OBJECTIVES: To determine the effectiveness of a 6-month course of nafarelin in the treatment of stage III-IV endometriosis and to determine if pre-operative use of nafarelin facilitates surgery. DESIGN: Prospective, multicenter, clinical trial. SETTING:Eight university hospitals and two private practice institutions in France. PATIENTS: Fifty-five patients with stage III and IV endometriosis. Two were excluded. INTERVENTIONS: The severity of endometriosis was assessed at the time of laparoscopy and patients were randomized to have either laparosopic surgery at that time following 6 months of nafarelin therapy (n=28), or laparoscopic surgery following 6 months of nafarelin therapy (n=25). All had 200 microg intranasal nafarelin twice a day for 6 months and a second look laparoscopy. MAIN OUTCOME MEASURE: Clinical efficacy, tolerance to the treatment. RESULTS:Efficacy and tolerance to the treatment were the same in both groups. AFS scores compared on both laparoscopies were significantly better if nafarelin was given prior to surgery (P=0.007). CONCLUSIONS: This preliminary study shows that in cases of combined medico-surgical treatment for stage III-IV endometriosis, preoperative medical treatment with GnRH-a gives a better AFS score improvement, but no conclusion was possible whether preoperative treatment facilitates surgery.
RCT Entities:
OBJECTIVES: To determine the effectiveness of a 6-month course of nafarelin in the treatment of stage III-IV endometriosis and to determine if pre-operative use of nafarelin facilitates surgery. DESIGN: Prospective, multicenter, clinical trial. SETTING: Eight university hospitals and two private practice institutions in France. PATIENTS: Fifty-five patients with stage III and IV endometriosis. Two were excluded. INTERVENTIONS: The severity of endometriosis was assessed at the time of laparoscopy and patients were randomized to have either laparosopic surgery at that time following 6 months of nafarelin therapy (n=28), or laparoscopic surgery following 6 months of nafarelin therapy (n=25). All had 200 microg intranasal nafarelin twice a day for 6 months and a second look laparoscopy. MAIN OUTCOME MEASURE: Clinical efficacy, tolerance to the treatment. RESULTS: Efficacy and tolerance to the treatment were the same in both groups. AFS scores compared on both laparoscopies were significantly better if nafarelin was given prior to surgery (P=0.007). CONCLUSIONS: This preliminary study shows that in cases of combined medico-surgical treatment for stage III-IV endometriosis, preoperative medical treatment with GnRH-a gives a better AFS score improvement, but no conclusion was possible whether preoperative treatment facilitates surgery.
Authors: Innie Chen; Veerle B Veth; Abdul J Choudhry; Ally Murji; Andrew Zakhari; Amanda Y Black; Carmina Agarpao; Jacques Wm Maas Journal: Cochrane Database Syst Rev Date: 2020-11-18