Have you seen the TV commercials targeting men who are “feeling down”…seem like “shadows of their former selves”…and have “lost their appetite for romance”? The voice-over suggests that a hormone problem may be causing their symptoms, then routes viewers’ attention to a Web site that markets testosterone-replacement therapy.

The ads are part of a so-called disease-awareness campaign, with the condition in question being low testosterone (aka low T)…and the implied solution being testosterone therapy. Problem: This treatment may increase the risk of suffering a heart attack or dying! Just recently, the FDA announced that it was launching an investigation into the link between testosterone therapy and cardiovascular risk after yet another large study showed that men are at increased risk for heart attack after they start taking testosterone.

Despite the potential dangers, use of the treatment has quadrupled in the US over the course of a decade. In some cases, this therapy is being prescribed for men who don’t need it—including those whose testosterone levels are normal. Why this surge in usage? In part, because testosterone therapy is big business—a whopping $1.6 billion-per-year business.

Still, we shouldn’t be too quick to slam the whole idea of testosterone therapy—because some men really do require and benefit from the treatment…and because the studies showing risks are contradicted by other studies suggesting that testosterone therapy is safe.

Clearly, this is not a settled topic, and misimpression and misinformation abound. So to help readers make sense of it all, Daily Health News spoke to two experts on the subject. Here’s what you should know…

Just What Is Low T?

Low testosterone is sometimes a sign of hypogonadism, a syndrome caused by a glitch with one of three glands that normally work together—the pituitary, the hypothalamus and the testes. When something goes awry within this system, the testes end up producing too little testosterone (and fewer sperm). Symptoms: Hypogonadism can lead to loss of height, body hair and muscle mass…low-trauma bone fractures (bones that fracture easily)…hot flashes and sweats…breast tissue development…and fertility problems. Hypogonadism also causes less specific symptoms—fatigue, sleep disturbances, low libido, reduced strength, poor concentration, depression—though, of course, these vague symptoms can result from other health problems as well.

However, low testosterone by itself does not signal hypogonadism. Especially in the absence of clear symptoms, a reduced testosterone level does not necessarily indicate a problem that needs treatment.

How low is too low? Unfortunately, there is no clear answer to that question. One reason for the current overtreatment of low T is that it’s not easy to draw a line between normal testosterone levels and abnormally low levels. Here’s why…

  • The lower limit of the normal range varies depending on whom you ask. Some experts give a cutoff of 200 nanograms of testosterone per deciliter (ng/dL) of blood, while others define low T as anything below 300 ng/dL or even 350 ng/dL.

  • However “normal” is defined, those numbers were established by looking at healthy young men—so they aren’t necessarily applicable to older men. Testosterone levels typically do fall with age, declining by about 1% to 2% per year beginning in men’s 40s or 50s. By the time men are in their 60s, one-fifth have testosterone levels that some doctors would consider low…by their 80s, about one-half of men have testosterone levels that some would call low. The fact that older men are more likely than younger ones to have chronic medical conditions that affect hormone levels makes it more difficult to pinpoint how much of the testosterone decline is attributable to normal aging.

  • Testosterone tests are not standardized. For one thing, there are various types of tests. Some measure total testosterone…others measure what’s called free (unbound) testosterone, which is a mere fraction of the total…still others measure bioavailable testosterone, which also is less than the total. A doctor who’s not well-versed in the differences could wrongly interpret the numbers that these different tests yield. Furthermore, lab results don’t always agree—so two different labs (even careful labs) can come up with two very different numbers.

  • A man’s testosterone level fluctuates throughout the day, with the highest reading in the morning, so his test results depend in part on the time of day at which his blood was drawn. Even among healthy young men, for instance, 15% will have a testosterone reading that drops below the normal range at some point in a 24-hour period. Often these daily fluctuations are not taken into consideration when interpreting test results.

  • One man’s low is not necessarily the same as another man’s because the level at which symptoms appear varies widely. And the presence or absence of symptoms makes a big difference (or at least it should make a big difference, as we’ll discuss in a moment) in the decision about whether or not to treat low T.

    Increased Testing, Increased Treatment

    Despite the lack of any agreed-upon definition of testosterone deficiency, testosterone testing and replacement therapy have become very popular in the US…in some cases, even among men who probably don’t need it.

    For instance, a study led by epidemiologist J. Bradley Layton, PhD, of the University of North Carolina at Chapel Hill, found that testosterone testing increased 329% from 2000 to 2010—an increase that researchers attributed in part to heavy direct-to-consumer marketing (such as those TV ads encouraging men to get their mojo back).

    Disturbingly, among the American men who started on testosterone replacement, pretreatment testing showed that about 20% already had normal or high testosterone levels…and 40% started treatment without having been recently tested at all!

    Questions About Safety

    Dr. Layton’s study is not the first to sound alarms about testosterone therapy. For instance: In one observational study of veterans with low testosterone, those who started replacement therapy were 30% more likely to have a heart attack or stroke or to die from any cause during the study period. In another observational study, in the 90 days after starting testosterone therapy, nonfatal heart attack risk rose 36% overall…more than doubled for men age 65 and up…and nearly tripled for men under age 65 who had a history of heart disease. And one clinical trial of older men was stopped early when it became obvious that the men on testosterone therapy had a significantly higher risk for heart attack or irregular heart rhythm than the participants taking a placebo.

    However, while the results of the above studies are worrisome, they don’t tell the whole story. For one thing, it’s important to note that there’s considerable data showing that low testosterone itself is associated with increased cardiovascular and mortality risks, according to Glenn R. Cunningham, MD, an endocrinologist at Baylor College of Medicine in Houston. Dr. Cunningham was a member of a task force that wrote the 2010 guidelines on testing and treating testosterone deficiency for the Endocrine Society, a professional organization devoted to research on hormones and the clinical practice of endocrinology.

    Also, the studies cited above have limitations. In the veterans study, the analysis of the data may have been flawed, Dr. Cunningham said—and a different veterans’ study showed that testosterone therapy was associated with a lower risk of dying. Also, a meta-analysis of about 50 small observational studies did not find an increase in cardiovascular events or death. And in the clinical trial cited above, the testosterone dosage was higher than is normally prescribed—whereas in a large European study that used more typical dosages, treatment did not increase cardiovascular risk.

    Bottom line: “At this point, we do not know if there is danger of increased cardiovascular events associated with testosterone treatment—and we need a very rigorous, placebo-controlled trial, following at least 6,000 men for at least five years, to find out,” Dr. Cunningham said.

    What Men Considering Treatment Can Do

    If you are concerned about possible low T, the first step is to visit your doctor and discuss your symptoms. If you have any of the more specific signs that suggest hypogonadism (such as loss of height, hot flashes or breast tissue development or a history of low-trauma bone fractures), testing is definitely warranted, Dr. Cunningham said. With the more vague symptoms (decreased energy, increased body fat, low libido, concentration or mood problems), testosterone testing may be considered—though it’s also important to rule out other conditions that could underlie such symptoms.

    Testing is not a one-shot deal—because up to 30% of men who initially have a low testosterone measurement have a normal level on their next test without any therapy. Dr. Cunningham stressed that if a second test, done at least a few days later, also shows a low testosterone level, it’s important to keep digging for more information. “More sophisticated lab tests can tell if the problem is originating in the testes or in either the pituitary gland or hypothalamus. Also, because the protein that carries testosterone in the blood is reduced in overweight and obese men, such patients may need special tests to uncover their true testosterone levels,” he said.

    It’s also important to explore whether low testosterone itself actually is causing the symptoms…or whether, instead, some other underlying problem is causing the symptoms and affecting testosterone levels. Low testosterone can be the result of depression, stress, sleep apnea, eating disorders, pituitary tumors, liver or kidney abnormalities, and many other systemic illnesses. In such cases, Dr. Cunningham said, “Treatment of the associated medical problem may improve testosterone levels. If it does not, testosterone therapy may be helpful.” 

    The Endocrine Society’s guidelines suggest treating low testosterone only when symptoms are present and when testing shows unequivocally low testosterone levels. Even then, it’s essential to weigh the benefits against the risks while taking overall health status into consideration. Testosterone therapy may be inadvisable for a man with heart disease…uncontrolled sleep apnea, which can worsen with testosterone therapy…a history of blood clots, because testosterone therapy can increase clotting…or a high hematocrit (a measure of red blood cell concentration), which may increase further if testosterone is given, elevating heart attack risk. Some doctors also advise against testosterone therapy for men who have been treated for prostate cancer, though others say that it’s OK.

    Natural Ways to Boost Testosterone

    Before you resort to hormone therapy, it’s also wise to talk with your doctor about safe, natural ways to increase testosterone levels. It often helps to…

  • Lose excess weight. One 2012 study found that obese men can increase their testosterone levels by 15% by shedding just 17 pounds.

  • Maintain a healthful diet that includes plenty of vegetables, fruits, whole grains, legumes and monounsaturated fats…limits processed carbohydrates, such as sugar and white flour…and emphasizes organic food (since estrogen-like pesticides can stymie testosterone).

  • Get your vitamin D level tested—and if it is low, ask your doctor about taking daily supplements of vitamin D-3.

  • Get regular exercise, including weight lifting and interval training (for instance, exercise to maximum capacity for one minute…slow down until normal breathing is restored, usually about one minute…then repeat that two-part cycle for 20 minutes).

  • Limit alcohol to no more than two drinks a day…don’t smoke…manage stress…and get adequate sleep.

    Remember: Such healthy lifestyle practices can go a long way toward normalizing testosterone levels—without the risks that go along with testosterone-replacement therapy.