A Randomized Placebo-Controlled Trial of Low-Dose Testosterone Therapy in Women With Anorexia Nervosa.

Abstract

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.

• Authors: Allison Kimball, Melanie Schorr, Erinne Meenaghan, Katherine N Bachmann, Kamryn T Eddy, Madhusmita Misra, Elizabeth A Lawson, Elana Kreiger-Benson, David B Herzog, Stuart Koman, Robert J Keane, Seda Ebrahimi, David Schoenfeld, Anne Klibanski, Karen K Miller
• Journal: The Journal of clinical endocrinology and metabolism (J Clin Endocrinol Metab) Vol. 104 Issue 10 Pg. 4347-4355 (10 01 2019) ISSN: 1945-7197 [Electronic] United States
• PMID: 31219558 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, N.I.H., Extramural)
• Copyright: Copyright © 2019 Endocrine Society.

Chemical References

• Testosterone

Topics

• Administration, Cutaneous
• Adolescent
• Adult
• Age Factors
• Anorexia Nervosa (diagnosis, drug therapy)
• Anxiety (drug therapy, physiopathology)
• Body Mass Index
• Depression (drug therapy, physiopathology)
• Dose-Response Relationship, Drug
• Double-Blind Method
• Drug Administration Schedule
• Female
• Follow-Up Studies
• Humans
• Middle Aged
• Patient Selection
• Reference Values
• Risk Assessment
• Severity of Illness Index
• Testosterone (therapeutic use)
• Treatment Failure
• United States
• Young Adult