Efficacy of Mifepristone versus GNRH Analogue in the Treatment of Uterine Leiomyoma- A Comparative Study
Background: Uterine fibroids also called as uterine leiomyoma is the most common benign tumor of the uterus. Most women develop one or more uterine leiomyoma during their reproductive years. Hence; we assessed the efficacy of Mifepristone 25mg versus Inj.Leuprolide acetate 3.75mg in reducing size of uterine myoma. Subjects and Methods: The study was planned for detecting difference of 15 percent in the outcome variables between the two groups and Standard deviation of 156.00, with 90% statistical power and 5% level of significance, the sample size was calculated to be 70 for the study. The study subjects were randomly assigned into 2 groups of 35 patients each. Group 1: Patients treated with Tablet Mifepristone 25mg once daily for 3 months; Group 2: Patients treated with Inj. Leuprolide acetate depot preparation 3.75mg IM once a month for 3 months. Demographic data, history, clinical examination, details of drug prescription, laboratory investigations and imaging reports were recorded in the study proforma. Various clinical assessment parameters were assessed. Results: After three months of treatment, there was a marked relief with significant decrease in visual analog scale score in both the groups (p <0.001). 21 patients (60%) in group 1 and 25 patients (71%) in group 2 presented with mild anemia at the beginning of the study. After three months of treatment, there was a significant (p <0.001) rise in the hemoglobin and hematocrit values in both the groups. There was an increase in mean hemoglobin level by 2.9gm/dl in mifepristone group and 3gm/dl in leuprolide group. Conclusion: Treatment with either mifepristone or leuprolide acetate in uterine leiomyoma is safe and causes significant but temporary reductions in uterine size and myoma related symptoms.