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Randomized, Double-Blind, Placebo-Controlled Trial of Cimicifuga racemosa (Black Cohosh) in Women With Anxiety Disorder Due to Menopause

Amsterdam, Jay D. MD*; Yao, Yubing MS; Mao, Jun James MD, MSCE; Soeller, Irene MSN, CRNP*; Rockwell, Kenneth MS, PharmD§; Shults, Justine PhD

Journal of Clinical Psychopharmacology: October 2009 - Volume 29 - Issue 5 - p 478-483
doi: 10.1097/JCP.0b013e3181b2abf2
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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.

Materials and 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.

From the *Depression Research Unit, Department of Psychiatry, †Center for Clinical Epidemiology and Biostatistics, and ‡Department of Family Medicine and Community Health, University of Pennsylvania School of Medicine; and §Investigational Drug Service, University of Pennsylvania Medical Center, Philadelphia, PA.

Received December 1, 2008; accepted after revision June 5, 2009.

Reprints: Jay D. Amsterdam, MD, Depression Research Unit, University Science Center, 3rd Floor, 3535 Market St, Philadelphia, PA 19104-3309 (e-mail: jamsterd@mail.med.upenn.edu).

This research was funded by the National Institutes of Health/National Center for Complementary and Alternative Medicine grant AT002289. The black cohosh and placebo materials were provided by the University of Illinois/National Institutes of Health-funded Center for Botanical Dietary Supplements Research-Program for Collaborative Research in the Pharmaceutical Sciences (MC 877), College of Pharmacy, Chicago, Ill.

Trial registration: Black Cohosh for Menopause-Related Anxiety, NCT 00120458, http://www.clinicaltrials.gov/ct2/show/NCT00120458?term=Black+Cohosh+and+Philadelphia&rank=1.

© 2009 Lippincott Williams & Wilkins, Inc.