Comparing the Effect of Dienogest and OCPS on Pain and Quality of Life in Women with Endometriosis: A Randomized, Double-Blind, Placebo-Controlled Trial

Abstract

Background: Endometriosis is an estrogen-dependent disease that adversely affects women’s quality of life (QOL). We aimed to compare the effect of dienogest and oral contraceptive pills (OCPs) on pain and QOL in women with endometriosis. Methods: This randomized double-blind trial was conducted at Rasoul-e-Akram hospital, affiliated to Iran University of Medical Sciences, Tehran, Iran, from March 2018 to March 2020, on women with severe endometriosis confirmed by laparoscopic surgery. Ninety patients were randomly given either dienogest (Vissane 2 mg tablet; n = 30), or OCPs (LD; n = 30), or placebo (n = 30) daily for 12 weeks. The primary objective of this study was to evaluate the patient’s pain including dyspareunia, dysuria, dyschezia, and pelvic pain. The secondary outcome was considered as a change in patients’ QOL score. Results: The mean age of population was 32.99 ± 7.1 years. There was no significant difference in the three groups regarding baseline characteristics. Pelvic pain was significantly reduced, while the effect of medication on dysuria and dyschezia was not significant. The overall QOL score between the control and dienogest (P = 0.02) and OCPs groups (P = 0.001) was significantly different; however, the difference was not significant between the two intervention groups Conclusion: The finding of the present study revealed that there is no difference in the efficacy of dienogest and OCPs in management of pain and the QOL. But there was a significant difference between the placebo and intervention groups.