The Journal of clinical endocrinology and metabolism · 2019
A Randomized Placebo-Controlled Trial of Low-Dose Testosterone Therapy in Women With Anorexia Nervosa.
СтатьяРандомизированное исследованиеПоддержка NIH: внешняя программаНазвание и аннотация: Перевод пока не подготовлен
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Kimball Allison, Schorr Melanie, Meenaghan Erinne, Bachmann Katherine N, Eddy Kamryn T, Misra Madhusmita, Lawson Elizabeth A, Kreiger-Benson Elana, Herzog David B, Koman Stuart, Keane Robert J, Ebrahimi Seda, Schoenfeld David, Klibanski Anne, Miller Karen K
Аннотация
CONTEXT: Anorexia nervosa (AN) is a psychiatric illness with considerable morbidity and no approved medical therapies. We have shown that relative androgen deficiency in AN is associated with greater depression and anxiety symptom severity.
OBJECTIVE: To determine whether low-dose testosterone therapy is an effective endocrine-targeted therapy for AN.
DESIGN: Double-blind, randomized, placebo-controlled trial.
SETTING: Clinical research center.
PARTICIPANTS: Ninety women, 18 to 45 years, with AN and free testosterone levels below the median for healthy women.
INTERVENTION: Transdermal testosterone, 300 μg daily, or placebo patch for 24 weeks.
MAIN OUTCOME MEASURES: Primary end point: body mass index (BMI). Secondary end points: depression symptom severity [Hamilton Depression Rating Scale (HAM-D)], anxiety symptom severity [Hamilton Anxiety Rating Scale (HAM-A)], and eating disorder psychopathology and behaviors.
RESULTS: Mean BMI increased by 0.0 ± 1.0 kg/m2 in the testosterone group and 0.5 ± 1.1 kg/m2 in the placebo group (P = 0.03) over 24 weeks. At 4 weeks, there was a trend toward a greater decrease in HAM-D score (P = 0.09) in the testosterone vs placebo group. At 24 weeks, mean HAM-D and HAM-A scores decreased similarly in both groups [HAM-D: -2.9 ± 4.9 (testosterone) vs -3.0 ± 5.0 (placebo), P = 0.72; HAM-A: -4.5 ± 5.3 (testosterone) vs -4.3 ± 4.4 (placebo), P = 0.25]. There were no significant differences in eating disorder scores between groups. Testosterone therapy was safe and well tolerated with no increase in androgenic side effects compared with placebo.
CONCLUSION: Low-dose testosterone therapy for 24 weeks was associated with less weight gain-and did not lead to sustained improvements in depression, anxiety, or disordered eating symptoms-compared with placebo in women with AN.
OBJECTIVE: To determine whether low-dose testosterone therapy is an effective endocrine-targeted therapy for AN.
DESIGN: Double-blind, randomized, placebo-controlled trial.
SETTING: Clinical research center.
PARTICIPANTS: Ninety women, 18 to 45 years, with AN and free testosterone levels below the median for healthy women.
INTERVENTION: Transdermal testosterone, 300 μg daily, or placebo patch for 24 weeks.
MAIN OUTCOME MEASURES: Primary end point: body mass index (BMI). Secondary end points: depression symptom severity [Hamilton Depression Rating Scale (HAM-D)], anxiety symptom severity [Hamilton Anxiety Rating Scale (HAM-A)], and eating disorder psychopathology and behaviors.
RESULTS: Mean BMI increased by 0.0 ± 1.0 kg/m2 in the testosterone group and 0.5 ± 1.1 kg/m2 in the placebo group (P = 0.03) over 24 weeks. At 4 weeks, there was a trend toward a greater decrease in HAM-D score (P = 0.09) in the testosterone vs placebo group. At 24 weeks, mean HAM-D and HAM-A scores decreased similarly in both groups [HAM-D: -2.9 ± 4.9 (testosterone) vs -3.0 ± 5.0 (placebo), P = 0.72; HAM-A: -4.5 ± 5.3 (testosterone) vs -4.3 ± 4.4 (placebo), P = 0.25]. There were no significant differences in eating disorder scores between groups. Testosterone therapy was safe and well tolerated with no increase in androgenic side effects compared with placebo.
CONCLUSION: Low-dose testosterone therapy for 24 weeks was associated with less weight gain-and did not lead to sustained improvements in depression, anxiety, or disordered eating symptoms-compared with placebo in women with AN.
Предметные рубрики MeSH
Administration, CutaneousAdolescentAdultAge FactorsAnorexia NervosaAnxietyBody Mass IndexDepressionDose-Response Relationship, DrugDouble-Blind MethodDrug Administration ScheduleFemaleFollow-Up StudiesHumansMiddle AgedPatient SelectionReference ValuesRisk AssessmentSeverity of Illness IndexTestosteroneTreatment FailureUnited StatesYoung Adult