Mifepristone 2.5 mg versus 5 mg daily in the treatment of leiomyoma before surgery

OBJECTIVES To evaluate the efficacy and safety of 2.5 mg and 5 mg mifepristone during 3 months for the treatment of uterine fibroids before surgery. DESIGN Multicenter randomized clinical trial. LOCATIONS Eusebio Hernández Hospital, Havana, Cuba and the Alemán Hospital, Managua, Nicaragua. SUBJECTS Included in the study were 146 women with symptomatic uterine fibroids. TREATMENT GROUP I: half a tablet of 5 mg (2.5 mg) mifepristone taken orally every 24 hours, and Group II: one tablet of 5 mg mifepristone taken orally every 24 hours over a period of 3 months in both groups. Two endometrial biopsies were performed. VARIABLES TO EVALUATE EFFICACY: Increase in average hemoglobin, changes in fibroid and uterine volume, and symptomatic improvement. RESULTS The average hemoglobin at the end of treatment was 0.6 g/dL greater in the 5 mg mifepristone group (P = 0.033). In both groups there were similar reductions in fibroid volumes. Clinical improvement was more significant in the 5 mg group. CONCLUSION The dose to be used should be 5 mg.