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Comparison of Efficacy and Safety between Dienogest and Danazol in Women with Endometriosis

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.