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升麻提取物缓解更年期症状:一项随机对照试验

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

作者信息

Tanmahasamut P, Vichinsartvichai P, Rattanachaiyanont M, Techatraisak K, Dangrat C, Sardod P

机构信息

Gynecologic Endocrinology Unit, Department of Obstetrics and Gynecology, Faculty of Medicine Siriraj Hospital, Mahidol University , Bangkok , Thailand.

出版信息

Climacteric. 2015 Feb;18(1):79-85. doi: 10.3109/13697137.2014.933410. Epub 2014 Sep 22.

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.

摘要

目的

评估每日40毫克黑升麻提取物缓解泰国女性中度至重度更年期症状及改善生活质量的有效性。

方法

2011年至2013年期间,在一家三级大学医院的更年期诊所进行了一项随机、双盲、安慰剂对照临床试验。参与者为年龄至少40岁的围绝经期或绝经后泰国女性,她们使用库珀曼指数(KI)评估有中度至重度更年期症状。结果指标包括KI、潮热频率、更年期特异性生活质量(MENQOL)评分、参与者的总体满意度和安全性结果。

结果

54名参与者被分配到治疗组(每日40毫克黑升麻提取物,n = 27)或安慰剂组(n = 27)。治疗组和安慰剂组的基线KI评分(33.9 ± 7.9对31.3 ± 6.8)、潮热频率(3.1 ± 2.0对2.8 ± 2.1)和MENQOL评分相当,所有这些指标都随时间有所改善。两组之间的改善情况和总体满意度均无显著差异;但治疗组中中度至重度症状参与者的比例似乎低于安慰剂组(40%对60%,p = 0.174)。没有严重不良事件或肝功能测试的显著变化。

结论

对于缓解泰国女性中度至重度更年期症状或改善生活质量评分,每日40毫克的黑升麻提取物并不优于安慰剂。

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