WASHINGTON (September 21, 2016) — The prescription of testosterone supplementation for cardiovascular health, sexual function, physical function, mood, or cognitive function in men with “low T” is not supported by clinical trials data, conclude researchers who describe a review of more than 150 clinical trials published Sept. 21 in PLOS One.
“Testosterone has been marketed to improve a number of conditions but for the vast majority, our review of the data shows that not one of these claims has adequate clinical trial support,” says Adriane Fugh-Berman, MD, a pharmaceutical marketing expert at Georgetown University Medical Center.
Fugh-Berman and her colleagues conducted analyzed 156 eligible randomized controlled trials conducted between 1950 and 2016 in which testosterone was compared to placebo for cardiovascular health, sexual function, physical function, mood, or cognitive function. (Studies involving bodybuilding, contraceptive effectiveness, or treatment of any condition in women or children were excluded).
The researchers concluded:
- Testosterone supplement “did not show consistent benefit for cardiovascular risk, sexual function, mood and behavior, or cognition;”
- Improvement is seen in some surrogate markers of cardiovascular risk, but there is “little evidence” of clinical benefit;
- Studies that examined clinical cardiovascular endpoints “have not favored testosterone therapy over placebo;”
- Testosterone is “ineffective” in treating erectile dysfunction and “did not show a consistent effect on libido;”
- Testosterone supplementation consistently increased muscle strength but “did not have beneficial effects on physical function;” and
- “Most studies on mood-related endpoints found no beneficial effect of testosterone treatment on personality, psychological well-being, or mood.”
“Testosterone products are marketed for non-specific symptoms associated with normal aging, but testosterone is not a reasonable treatment for aging,” says Fugh-Berman. “Testosterone has known risks and no clear benefits, and shouldn't be used by men with intact testicles.”
In addition to Fugh-Berman, Georgetown authors include Anthony R. Scialli, Sean McGarvey,
Elizabeth Hill and Alycia Hogenmiller. Additional authors include. Buğra Tügertimur for University of Florida and Alessandra Hirsch from the University of Illinois-Chicago.
Scialli is a consultant for Scialli Consulting. He directors the Reproductive Toxicology Center in Washington, DC, which maintains an online database on the effects of reproduction drugs, chemicals, biologicals and physical agents. Fugh-Berman directs PharmedOut, a Georgetown project of professionals, researchers, students and other volunteers who promote evidence-based prescribing, educate health care professionals about pharmaceutical marketing practices, and provide access to unbiased information about medications. Fugh-Berman is a paid expert witness in litigation regarding pharmaceutical marketing practices.
About Georgetown University Medical Center Georgetown University Medical Center (GUMC) is an internationally recognized academic medical center with a three-part mission of research, teaching and patient care (through MedStar Health). GUMC’s mission is carried out with a strong emphasis on public service and a dedication to the Catholic, Jesuit principle of cura personalis -- or "care of the whole person." The Medical Center includes the School of Medicine and the School of Nursing & Health Studies, both nationally ranked; Georgetown Lombardi Comprehensive Cancer Center, designated as a comprehensive cancer center by the National Cancer Institute; and the Biomedical Graduate Research Organization, which accounts for the majority of externally funded research at GUMC including a Clinical and Translational Science Award from the National Institutes of Health. Connect with GUMC on Facebook (Facebook.com/GUMCUpdate), Twitter (@gumedcenter) and Instagram (@gumedcenter).