The Effects of Gonadotropin-Releasing Hormone Agonist Combined with Add-Back Therapy on Quality of Life for Adolescents with Endometriosis: A Randomized Controlled Trial - 18/04/17
, Henry A. Feldman, PhD 3, Natalie A. Stokes, BA 4, Marc R. Laufer, MD 2, 5, 6, Mark D. Hornstein, MD 2, 6, Catherine M. Gordon, MD, MSc 7, Amy D. DiVasta, MD, MMSc 1, 2, 5Abstract |
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.
Le texte complet de cet article est disponible en PDF.Key Words : Endometriosis, Adolescence, Gonadotropin releasing hormone agonist, Add-back therapy, Quality of life
Plan
| Dr Hornstein is an author with Up to Date, and is on the medical advisory board for WIN Fertility. The authors indicate no conflicts of interest. |
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| Clinical trials registration: ClinicalTrials.gov NCT00474851. |
Vol 30 - N° 2
P. 215-222 - avril 2017 Retour au numéro
Article précédent
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