植物性雌激素补充剂治疗热:异黄黄提取物 (ICE) 研究:一种随机对照试验
Jeffrey A Tice1, Bruce Ettinger, Kris Ensrud
1Division of General Internal Medicine, Department of Medicine, University of California, San Francisco 94143, USA. jtice@medicine.ucsf.edu
JAMA
|July 10, 2003
概括
与安慰剂相比,红三叶草异黄补充剂Promensil和Rimostil并没有显著减少更年期妇女的热. 两种补充都没有显示出对更年期症状具有临床意义的作用.
科学领域:
- 更年期管理管理
- 食补充剂 食补充剂
- 临床试验 临床试验
背景情况:
- 由于与激素替代疗法相关的风险,对治疗更年期症状的非激素疗法越来越感兴趣.
- 食异黄补充剂是热的流行替代品,但有效性的证据有限.
研究的目的:
- 评估两种红三叶草衍生异黄补充剂Promensil和Rimostil在经历更年期症状的妇女中与安慰剂的疗效和安全性.
主要方法:
- 一项随机,双盲,安慰剂对照试验,涉及252名更年期妇女 (年龄在45-60岁) 频繁出现热.
- 参与者每天接受Promensil (82毫克异黄),Rimostil (57毫克异黄) 或安慰剂,经过2周的安慰剂试验期,每天服用12周.
- 监测了热闪的频率,生活质量和不良事件.
主要成果:
- 在12周后,Promensil,Rimostil和安慰剂组中,每日热的减少是可比的.
- 与安慰剂相比,Promensil在统计学上显示出更快地减少热 (P=0.03),但这在临床上没有显著意义.
- 在所有治疗组中,生活质量和不良事件概况是相似的.
结论:
- 虽然Promensil表现出潜在的生物效应,但红叶草异黄补充剂都没有在临床上有意义地改善热或其他更年期症状.
- 可能需要进一步的研究来澄清异黄在治疗更年期症状中的作用.
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