Efficacy of Mifepristone versus GNRH Analogue in the Treatment of Uterine Leiomyoma- A Comparative Study

Uterine Leiomyoma

  • Georgy Joy Eralil Professor, Department of Obstetrics & Gynaecology, Sree Narayana Institute of Medical Science, Chalakka, Emakulam.
  • Junaid Naina M Post Graduate Student, Department of Pharmacology, Sree Narayana Institute of Medical Science, Chalakka, Emakulam.
  • T. N. Kumar Professor & HOD, Department of Pharmacology, Sree Narayana Institute of Medical Science, Chalakka, Emakulam.
Keywords: Leuprolide acetate, Mifepristone, Uterine myoma

Abstract

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.

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Published
2019-05-10
How to Cite
Eralil, G. J., M, J. N., & Kumar, T. N. (2019). Efficacy of Mifepristone versus GNRH Analogue in the Treatment of Uterine Leiomyoma- A Comparative Study. Asian Journal of Medical Research, 8(2), PC01-PC04. https://doi.org/10.21276/ajmr.2019.8.2.PC1
Section
Pharmacology