Do you have ‘Low T?’ Or is it just hype?

Middle-aged men sit around looking forlorn, while their shadows appear to be having all the fun. The men are moody, they have low libido, and they lack energy.

The scene is from an ad running during the US National Basketball Association playoffs sponsored by Solvay Pharmaceuticals, which makes AndroGel, a prescription ointment for men with low testosterone. The ads direct viewers to a Web site called “Is It Low T?”—http://www.isitlowt.com—and urge them to discuss the symptoms and others with their doctors.

But is that good advice?

While experts welcome a public discussion of the ailments of middle-aged men with “Low T,” they say that testosterone replacement therapy isn’t necessarily the solution for these problems. The symptoms described in the ads occur in other diseases, they note, and could also be chalked up to plain old aging, or “male menopause.”

According to a review in the June issue of the Drug and Therapeutics Bulletin, testosterone replacement therapy is questionable because it has risks, its efficacy is uncertain, and there’s no strong agreement about whether low testosterone is really a disease in older age. The review is available at http://dtb.bmj.com/content/48/6/69.abstract.

“We’re skeptical about this,” Dr. Ike Iheanacho, the journal’s editor, told Reuters Health. “You may have men who have symptoms who have low testosterone levels, but in our view it doesn’t add up convincingly to an undoubted medical condition.”

Iheanacho said that men do tend to produce less testosterone as they age, but it’s not inevitable, and even if it does happen it doesn’t necessarily produce symptoms. Half of all men 80 years and older produce normal levels of testosterone, he said.

University of Washington professor Dr. Alvin Matsumoto said that the condition does exist, but that the symptoms should be carefully evaluated along with a series of tests for testosterone levels.

“There does need to be an increased awareness of true clinical hypogonadism,” he told Reuters Health, using the clinical term for low testosterone. “I think a lot of people are missed.”

But the campaign “is casting a wider net than necessarily needs to be cast,” added Matsumoto, who co-authored the Endocrine Society’s just-revised guidelines on sex hormone treatment. “The thing I’m a little worried about is that there will be a lot of people out there who will be treated inappropriately.”

Iheanacho and Matsumoto said separately that the symptoms described in the campaign are “nonspecific,” and could be linked to diabetes, circulation problems, or depression, as well as aging. The Low T site does say that the problem is more common in diabetics and the overweight.

“If someone is low in energy and is 65, that might be entirely compatible with his general life and—let’s face it—decline,” Iheanacho said. “It would be entirely normal.”

The endocrine group’s guidelines, which appear in the June issue of the Journal of Clinical Endocrinology & Metabolism, say doctors should only make a diagnosis of low testosterone “in men with consistent symptoms and signs and unequivocally low serum testosterone levels.”

The group recommends against screening the general population. The guidelines do call for the use of testosterone therapy - which comes in patches, pellets, and tablets—in many cases. It could be prescribed, for instance, for men with erectile dysfunction or loss of libido, provided that other underlying causes and therapies are evaluated.

The treatment isn’t without peril. The Endocrine Society said it’s not recommended for men with prostate cancer or for African-American men with fathers, brothers, or children with prostate cancer. In 2009, the Food and Drug Administration required that testosterone gels be labeled with a prominent warning after repeated reports that young children showed signs of early puberty after being exposed to it, typically through skin contact with their fathers.

According to Solvay’s Web site, a man’s level of testosterone is considered low when it goes below 300 nanograms per deciliter of blood. But Matsumoto said that a single test won’t suffice, because “30% of the time tests are normal after you repeat them.”

Solvay says that low testosterone affects 13 million men in the U.S. over age 45. According to the FDA, prescriptions for testosterone gel nearly doubled between 2002 and 2008. AndroGel is the most popular gel, with 1.7 million prescriptions filled in 2007, according to the FDA. Matsumoto said the gel is expensive, but is covered by insurance more often than not.

The ad campaign isn’t meant to drive sales of AndroGel, said Neil Hirsch, a spokesman for Solvay, which coined the phrase “Low T.”

“The purpose of the ad is to raise awareness, not any specific treatment option,” he said. It helps men “connect the dots between what they may be experiencing themselves so they can have a dialogue with their practitioner.”

Iheanacho said a European doctor “would look at you blankly” if you asked about Low T.

“It sounds like a rapper,” Matsumoto said.

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By John Dillon

NEW YORK (Reuters Health)