ObjectivesTo evaluate the efficacy and safety of 2.5 mg and 5 mg mifepristone during 3 months for the treatment of uterine fibroids before surgery.DesignMulticenter randomized clinical trial.LocationsEusebio Hernández Hospital, Havana, Cuba and the Alemán Hospital, Managua, Nicaragua.SubjectsIncluded in the study were 146 women with symptomatic uterine fibroids.TreatmentGroup 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 efficacyIncrease in average hemoglobin, changes in fibroid and uterine volume, and symptomatic improvement.ResultsThe 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.ConclusionThe dose to be used should be 5 mg.
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