Efficacy of black cohosh (Cimicifuga racemosa L.) in treating early symptoms of menopause: a randomized clinical trial

BACKGROUND: This study aims to evaluate the efficacy of Black cohosh (Cimicifuga racemosa L.) in treating early menopausal symptoms. METHODS: This randomized, double-blind, placebo-controlled clinical trial was conducted on 84 early post-menopausal participants with Greene climacteric scale (GCS) scores of 15 to 42, who were referred to two public health care centers in Tehran, Iran, in 2011-2012. The participants were randomly allocated into treatment (6.5 mg of dried extract of Black cohosh roots daily) and control (placebo) groups with a ratio of 1:1. The participants took one tablet per day for 8 weeks. The GCS scores were recorded at baseline, and after 4 and 8 weeks of treatment. Data analysis was carried out using a general linear model with repeated measures with SPSS software. The level of significance was set at P < 0.05. RESULTS: There was no loss to follow-up during the 8 weeks of treatment. The GCS total score (primary outcome) in the treatment group was significantly lower than that in the control group at both week 4 adjusted mean difference: -7.8 (95% confidence interval: -11.1 to -4.4) and week 8 -12.9 (-16.2 to -9.3). The treatment group showed significantly more improvement than the control group in all GCS subscale scores (vasomotor, psychiatric, physical, and sexual symptoms; secondary outcomes). The differences between the treatment and control groups at week 8 were significantly higher (P < 0.001) than those at week 4 in terms of the total scores and the vasomotor and psychiatric subscale scores. No side effects were reported. CONCLUSIONS: Black cohosh reduced the GCS total score and all GCS subscale scores (vasomotor, psychiatric, physical, and sexual symptoms) during 4 and 8 weeks of treatment. CLINICAL TRIAL REGISTRATION: This study was approved (Code 9061) by the Ethics Committee of Tabriz University of Medical Sciences and registered at the Iranian Registry of Clinical Trials with IRCT201107186709N4 on 15 January 2012.