HEALTH FEATURE ARCHIVE

Men Rush Into Testosterone But...

Quote: Can American men be rushing into the same reckless use of hormones that brought grief and anxiety to so many unsuspecting women? That disquieting possibility is raised by a new report that laments a huge upsurge in testosterone replacement therapy for men despite a paucity (small quantity) of evidence that it is safe or beneficial. One wonders whether another medical debacle is in the making. (The lead editorial, The New York Times, Nov. 13, 2003)

Comment: The annual market for testosterone replacement is estimated at $400 million and growing. Can common sense and caution prevail when that kind of money is at stake? and when eternal youth may be captured in a pill?

Barbara K. Hecht, Ph.D.
Frederick Hecht, M.D.
Medical Editors, MedicineNet.com


Testosterone Therapy Studies Should Determine Benefits First, Then Risks; Study Participants Should Be Limited, Carefully Screened

WASHINGTON -- After evaluating the pros and cons of conducting a large-scale clinical study of testosterone therapy to treat age-related conditions in men 65 and older, an expert committee of the Institute of Medicine of the National Academies recommended going forward with trials, but only with a limited group of participants and in a stepwise fashion. Initial studies should focus on determining the efficacy of testosterone therapy in older men and the nature and extent of the potential benefits. A large-scale trial to determine long-term risks and effectiveness should be undertaken only if clinically significant benefits are demonstrated in the initial, shorter studies. The studies should involve only older men who have been diagnosed with low testosterone levels and at least one symptom that might be remedied by the therapy, and who are not at high risk for developing prostate cancer, says the committee's report.

Testosterone therapy products have been approved by the U.S. Food and Drug Administration for treating a limited number of conditions, particularly hypogonadism, a clinical condition marked by -- but not defined solely by -- inadequate testosterone production. Hypogonadism occurs in men of various ages, and most clinical studies of the therapy so far have been in younger hypogonadal men. The rapidly growing use of testosterone therapy among men seeking to counter the effects of aging has outpaced the scientific evidence about the therapy's benefits and risks for users -- particularly its possible effects on the prostate, the report notes.

"There is still much we don't know about normal levels of testosterone at different ages, how decreased testosterone levels affect men's health, and whether testosterone therapy might increase the risk of prostate cancer," said committee chair Dan Blazer, professor of psychiatry and behavioral sciences, Duke University Medical Center, Durham, N.C. "There have been only 31 small placebo-controlled studies of testosterone therapy in men ages 65 and older, and just one lasted longer than a year. Recent experience with the Women's Health Initiative -- which studied hormone therapy in postmenopausal women for many years -- underscores the importance of approaching future studies of testosterone therapy thoughtfully and carefully. We have laid out what we believe to be the most prudent course for collecting the data needed to determine if testosterone therapy is an effective and safe treatment option for older men."

Because little is known about the benefits of testosterone therapy and because the number of study participants and amount of time required to assess the therapy's benefits are far less than those needed to assess its risks, resources should be targeted first at firmly establishing the efficacy of testosterone therapy for older males, the report says. The committee estimated that several hundred older men would need to be monitored for one to two years to determine whether testosterone is effective in treating specific health conditions. If clear efficacy is demonstrated in the initial studies, then a large-scale trial involving several thousand men followed over a longer time frame would be warranted, the report says. The limited preliminary evidence currently available suggests that testosterone therapy may have potential benefit for older men in terms of improving strength, sexual function, cognitive function, and general well-being, the committee said.



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