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PLoS One. 2016 Sep 21;11(9):e0162480. doi: 10.1371/journal.pone.0162480. eCollection 2016.

Treatment of Men for "Low Testosterone": A Systematic Review.

Author information

1
Tulane University, School of Medicine, New Orleans, LA, United States of America.
2
Department of Pharmacology and Physiology, Georgetown University Medical Center, Washington, DC, United States of America.
3
Scialli Consulting LLC, Washington, DC, United States of America.
4
University of South Florida, Tampa, FL, United States of America.
5
University of Illinois, Chicago, IL, United States of America.

Abstract

Testosterone products are recommended by some prescribers in response to a diagnosis or presumption of "low testosterone" (low-T) for cardiovascular health, sexual function, muscle weakness or wasting, mood and behavior, and cognition. We performed a systematic review of 156 eligible randomized controlled trials in which testosterone was compared to placebo for one or more of these conditions. We included studies in bibliographic databases between January 1, 1950 and April 9, 2016, and excluded studies involving bodybuilding, contraceptive effectiveness, or treatment of any condition in women or children. Studies with multiple relevant endpoints were included in all relevant tables. Testosterone supplementation did not show consistent benefit for cardiovascular risk, sexual function, mood and behavior, or cognition. Studies that examined clinical cardiovascular endpoints have not favored testosterone therapy over placebo. Testosterone is ineffective in treating erectile dysfunction and controlled trials did not show a consistent effect on libido. Testosterone supplementation consistently increased muscle strength but did not have beneficial effects on physical function. Most studies on mood-related endpoints found no beneficial effect of testosterone treatment on personality, psychological well-being, or mood. The prescription of testosterone supplementation for low-T for cardiovascular health, sexual function, physical function, mood, or cognitive function is without support from randomized clinical trials.

Conflict of interest statement

Adriane Fugh-Berman is an expert witness at the request of plaintiffs in litigation regarding pharmaceutical marketing practices (Adriane Fugh-Berman was briefly engaged as an expert in testosterone litigation last year but has no relevant conflicts now). Adriane Fugh-Berman also directs PharmedOut, a Georgetown University Medical Center project that advances evidence-based prescribing and educates healthcare professionals about pharmaceutical marketing practices, and provides educational content for the Washington DC Department of Health-funded DC Center for Rational Prescribing through a contract with the George Washington University Milken School of Public Health. Alessandra Hirsch is a former project manager of PharmedOut and Alycia Hogenmiller is the current project manager of PharmedOut; their salaries are provided by Georgetown University Medical Center. Dr. Scialli is the sole participant in Scialli Consulting LLC. He is a reproductive toxicologist who consults for industry, government, and educational institutions. He has consulted for manufacturers of testosterone products, but never about testosterone. There are no patents, products in development or marketed products to declare. This does not alter our adherence to all the PLOS ONE policies on sharing data and materials.

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