Estroprogestin vs. gonadotrophin agonists plus estroprogestin in the treatment of endometriosis-related pelvic pain: a randomized trial. Gruppo Italiano per lo Studio dell'Endometriosi.
OBJECTIVE: This is a randomized clinical trial comparing estroprogestin (E/P) pill given for 12 months vs. gonadotrophin releasing hormone agonist (GNRHa) given for 4 months followed by E/P pill treatment for 8 months in the relief of endometriosis-related pelvic pain. METHODS: Eligible for the study were women with laparoscopically confirmed endometriosis and pelvic pain lasting 3-12 months after diagnosis. Eligible women were randomly assigned to treatment with E/P pill (gestroden 0.75 mg and ethynlestradiol 0.03 mg) for 12 months (47 patients) vs. tryptorelin 3.75 mg slow release every 28 days for 4 months followed by E/P pill for 8 months (55 patients). RESULTS: At baseline, dysmenorrhea was reported in 46 women allocated to E/P pill only (97.9%), and in all the 55 women allocated to GNRHa+E/P pill. The corresponding value at the 12 months follow-up visit was 14 subjects (35.9%) and 16 subjects (34.8%). The baseline median values of the multidimensional and analog scale were for dysmenorrhea 4 and 6 in the EP only and 3 and 6 in the GNRHa+E/P group. The corresponding value at the 12 months follow-up visit were 2 and 6 and 0 and 5. Non-menstrual pain was reported, respectively, at baseline and 12 month visit by 46 (97.9%) and 15 (38.5%) subjects in the E/P pill group and 49 (89.1%) and 17 (37.0%) of the GNRHa+E/P pill one. The baseline median values of the multidimensional and analog scale were for non-menstrual pain 3 and 5 in the E/P only and 2 and 6 in the GNRHa+E/P group. The corresponding values at the 12 month follow-up visit were 0 and 4 and 0 and 4. These differences between the two groups were not statistically significant. CONCLUSIONS: 1 year after randomization, the two treatment schedules show similar relief of pelvic pain in women with endometriosis.