008875:Middle Aged; D008517:Phytotherapy; D010919:Placebos; D010936:Plant Extracts / Q000009:adverse effects* / Q000627:therapeutic use*; D013546:Sweating; D029921:Trifolium / Q000009:adverse effects / Q000737:chemistry*
D004966:Estrogens, Conjugated (USP); D010919:Placebos; D010936:Plant Extracts; D017258:Medroxyprogesterone Acetate