How Stanley got his groove back

Does testosterone replacement help or are we
on the brink of another HRT disaster?

By Brian Hoyle

Stanley Patterson, a 53-year-old healthy male, had one request for his doctor at the end of his last visit: "I think I need a little 'topping-up.'" Mr Patterson explained to his physician that he had felt a change lately. He was moody and tired, and just didn't feel like king of the boudoir anymore. He had heard rumours that middle-aged men often 'lost' testosterone and maybe he was losing some of his along with his sexual drive. And he wanted it back.

These days, testosterone replacement therapy (TRT) is as popular as Viagra for men seeking to beat the middle-aged blahs, tiredness and declining sexual desire, according to a 2003 study by the US National Academy of Sciences' Institute of Medicine. In the US alone over 1.75 million prescriptions for testosterone patches, gels and injections were written in 2002.

HOLD THE HORMONES
Despite this explosive popularity, there is "little to no evidence" to support testosterone's ability to crank back the biological clock, said Dr Douglas Kamerow, chief scientist at Research Triangle Institute (RTI) International, a nonprofit research and development organization based in North Carolina. Dr Kamerow's conclusion was based on a systematic review of published studies that RTI conducted at the behest of the National Institute on Aging and the National Cancer Institute. The results were presented in late February at the annual meeting of the American College of Preventive Medicine.

Testosterone is approved for the treatment of hypogonadism, a condition where a deficit of the hormone leads to the malfunctioning of the male testes or female ovaries. The other, more controversial claims touting the hormone's healing powers include improvements in sleep, bone density, mood, cognitive function and sexual desire.

Dr Kamerow and his colleagues identified 48 publications that described the results of 39 testosterone trials. Most were poorly designed with small study populations (six to 108 men) and were of short duration. Eight of the trials didn't use placebos, and so the authors couldn't conclude that the observed effects were strictly due to testosterone. But, most importantly, "all the studies were done on men who received intramuscular injections of testosterone," said Dr Kamerow. "The prescriptions now being written are for patches or gel. There are no studies of these formulations."

The researchers were also concerned with the known increase of prostate specific antigen (PSA) that accompanies elevated testosterone concentration in the body. Even after the literature review, the significance of this increase remains unknown. For now, prescriptions of testosterone for the boudoir blues should include "PSA tests every six months or so," cautioned Dr Kamerow.

Studies that are designed to conclusively establish the safety of TRT are needed. Such randomized, placebo-controlled trials should involve the main consumers of the compound — men aged 46 to 65.