Clinical and Biochemical Changes in Polycystic Ovarian Syndrome Patients in Response to 3 Different Oral Hypoglycemic Drugs: A Double Blind Randomized Controlled Study

Abstract

Introduction: This study was done to evaluate other oral hypoglycemic medications; especially the new ones in the management of PCOS patients as alternatives to the standard medication used for this purpose Metformin. Patients and Methods: 105 patients were enrolled and randomly distributed into 3 groups according to sequence of computer-generated block-random numbers. Each group included 35 patients. This randomized double blind case controlled study was conducted at Tanta University Hospital from December 1, 2015 to October, 1, 2016. In group A (study group 1) the patients received Pioglitazobe 30 mg once a day for 6 months while in group B (study group 2) the patients received Vildagliptin 50 mg once daily. In Group C (control group) the patients received Metformin 500 mg tds. for 6 months. The clinical outcome measures of the study were the improvement in the regularity of the menstrual cycle, the BMI and the improvement in the modified Ferriman-Gallwey (F-G) score for hirsutism. The biochemical outcome measures will be the change in the Serum Free testosterone, dehydroepiandrosterone (DHEA), fasting insulin level, Glcosylated hemoglobin (Hb A1c) and fasting Low Density Lipoproteins (LDL) levels. Results: Pioglitazobe in the study group 1 patients showed a significant reduction of BMI (p = 0.016), Ferriman-Gallwey score (p = 0.003), free testosterone level (p = 0.003), DHEA level (p = 0.001), fasting insulin level (p = 0.036) and Hb a1c level (p = 0.000), and also significant reduction of menstrual irregularities (p = 0.035). When compared to Metformin in the control group 3, there were significant reduction of BMI (p = 0.010), Ferriman-Gallwey score (p = 0.002), free testosterone level (p = 0.034), Hb a1c (p = 0.000) level and significant reduction of menstrual irregularities (p = 0.004) only. This means that the clinical and metabolic effect of Pioglitazobe is better than Metformin in PCOS patients. On the contrary there were disappointing results of the new drug Vildagliptin in group 2; the patients in this group showed significant reduction of BMI (p = 0.001), Ferriman-Gallwey score (p = 0.046) and Hb a1c (p = 0.000) level only. Non significant effect on menstrual irregularities and non significant reduction of LDL level are noticed. But there is elevation of Ferriman-Gallwey score, free testosterone level, DHEA level and fasting insulin level. Conclusion: Pioglitazobe is an effective and safe alternative to Metformin in the management of PCOS patient although further studies including larger number of patients should be done while Vildagliptin should be omitted for use in PCOS patients.