Safety and efficacy of black cohosh and red clover for the management of vasomotor symptoms: a randomized controlled trial.
Safety and efficacy of black cohosh and red clover for the management of vasomotor symptoms: a randomized controlled trial.
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DOI：
10.1097/gme.0b013e3181ace49b
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发表时间：
2009-11
期刊：
影响因子：
--
通讯作者：
Farnsworth NR
中科院分区：
文献类型：
--
作者：
Geller SE;Shulman LP;van Breemen RB;Banuvar S;Zhou Y;Epstein G;Hedayat S;Nikolic D;Krause EC;Piersen CE;Bolton JL;Pauli GF;Farnsworth NR
本研究的目的是评估与安慰剂相比，黑升麻和红三叶草缓解绝经期血管痉挛症状的安全性和有效性。本研究是一项随机、四臂、双盲临床试验，采用标准化黑升麻、红三叶草、安慰剂和0.625 mg结合马雌激素加2.5 mg醋酸甲羟孕酮（CEE/MPA; n = 89）。主要结果指标是与安慰剂相比，黑升麻和红三叶草减少血管痉挛症状（潮热和盗汗）;次要结果包括安全性评价、躯体症状减少、性功能障碍缓解和生活质量总体改善。12个月干预后血管舒缩症状数量减少的情况如下：黑升麻（34%）、红三叶草（57%）、安慰剂（63%）和CEE/MPA（94%），只有CEE/MPA与安慰剂有显着差异。与安慰剂相比，黑升麻和红三叶草没有显著降低血管痉挛症状的频率。次要指标表明，两种植物药给药均安全。一般而言，其他更年期症状没有改善。与安慰剂相比，黑升麻和红三叶草并没有减少血管痉挛症状的数量。安全性监测表明，化学和生物标准化的黑升麻和红三叶草提取物在12个月的每日给药期间是安全的。
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 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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影响因子：
5.9
作者：
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通讯作者：
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