Evaluation of the Clinical and Biochemical Effects of Medical Therapy in Women with Polycystic Ovary Syndrome

Background: Oral contraceptive pills are commonly used in the treatment of PCOS; but, their influence on metabolic parameters is not well known. Metformin, a biguanide antihyperglycemic drug, has been shown to improve ovarian function and glucose metabolism in women with polycystic ovary syndrome (PCOS), but results concerning its effects are controversial. Objective: The aim of the study is to evaluate the effects of ethinyl oestradiol-cyproterone acetate and those of metformin on clinical, endocrinal and metabolic parameters in patients with PCOS. Setting: The study was conducted at gynaecology and obstetrics outpatient clinic in Kasr AlAini teaching hospital, Cairo University. Patients and Methods: We conducted a randomized, clinical trial on forty two women with PCOS. Patients under-went clinical and biochemical evaluation at baseline. Clinical evaluation included recording of menstrual regularity, hirsutism scores, BMI and WHR. Laboratory investigations included androgen levels, lipid profile, and parameters of insulin resistance. Patients were randomized to either oral treatment with metformin (1000mg twice daily) or to the Diane 35 pill (35 μg of ethinyl-estradiol plus 2 mg of cyproterone acetate) for 16 wk. The baseline evaluation was repeated after 16 wk of treatment in both groups. Results: Forty two PCOS subjects participated in the study; twenty one in each group. All women had BMI 25. The patients in both groups were comparable at baseline. Subjects in the Diane arm had significant improvement of hirsutism and restoration of regular menstrual cycles. Diane significantly decreased free testosterone and DHEAS levels. Total and HDL- cholesterol aas well as fasting triglycerides were significantly increased on Diane therapy. Subjects in the metformin arm had significant decrease in BMI and free testosterone levels paralleled with improvement in cycle regularity. Fasting blood glucose, fasting insulin and HOMA scores also significantly decreased on metformin therapy. Metformin significantly increased HDL- and reduced LDL-cholesterol. Conclusion: Diane is superior to metformin in amelioration of hirsutism and restoration of cycle regularity. It has both beneficial and negative effects on lipid profile. Metformin improves parameters of insulin resistance as well as the lipid profile.