Impact of depression on improvement of pain symptoms caused by norethindrone acetate in women with rectovaginal endometriosis

OBJECTIVE: To assess the efficacy of norethindrone acetate (NETA) for the treatment of pain symptoms caused by rectovaginal endometri- osis in depressed patients (group D) and in non-depressed controls (group N). DESIGN: Open-label assessor-blinded prospective comparative study. MATERIALS AND METHODS: Patients were treated with NETA (2.5 mg/day) for 12 months. Patients completed the Beck Depression Inventory (BDI) at baseline. On the basis of the results of BDI, patients were divided in group N (BDI score < 17) or in group D (BDI score R 17). The investi- gators were blinded to the depression status. The volume of the rectovaginal nodules was determined by virtual organ computer-aided analysis (VOCAL). The Endometriosis Health Profile-30 (EHP-30) questionnaire was used to assess QoL. The primary endpoint of the study was to evaluate the rate of satisfied patients in the two study groups at the end of treatment. Secondary endpoint was the assessment of the changes in pain symptoms and QoL be- tween the study groups. RESULTS: Forty-seven women with rectovaginal endometriosis were enrolled in the study. At the end of treatment, the percentage decrease in the volume of the nodule similar in the two study groups (p1⁄40.869). At 12-month follow-up, the rate of satisfied patients was higher in group N than in group D (p<0.05). At baseline, the intensity of dysmenorrhea, deep dyspareunia, non-menstrual pelvic pain and dyschezia was similar in the two study groups. At 1-year follow-up, the intensity of deep dyspareunia and non-menstrual pelvic pain was significantly higher in group D than in group N (p<0.01). The EHP-30 scores were similar at baseline between the two study groups, but they were significantly lower in group N than in group D (p<0.05) at 12-month follow-up. CONCLUSION: Depressed women with rectovaginal endometriosis treated with NETA have decreased improvement in pain symptoms and QoL compared with non-depressed patients.