‘Add-back’ therapy for teens with endometriosis?

Results of a small new trial performed in a pediatric gynecology clinic show that an endometriosis therapy previously studied only in adults may be effective for teens. The findings reflect outcomes for quality of life in adolescents treated with “add-back” therapy with norethindrone acetate (NA) plus conjugated estrogens (CEE) versus NA alone.

Published in The Journal of Pediatric and Adolescent Gynecology, the data are from a 12-month double-blind placebo-controlled trial that enrolled 50 females aged 15 to 22. All of them had surgically confirmed endometriosis and were beginning treatment with a gonadotropin-releasing hormone agonist (GnRHa).

The participants were randomized to 5 mg/d of NA plus 0.625 mg/d of CEE or 5 mg/d of NA plus placebo. They all received leuprolide acetate depot every 3 months. At repeated intervals during the study, the Short Form-36 v2 Health Survey, Beck Depression Inventory II, and Menopause Rating Scale were completed.

At baseline, the adolescents all had impaired physical health-related quality of life (QoL) compared with national norms. During the course of the study, their Short Form-36 v2 scores improved (P < .05). The adolescents who received NA plus CEE had greater improvements in the pain, vitality, and physical health subscales than those who received NA alone (P_{between groups} < .05) and better physical functioning (P < .05). There were no changes in depression or menopause-like symptoms in either group.

The researchers said their data indicate that treatment with GnRHa with add-back therapy improves QoL in adolescents without worsening mood or menopausal side effects and was superior to NA alone for improving physical health-related QoL.