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

M Sayyah-Melli, Manizheh Sayyah-Melli, Sanam Bidadi, S Bidadi, S Taghavi, Simin Taghavi, Elaheh Ouladsahebmadarek, E Ouladsahebmadarek, M Jafari-Shobeiri, Mehri Jafari-Shobeiri, Morteza Ghojazadeh, M Ghojazadeh, Vahideh Rahmani, V Rahmani
European journal of obstetrics, gynecology, and reproductive biology · 2015 · vol. 196 , pp. 48–51 · doi:10.1016/j.ejogrb.2015.10.021 · PMID:26675055 · W2180111622
RCT OA: closed CC0
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This randomized controlled trial compared vaginal danazol and diphereline for controlling bleeding during hysteroscopic myomectomy in women with abnormal uterine bleeding.

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Abstract

OBJECTIVE: To compare the usefulness of vaginal danazol and diphereline in the management of intra-operative bleeding during hysteroscopy. DESIGN: Randomized controlled clinical trial. SETTING: University hospital. PATIENTS: One hundred and ninety participants of reproductive age were enrolled for operative hysteroscopy. Thirty women were excluded from the study. INTERVENTIONS: One 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 MEASURES: Severity of intra-operative bleeding, clarity of the visual field, volume of media, operative time, success rate for completion of operation and postoperative complications. RESULTS: Overall, 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 10.6 min 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. CONCLUSION: Both vaginal danazol and diphereline were effective in controlling uterine bleeding during operative hysteroscopy. However, vaginal danazol provided a clearer visual field.

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MeSH descriptors

Danazol Hemostasis, Surgical Hysteroscopy Promethazine Uterine Hemorrhage Uterine Myomectomy Adult Blood Loss, Surgical Danazol Female Hemostasis, Surgical Humans Hysteroscopy Middle Aged Promethazine Treatment Outcome Uterine Hemorrhage Uterine Hemorrhage Uterine Myomectomy

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