American Research Journal of Endocrinology

Polycystic ovary syndrome (PCOS) is a heterogeneous endocrine disorder affecting women of reproductive age. Treatment by metformin is based on the basis of insulin resistance in PCOS. Objective: To see the effect of metformin therapy for 9 months on hormonal profiles in PCOS. Methods: Present double blind placebo-controlled study encompassed 80 PCOS subjects (age, mean±SD: 23.10±4.30; married/unmarried: 44/36; amenorrhea/oligomenorrhea: 90%; abortion: 25%; infertility: 38.6%) who were tested for hormonal profiles (serum testosterone, progesterone and anti-mullerian hormone, AMH) at recruitment and after 9 months of therapy with metformin/placebo having >80% compliance. Among 80, 49 completed the study (metformin=26, placebo=23), 4 became pregnant before reaching the end point (metformin=1, placebo=3), and 27 dropped out (metformin=13, placebo=14). AMH was assayed by ELISA whereas testosterone and progesterone by chemiluminescent method. Results: Baseline characteristics as well as hormonal and biochemical profiles were statistically similar between metformin and placebo groups. After 9 months, AMH (ng/ml) increased significantly in both metformin (6.10±5.68 vs. 8.67±4.27, p<0.003) and placebo (4.89±3.70 vs. 10.54±3.58, p<0.001) groups. Progesterone (1.55±2.58 vs. 5.16±5.20, ng/ml, p=0.006) increased whereas testosterone significantly decreased (8.11±3.98 vs. 5.96±1.72, ng/ml, p=0.003) in the metformin group. Unlike metformin, testosterone (8.88±3.10 vs. 8.86±3.06, ng/ml, p=0.989) and progesterone (0.94±0.85 vs 0.82±1.34, ng/ml, p=0.670) were unchanged in placebo. Side effect like loose motion, abdominal pain, nausea and vomiting were observed during the initial part of therapy in both groups. Conclusions: The present double-blind placebo-controlled RCT of nine months revealed that metformin has significant beneficial effect on androgenous activity of PCOS. Keywords: PCOS, Metformin AMH, Testosterone, Progesterone