Data from: An investigation of the therapeutic effects of statins with metformin on polycystic ovary syndrome: a meta-analysis of randomized controlled trials

Objectives: To investigate the therapeutic effects of statins with metformin on polycystic ovary syndrome (PCOS). Settings: Endocrinology department. Participants: MEDLINE, EMBASE and Cochrane Central Register of Controlled Trials were searched until October 2014. Studies comparing statins and placebo, as well as the combination of statins and metformin and metformin alone, were included in the analysis. Interventions: Data were independently extracted by two researchers; any convergence was resolved by a third reviewer. Primary and secondary outcome measures: The following properties were extracted from the qualified trials to identify the effects of statins: clinical variables, metabolic characteristics, hormone outcomes, sign of inflammation, glucose parameters and insulin outcomes. Results: Data from four trials comparing statin and metformin with metformin alone were analysed. The combination of statins and metformin decreases the levels of C reactive protein (standardised mean difference (SMD) −0.91; 95% CI −1.81 to −0.02; p=0.046), triglyceride (SMD −1.37; 95% CI −2.46 to −0.28; p=0.014), total cholesterol (SMD −1.28; 95% CI −1.59 to −0.97; p=0.000) and low-density lipoprotein (LDL) cholesterol (SMD −0.74; 95% CI −1.03 to −0.44; p=0.000). However, the combined therapy fails to reduce fasting insulin (SMD −0.92; 95% CI −2.07 to 0.24; p=0.120), homeostasis model assessment of insulin resistance (SMD −1.15; 95% CI −3.36 to 1.06; p=0.309) and total testosterone (SMD −1.12; 95% CI −2.29 to 0.05; p=0.061). Analysis of the five trials comparing statin with placebo shows that statin monotherapy reduces LDL-cholesterol, triglyceride and total cholesterol. Conclusions: Combined statin and metformin therapy can improve lipid and inflammation parameters, but cannot effectively improve insulin sensitivity and reduce hyperandrogenism in women with PCOS. A large-scale randomised controlled study must be conducted to ascertain the long-term effects of the therapy.

研究目标：探究他汀类药物联合二甲双胍对多囊卵巢综合征（Polycystic Ovary Syndrome, PCOS）的治疗效果。
研究场所：内分泌科。
研究对象与检索策略：本研究检索MEDLINE、EMBASE及Cochrane对照试验中心注册库（Cochrane Central Register of Controlled Trials），检索时限截至2014年10月。分析纳入对比他汀类药物与安慰剂、他汀类联合二甲双胍与单用二甲双胍的对照研究。
数据提取方法：由两名研究者独立提取数据，若存在意见分歧，则由第三名研究者协调解决。
主要与次要结局指标：从符合纳入标准的试验中提取以下指标，以评估他汀类药物的治疗效应：临床变量、代谢特征、激素结局、炎症标志物、血糖参数及胰岛素相关指标。
研究结果：本分析共纳入4项对比他汀类联合二甲双胍与单用二甲双胍的研究。结果显示，联合他汀类与二甲双胍治疗可降低C反应蛋白（C reactive protein, CRP）水平（标准化均数差（standardised mean difference, SMD）=-0.91；95%置信区间（confidence interval, CI）：-1.81~-0.02；P=0.046）、甘油三酯（SMD=-1.37；95%CI：-2.46~-0.28；P=0.014）、总胆固醇（SMD=-1.28；95%CI：-1.59~-0.97；P=0.000）及低密度脂蛋白胆固醇（low-density lipoprotein cholesterol, LDL-C）（SMD=-0.74；95%CI：-1.03~-0.44；P=0.000）。但联合治疗未能降低空腹胰岛素水平（SMD=-0.92；95%CI：-2.07~0.24；P=0.120）、胰岛素抵抗稳态模型评估指数（homeostasis model assessment of insulin resistance, HOMA-IR）（SMD=-1.15；95%CI：-3.36~1.06；P=0.309）及总睾酮水平（SMD=-1.12；95%CI：-2.29~0.05；P=0.061）。对5项对比他汀类单药与安慰剂的研究进行分析后发现，他汀类单药治疗可降低LDL-C、甘油三酯及总胆固醇水平。
结论：他汀类与二甲双胍联合治疗可改善多囊卵巢综合征患者的脂质及炎症相关指标，但无法有效改善胰岛素抵抗及降低高雄激素血症。未来需开展大规模随机对照研究，以明确该治疗方案的长期临床效应。