Combined lifestyle modification and metformin in obese patients with polycystic ovary syndrome. A randomized, placebo-controlled, double-blind multicentre study
Combined lifestyle modification and metformin in obese patients with polycystic ovary syndrome. A randomized, placebo-controlled, double-blind multicentre study
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DOI：
10.1093/humrep/dei311
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发表时间：
2006-01-01
影响因子：
6.1
通讯作者：
Balen, AH
中科院分区：
文献类型：
--
作者：
Tang, T;Glanville, J;Balen, AH
背景：据报道，多囊卵巢综合征（PCOS）妇女受益于二甲双胍治疗。方法：对肥胖（体重指数> 30 kg/m2）、少/闭经的PCOS妇女进行随机、安慰剂对照、双盲研究。二甲双胍（850 mg，每日两次）与安慰剂进行了为期6个月的比较。所有人都从营养师那里得到了同样的建议。主要结局指标为：（i）月经周期的变化;（ii）关节测量的变化;（iii）内分泌参数、胰岛素敏感性和血脂谱的变化。结果：共143例受试者接受随机化[二甲双胍（MET）= 69;安慰剂（PL）= 74]。两组均显示月经频率[中位数增加（MET = 1，P < 0.001; PL = 1，P <0.001）]和体重减轻[平均值（kg）（MET = 2.84; P < 0.001和PL = 1.46; P = 0.011）]显著改善。然而，两组之间没有显著差异。采用Logistic回归分析方法对二甲双胍、体重减轻百分比、初始BMI和年龄等自变量进行分析，以预测月经改善情况。只有体重减轻百分比与月经改善相关（回归系数= 0.199，P = 0.047，比值比= 1.126，95%CI 1.001，1.266）。两组的胰岛素敏感性或血脂谱均无显著变化。接受二甲双胍治疗的患者腰围和游离雄激素指数显著降低。结论：二甲双胍不能改善PCOS肥胖患者的体重减轻或月经频率。通过改变生活方式来减肥可以改善月经频率。
BACKGROUND: It has been reported that women with polycystic ovary syndrome (PCOS) benefit from metformin therapy. METHODS: A randomized, placebo-controlled, double-blind study of obese (body mass index > 30 kg/m(2)), oligo-/amenorrhoeic women with PCOS. Metformin (850 mg) twice daily was compared with placebo over 6 months. All received the same advice from a dietitian. The primary outcome measures were: (i) change in menstrual cycle; (ii) change in arthropometric measurements; and (iii) changes in the endocrine parameters, insulin sensitivity and lipid profile. RESULTS: A total of 143 subjects was randomized [metformin (MET) = 69; placebo (PL) = 74]. Both groups showed significant improvements in menstrual frequency [median increase (MET = 1, P < 0.001; PL = 1, P < 0.001)] and weight loss [mean (kg) (MET = 2.84; P < 0.001 and PL = 1.46; P = 0.011)]. However, there were no significant differences between the groups. Logistic regression analysis was used to analyse the independent variables (metformin, percentage of weight loss, initial BMI and age) in order to predict the improvement of menses. Only the percentage weight loss correlated with an improvement in menses (regression coefficient = 0.199, P = 0.047, odds ratio = 1.126, 95% CI 1.001, 1.266). There were no significant changes in insulin sensitivity or lipid profiles in either of the groups. Those who received metformin achieved a significant reduction in waist circumference and free androgen index. CONCLUSIONS: Metformin does not improve weight loss or menstrual frequency in obese patients with PCOS. Weight loss alone through lifestyle changes improves menstrual frequency.