Efficacy of myo-inositol and d-chiro-inositol combination on menstrual cycle regulation and improving insulin resistance in young women with polycystic ovary syndrome: A randomized open-label study.

Abstract

To compare the effect of myo-inositol and d-chiro-inositol in combination (MI+DCI) with combined hormonal contraceptive (CHC) on menstrual cycle regulation in young Indian women with polycystic ovary syndrome (PCOS). Seventy young women with PCOS aged 15-24years with delayed cycles were randomized into two groups and were treated for 6months with MI+DCI (550+150mg, 3.6:1 ratio) twice a day and CHC (ethinyl estradiol 20µg+drospirenone 3mg) once a day. Spontaneous menses resumed in 28 (84.85%) young women on MI+DCI, compared with withdrawal bleeding in 34 (100%) on CHC. The mean cycle length reduced with both MI+DCI (124.54±8.08 to 57.75±3.00days, P<0.001) and CHC (105.88±7.96 to 30.53±2.95days, P<0.001). Regular menstrual cycles were established in 9 (27.27%) young women with MI+DCI (P=0.001) and 30 (88.23%) with CHC (P<0.001). Three months after stopping the treatment, 24 young women (85.71%) on MI+DCI and 25 (73.53%) on CHC continued to have spontaneous cycles. Anti-Müllerian hormone decreased with both the drugs (P=0.001), whereas luteinizing hormone (P=0.001) and testosterone (P=0.04) decreased with CHC and homeostatic model assessment of insulin resistance (P<0.001) with MI+DCI. Myo-inositol and d-chiro-inositol in combination (3.6:1 ratio) are effective in regularizing menstrual cycles and improving insulin resistance. Clinical Trials Registry of India (CTRI/2018/03/012643). http://ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=20969&EncHid=&userName=myo-inositol.