Randomized, double-blind, placebo-controlled trial of Cimicifuga racemosa (black cohosh) in women with anxiety disorder due to menopause.
OBJECTIVE
We conducted a randomized, double-blind, placebo-controlled, parallel group trial of the efficacy and tolerability of Cimicifuga racemosa (black cohosh) extract for the treatment of anxiety disorder due to menopause. We hypothesized that black cohosh would be superior to placebo in reducing anxiety symptoms of menopause, with a comparable tolerability profile to placebo.


METHODS
Subjects were randomized to therapy with either pharmaceutical-grade black cohosh extract (n = 15) or placebo (n = 13) for up to 12 weeks. The primary outcome measure was changed over time in total Hamilton Anxiety Rating Scale (HAM-A) scores. Secondary outcomes included a change in scores on the Beck Anxiety Inventory, Green Climacteric Scale (GCS), and Psychological General Well-Being Index (PGWBI) and the proportion of patients with a change of 50% or higher in baseline HAM-A scores.


RESULTS
There was neither a significant group difference in change over time in total HAM-A scores (P = 0.294) nor a group difference in the proportion of subjects with a reduction of 50% or higher in baseline HAM-A scores at study end point (P = 0.79). There was a significantly greater reduction in the total GCS scores during placebo (vs black cohosh; P = 0.035) but no group difference in change over time in the GCS subscale scores or in the PGWBI (P = 0.140). One subject (3.6%) taking black cohosh discontinued treatment because of adverse events.


CONCLUSIONS
We found no statistically significant anxiolytic effect of black cohosh (vs placebo). However, small sample size, choice of black cohosh preparation, and dosage used may have been limiting factors producing negative results.
Amsterdam
Jay D
JD
Depression Research Unit, Department of Psychiatry, University of Pennsylvania School of Medicine, Philadelphia, PA 19104-3309, USA. jamsterd@mail.med.upenn.edu
Yao
Yubing
Y
Mao
Jun James
JJ
Soeller
Irene
I
Rockwell
Kenneth
K
Shults
Justine
J
D000368:Aged; D001008:Anxiety Disorders / Q000188:drug therapy* / Q000209:etiology / Q000523:psychology; D031885:Cimicifuga / Q000009:adverse effects; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008593:Menopause / Q000187:drug effects* / Q000523:psychology*; D008875:Middle Aged; D008517:Phytotherapy / Q000379:methods; D010936:Plant Extracts / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use; D014666:Vasomotor System / Q000187:drug effects / Q000502:physiology
D010936:Plant Extracts