Objectives: To systematically evaluate the efficacy and safety of Diane-35 for treating polycystic ovary syndrome (PCOS) and compare it with metformin, either in combination or alone.
Study design: A systematic review and meta-analysis were conducted. Randomized controlled studies applying Diane-35 and metformin for treating PCOS were included. The primary outcome was hirsutism. Authors of primary articles were contacted and methodological quality was evaluated. Subgroups were drawn based on treatment duration and sensitivity analysis was conducted; heterogeneity and bias are discussed.
Results: Twelve studies were included. The effect on improving hirsutism was not different between Diane-35 and metformin. Compared with Diane-35, metformin appeared to protect patients against glucose metabolic abnormality with treatment of at least 6 months. Except for triglycerides, no difference in lipid profile existed between Diane-35 and metformin. The evidence that Diane-35 deteriorates lipid and glucose metabolism was insufficient. Diane-35 could result in hypertension and headache. Methodological quality was still the key problem for studies.
Conclusions: Diane-35 is superior to metformin in reducing androgens, but inferior to metformin in reducing insulin. Whether Diane-35 deteriorates lipid metabolism and insulin resistance is still unclear.