Jenny Sadler Gallagher1, Henry A Feldman2, Natalie A Stokes3, Marc R Laufer4, Mark D Hornstein5, Catherine M Gordon6, Amy D DiVasta7. 1. Division of Adolescent Medicine, Boston Children's Hospital, Boston, Massachusetts; Boston Center for Endometriosis, Boston, Massachusetts. Electronic address: jenny.sadler@childrens.harvard.edu. 2. Clinical Research Program, Boston Children's Hospital, Boston, Massachusetts. 3. University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania. 4. Boston Center for Endometriosis, Boston, Massachusetts; Division of Gynecology, Boston Children's Hospital, Boston, Massachusetts; Department of Obstetrics and Gynecology, Brigham and Women's Hospital, Boston, Massachusetts. 5. Boston Center for Endometriosis, Boston, Massachusetts; Department of Obstetrics and Gynecology, Brigham and Women's Hospital, Boston, Massachusetts. 6. Division of Adolescent and Transition Medicine, Cincinnati Children's Hospital Medical Center and University of Cincinnati College of Medicine, Cincinnati, Ohio. 7. Division of Adolescent Medicine, Boston Children's Hospital, Boston, Massachusetts; Boston Center for Endometriosis, Boston, Massachusetts; Division of Gynecology, Boston Children's Hospital, Boston, Massachusetts.
Abstract
STUDY OBJECTIVE: Use of gonadotropin-releasing hormone agonists (GnRHa) to treat endometriosis can cause mood and vasomotor side effects. "Add-back therapy," the combination of low-dose hormones, limits side effects but research is limited to adults. We sought to characterize quality of life (QOL) before treatment and to compare an add-back regimen of norethindrone acetate (NA) with conjugated estrogens (CEE) to NA alone for preventing side effects of GnRHa therapy in female adolescents with endometriosis. DESIGN: Twelve-month double-blind, placebo-controlled trial. SETTING:Pediatric Gynecology clinic in Boston, Massachusetts. PARTICIPANTS: Fifty female adolescents (aged 15-22 years) with surgically confirmed endometriosis initiating treatment with GnRHa. INTERVENTIONS: Subjects were randomized to: NA (5 mg/d) with CEE (0.625 mg/d) or NA (5 mg/d) with placebo. All subjects received leuprolide acetate depot every 3 months. MAIN OUTCOME MEASURES: The Short Form-36 v2 Health Survey, Beck Depression Inventory II, and Menopause Rating Scale were completed at repeated intervals. RESULTS: At baseline, subjects reported impaired physical health-related QOL compared with national norms (all P < .0001). Over 12 months, these Short Form-36 v2 scores improved (all P < .05). Subjects receiving NA with CEE showed greater improvements in the pain, vitality, and physical health subscales (Pbetween groups < .05) than those receiving NA alone, as well as better physical functioning (P < .05). There were no changes in depression or menopause-like symptoms in either group. CONCLUSION:Female adolescents with endometriosis initiating GnRHa therapy have impaired QOL. Treatment with GnRHacombined with add-back therapy led to improved QOL, with no worsening of mood or menopausal side effects. NA with CEE was superior to NA alone for improving physical health-related QOL.
RCT Entities:
STUDY OBJECTIVE: Use of gonadotropin-releasing hormone agonists (GnRHa) to treat endometriosis can cause mood and vasomotor side effects. "Add-back therapy," the combination of low-dose hormones, limits side effects but research is limited to adults. We sought to characterize quality of life (QOL) before treatment and to compare an add-back regimen of norethindrone acetate (NA) with conjugated estrogens (CEE) to NA alone for preventing side effects of GnRHa therapy in female adolescents with endometriosis. DESIGN: Twelve-month double-blind, placebo-controlled trial. SETTING: Pediatric Gynecology clinic in Boston, Massachusetts. PARTICIPANTS: Fifty female adolescents (aged 15-22 years) with surgically confirmed endometriosis initiating treatment with GnRHa. INTERVENTIONS: Subjects were randomized to: NA (5 mg/d) with CEE (0.625 mg/d) or NA (5 mg/d) with placebo. All subjects received leuprolide acetate depot every 3 months. MAIN OUTCOME MEASURES: The Short Form-36 v2 Health Survey, Beck Depression Inventory II, and Menopause Rating Scale were completed at repeated intervals. RESULTS: At baseline, subjects reported impaired physical health-related QOL compared with national norms (all P < .0001). Over 12 months, these Short Form-36 v2 scores improved (all P < .05). Subjects receiving NA with CEE showed greater improvements in the pain, vitality, and physical health subscales (Pbetween groups < .05) than those receiving NA alone, as well as better physical functioning (P < .05). There were no changes in depression or menopause-like symptoms in either group. CONCLUSION: Female adolescents with endometriosis initiating GnRHa therapy have impaired QOL. Treatment with GnRHa combined with add-back therapy led to improved QOL, with no worsening of mood or menopausal side effects. NA with CEE was superior to NA alone for improving physical health-related QOL.
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