Journal of pediatric and adolescent gynecology · 2016
The Effects of Gonadotropin-Releasing Hormone Agonist Combined with Add-Back Therapy on Quality of Life for Adolescents with Endometriosis: A Randomized Controlled Trial.
СтатьяРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Sadler Gallagher Jenny, Feldman Henry A, Stokes Natalie A, Laufer Marc R, Hornstein Mark D, Gordon Catherine M, DiVasta Amy D
Аннотация
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.
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.