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

istone 2.5 mg versus 5 mg daily in the treatment of leiomyoma before surgery Original Research (2610) Total Article Views Authors: Carbonell Esteve JL, Riverón AM, Cano M, Ortiz AI, Valle A, Texidó CS, Tomasi G Published Date March 2012 Volume 2012:4 Pages 75 - 84 DOI: http://dx.doi.org/10.2147/IJWH.S28103 Received: 09 November 2011 Accepted: 01 February 2012 Published: 13 March 2012 Josep L Carbonell Esteve1, Ana M Riverón2, Mariela Cano2, Alma I Ortiz3, Aleta Valle2, Carlos S Texidó2, Giuseppe Tomasi4 1Mediterránea Médica Clinic, Valencia, Spain; 2Eusebio Hernández Obstetrics Teaching Hospital, Havana, Cuba; 3Alemán Hospital, Managua, Nicaragua; 4Chemistry Department, University of the Basque Country, San Sebastian, Spain 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.