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.
Highlights
The selective progesterone receptor modulators (SPRMs) are proving to be a new source of hope in treating uterine fibroids [1, 2]
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
The aim of this study is to evaluate the effectiveness, safety, and quality of life obtained using 2.5 versus 5 mg mifepristone daily over 3-month treatment and 9-month followup
Summary
The selective progesterone receptor modulators (SPRMs) are proving to be a new source of hope in treating uterine fibroids [1, 2]. Ulipristal acetate has been authorized for use in the European Union in 5 mg daily doses over 3 months to improve symptoms in presurgery patients [3, 4]. Eisinger et al in a 17-case pilot study using 2.5 mg doses of mifepristone obtain lesser reductions in uterine volume, but a similar quality of life in comparison with 5 mg mifepristone [11]. Feng et al demonstrate that the improvement in quality of life obtained with 2.5 or 5 mg doses of mifepristone is partially related to the reduction in symptoms, pain and bleeding, but bears no relationship with reduction in uterine volume [9]
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