Risks of testosterone replacement therapy in menMillions of American men use a prescription testosterone gel or injection to restore normal levels of the manly hormone. The ongoing pharmaceutical marketing blitz promises that treating "low Trt therapy risks this way can make men feel more alert, energetic, mentally sharp, and sexually functional. However, legitimate safety concerns linger. For example, some older men on testosterone could face higher cardiac risks. Carl Pallais, an endocrinologist and assistant professor of medicine at Harvard Medical School. A loophole in FDA regulations trt therapy risks pharmaceutical marketers to urge men to talk to their doctors if they have certain "possible signs" of tren e dosage deficiency.
The Lowdown on Testosterone Replacement Therapy | Berkeley Wellness
CNN Testosterone therapy, when used by men over age 65 who have low testosterone levels, offers some health benefits but also poses potential risks, suggests a roundup of five new studies in the Journal of American Medicine and JAMA Internal Medicine.
Business Markets Tech Luxury. Stars Screen Binge Culture Media. Business Culture Gadgets Future Startups. Chat with us in Facebook Messenger. Find out what's happening in the world as it unfolds. Story highlights Testosterone treatment improves bone density, anemia in older men with low testosterone levels It is associated with a lower risk of cardiovascular events in men who are 40 or older and have low levels. Testosterone treatment improves bone density and anemia in those men, the results indicated.
But on the downside, it increases the amount of plaque buildup in coronary arteries while doing nothing to improve cognitive function, the researchers found. A separate study separate study, published in JAMA Internal Medicine, also showed that testosterone therapy is associated with a lower risk of cardiovascular events in men 40 or older over a period of about three years.
Testosterone therapy is recommended for men whose blood levels of this masculine hormone fall below the normal range. Symptoms of low blood levels include low sex drive, fatigue, body and facial hair loss, and decreased muscle mass. Supplemental testosterone is usually taken as a gel, by injection or via a skin or mouth patch. Researchers at the Perelman School of Medicine at the University of Pennsylvania designed and coordinated the Testosterone Trials, a series of studies at 12 academic medical centers across the United States.
The studies were a response to the Institute of Medicine's call in for more rigorous study of the positive and negative health effects of testosterone replacement therapy in older men. The studies received support from the National Institutes of Health and from AbbVie formerly Solvay and Abbott Laboratories , which makes a testosterone product.
The Testosterone Trials included men who were 65 years or older and had low blood levels of testosterone. The researchers randomly assigned half the participants to use a daily testosterone gel and the other half a placebo gel for one year. Then, the researchers measured specific health outcomes in each participant at three months, six months, nine months and one year, with an additional year of followup in some of the studies.
Baby boomers find youth in testosterone. According to Susan S. Ellenberg, lead biostatistician on the study and a professor at the University of Pennsylvania, the Testosterone Trials are really a "single trial" and "a single randomization.
She added that all of the sub-studies did not include the total participants. The Cognition Trial , which looked at memory and general cognitive function, did include all participants. The results showed no improvements in memory or any other measure of cognitive function for the men using the testosterone gel. The Bone Trial found that testosterone treatment improved bone density and bone strength in the men. However, the Cardiovascular Trial showed more plaque buildup in the coronary arteries of men treated with testosterone.
Yet the number of cardiovascular events, such as heart attacks, was similar for the men treated with testosterone and those using placebo. The Bone and Cardiovascular Trials, made use of high-tech CT scan measurements and compared both groups.
Finally, in the Anemia Trial , testosterone treatment helped correct anemia with no identifiable cause and helped correct anemia caused by iron deficiencies. Turns out it was efficacious in some but not in others," said Dr. Peter Snyder, senior author and a professor of medicine at the University of Pennsylvania.
In February , Snyder and his colleagues published in the New England Journal of Medicine the very first results from the Testosterone Trials , which he explained were designed to study efficacy of the treatment but not risk. Ellenberg said the results of these four studies do not produce some "overwhelming single answer" to the question of whether testosterone therapy has positive health effects.
She noted a definitive finding was that "for men who are mildly anemic, testosterone treatment might move them into normal hemoglobin level.
However, the studies do not address the long-term effects of testosterone. There were not enough people and not enough follow-up time "to be able to really assess those, and that's a really important piece within the spectrum of making treatment decisions," Ellenberg said.
Looking ahead, she said, "we have additional data from these studies that we will be analyzing, and some we are in the process of analyzing, and we will be publishing more papers from this study.
A wholly separate study , led by T. Craig Cheetham of the Southern California Permanente Medical Group in Pasadena, examined the association between testosterone therapy and cardiovascular events in men 40 or older with a verified diagnosis of low testosterone.
Participants, all members of the Kaiser Permanente California health care plan, included 8, men prescribed testosterone therapy, whether as an injection, orally or topically. This study, which was funded by the National Institutes of Health, examined their pharmacy and medical records for heart attacks, unstable angina, stroke or sudden cardiac death over a period of three years and four months on average.
Cheetham said he and his colleagues conducted this study "because of concerns regarding the cardiovascular safety of testosterone replacement therapy. Among men with low testosterone, Cheetham's study found, testosterone prescriptions are associated with a lower risk of cardiovascular events over a median follow-up of about three years. This finding is consistent with a couple of Department of Veterans Affairs studies that "suggest testosterone replacement therapy is associated with lower risk of all-cause mortality," said Cheetham, and the normalization of testosterone levels after therapy is associated with "a reduced risk of myocardial infarction and stroke.
Despite his own results, Cheetham is not suggesting men ignore studies that found an increased risk. Bradley Anawalt, a member of the Endocrine Society Leadership Council, said the Testosterone Trials in particular "were necessary and important.
There is too little known about the effects of testosterone on men's health in general and in older men in particular. Meanwhile, older men have a general interest in the "possible 'rejuvenating' effects of testosterone," said Anawalt, who was not involved in the studies. There are no major flaws, just the caveat that the studies were not designed to determine" the long-term effects, he said.
He added that they also were not designed to determine whether testosterone might prevent heart attacks or dementia in men. As a whole, the testosterone trials suggest that older men with low testosterone levels "may benefit from testosterone therapy with improved sexual function and bone mass and strength," he said. Unfortunately, many men believe just the opposite and want a prescription for testosterone therapy despite having adequate levels.
Caroline Messer, an endocrinologist at Lenox Hill Hospital in New York City, said she is visited "all the time" by patients of all ages who are shopping for a prescription. Young men want it for "higher libido and to build muscles," she said. Sometimes, they have body dysmorphic disorder; other times, they're bodybuilders. Older men "think of it sort of as an elixir of youth," Messer said. This same study finds a fourfold increase in the use of testosterone therapy in the US between and Although she hasn't personally seen any extreme medical harms in those who take testosterone, she has heard complaints, including testicular shrinkage.
That said, she's mainly seen positive effects in the men taking testosterone. Still, worries about the unknown health risks and says longer-term studies are needed. It's really all about libido. That's what I see in my practice.