College of Pharmacy, Dalhousie University, Halifax, Nova Scotia, Canada.
Ann Pharmacother. 2013 Jan;47(1):112-6. doi: 10.1345/aph.1R362. Epub 2012 Dec 18.
To evaluate the efficacy of bioidentical progesterone cream in the treatment of menopause-related vasomotor symptoms.
A systematic search (from time of inception to September 2012) of PubMed, EMBASE, International Pharmaceutical Abstracts, International Journal of Pharmaceutical Compounding, Cochrane, and CINAHL was conducted using the terms progesterone, vasomotor symptoms, night sweats, hot flash or flush, and randomized controlled trials (RCTs). Hand-searching of citations from relevant articles was also performed.
Articles selected for inclusion described RCTs evaluating the use of bioidentical progesterone cream for the treatment of menopause-related vasomotor symptoms. Studies included were placebo controlled and participants were postmenopausal women experiencing vasomotor symptoms.
Searching identified 3 published RCTs. Only one study, which used a bioidentical progesterone cream specifically compounded for the trial, found that the bioidentical progesterone was more effective than placebo in relieving menopause-related vasomotor symptoms. The 2 studies using manufactured bioidentical progesterone creams found that the creams were no more effective than placebo. Vaginal bleeding and headaches were the most commonly reported adverse effects in the studies.
Available evidence from RCTs does not support the efficacy of bioidentical progesterone cream for the management of menopause-related vasomotor symptoms. Adverse effects appear to be mild and self-limiting.
评估生物等效性孕激素乳膏治疗与绝经相关的血管舒缩症状的疗效。
系统检索（从建库开始到 2012 年 9 月）PubMed、EMBASE、国际药学文摘、国际药物配制杂志、 Cochrane 和 CINAHL，使用的检索词包括孕激素、血管舒缩症状、夜间出汗、热潮红或潮红以及随机对照试验（RCT）。还对手头相关文章的参考文献进行了手工检索。
入选的文章描述了 RCT，评估了生物等效性孕激素乳膏治疗与绝经相关的血管舒缩症状的用途。入选的研究为安慰剂对照，参与者为绝经后出现血管舒缩症状的女性。
检索共确定了 3 项已发表的 RCT。只有一项研究使用了专门为试验配制的生物等效性孕激素乳膏，发现与安慰剂相比，生物等效性孕激素在缓解与绝经相关的血管舒缩症状方面更有效。另外两项使用市售生物等效性孕激素乳膏的研究发现，乳膏与安慰剂相比没有更有效。研究中最常报告的不良反应是阴道出血和头痛。
来自 RCT 的现有证据不支持生物等效性孕激素乳膏用于治疗与绝经相关的血管舒缩症状。不良反应似乎是轻微的、自限性的。
