Comparative study of vaginal danazol vs diphereline (a synthetic GnRH agonist) in the control of bleeding during hysteroscopic myomectomy in women with abnormal uterine bleeding: a randomized controlled clinical trial

Abstract

ObjectiveTo compare the usefulness of vaginal danazol and diphereline in the management of intra-operative bleeding during hysteroscopy. DesignRandomized controlled clinical trial. SettingUniversity hospital. PatientsOne hundred and ninety participants of reproductive age were enrolled for operative hysteroscopy. Thirty women were excluded from the study. InterventionsOne hundred and sixty participants with submucous myomas were allocated at random to receive either vaginal danazol (200mg BID, 30 days before surgery) or intramuscular diphereline (twice with a 28-day interval). Main outcome measuresSeverity of intra-operative bleeding, clarity of the visual field, volume of media, operative time, success rate for completion of operation and postoperative complications. ResultsOverall, 145 patients completed the study. In the danazol group, 78.1% of patients experienced no intra-operative uterine bleeding, and 21.9% experienced mild bleeding. In the diphereline group, 19.4% of patients experienced no intra-operative uterine bleeding, but mild, moderate and severe bleeding was observed in 31.9%, 45.8% and 2.8% of patients, respectively. The difference between the groups was significant (p<0.001). A clear visual field was reported more frequently in the danazol group compared with the diphereline group (98.6% vs 29.2%, p<0.001). The mean operative time was 10.9 min and 10.6min in the danazol and diphereline groups, respectively (p=0.79). The mean volume of infused media was 2.0L in both groups (p=0.99). The success rate was 100% for both groups with no intra-operative complications. ConclusionBoth vaginal danazol and diphereline were effective in controlling uterine bleeding during operative hysteroscopy. However, vaginal danazol provided a clearer visual field.