Li Lujin, Lv Yinghua, Xu Ling, Zheng Qingshan
Center for Drug Clinical Research, Shanghai University of Traditional Chinese Medicine, no. 1200 Cailun Road, Shanghai, 201203, China.
Br J Clin Pharmacol. 2015 Apr;79(4):593-604. doi: 10.1111/bcp.12533.
This study aimed to quantitate the efficacy of soy isoflavones in the treatment of menopausal hot flashes.
Model based meta-analysis (MBMA) was used to quantitate the efficacy of soy isoflavones. We conducted a systemic literature search to build a time-effect model for placebo and soy isoflavones in treating menopausal hot flashes. Studies were identified, subjected to inclusion and exclusion criteria, and reviewed.
From 55 articles, 16 studies of soy isoflavones met the inclusion criteria, and contained 65 and 66 mean effect values in placebo and soy isoflavone groups, respectively, from about 1710 subjects. Interestingly, the developed model was found to describe adequately the time course of hot flashes reduction after administration of placebo and soy isoflavones. Using this model, we found that the maximal percentage change of hot flashes reduction by soy isoflavones was 25.2% after elimination of the placebo effect, accounting for 57% of the maximum effects of estradiol (Emax-estradiol = 44.9%). However, a time interval of 13.4 weeks was needed for soy isoflavones to achieve half of its maximal effects, much longer than estradiol, which only required 3.09 weeks. These results suggest that treatment intervals of 12 weeks are too short for soy isoflavones, which require at least 48 weeks to achieve 80% of their maximum effects.
Soy isoflavones show slight and slow effects in attenuating menopausal hot flashes compared with estradiol.
本研究旨在定量分析大豆异黄酮治疗更年期潮热的疗效。
采用基于模型的荟萃分析(MBMA)来定量分析大豆异黄酮的疗效。我们进行了系统的文献检索,以建立安慰剂和大豆异黄酮治疗更年期潮热的时间效应模型。对研究进行识别、纳入和排除标准筛选,并进行综述。
从55篇文章中,16项关于大豆异黄酮的研究符合纳入标准,共纳入约1710名受试者,安慰剂组和大豆异黄酮组分别有65个和66个平均效应值。有趣的是,所建立的模型被发现能够充分描述服用安慰剂和大豆异黄酮后潮热减少的时间进程。使用该模型,我们发现消除安慰剂效应后,大豆异黄酮使潮热减少的最大百分比变化为25.2%,占雌二醇最大效应(Emax-雌二醇 = 44.9%)的57%。然而,大豆异黄酮需要13.4周的时间间隔才能达到其最大效应的一半,这比雌二醇长得多,雌二醇仅需3.09周。这些结果表明,12周的治疗间隔对大豆异黄酮来说太短,大豆异黄酮至少需要48周才能达到其最大效应的80%。
与雌二醇相比,大豆异黄酮在减轻更年期潮热方面效果轻微且缓慢。