Comparative study of dienogest and danazol as endometrial preparation for hysteroscopic myomectomy in patients with intrauterine myoms

Abstract

Submucosal myomas are the cause of abnormal uterine bleeding. Hysteroscopy is a minimally invasive surgery that can be used to resect submucosal myomas. For reducing bleeding and succeeding in myomectomy, various drugs are used to reduce the thickness of the endometrium (endometrial preparation). This study compared dienogest with danazol in endometrial preparation in myomectomy with hysteroscopy in patients with intrauterine myoma. Materials and Methods: In this clinical trial study, 62 patients with submucosal myoma of 30 mm or less and grade zero or 1 were randomly divided into two equal groups. In the first group, Dienogest 2 mg was used once a day for four weeks and in the second group, Danazol 200 mg twice daily from the first day of the period for four weeks. The endometrial preparation was assessed by the appearance of the endometrium under the direct view of a hysteroscope and was divided into three categories: atrophic, normo-trophic and hypo-trophic. The amount of bleeding during surgery was determined by two methods, Visual Analog Scale (VAS) and the objective method. The primary outcomes of the study were endometrial atrophy, intraoperative hemorrhage, and secondary outcomes were myomectomy success rates, the duration of surgery, and hysteroscopic resolution. Results: The mean age of patients receiving dienogest was 42.84±7.92 years and the patients receiving danazol was 43.35±7.20 years (p=0.789). Mild (Grade 1) and moderate (Grade 2) bleeding in the danazol group was greater than in the dienogest group and there were no cases of severe bleeding in patients. The rate of hemoglobin reduction was significantly lower in the dienogest group than in the danazol group (0.33±0.44 vs. 0.94±0.75; p=0.001). Also, the rate of hematocrit reduction was lower in the dienogest group than in the danazol group (1.40±2.12 vs. 2.12±1.11; p=0.023). The frequency of atrophic endometrium in the dienogest group was significantly higher than the danazol group, and in contrast, the frequency of hypo-trophic and normo-trophic endometrium in the danazol group was significantly higher than the dienogest group. In the group receiving dienogest 26 patients (83.9%) experienced uncomplication and in the group of receiving danazol 15 patients (48.4%) were uncomplicated. The thickness of the endometrium on the last day of dienogest treatment was significantly less than that in the danazol group.