SOURCES: Shalender Bhasin, M.D., director, Boston Claude D. Pepper Older Americans Independence Center and Research Program in Men's Health: Aging and Metabolism, Brigham and Women's Hospital, Boston; Andrew Freeman, M.D., FACC, FACP, director, clinical cardiology, National Jewish Health, Denver, and member, American College of Cardiology's Patient-Centered Care Committee; Aug. 11, 2015, Journal of the American Medical Association
TUESDAY, Aug. 11, 2015 (HealthDay News) -- Testosterone therapy may not be as bad for men's heart health as previously thought, but it doesn't seem to turn back time on their sex lives either, a new trial shows.
"That was the surprising thing," said senior study author Dr. Shalender Bhasin, director of the Boston Claude D. Pepper Older Americans Independence Center at Brigham and Women's Hospital in Boston. "Many middle-aged and older men take testosterone because they feel it will improve their sex life, but the study showed that men who had low-normal or slightly low levels did not show any improvement."
Testosterone therapy has become big business in the United States, as baby boomers seek ways to counter the effects of aging, Bhasin said.
Sales of testosterone amounted to around $20 million a year in the early 1990s, but by 2012 it had grown into a $2 billion industry, he said.
However, recent studies have cast a pall on testosterone therapy, indicating it may increase risk of heart attacks and strokes, said Bhasin, who also serves as director of the hospital's Research Program in Men's Health: Aging and Metabolism.
The U.S. Food and Drug Administration in March started requiring all prescription testosterone products to carry a label warning about possible increased risk of heart attacks and strokes.
"Testosterone has become a blockbuster drug," he said. "It's just extraordinary growth, and there's been growing concern among the regulatory agencies about the potential for the increase in risk of cardiac events."
To assess the safety and effectiveness of testosterone treatment, Bhasin and his colleagues enrolled 308 men older than 60 with testosterone levels in the low or low-normal range, or about what you'd expect in normally aging males.
As men age, their testosterone levels naturally decline, on average by 1 percent a year after age 40, researchers said. Testosterone, a hormone primarily secreted by the testicles, plays a key role in male reproduction, muscle growth, bone mass and body hair.
About half the men were provided daily testosterone gel packets, which they rubbed into their skin. The other men were given a placebo gel that contained no medicine. The research was supported by drug manufacturers Solvay Pharmaceuticals Inc. and Abbvie Pharmaceuticals, which provided the testosterone gel.
After three years, researchers found that men using testosterone gel had not suffered any additional hardening of their arteries, compared with men using a placebo gel. Researchers used hardening of the arteries as a measure because it is one of the leading causes of heart attacks and strokes, Bhasin said.
However, the men also hadn't shown any improvement in their sex lives, researchers said. Their levels of sexual desire, erectile function and overall sexual function were about the same as men taking the placebo. Their health-related quality of life also did not differ significantly, the investigators found.
"The study shows that indiscriminate use of testosterone by older men, whose levels are low-normal, is not indicated," Bhasin said. "If your levels are low-normal, it's not going to help your sexual function or quality of life."
The findings were reported in the Aug. 11 issue of the Journal of the American Medical Association.
The study results call into question the whole purpose of testosterone therapy, said Dr. Andrew Freeman, director of clinical cardiology at National Jewish Health in Denver and a member of the American College of Cardiology's Patient-Centered Care Committee.
"You have to ask yourself, why go on this drug if it doesn't make anyone feel better?" Freeman said.
At the same time, other studies have shown that a healthy diet and regular exercise can improve the sexual ability of aging men, he added.
"The magic bullet may be lifestyle, not testosterone," Freeman said. "Maybe we're looking in the wrong area. You can markedly improve sexual function with diet and exercise, although many people don't want to do that."
Bhasin pointed out that his clinical trial only looked at hardening of the arteries, and was not lengthy enough to assess overall risk of heart attack or stroke. There may be increased cardiac risk that the trial could not detect, he said.
"We really need long-term trials to look at the effect of testosterone on heart attacks or strokes," he said.
For more on testosterone therapy, visit the U.S. Food and Drug Administration.