Adverse Effects of Testosterone
Therapy in Older Males: Report
Nov. 12, 2003 - Is testosterone
replacement for older men safe? The Institute of Medicine of the
National Academies released a report today setting a direction for the
study of the safety of testosterone replacement therapy for older men.
Tens of thousands of aging men are trying testosterone
shots, patches and gel in hopes of regaining youthful vigor and virility.
This report uncovers little evidence it works - or that the therapy is even
safe - but recommends careful study to find out.
Testosterone and Aging: Clinical Research Directions
assesses what is currently known about the beneficial and adverse health
effects of testosterone therapy in older men and provides
recommendations regarding clinical trials of this therapy, including the
parameters that should be considered in study design and conduct. The
reports findings also address the ethical issues related to the conduct
of clinical trials of testosterone therapy in an older male population.
Testosterone has been approved by
the Food and Drug Administration for treating a limited number of
conditions, particularly male hypogonadism, a clinical condition marked
bybut not defined solely byinadequate testosterone production.
Hypogonadism occurs in men of various ages, and most clinical studies of
the therapy so far have been in younger hypogonadal men. Less is known
about the potential beneficial or adverse effects of testosterone
therapy in older males and there have been concerns regarding prostate
outcomes.
A copy of the report can be viewed
on line at http://www.nap.edu/books/0309090636/html/
John Morley, M.D., chair of the
division of geriatric medicine at Saint Louis University School of
Medicine and an endocrinologist, is available to discuss what these
findings mean to men.
"There has been a marked increase in
testosterone prescriptions in the last few years," says John Morley,
M.D., chair of the division of geriatric medicine at Saint Louis
University School of Medicine. "With more new products on the horizon,
the market is likely to grow exponentially over the next decade. It is
likely to become a market of more than $3 billion a year within five
years. Determining the safety of long-term testosterone treatment is
critical."
Dr. Morley is one of the nation's
foremost experts on testosterone replacement therapy and is the creator
of the ADAM questionnaire, a tool men can use to find out if they might
have low testosterone. He has conducted research on hormone replacement
therapy for men and prescribes testosterone in his clinical practice to
men who have symptoms of low testosterone.
A copy of the ADAM questionnaire can
be found on
http://www.slu.edu/adam/maletquiz.pdf
NIA issues statement on
IOM testosterone report
Nov. 12, 2003 - The National Institute on
Aging (NIA) commends the Institute of Medicine (IOM) for its thoughtful
report evaluating the pros and cons of conducting clinical trials of
testosterone replacement in older men. The NIA appreciates the effort
and care that went into formulating the report and its recommendations,
including those regarding the design, safety and ethics of conducting
such trials.
One of the reasons the NIA requested this IOM
report is because of growing concern about the increase in the number of
men using testosterone replacement therapy in the absence of sufficient
scientific information about its risks and benefits. This concern
remains. This report offers an initial approach to addressing this
problem.
We will consider the IOM recommendations very
carefully, including options for implementing the type of trials
suggested in the IOM report. In particular, the recommendation that
researchers focus their initial efforts on conducting short-term,
randomized, double blind, placebo-controlled studies of testosterone in
symptomatic older men with low testosterone levels to determine the
potential risks and benefits seems to be a reasonable strategy. While
there may be risk of yet unknown consequences, there is also some
prospect of potential benefit for men with low testosterone levels who
have one or more symptoms that might be related to deficiency of this
hormone. Consideration of any trials to assess longer term risks and
benefits of testosterone therapy should be contingent on the results of
these shorter-term studies.
We concur with the IOM's recommendation that
any trial be designed in such a way that it elicits useful information
about the effects of testosterone therapy on a variety of conditions
associated with deficiencies of this hormone. These problems, including
frailty, disability and sexual and cognitive disorders, are serious
concerns for older men, and it is important to learn more about the
potential risks and benefits of testosterone treatment for older men who
suffer from these conditions. However, it is also important to point out
that these initial studies will not address generalized use of
testosterone therapy in men--regardless of age--who do not have extreme
deficiencies of this hormone.
The NIA shares the IOM Committee's concern
about minimizing the risk and protecting those participating in clinical
trials of testosterone therapy. Therefore, we will do our utmost to
adhere to the Committee's recommendations regarding the safety of trial
participants. As is common practice in all National Institutes of Health
sponsored clinical studies, we will carefully communicate the potential
risks and benefits of participation to all volunteers prior to
enrollment.
Finally, although some older men who have
tried these treatments report feeling "more energetic" or "younger,"
testosterone therapy remains a scientifically unproven method for
preventing or relieving any physical or psychological changes that men
with normal testosterone levels may experience as they get older. Except
for a relatively few younger and older men with extreme deficiencies,
testosterone treatment is not deemed appropriate therapy for most men at
this time. For now, the risks and benefits of testosterone therapy for
most men who do not have extreme deficiencies of the hormone are
unknown, and there is insufficient evidence for making well-informed
decisions on whether this therapy is suitable in these individuals. The
clinical trials and other studies recommended by the IOM could do much
to clarify the future role of testosterone therapy in aging men.
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