%0 Journal Article
%T Treatment of Uterine Myoma with 2.5 or 5£¿mg Mifepristone Daily during 3 Months with 9 Months Posttreatment Followup: Randomized Clinical Trial
%A Josep Lluis Carbonell
%A Rita Acosta
%A Yasmirian P¨¦rez
%A Roberto Garc¨¦s
%A Carlos S¨¢nchez
%A Giuseppe Tomasi
%J ISRN Obstetrics and Gynecology
%D 2013
%R 10.1155/2013/649030
%X 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 Hern¨¢ndez¡± 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¨C35) and 45.5% (CI 95% 37¨C62), in the 2.5 and 5£¿mg groups, respectively, . 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, . 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. 1. Introduction The selective progesterone receptor modulators (SPRMs) are proving to be a new source of hope in treating uterine fibroids [1, 2]. Recently, 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]. The oldest, almost pure antiprogestin, mifepristone, has shown great effectiveness with different dosages in multiple studies into the treatment of this condition [5, 6]. Mifepristone in 5£¿mg doses has proven itself to be an efficient and safe therapeutic medicine as well as achieving an observable improvement in quality of life [5¨C10]. 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, particularly pain and bleeding, but bears no relationship with reduction in uterine volume [9]. 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. 2. Material and Methods 2.1. Design This randomized clinical
%U http://www.hindawi.com/journals/isrn.obgyn/2013/649030/