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Use of nafarelin versus placebo after reductive laparoscopic surgery for endometriosis
M D Hornstein1, R Hemmings, A A Yuzpe
1Department of Obstetrics and Gynecology, Brigham and Women's Hospital, Boston, Massachusetts 02115, USA.
Objective:
To evaluate the efficacy of the GnRH agonist (GnRH-a) nafarelin compared with placebo administered for 6 months after reductive laparoscopic surgery for symptomatic endometriosis.
Design:
Randomized, prospective, placebo-controlled, multicenter clinical trial.
Setting:
Thirteen clinics including private practice and university centers.
Patient(S):
One hundred nine women aged 18-47 with laparoscopically proven endometriosis and pelvic pain who had undergone reductive laparoscopic surgery for endometriosis.
Intervention(S):
Patients were randomized to receive either the GnRH-a nafarelin (200 micrograms twice daily) or placebo for 6 months.
Main Outcome Measure(S):
Time to initiation of alternative treatment (the length of time from beginning study medication to receiving alternative therapy or to deeming that the study drug was ineffective) and patient-reported and physician-assessed pelvic pain scores.
Result(S):
The median time to initiation of alternative treatment was > 24 months in the nafarelin group versus 11.7 months in the placebo group. Fifteen (31%) of 49 nafarelin-treated patients required alternative therapy, compared with 25 (57%) of 44 placebo-treated patients. The patients' pelvic pain scores dropped significantly in the nafarelin and placebo groups after 6 months of treatment. Physician summary ratings showed significant improvement in the nafarelin group and no significant changes in the placebo group after 6 months of treatment.
Conclusion(S):
Compared with placebo, nafarelin administered after reductive laparoscopic surgery for endometriosis significantly delays the return of endometriosis symptoms requiring further treatment.