Objective: To determine whether metformin or placebo could,in conjunction with healthy lifestyle counseling,decrease serum testosterone levels and related aberrations in adolescents with hyperandrogenism,hyperinsuline...Objective: To determine whether metformin or placebo could,in conjunction with healthy lifestyle counseling,decrease serum testosterone levels and related aberrations in adolescents with hyperandrogenism,hyperinsulinemia,and polycystic ovarian syndrome. Design: Randomized,placebo-controlled,double-blind trial. Setting: Pediatric university teaching hospital. Participants: Twenty-two adolescents aged 13 to 18 years with hyperinsulinemia and polycystic ovarian syndrome. Intervention: Participants were randomly assigned to take a 12-week course of either metformin or placebo. Main Outcome Measures: Pretreatment and posttreatment oral glucose tolerance tests,fasting lipid profiles,and clinical measurements. Results: There was a significant decline in mean serum testosterone concentration with metformin (-38.3 ng/dL) compared with placebo (-0.86 ng/dL) (95% confidence interval,-∞ to -0.29 for the mean difference between groups). At completion,the relative risk of menses was 2.50 times higher in the metformin group compared with the placebo (95% confidence interval,1.12 to 5.58). Measures of insulin sensitivity,including insulin area under the curve and HOMA (homeostasis model assessment)-,demonstrated improvement only with metformin,but these did not reach statistical significance. High-density lipoprotein cholesterol levels increased by 6.98 mg/dL with metformin vs a decrease of -2.33 mg/dL with placebo (95% confidence interval,0.78 to 18.23 for the mean difference between groups). There were no significant changes in body mass index,hirsutism,triglyceride levels,or total and low-density lipoprotein cholesterol levels. Conclusion: Metformin significantly lowered total testosterone concentrations,increased the likelihood of menses,and improved high-density lipoprotein cholesterol levels without affecting measures of insulin sensitivity or body weight.展开更多
文摘Objective: To determine whether metformin or placebo could,in conjunction with healthy lifestyle counseling,decrease serum testosterone levels and related aberrations in adolescents with hyperandrogenism,hyperinsulinemia,and polycystic ovarian syndrome. Design: Randomized,placebo-controlled,double-blind trial. Setting: Pediatric university teaching hospital. Participants: Twenty-two adolescents aged 13 to 18 years with hyperinsulinemia and polycystic ovarian syndrome. Intervention: Participants were randomly assigned to take a 12-week course of either metformin or placebo. Main Outcome Measures: Pretreatment and posttreatment oral glucose tolerance tests,fasting lipid profiles,and clinical measurements. Results: There was a significant decline in mean serum testosterone concentration with metformin (-38.3 ng/dL) compared with placebo (-0.86 ng/dL) (95% confidence interval,-∞ to -0.29 for the mean difference between groups). At completion,the relative risk of menses was 2.50 times higher in the metformin group compared with the placebo (95% confidence interval,1.12 to 5.58). Measures of insulin sensitivity,including insulin area under the curve and HOMA (homeostasis model assessment)-,demonstrated improvement only with metformin,but these did not reach statistical significance. High-density lipoprotein cholesterol levels increased by 6.98 mg/dL with metformin vs a decrease of -2.33 mg/dL with placebo (95% confidence interval,0.78 to 18.23 for the mean difference between groups). There were no significant changes in body mass index,hirsutism,triglyceride levels,or total and low-density lipoprotein cholesterol levels. Conclusion: Metformin significantly lowered total testosterone concentrations,increased the likelihood of menses,and improved high-density lipoprotein cholesterol levels without affecting measures of insulin sensitivity or body weight.