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

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Abstract

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.

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Most cited references 20

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Quality of life after the menopause: a population study.

J.E. Blümel, C. Castelo-Branco, L Binfa … (2000)

To assess the impact of menopause and some sociodemographic variables on quality of life (QoL). Four hundred and eighty-one women aged 40-59 years attending the Southern Metropolitan Health Service in Santiago de Chile were studied using the Specific Quality of Life Questionnaire for Menopause from Toronto University. Univariate analysis showed that menopausal women have worse QoL scores than women conserving cycles in the four areas of the questionnaire: They show a 10.6-fold higher risk for suffering vasomotor disorders affecting QoL, a 3.5-fold higher risk for psychosocial impairment, a 5.7-fold higher risk for physical disorders, and a 3.2-fold higher risk for sexual disorders (P < 0.0001). Regarding the influence of social markers (age, marital status, school years, work, number of children and sexual activity), housewives were found to have higher, worse, scores than working women in all test components (vasomotor, 3.11+/-1.90 versus 2.57+/-1.71, P < 0.003; psychosocial, 3.44+/-1.59 versus 2.92+/-1.45, P < 0.0007; physical, 3.45+/-1.36 versus 2.96+/-1.20, P < 0.0001; sexual, 3.63+/-2.23 versus 2.49+/-1.95, P < 0.0001). However, logistic regression demonstrated that the only variable found to cause a significant impairment in QoL was menopause. Menopause causes a decrease in quality of life, which is independent from age and other sociodemographic variables.

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Dietary supplements in a national survey: Prevalence of use and reports of adverse events.

Tommie McCarthy, Jason P. Ross, Chung-Tung J Lin … (2006)

To examine information collected from the 2002 Health and Diet Survey regarding the use dietary supplements and self-reported health problems that the survey participants believed were related to dietary supplements. The US Food and Drug Administration sponsors a Health and Diet Survey to track trends of consumer awareness, attitudes, and practices related to health and diet issues. By telephone, the 2002 Health and Diet Survey staff interviewed English-speaking noninstitutionalized adults aged 18 years or older in households in the 50 states and District of Columbia. Survey respondents were queried as to whether or not they had taken a dietary supplement during the past year and if they had experienced any health problem that they attributed to supplement use. Seventy-three percent of US noninstitutionalized adults aged 18 years or older who spoke English and resided in households with telephones used a dietary supplement in the previous 12 months and 4% of them had experienced an adverse event that they believed might be related to dietary supplement use. Eighty-five percent of supplement users reported taking multivitamins/multiminerals and 13.3% of adverse events reported were attributed to multivitamins/multiminerals. A higher proportion of supplement users with adverse events than users without adverse events were concurrently taking supplements and prescription drugs or were taking supplements instead of prescription drug to treat or prevent a health condition. This self-reported data describes the prevalence of supplement use and related adverse events. Multivitamins/multiminerals accounted for much of the supplements use and was attributed to a little more than 10% of the adverse events reported. Food and nutrition-professionals and other health care professionals should take special care to learn about their patients' use of these products.

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Safety and efficacy of black cohosh and red clover for the management of vasomotor symptoms: a randomized controlled trial.

Stacie Geller, Lee P Shulman, Richard B. van Breemen … (2015)

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. 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. 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. 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.

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Author and article information

Contributors

Sakineh Mohammad-Alizadeh-Charandabi

Mahnaz Shahnazi

Jila Nahaee

Somaei Bayatipayan

Journal

Journal ID (nlm-ta): Chin Med

Journal ID (iso-abbrev): Chin Med

Title: Chinese Medicine

Publisher: BioMed Central

ISSN (Electronic): 1749-8546

Publication date Collection: 2013

Publication date (Electronic): 1 November 2013

Volume: 8

Page: 20

Affiliations

[1 ]Midwifery Department, Tabriz University of Medical Sciences, Tabriz, Iran

Article

Publisher ID: 1749-8546-8-20

DOI: 10.1186/1749-8546-8-20

PMC ID: 4029542

PubMed ID: 24499633

SO-VID: 59c1dd04-6719-4974-b6ca-00b3c40b2d7b

License:

This is an open access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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

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Abstract

Background

Methods

Results

Conclusions

Clinical trial registration

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The International Journal of Person Centered Medicine

Most cited references 20

Quality of life after the menopause: a population study.

Dietary supplements in a national survey: Prevalence of use and reports of adverse events.

Safety and efficacy of black cohosh and red clover for the management of vasomotor symptoms: a randomized controlled trial.

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