Cimicifuga racemosa extract for relieving menopausal symptoms: a randomized controlled trial

Abstract

Objectives To evaluate the effectiveness of black cohosh extract 40 mg/day for relieving moderate to severe menopausal symptoms and improving quality of life in Thai women.

Methods A randomized, double-blind, placebo-controlled clinical trial was conducted in a menopause clinic of a tertiary-care university hospital during 2011–2013. Participants were peri- or postmenopausal Thai women aged at least 40 years, who have moderate to severe menopausal symptoms evaluated using the Kupperman index (KI). Outcome measures included KI, frequency of hot flushes, Menopause-Specific Quality of Life (MENQOL) score, participants’ global satisfaction and safety outcomes.

Results There were 54 participants assigned to treatment (black cohosh extract 40 mg/day, n = 27) or placebo group (n = 27). Both the treatment and placebo groups had comparable baseline KI scores (33.9 ± 7.9 vs. 31.3 ± 6.8), frequency of hot flushes (3.1 ± 2.0 vs. 2.8 ± 2.1), and MENQOL scores, all of which improved with time. Neither the improvements nor the global satisfaction were significantly different between the two groups; but the proportion of participants with moderate to severe symptoms seemed to be lower in the treatment group than in the placebo group (40% vs. 60%, p = 0.174). There was no serious adverse event or significant change in liver function tests.

Conclusions A black cohosh extract of 40 mg/day is not superior to a placebo for relieving moderate to severe menopausal symptoms or improving quality-of-life scores in Thai women.

Key words::

• BLACK COHOSH
• CIMICIFUGA RACEMOSA
• KUPPERMAN INDEX
• MENQOL
• MENOPAUSAL SYMPTOMS

ACKNOWLEDGEMENT

The authors would like to thank all staff members of the Gynecologic Endocrinology Unit, Faculty of Medicine Siriraj Hospital, Mahidol University for their contribution in taking care of the study participants.

Conflict of interest All authors are faculty staff of a non-profit, university hospital. The authors report no conflicts of interest. The authors alone are responsible for the content and writing of the paper.

Source of funding The study medications were provided by Mega Lifesciences Pty. Ltd. (Bangkok, Thailand). The pharmaceutical company did not have any influence on the study design, data collection, analysis, or interpretation of results.