Randomized controlled trial of the effects of metformin versus combined oral contraceptives in adolescent PCOS women through a 24 month follow up period

Objective: To compare metformin and combined oral contraceptive pill (COC) effects over 24 months in adolescent PCOS. Design: Randomized controlled study. Setting: Alexandria ICSI centre. Patients: 117 adolescent girls with PCOS, were randomized to: group A (n=40): metformin, group B (n=40): COC, and group C (n=39): control. Interventions: Group A: received metformin, group B: received combined oral contraceptives. Main outcome measures: Improvement in cycle rhythm and hirsutism. Results: In group B a significant decline in serum testosterone reached the lowest value by the end of the second year (0.7 +/- 0.2 versus 1.3 +/- 0.5 mu g/ml). By the end of the study, group A showed a significant decline in fasting (18.6 +/- 3.0-10.0 +/- 3.0 mu IU/ml) and after-load insulin levels (126 +/- 43-64 +/- 15 mu IU/ml) with a significant rise in glucose/insulin ratio (GIR) from 4.1 +/- 0.3 to 4.6 +/- 0.5. Group B showed a significant rise in fasting and after-load insulin (from 15.0 +/- 3.0 mu IU/ml and 103.0 +/- 91.0 mu IU/ml to 19.0 +/- 4.0 and 187.0 +/- 22.0 mu IU/ml, respectively) and GIR dropped significantly from 4.4 +/- 0.2 to 3.1 +/- 0.3. Metformin was associated with a significant loss of weight from 87.0 +/- 6.0 to 72.0 +/- 0.5 kg while COC was associated with a non-significant gain in weight (from 84.0 +/- 6.0 to 91.0 +/- 9.0 kg). Conclusions: Metformin and COC have comparable therapeutic effectiveness on cycle regularity and hirsutism. Metformin was associated with a significant improvement in metabolic syndrome, while COC was associated with a deterioration of metabolic syndrome. (C) 2014 The Authors. Production and hosting by Elsevier B.V. on behalf of Middle East Fertility Society. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-ncnd/3.0/).