Pillai Anush, Bang Heejung, Green Charles
Methodist Family Medicine Residency Program, Houston, TX, USA.
J Fam Pract. 2007 Jun;56(6):444-53.
Polycystic ovarian syndrome (PCOS) leads to a multitude of clinical and biochemical alterations in patients. Metformin and the thiazolidenediones (TZDs)--which have insulin-sensitizing properties--are believed to be effective in minimizing the changes caused by this syndrome.
Our goal was to assess the evidence for the use of TZDs or metformin in the treatment of PCOS patients. In addition, we sought to assess and compare the effectiveness of metformin vs TZDs in the clinical and biochemical regression of PCOS based on available randomized controlled trials (RCTs).
We searched Medline (January 1966 to January 2007), PubMed (January 1954 to January 2007), Google Scholar search engine (through January 2007), and reference lists of articles. We also contacted researchers and clinicians in the field.
We reviewed RCTs involving women diagnosed with PCOS (based on 1990 the National Institutes of Health Criteria) who were treated with either metformin or TZDs. Trials were limited to those that were testing only the effects of either of these agents as their primary endpoint.
A total of 115 trials were obtained, of which only 33 trials met the inclusion criteria. Ultimately, 31 trials involving total 1892 patients were included in the analysis (23 metformin, 2 rosiglitazone, 1 pioglitazone, 5 troglitazone) with 2 unobtainable trials. There was insufficient data to compare metformin to the TZDs in any parameter because the literature often contained inadequate quantitative data, or there were too few published trials. As a result, we performed the meta-analysis for metformin only. Among the outcomes examined, the only statistically significant changes were minimal decreases with metformin in ovulation rates and luteinizing hormone to follicle stimulating hormone ratio (LH/FSH), and an increase in fasting insulin. There was no clinically significant change with metformin in ovulation rate, pregnancy rate, body mass index, waist-to-hip ratio, hirsutism (F-G score), LH/FSH, fasting insulin, fasting blood glucose, total testosterone, free testosterone, androstenedione, and dehydroepiandrosterone sulfate.
AUTHORS' CONCLUSIONS: There is a paucity of data from RCTs to compare the effectiveness of metformin vs TZDs as well as the effects of either agent in treating the clinical and biochemical features of PCOS. Further research involving RCTs with larger sample sizes is needed before any recommendation can be made on the usefulness of these agents in the treatment of PCOS.
多囊卵巢综合征(PCOS)会导致患者出现多种临床和生化改变。二甲双胍和噻唑烷二酮类药物(TZDs)具有胰岛素增敏特性,被认为能有效减轻该综合征引起的变化。
我们的目标是评估使用TZDs或二甲双胍治疗PCOS患者的证据。此外,我们试图根据现有的随机对照试验(RCTs)评估和比较二甲双胍与TZDs在PCOS临床和生化指标改善方面的有效性。
我们检索了Medline(1966年1月至2007年1月)、PubMed(1954年1月至2007年1月)、谷歌学术搜索引擎(截至2007年1月)以及文章的参考文献列表。我们还联系了该领域的研究人员和临床医生。
我们回顾了涉及被诊断为PCOS的女性(基于1990年美国国立卫生研究院标准)且接受二甲双胍或TZDs治疗的RCTs。试验仅限于那些仅将这两种药物中任一种的效果作为主要终点进行测试的研究。
共获得115项试验,其中仅33项试验符合纳入标准。最终,31项试验共纳入1892例患者进行分析(23项二甲双胍试验、2项罗格列酮试验、1项吡格列酮试验、5项曲格列酮试验),有2项试验无法获取。由于文献中常常缺乏足够的定量数据,或者已发表的试验数量过少,因此没有足够的数据在任何参数上比较二甲双胍和TZDs。结果,我们仅对二甲双胍进行了荟萃分析。在所检查的结果中,唯一具有统计学显著差异的变化是使用二甲双胍后排卵率和黄体生成素与卵泡刺激素比值(LH/FSH)略有下降,以及空腹胰岛素升高。使用二甲双胍后,排卵率、妊娠率、体重指数、腰臀比、多毛症(F - G评分)、LH/FSH、空腹胰岛素、空腹血糖、总睾酮、游离睾酮、雄烯二酮和硫酸脱氢表雄酮均无临床显著变化。
随机对照试验中缺乏数据来比较二甲双胍与TZDs的有效性以及这两种药物在治疗PCOS临床和生化特征方面的效果。在就这些药物在治疗PCOS中的有用性提出任何建议之前,需要进行更多涉及更大样本量的随机对照试验。