Efficacy and Safety of Dienogest in the Management of Women with Endometriosis; Systematic Review and Meta-Analysis

Abstract

Introduction: Endometriosis is a sex hormone-dependent disease in which the uterine glands are out of the endometrial cavity. It affects about 10.8%–18.6% of women in the childbearing period. Methods: We searched PubMed, Cochrane CENTRAL, SCOPUS, and Web of Science for randomized, double-blind, placebo-controlled studies. Quality assessment was evaluated according to GRADE. Clinical trials were assessed according to Cochrane’s risk of bias tool. We included the following outcomes: Vas score for Pelvic pain, Bleeding or spotting, Adverse events, Physical health, Number of bleeding or spotting episodes, and Duration of bleeding or spotting episodes. We analyzed continuous data using mean difference (MD) and 95% confidence interval (CI), while dichotomous data were analyzed using odds ratio (OR) and 95% CI Results: Five studies met the eligibility criteria for our meta-analysis. We found that dienogest was statistically better than placebo in terms of Vas score for Pelvic pain (MD=-26.68 [-40.74, -12.61], (P = 0.002), and physical health (MD=3.68 [2.40, 4.96], ( P < 0.001), While placebo was better than dienogest regarding bleeding (RR=2.46 [1.65, 3.68], ( P < 0.001), and adverse events (RR=1.19 [1.00, 1.42], (P = 0.04). There was no significant difference between both groups regarding number of bleeding or spotting episodes (MD=-0.51 [-1.10, 0.07], (P = 0.09), and duration of bleeding or spotting episodes (MD=8.69 [-0.84, 18.22], (P = 0.07). Conclusions: Our results prove that dienogest is well tolerated and effective in the management of pelvic pain related to endometriosis