The treatments did not significantly improve vitality or walking
distance in people tested for those problems, according to the
results in the New England Journal of Medicine.
However, researchers did find that when they tested all 790
volunteers to search for improvements in walking and mood - even if
men hadn't complained about problems in those areas - they saw
significant improvement
The participants were all at least 65 years old, and they all had
unequivocally low testosterone concentrations.
"The results don't apply to others," chief author Dr. Peter Snyder
at the University of Pennsylvania in Philadelphia told Reuters
Health.
Altogether, the researchers tested the gel in seven different
trials, and men could participate in more than one. The new report
focuses on the trials that assessed the effect of testosterone gel
on sexual function, physical function and vitality. Data on its
effect on bones and cognitive function, and whether it causes anemia
or heart problems, are still being analyzed.
"This is the first time any benefit for those men has been
demonstrated. But we still have to wait for the other four trials
before we know about most of the benefits of testosterone. And to
know about possible risks, we need a larger, longer trial," Snyder
said.
"There is one positive finding. The rest is inconclusive," said Dr.
Colin Barker, a cardiologist with Houston Methodist DeBakey Heart
and Vascular Center, who was not connected to the study.
But Dr. Abraham Morgentaler, director of Men’s Health Boston and a
urologist on staff at Beth Israel Deaconess Medical Center, called
the results "a game changer" that no longer allows critics of
testosterone therapy to say the benefits of the treatment are
unproven. He is the author of the book "Testosterone for Life,"
which promotes the therapy.
Morgentaler told Reuters Health that such treatments probably cost
$300 to $400 per month if not covered by health insurance.
Testosterone levels decrease with age and have been linked to
declines in energy, sexual function and mobility. Past attempts to
use testosterone treatment to reverse those problems have produced
inconsistent results. Nonetheless, 430 million testosterone
prescriptions were written in 2012 - often for middle-aged men - in
part because of "Low T" commercials on television.
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At a dozen locations in the U.S., half the men were given AndroGel 1
percent to apply to their shoulders each day for one year while the
rest used an identical placebo gel. All began the test with blood
testosterone levels below 275 nanograms per deciliter. Men at risk
for prostate cancer or potential heart problems, two areas of
concern for testosterone therapy, were excluded.
Men were included in the sexual function trial if they reported a
low sex drive. Volunteers were included in the physical function arm
if they had difficulty walking or climbing stairs, although men who
couldn't walk at all or had disabling arthritis were excluded. Men
were included in the vitality portion if they reported fatigue. Some
men were in more than one portion of the study.
The dose of the gel was designed to raise testosterone levels to
what is typically seen in healthy men between 19 and 40 years old.
Compared to men in the placebo group, testosterone recipients
reported higher sexual desire and increased erectile function.
The benefits were modest and tended to wane with time, noted Dr.
Eric Orwoll of the Oregon Health and Science University in an
accompanying editorial.
Only when they included men from the other two portions of the trial
did the researchers see a significant improvement in physical
functioning among the testosterone recipients. "Men who received
testosterone were more likely than those who received placebo to
perceive that their walking ability had improved since the beginning
of the trial," the researchers reported.
Sixteen of the 33 study authors have financial ties to drug
companies. Seven of the 16 have worked for AbbVie, which made the
testosterone gel used in the study, and the company helped to pay
for the test.
SOURCE: http://bit.ly/1WrIe3V New England Journal of Medicine,
online February 17, 2016.
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