Dr. Mst. Amena Khatun
Assistant Surgeon, 250 Beded District Hospital, Chapainawabganj, Rajshahi, Bangladesh
Dr. Most. Salma Akhtar Zahan
Jr. Consultant, 250 Beded District Hospital, Chapainawabganj, Rajshahi, Bangladesh, ORCID: 0000-0003-1295-9713
Dr. Anju Ara Khatun
Medical Officer, 250 Beded District Hospital, Chapainawabganj, Rajshahi, Bangladesh
Dr. Mst. Hazera khatun
Assistant Surgeon, 250 Beded District Hospital, Chapainawabganj, Rajshahi, Bangladesh
DOI: 10.36347/sjams.2022.v10i08.039
Abstract |
Background: Endometriosis is a common gynecologic disease associated with a significant burden on women’s health and healthcare systems. Currently approved hormonal treatments for Endometriosis can effectively control symptoms but may have clinically relevant side effects that limit their use. Objective: This study aimed to compare the Efficacy and safety of commonly used drugs dienogest and danazol in patients with Endometriosis. Methods and Material: This randomized clinical trial was conducted at the department of Obst and Gynae in Rajshahi Medical College Hospital from June 2020 to May 2021. A total of 100 diagnosed cases of Endometriosis were included in this study according to inclusion and exclusion criteria. The study population was divided into two groups randomly by flipping a coin; group A is the dienogest group (experimental group), and group B is the danazol group (control group). Informed written consent was obtained from all cases. Patients were followed up after 3 months of treatment following a standard management plan. After data collection, data analysis was done using SPSS version 23. Result: Mean age of the study patients was 28.72±4.71 (SD) years in group A and 29.52±5.23 (SD) years in group B patients with a majority in the age group 26-30 years. Age and other socio-demographic variables were statistically similar in both groups. Symptomatic improvement was observed with statistical significance in both groups regarding visual analog scale (VAS) pain score and severity of dyspareunia and bleeding pattern according to pictorial blood loss assessment chart (PBAC) score (p<.05). But post-treatment VAS pain score and severity of dyspareunia and bleeding pattern was similar in both groups (p>.05). Pre-treatment size of ovarian endometrioma was 4.02±0.227 cm (SD) in group A patients and 3.98±0.212 cm (SD) in group B patients. After treatment, ovarian endometrioma significantly (p<.05) reduced to 1.33±0.698 cm (SD) in group A and 1.47±0.967 cm (SD) in group B. But post-treatment size of endometrioma was similar in both groups (p>.05). Pre-treatment CA-125 level was 70.50±7.16 U/mL (SD) in group A patients and 65.85±6.10 U/mL (SD) in group B patients & significantly (p<0.05) reduced in both groups. Adverse events including hot flush, joint pain, vaginal dryness, decreased libido, and sleep disorder were significantly higher in patients who received Danazol (group B). Conclusion: This study demonstrated similar Efficacy of dienogest and danazol in patients with Endometriosis. A higher frequency of adverse events was observed in patients receiving danazol. Still, larger trials are recommended. |
Keywords: Dienogest, Endometriosis, Progestins, Long-Term Treatment, Quality of Life, Symptoms, Pain.