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 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...

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Bibliographic Details
Published in:European journal of obstetrics & gynecology and reproductive biology 2016-01, Vol.196, p.48-51
Main Authors: Sayyah-Melli, M, Bidadi, S, Taghavi, S, Ouladsahebmadarek, E, Jafari-Shobeiri, M, Ghojazadeh, M, Rahmani, V
Format: Article
Language:English
Subjects:
Adult
Blood Loss, Surgical
Danazol
Danazol - therapeutic use
Female
Gonadotropin-releasing hormone agonist
Hemostasis, Surgical - methods
Humans
Hysteroscopy
Hysteroscopy - adverse effects
Middle Aged
Obstetrics and Gynecology
Promethazine - therapeutic use
Treatment Outcome
Uterine bleeding
Uterine Hemorrhage - drug therapy
Uterine Hemorrhage - surgery
Uterine Myomectomy - adverse effects
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Summary: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 (200 mg 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 2.0 L 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.
ISSN:0301-2115
1872-7654
DOI:10.1016/j.ejogrb.2015.10.021