by Dudley S. Danoff, MD, FACS
A study recently published in the medical journal JAMA Internal Medicine noted that prescriptions given to men 40 and older for testosterone replacement therapy (TRT) increased by 300 percent between the years 2001 and 2011. An even more astonishing fact? About one-fourth of the men involved had not received a baseline testosterone test. Blame this wave of interest on the plethora of synthetic TRTs now available and the pervasive promotion and constant advertising. But research has repeatedly shown that only about 2 percent of the United States male population ages 40-79 truly needs TRT.
In addition to the heavy advertisement by mainstream pharmaceutical companies pushing products like Axiron, Fortesta Gel, Testim, Bio-T-Gel, and AndroGel, the popularity of these FDA-approved medications has been further accelerated by the technology that allows these drugs to be absorbed transdermally by patch, gel, or cream.
But even when used by men with hypogonadism (legitimately low serum testosterone), there are dangers. All these drugs can cause diminished sperm count, thickening of the blood, and acceleration of a previously undiagnosed prostate cancer.
Compounding the problem (and trying to ride on the coattails of legitimate TRTs) are an endless number of non-FDA-approved supplements that are heavily promoted and overrun by false claims and exaggerated innuendo. These “snake oils” are marketed with promises to melt body fat; improve motivation and zest for life; recharge energy, strength, stamina, and sports performance; enhance sexual performance; and bring back romance. With names like Troxyphen, HexaTest, High T, Manimal, and Andro400, these supplements are guaranteed to benefit the seller far more than the buyer. These products are not FDA approved, nor are they generally tested to see how well they work. Advertisers can make any claim without the need to verify.
“It’s just a bunch of nonsense,” said Dr. Ellis Levin, chief of endocrinology, diabetes, and metabolism at UC Irvine School of Medicine. “People can claim whatever they want, and nobody will hold them to the truth.”
However, hypogonadism is a real medical problem, and patients with abnormally low testosterone levels will benefit from TRT. In order to establish this diagnosis, a blood test measuring testosterone level must be done by a responsible physician or lab. (The normal level of testosterone is 300-1,000 nanograms per deciliter of blood.) The test must be performed twice, once in the morning when levels are at their highest and once after fasting. If both levels are low, such a patient is an excellent candidate for TRT. The level of testosterone must be monitored to ensure that it remains within the normal range to be therapeutic without being harmful.
After a man turns 40, his testosterone will decrease roughly 1 percent a year. But that does not mean that a responsible physician will treat all older men with TRT. The responsible urologist will treat patients only if they are symptomatic, particularly as they age. Symptoms might include loss of energy, “grumpy old man syndrome,” loss of libido, loss of muscle mass, and difficulty with weight control.
Another key issue when dealing with male sexual dysfunction or male sexuality in general is the placebo effect. Over the years, much of male sexuality has been defined as “99 percent between the ears and 1 percent between the legs.” The unscrupulous marketers of non-FDA-approved products and supplements, who often make bold and false claims that we all recognize—love, sex, size, desire, and performance will all be enhanced—rely on this placebo effect. In many well-controlled scientific studies, about 40 percent of patients receiving the placebo report that they experienced effects similar to those experienced by patients receiving the medication. Male sexuality—being so intertwined with imagination, mental gymnastics, the power of suggestion, and the illusion of sex appeal—becomes the perfect foil for the wide distribution and enormous profitability of thousands of male-enhancement products by companies capitalizing on the placebo effect or the power of suggestion.
There is a real place for TRT in patients who are hypogonadal, but these men represent a minority among the number of men who are spending their hard-earned dollars on worthless placebos.
The takeaway message is that if you have legitimate symptoms—weakness, fatigue, loss of libido, increasing abdominal girth, the grumpy old man syndrome—then it is wise to seek urologic care, have your serum testosterone appropriately tested, and, if deficient, use an FDA-approved product in accordance with the directions prescribed by your physician.