Continuous Dienogest vs Cyclical Dienogest with Ethinyl Estradiol in the Management of Pelvic EndometriosisA Prospective Interventional Study

Abstract

Introduction: Endometriosis is a disease of adolescents and women of reproductive age group characterised by the presence of endometrial tissue outside the uterine cavity. It is a typical gynaecological condition that causes symptoms such as dysmenorrhoea, dyspareunia, dyschezia, chronic pelvic pain, irregular uterine bleeding, and infertility. Being a prevalent disease primarily affecting women of reproductive age, this condition significantly reduces the Quality of Life (QoL) with frequent recurrence of symptoms after discontinuation of conservative therapy. Aim: The aim of this study was to investigate the alleviation of Endometriosis-associated Pelvic Pain (EAPP), effective cycle control, and to compare the side effects of continuous dienogest and cyclical dienogest with ethinylestradiol, as well as the improvement in QoL in the two study groups. Materials and Methods: A prospective interventional study was conducted at the Department of Obstetrics and Gynaecology, Medical College Kolkata, West Bengal, India. The study duration was 12 months, from June 2020 to May 2021. Patients attending the Gynaecology Outpatient Department (GOPD) with clinical, sonological, and/or surgical diagnosis of endometriosis were enrolled in the study and divided into two groups of 30 patients each. Group 1 was treated with Dienogest (D) 2 mg, and group 2 received a combination of dienogest 2 mg and Ethinyl Estradiol 30 mcg (D+EE) combination. The Visual Analogue Scale (VAS) was used to define endometriosis-related symptoms. Patient satisfaction in terms of improvement in QoL was measured using a free online calculator based on the 12- item Short Form Health Survey (SF-12), which includes both physical and mental components. Follow-ups were conducted at one, three, and six months. Data were summarised as mean and Standard Deviation (SD) for numerical variables and count and percentages for categorical variables. A p-value <0.05 was considered statistically significant. Results: A total of 60 patients were enrolled in the study and divided into two groups of 30 patients each. At three and six months, endometriosis-associated pelvic pain significantly decreased in patients receiving Dienogest+Ethinylestradiol (D+EE) compared to patients receiving dienogest alone (p<0.001). The effectiveness in cycle control at three and six months was also higher in the D+EE group (p=0.0098 and 0.0443, respectively). The safety profile was similar in both groups during follow-ups. QoL, as assessed by the Physical Component Score (PCS-12), showed a significant decrease at one, three, and six months with D+EE compared to Dienogest alone (p=0.0135, p=0.0058, and p<0.0001, respectively). The Mental Component Score (MCS-12) at three and six months significantly improved in patients on D+EE (p=0.0101, p<0.0001, respectively). Conclusion: Cyclical D+EE was found to be more effective in the management of pelvic endometriosis compared to continuous dienogest alone, resulting in reduced EAPP, improved cycle control, and enhanced QoL.