Mifepristone in fibroids: Comparative study of safety and efficacy of biweekly dosage vs daily dosage schedule

Abstract

Background: Leiomyomas are the most prevalent benign tumors of the uterus and are seen more with increasing age. 50 mg biweekly dose was compared with 25 mg daily dose in terms of efficacy and safety in symptomatic women as the biweekly dose maybe an economically better alternative. Two different dosages of mifepristone for medical management of fibroids were compared in terms of efficacy and safety in symptomatic women. Materials and Methods: Ninety-two women were recruited who fulfilled the criteria after informed consent and were randomized in two groups. Sample size was calculated on the basis of earlier literature, for response in terms of reduction in fibroid volume, assuming 1% level of significance and 95 % power of study, the optimum sample size came out to be minimum 27 in each group. Assuming loss to follow up of few patients, we took 45 patients in group 1 and 47 patients in group 2. Group 1 was given mifepristone in a dose of 25 mg once a day and Group 2 was given mifepristone 50 mg biweekly for 3 months. Fibroid volume, uterine volume, endometrial thickness, pictorial blood loss assessment chart score, hemoglobin levels, and liver transaminases were recorded at the beginning and at the end of treatment. Side effects were noted at the end of the treatment. Results: Both the dosages lead to improvement in symptoms of the patients. Mifepristone significantly reduced fibroid volume in both the groups, but the difference between the groups was not significant (P = 0.99). Mifepristone treatment significantly reduced bleeding and increased hemoglobin levels in both the groups. The side effects were mild and tolerable. Conclusion: Mifepristone in both dosages is highly efficacious in causing amenorrhea, improving anemia, and enhancing the quality of life, and hence 50 mg biweekly dosage shows potential for being cost efficient.