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. 2013 Jul 29:2013:649030.
doi: 10.1155/2013/649030. eCollection 2013.

Treatment of Uterine Myoma with 2.5 or 5 mg Mifepristone Daily during 3 Months with 9 Months Posttreatment Followup: Randomized Clinical Trial

Josep Lluis Carbonell  1 , Rita Acosta, Yasmirian Pérez, Roberto Garcés, Carlos Sánchez, Giuseppe Tomasi
Affiliations

Treatment of Uterine Myoma with 2.5 or 5 mg Mifepristone Daily during 3 Months with 9 Months Posttreatment Followup: Randomized Clinical Trial

Josep Lluis Carbonell et al. ISRN Obstet Gynecol. .

Abstract

Objectives. To evaluate the efficacy, safety, and quality of life by using 2.5 and mifepristone 5 mg daily doses to treat uterine fibroids over 3 months with a 9-month followup period. Design. Randomized clinical trial. Place. "Eusebio Hernández" Hospital, Havana, Cuba. Subjects. 220 women with symptomatic uterine fibroids. Treatment. One-half (2.5 mg) or one-whole 5 mg mifepristone tablet. Variables to Evaluate Efficacy. Changes in fibroid and uterine volumes, in symptomatic prevalence and intensity, and in quality of life. Results. After 3-month treatment, fibroid volume decreased by 27.9% (CI 95% 20-35) and 45.5% (CI 95% 37-62), in the 2.5 and 5 mg groups, respectively, P = 0.003. There was no difference in the prevalence of symptoms at the end of treatment, unlike after 6- and 9-month followup when there was a difference. Amenorrhea was significantly higher in the 5 mg group, P = 0.001. There were no significant differences in mifepristone side effects between the groups. Both groups displayed a similar improvement in quality of life. Conclusions. The 2.5 mg dosage resulted in a lesser reduction in fibroid size but a similar improvement in quality of life when compared to the 5 mg dose. This trial is registered with ClinicalTrials.gov NCT01786226.

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Figures

Figure 1
Figure 1
Flow chart for the trial.
See this image and copyright information in PMC

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