Zhang Jing, Li Tingting, Zhou Lingling, Tang Liulin, Xu Liangzhi, Wu Taixiang, Lim Danforn Ce
Reproductive Endocrinology, Department of Obstetrics and Gynecology, West China Second University Hospital, Sichuan University, No. 20, 3rd Section, Renmin South Avenue, Chengdu, Sichuan, China, 610041.
Cochrane Database Syst Rev. 2010 Sep 8(9):CD007535. doi: 10.1002/14651858.CD007535.pub2.
Polycystic ovarian syndrome (PCOS) is one of the most common reproductive endocrinology abnormalities, affecting 5% to 10% of women of reproductive age. Western medicines, such as oral contraceptives and insulin sensitizers, have been widely used to improve the symptoms and signs for PCOS. Recently, many studies have been published considering Chinese herbal medicine (CHM) as an alternative treatment for women with PCOS.
To evaluate the efficacy and safety of Chinese medicinal herbs for subfertile women with PCOS.
We searched the following databases (from inception to March 2010): Menstrual Disorders and Subfertility Group Specialised Register (MDSG), Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, Allied and Complementary Medicine (AMED), PsycINFO, Chinese National Knowledge Infrastructure (CNKI), VIP, Wanfang. In addition, all reference lists of included trials were searched and experts in the field were contacted to locate trials.
Randomized controlled trials (RCT) considering the use of CHM for the treatment of subfertile women with PCOS.
Two review authors independently screened appropriate trials for inclusion, assessed methodological quality, and extracted data. We contacted primary authors for additional information. Meta-analysis was conducted. Odds ratio (OR) was used for reporting dichotomous data with 95% confidence intervals (CI).
Four RCTs involving 344 participants were included. The methodological risk of bias of included studies was poor. Different interventions were used in these four RCTs.There was evidence of statistically significant difference seen improving pregnancy rate (per woman) between CHM plus clomiphene and clomiphene (OR 2.97, 95%CI 1.71 to 5.17). However, there was no statistically significant difference seen in the other comparison groups for improving pregnancy rate (per woman).There was no evidence of statistically significant difference in improving ovulation rate (per woman) between CHM and clomiphene (OR 1.42, 95%CI 0.19 to 10.49), between CHM plus laparoscopic ovarian drilling (LOD) and LOD (OR 2.43, 95%CI 0.39 to 15.08).There were not statistically significant difference between CHM plus follicle aspiration, ovulation induction and follicle aspiration plus ovulation induction for adverse events including LUFS, OHSS and multiple pregnancy.Live birth rate was not reported by any studies.
AUTHORS' CONCLUSIONS: There is limited evidence that the addition of CHM to clomiphene is associated with improved clinical pregnancy outcomes and no other evidence of any other effect. The methodology of RCTs was not adequately reported by primary studies.
多囊卵巢综合征（PCOS）是最常见的生殖内分泌异常疾病之一，影响5%至10%的育龄妇女。西药，如口服避孕药和胰岛素增敏剂，已被广泛用于改善PCOS的症状和体征。最近，许多研究表明，中药（CHM）可作为PCOS女性的替代治疗方法。
评估中药对PCOS不孕女性的疗效和安全性。
我们检索了以下数据库（从创建至2010年3月）：月经失调与不孕专科注册库（MDSG）、Cochrane对照试验中心注册库（CENTRAL）、医学索引（MEDLINE）、荷兰医学文摘数据库（EMBASE）、联合与补充医学数据库（AMED）、心理学文摘数据库（PsycINFO）、中国知网（CNKI）、维普资讯（VIP）、万方数据库。此外，我们还检索了纳入试验的所有参考文献列表，并联系了该领域的专家以查找试验。
考虑使用中药治疗PCOS不孕女性的随机对照试验（RCT）。
两位综述作者独立筛选合适的试验以纳入研究，评估方法学质量，并提取数据。我们联系了第一作者以获取更多信息。进行了荟萃分析。比值比（OR）用于报告二分数据，并给出95%置信区间（CI）。
纳入了4项RCT，涉及344名参与者。纳入研究的方法学偏倚风险较差。这4项RCT使用了不同的干预措施。有证据表明，中药联合克罗米芬组与克罗米芬组相比，临床妊娠率（每位女性）有统计学显著差异（OR 2.97，95%CI 1.71至5.17）。然而，在其他比较组中，临床妊娠率（每位女性）没有统计学显著差异。中药组与克罗米芬组相比，排卵率（每位女性）没有统计学显著差异（OR 1.42，95%CI 0.19至10.49）；中药联合腹腔镜卵巢打孔（LOD）组与LOD组相比，排卵率（每位女性）也没有统计学显著差异（OR 2.43，95%CI 0.39至15.08）。中药联合卵泡抽吸、促排卵与卵泡抽吸加促排卵在包括未破裂卵泡黄素化（LUFS）、卵巢过度刺激综合征（OHSS）和多胎妊娠等不良事件方面没有统计学显著差异。所有研究均未报告活产率。
有限的证据表明，克罗米芬联合中药可改善临床妊娠结局，没有其他任何效果的证据。原始研究对RCT的方法学报告不充分。
