학술논문
A Randomized Placebo-Controlled Trial of Low-Dose Testosterone Therapy in Women With Anorexia Nervosa
CLINICAL RESEARCH ARTICLE
CLINICAL RESEARCH ARTICLE
Document Type
Academic Journal
Author
Source
Journal of Clinical Endocrinology & Metabolism. October 2019, Vol. 104 Issue 10, p4347, 9 p.
Subject
Language
English
ISSN
0021-972X
Abstract
Anorexia nervosa (AN), with an estimated prevalence of 0.5% to 2% among women (1), is a serious psychiatric condition with considerable premature mortality (2) and no approved medical therapies. Comorbid [...]
ORCiD numbers: 0000-0002-6750-644X (A. Kimball). 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 [micro]g 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 [+ or -] 1.0 kg/[m.sup.2] in the testosterone group and 0.5 [+ or -] 1.1 kg/[m.sup.2] 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 [+ or -] 4.9 (testosterone) vs -3.0 [+ or -] 5.0 (placebo), P = 0.72; HAM-A: -4.5 [+ or -] 5.3 (testosterone) vs-4.3 [+ or -] 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. (J Clin Endocrinol Metab 104: 4347-4355, 2019)
ORCiD numbers: 0000-0002-6750-644X (A. Kimball). 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 [micro]g 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 [+ or -] 1.0 kg/[m.sup.2] in the testosterone group and 0.5 [+ or -] 1.1 kg/[m.sup.2] 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 [+ or -] 4.9 (testosterone) vs -3.0 [+ or -] 5.0 (placebo), P = 0.72; HAM-A: -4.5 [+ or -] 5.3 (testosterone) vs-4.3 [+ or -] 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. (J Clin Endocrinol Metab 104: 4347-4355, 2019)