1 Endocrinology, Department of Clinical Research, Det Sundhedsvidenskabelige Fakultet, SDU2 Gynaecology and Obstetrics, Department of Clinical Research, Det Sundhedsvidenskabelige Fakultet, SDU3 Endocrinology, Department of Clinical Research, Det Sundhedsvidenskabelige Fakultet, SDU4 Gynaecology and Obstetrics, Department of Clinical Research, Det Sundhedsvidenskabelige Fakultet, SDU
Context: Central obesity in polycystic ovary syndrome (PCOS) is associated with increased inflammatory markers and increased risk for type 2 diabetes. Objective: The objective of the study was to evaluate whether treatment with metformin (M) or M combined with oral contraceptive pills (OCPs) resulted in a more advantageous body composition than treatment with OCP alone. Setting: The study was conducted at an outpatient clinic. Patients and Interventions: This was a randomized, controlled clinical trial. Ninety patients with PCOS were randomized to 12 months' treatment with M (2 g/d), M + OCP (150 mg desogestrel+30 μg ethinylestradiol), or OCP. Whole-body dual-energy x-ray absorptiometry scans and clinical and hormonal evaluations were performed before and after the intervention period. A total of 65 of 90 patients completed the study. Main Outcome Measures: Changes in weight at 6 and 12 months and changes in regional fat mass estimates at 12 months were measured. Results: Dropout rates between intervention groups were not significantly different. Treatment with M and M+OCP were superior to OCP regarding weight and regional fat mass. The median (quartiles) weight changes during 12 months of M, M+OCP, and OCP treatment were -3.0 (-10.3; 0.6), -1.9 (-4.9; 0.1), and 1.2 (-0.8; 3.0) kg, respectively, P < .05. Upper to lower fat mass ratio was unchanged. Changes in body composition were predicted by the type of medical intervention (M, M+OCP, or OCP) and not by body mass index at study inclusion. OCP and M+OCP were superior to M regarding reduction in free T levels. Conclusions: M treatment alone or in combination with OCP was associated with weight loss and improved body composition compared with OCP, whereas free T levels decreased during M+OCP or OCP. Combined treatment with M+OCP should be considered as an alternative to treatment with OCP alone to avoid weight gain in PCOS.
Journal of Clinical Endocrinology and Metabolism, 2014, Vol 99, Issue 7, p. 2584-91