Elsevier

Fertility and Sterility

Volume 95, Issue 3, 1 March 2011, Pages 1059-1066.e7
Fertility and Sterility

Polycystic ovary syndrome
The effects of metformin with lifestyle therapy in polycystic ovary syndrome: a randomized double-blind study

Presented in part at the 92nd Annual Meeting of the Endocrine Society, San Diego, California, June 18–22, 2010.
https://doi.org/10.1016/j.fertnstert.2010.12.002Get rights and content
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Objective

To determine if the combination of lifestyle (caloric restriction and exercise) and metformin (MET) would be superior to lifestyle and placebo (PBO) in improving the polycystic ovary syndrome (PCOS) phenotype.

Design

Double-blind randomized 6-month trial of MET versus PBO.

Setting

Two academic medical centers.

Patient(s)

One hundred fourteen subjects with PCOS were randomized to MET (N = 55) or PBO (N = 59).

Intervention(s)

Subjects collected urine daily for ovulation monitoring, had monthly monitoring of hormones and weight and determination of body composition by dual-energy x-ray absorptiometry, glucose tolerance, and were evaluated for quality of life at baseline and completion.

Main Outcome Measure(s)

Ovulation rates and testosterone levels.

Result(s)

Dropout rates were high. There was no significant difference in ovulation rates. Testosterone levels were significantly lower compared with baseline in the MET group at 3 mos but not at 6 mos. There were no differences in weight loss between groups, but MET showed a significant decline at 6 months compared with baseline (−3.4 kg, 95% confidence interval −5.3 to −1.5 kg). We noted divergent effects of MET versus PBO on oral glucose tolerance test indices of insulin sensitivity (increased) and secretion (worsened). Total bone mineral density increased significantly in MET. There were no differences in quality of life measures between the groups. The MET group had increased diarrhea and headache, but fewer bladder infections and musculoskeletal complaints.

Conclusion(s)

The addition of metformin to lifestyle therapy produced little reproductive or glycemic benefit in women with PCOS, although our study had limited power owing to a high dropout rate. It is not possible at baseline to identify women likely to drop out.

Key Words

Ovarian function
insulin action
nutrition
exercise
androgen

Cited by (0)

Trial Registration: Clinicaltrials.gov identification no. NCT00151411.

A.R.K. reports ownership of Merck stock. R.S.L. reports a paid lecture fee from Serono. G.L. has nothing to disclose. W.C.D. has nothing to disclose. S.D.S. has nothing to disclose. A.E.A. has nothing to disclose. L.M.D. has nothing to disclose. N.I.W. has nothing to disclose. P.C. has nothing to disclose.

Supported by grant no. PHS U54 HD044315 from the Meharry Medical College/Penn State Cooperative Reproductive Science Center and by grant no. MO1 RR 10732 and construction grant no. C06 RR016499 to Pennsylvania State University from the General Clinical Research Center.