Midwifery Department, Tabriz University of Medical Sciences, Tabriz, Iran.
Chin Med. 2013 Nov 1;8(1):20. doi: 10.1186/1749-8546-8-20.
This study aims to evaluate the efficacy of Black cohosh (Cimicifuga racemosa L.) in treating early menopausal symptoms.
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.
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.
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.
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.
本研究旨在评估黑升麻（Cimicifuga racemosa L.）治疗早期绝经症状的疗效。
这是一项随机、双盲、安慰剂对照的临床试验，于 2011 年至 2012 年在伊朗德黑兰的两家公共医疗保健中心进行，共纳入 84 名早期绝经后、格林绝经期量表（GCS）评分为 15 至 42 分的女性。参与者按 1:1 的比例随机分配至治疗组（每天服用 6.5 毫克黑升麻根干提取物）和对照组（安慰剂）。参与者每天服用一片，持续 8 周。在基线、治疗 4 周和 8 周时记录 GCS 评分。使用 SPSS 软件的重复测量一般线性模型进行数据分析。显著性水平设定为 P < 0.05。
在 8 周的治疗期间无失访。治疗组 GCS 总分（主要结局）在第 4 周[校正平均差值：-7.8（95%置信区间：-11.1 至 -4.4）]和第 8 周[-12.9（-16.2 至 -9.3）]显著低于对照组。治疗组在 GCS 所有子量表评分（血管舒缩、精神、躯体和性功能症状；次要结局）方面的改善均显著优于对照组。治疗组与对照组在第 8 周的差异（P < 0.001）明显高于第 4 周的差异，无论是在总分还是血管舒缩和精神子量表评分方面。未报告不良反应。
黑升麻可降低 GCS 总分和 GCS 所有子量表评分（血管舒缩、精神、躯体和性功能症状），治疗时间为 4 周和 8 周。
本研究经大不里士医科大学伦理委员会批准（编号 9061），于 2012 年 1 月 15 日在伊朗临床试验注册中心注册，注册号为 IRCT201107186709N4。
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