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.