Objectives: assessment of the outcomes of women had polycystic ovary syndrome (PCOS) received 6-month therapy of metformin (Met) or combination of myoinositol (MI)/D-chiro-inositol (DCI) or both.
Patients & Methods : 210 PCOS women underwent clinical, US and laboratory work-up to determine baseline T0-data and were divided into 3-equal groups: Met group received met 500 mg tab three times daily, MI-group received MI/DCI combination in 40:1 ratio twice daily and MM-group received both Met and MI therapy and at the end of 6-m (T6) therapy, all patients were re-evaluated to assess gynecological outcomes including resumption of regular menstrual pattern (RMP) and getting pregnant for PCOS-infertile women wishing for pregnancy and metabolic and endocrinal outcomes including impact on body mass index (BMI), glucose tolerance (GT), homeostasis model assessment of insulin resistance (HOMA-IR) index, and hyperandrogenemia.
Results: At T6, 126 women resumed RMP and 15.8% of women got pregnant. T6-BMI was significantly decreased in all women with improved GT and only 15 of 67 insulin resistant women were still resistant. The frequency of women had serum total testosterone (TT) 0.8 ng/ml was decreased from 35.2% to 13.3% with significantly lower levels of TT at T6-samples than T0-samples. The percentages of change in the studied parameters were higher with MM-therapy than either Met or MI-therapy. The rate of resumption of RMP and percentages of change of BMI, HOMA-IR and serum TT were positively correlated but showed negative relation to the use of insulin sensitizer monotherapy. The Receiver Operating Characteristic (ROC) curve analysis defined high percentage of decrease of HOMA-IR index as positive and the use of monotherapy as negative predictor for getting RMP.
Conclusion: Insulin sensitizers' therapy is effective and safe for control PCOS-associated endocrinal, metabolic and gynecological deregulations. Inositol is a synergistic additive to metformin and this combination results in favorable outcomes than monotherapy.