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Is testosterone therapy safe? Take a breath before you take the plunge

FEB 2014

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Understand the potential risks and consider alternatives before boosting your hormones indefinitely.

Millions of American men use a prescription testosterone gel or injection to restore normal levels of the manly hormone. The ongoing pharmaceutical marketing blitz promises that treating "low T" this way can make men feel more alert, energetic, mentally sharp, and sexually functional. However, legitimate safety concerns linger. For example, in November 2013 a study in The Journal of the American Medical Association reported new evidence that some older men on testosterone could face higher cardiac risks.

"Because of the marketing, men have been flooded with information about the potential benefit of fixing low testosterone, but not with the potential costs," says Dr. Carl Pallais, an endocrinologist and assistant professor of medicine at Harvard Medical School. "Men should be much more mindful of the possible long-term complications."

The low-T boom

A loophole in FDA regulations allows pharmaceutical marketers to urge men to talk to their doctors if they have certain "possible signs" of testosterone deficiency. "Virtually everybody asks about this now because the direct-to-consumer marketing is so aggressive," says Dr. Michael O'Leary, a urologist at Harvard-affiliated Brigham and Women's Hospital. "Tons of men who would never have asked me about it before started to do so when they saw ads that say ‘Do you feel tired?'"

Just being tired isn't enough to get a testosterone prescription. "General fatigue and malaise is pretty far down my list," Dr. O'Leary says. "But if they have significant symptoms, they'll need to have a lab test. In most men the testosterone level is normal."

If a man's testosterone looks below the normal range, there is a good chance he could end up on hormone supplements—often indefinitely. "There is a bit of a testosterone trap," Dr. Pallais says. "Men get started on testosterone replacement and they feel better, but then it's hard to come off of it. On treatment, the body stops making testosterone. Men can often feel a big difference when they stop therapy because their body's testosterone production has not yet recovered."

This wouldn't matter so much if we were sure that long-term hormone therapy is safe, but some experts worry that low-T therapy is exposing men to small risks that could add up to harm over time.

What are the risks?

A relatively small number of men experience immediate side effects of testosterone supplementation, such as acne, disturbed breathing while sleeping, breast swelling or tenderness, or swelling in the ankles. Doctors also watch out for high red blood cell counts, which could increase the risk of clotting.

The evidence for long-term risks is mixed. Some studies have found that men on testosterone have fewer cardiovascular problems, like heart attacks, strokes, and deaths from heart disease. Other studies have found a higher cardiac risk. For example, in 2010, researchers halted the Testosterone in Older Men study when early results showed that men on hormone treatments had noticeably more heart problems. "In older men, theoretical cardiac side effects become a little more immediate," Dr. Pallais says.

Some physicians also have a lingering concern that testosterone therapy could stimulate the growth of prostate cancer cells. As with the hypothetical cardiac risks, the evidence is mixed. But because prostate cancer is so common, doctors tend to be leery of prescribing testosterone to men who may be at risk.

"Like any treatment, there is risk," Dr. O'Leary says. "I would not give it to a man who is being treated for active prostate cancer, but it's pretty safe under careful supervision for those who need it."

For the time being, the long-term risks of testosterone therapy are "known unknowns." It offers men who feel lousy a chance to feel better, but that quick fix could distract attention from unknown long-term hazards. "I can't tell you for certain that this raises the risk of heart problems and prostate cancer, or that it doesn't," Dr. Pallais says. "We need a large study with multiple thousands of people followed for many years to figure it out."

So, keep risks in mind when considering testosterone therapy. "I frequently discourage it, particularly if the man has borderline levels," Dr. Pallais says.

Easy energy boosters

These steps can help you feel more energetic today without drugs or dietary supplements:

  • Pace yourself: Spread out activities throughout the day.

  • Take a walk: It gives you a lift when you feel pooped out.

  • Snack smart: Have a snack with fiber and some protein between meals.

Take a cautious approach

A large, definitive trial for hormone treatment of men is still to come. Until then, here is how to take a cautious approach to testosterone therapy.

Take stock of your health first

  • Have you considered other reasons why you may be experiencing fatigue, low sex drive, and other symptoms attributable to low testosterone? For example, do you eat a balanced, nutritious diet? Do you exercise regularly? Do you sleep well? Address these factors before turning to hormone therapy.

  • If your sex life is not what it used to be, have you ruled out relationship or psychological issues that could be contributing?

  • If erectile dysfunction has caused you to suspect "low T" as the culprit, consider that cardiovascular disease can also cause erectile dysfunction.

Get an accurate assessment

  • Inaccurate or misinterpreted test results can either falsely diagnose or miss a case of testosterone deficiency. Your testosterone level should be measured between 7 am and 10 am, when it's at its peak. Confirm a low reading with a second test on a different day. It may require multiple measurements and careful interpretation to establish bioavailable testosterone, or the amount of the hormone that is able to have effects on the body. Consider getting a second opinion from an endocrinologist.

  • After starting therapy, follow-up with your physician periodically to have testosterone checks and other lab tests to make sure the therapy is not causing any problems with your prostate or blood chemistry.

Be mindful of unknown risks

  • Approach testosterone therapy with caution if you are at high risk for prostate cancer; have severe urinary symptoms from prostate enlargement; or have diagnosed heart disease, a previous heart attack, or multiple risk factors for heart problems.

  • Ask your doctor to explain the various side effects for the different
    formulations of testosterone, such as gels, patches, and injections. Know what to look for if something goes wrong.

Have realistic expectations

Testosterone therapy is not a fountain of youth. There is no proof that it will restore you to the level of physical fitness or sexual function of your youth, make you live longer, prevent heart disease or prostate cancer, or improve your memory or mental sharpness. Do not seek therapy with these expectations in mind.

If erectile function has been a problem, testosterone therapy might not fix it. In fact, it might increase your sex drive but not allow you to act on it. You may also need medication or other therapy for difficulty getting or maintaining erections.