Mohamed Ghonim1,2, Rana Magdy1,2, Mohamed Sabbour1,2, Mohanad Ghonim1,2, Ashraf Nabhan2,3. 1. Extended Modular Program, Faculty of Medicine, Ain Shams University, Cairo, Egypt. 2. Egyptian Center for Evidence Based Medicine, Cairo, Egypt. 3. Department of Obstetrics and Gynecology, Faculty of Medicine, Ain Shams University, Cairo, Egypt.
Abstract
BACKGROUND: Uterine fibroids cause menorrhagia and adversely affect quality of life. Ulipristal acetate (UPA) can improve fibroid symptoms. OBJECTIVES: To assess the effectiveness of UPA in women with symptomatic uterine fibroids. SEARCH STRATEGY: We searched CENTRAL, MEDLINE, Embase, and CINHAL on December 31, 2018, using relevant search terms. Clinical trials registries were searched for ongoing trials and there were no language restrictions. SELECTION CRITERIA: We included randomized controlled trials (RCTs) comparing UPA with placebo/no treatment/any pharmacological intervention for symptomatic uterine fibroids. DATA COLLECTION AND ANALYSIS: Two authors independently screened trials, extracted data, and assessed the risk of bias in included studies. We used risk ratio (RR) for dichotomous outcomes and mean difference (MD) for continuous outcomes, plus their 95% confidence intervals (CIs). MAIN RESULTS: We identified six RCTs (1121 participants). Five studies (882 participants) compared UPA with placebo. UPA significantly achieved amenorrhea (RR 24.54; 95% CI, 10.82-55.64), reduced blood loss, and improved quality of life with insufficient evidence from RCTs for adverse events. There was insufficient evidence for improved outcomes when UPA was compared with leuprolide acetate. CONCLUSION: Compared with placebo, oral UPA significantly induces amenorrhea, reduces heavy menses, and improves quality-of-life in women with uterine fibroids.
BACKGROUND: Uterine fibroids cause menorrhagia and adversely affect quality of life. Ulipristal acetate (UPA) can improve fibroid symptoms. OBJECTIVES: To assess the effectiveness of UPA in women with symptomatic uterine fibroids. SEARCH STRATEGY: We searched CENTRAL, MEDLINE, Embase, and CINHAL on December 31, 2018, using relevant search terms. Clinical trials registries were searched for ongoing trials and there were no language restrictions. SELECTION CRITERIA: We included randomized controlled trials (RCTs) comparing UPA with placebo/no treatment/any pharmacological intervention for symptomatic uterine fibroids. DATA COLLECTION AND ANALYSIS: Two authors independently screened trials, extracted data, and assessed the risk of bias in included studies. We used risk ratio (RR) for dichotomous outcomes and mean difference (MD) for continuous outcomes, plus their 95% confidence intervals (CIs). MAIN RESULTS: We identified six RCTs (1121 participants). Five studies (882 participants) compared UPA with placebo. UPA significantly achieved amenorrhea (RR 24.54; 95% CI, 10.82-55.64), reduced blood loss, and improved quality of life with insufficient evidence from RCTs for adverse events. There was insufficient evidence for improved outcomes when UPA was compared with leuprolide acetate. CONCLUSION: Compared with placebo, oral UPA significantly induces amenorrhea, reduces heavy menses, and improves quality-of-life in women with uterine fibroids.