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Hormones at issue -- this time for men

An Institute of Medicine report finds little solid evidence that testosterone replacement therapy provides benefits.

By Susan J. Landers, amednews staff. Dec. 1, 2003.

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Washington -- Many physicians are still haunted by the turmoil that erupted over the use of estrogen plus progestin for managing menopause when the Women's Health Initiative found that hormone use increased women's risk of breast cancer.

It was a finding that shook many doctors and patients -- and even the practice of medicine.

One thing is for certain: No one wants to repeat the experience with another hormone and another population. And that's why questions about testosterone therapy persist.

On Nov. 12 an Institute of Medicine panel recommended that smaller trials to determine the benefits of testosterone replacement therapy be conducted before a large-scale, long-term trial is undertaken. It's a recommendation that has left some physicians wishing for more.

"I think it would have been nice if we could have started something equivalent to the Women's Health Initiative very quickly," said John Morley, MD, a professor of geriatrics at Saint Louis University College of Medicine.

In the five to 10 years it takes to conduct such a study, the testosterone replacement industry will likely continue its rapid growth. "By that time we are going to be looking at a $2.9 billion industry and a huge number of prescriptions," said Dr. Morley. Instead, "I think we'll see a lot of little studies, some will be positive and some negative, but what we won't know and desperately need to know is, 'Are there any really bad side effects?' "

IOM: Small-scale trials initially

In examining the available research, the IOM panelists said they were dismayed by the small number of placebo-controlled trials that examined testosterone therapy. "We identified 31 such trials in older men, and only one lasted for longer than a year. Most had fewer than 50 participants," said panel chair Dan Blazer, MD, PhD, MPH, a professor of psychiatry and behavioral sciences at Duke University Medical Center in Durham, N.C.

The panel decided that initial studies should focus on the efficacy of testosterone therapy in older men, and only if benefits are found should a large-scale trial be undertaken. Men 65 and older should be the initial participants in these trials, the panel said, because they stand to gain the most from treatment with testosterone.

The IOM was asked to examine the state of the research on testosterone therapy about a year ago by the National Cancer Institute and the National Institute on Aging because of growing concern over the increasing use of the hormone. The panel found that more than 1.75 million prescriptions were written in 2002, up from 648,000 in 1999.

An additional concern is that many of the men using the testosterone supplements are younger than 65, a group that some fear is on an unrealistic quest for a magic pill to combat the effects of aging.

"Society is being driven by the aging of the baby boomers," said IOM panelist William R. Hazzard, MD, professor of gerontology and geriatric medicine at the University of Washington School of Medicine, Seattle. "We saw this with women in the Women's Health Initiative and their concern about their future. We are starting to see that among men who are middle-aged."

The NIA, which had put a hold on one testosterone study pending the release of the IOM report, still has concerns about the use of the hormone, according to an agency statement issued in response to the report.

"This report offers an initial approach to addressing this problem," according to the statement. "We will consider the IOM recommendations very carefully, including options for implementing the types of trials suggested in the IOM report."

Physicians' experiences

However, some physicians say they have already seen the benefits their patients derive from testosterone supplements and do not see the need for any more efficacy studies.

"Testosterone for some men can be a wonderful treatment," said Abraham Morgentaler, MD, associate clinical professor at Harvard Medical School, Boston. "Some of my best patient-doctor stories were from men who were thrilled. They shake my hand when they come back for follow-up and say, 'Thank you for giving me back my life.' "

Testosterone levels decline gradually, and levels much below normal can lead to fatigue, depression, osteoporosis, muscle-wasting, decreased libido and erectile dysfunction.

Although Dr. Morgentaler would not prescribe testosterone to a man with prostate cancer, he sees very little risk to the therapy.

"The treatment has been around for more than 40 years, and there have not been any risk issues," he said. "If there were, there would be a much stronger call for studies to look at this."

Peter Snyder, MD, professor of medicine at the University of Pennsylvania Health System in Philadelphia, praised the report. "I think it's the best survey of the field I have ever seen, and I've written a number myself."

Dr. Snyder interprets the report as saying, "There are a lot of tantalizing data, but they are not conclusive."

He also fails to see the benefit of prescribing testosterone to aging baby boomers who think they might get a boost from the hormone.

"If someone isn't missing testosterone, [supplements] won't help them look younger. They may come seeking it, but it would be wrong to prescribe it," he said.

As of now, Robert Tan, MD, an associate professor of geriatrics at the University of Texas Medical School in Houston, doesn't prescribe testosterone therapy for long-term use. He would first like to see a large multicenter trial that examines safety.

But many patients ask him about it. "One of my most difficult roles is trying to convince patients that there is no magic pill to fix their problems," said Dr. Tan.

"A lot of patients are overweight, drink too much or are overstressed. In real-life practice, if one were to pay attention to those things I think the outcomes would be better over the long term."

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