For this study, they assigned 790 men 65 years of age or older with a serum T-concentration of less than 275 ng per deciliter and symptoms suggesting hypoandrogenism to receive either testosterone gel or placebo gel for 1 year.
Advertisement
For testosterone, this is the first adequately powered set of efficacy trials, which now provide a context for the potential benefits, so this will be part of the conversation between doctors and men who seek treatment for age-related symptoms.
Prof Thomas Gill, a co-author of the study, of Yale School of Medicine, said: “There appear to be benefits for treatment with testosterone among men who have unequivocally low levels of testosterone that are attributable exclusively to age”.
While the results were somewhat mixed, researchers said that an overall benefit that had not been seen in previous studies. “We should not assume that the benefits, lack of benefits, or adverse-event profile observed in these studies would be similar in younger men, men with higher testosterone levels, or those with different demographic or clinical characteristics”. The participants were either given a testosterone gel or a placebo gel for at least one year. “The effects on sexual function, mood, and depression are very small”, said Dr. Steven Woloshin, a professor at the Dartmouth Institute for Health Policy and Clinical Practice.
The study, conducted in partnership with the National Institute on Aging, was published by the New England Journal of Medicine.
The new research combines results from three of the government-funded studies. The results of the other four, which looked at testosterone’s effect on cognitive function, bone density, heart function, and anemia, are not yet available. “Men who received testosterone were more likely than those who received placebo to perceive that their walking ability had improved since the beginning of the trial”, the researchers reported.
I think there are a couple of things that are clear, which doctors can use in their conversations with patients who are seeking testosterone therapy. For men only enrolled in the physical function trial, treatment did not show significant improvement, but when comparing men in all the trials, more of the men on testosterone improved the distance they walked in six minutes.
The study included almost 800 men aged 65 and older at dozens of academic medical centers, health care institutions and Veterans Affairs facilities from Seattle to Boston. Some of the men said they had lost their sexual drive, others said they were walking much slower than they used to, and others said they just felt blah as if they had lost their zest for life. Each man participated in one or more of three clinical trials: the Sexual Function Trial, the Physical Function Trial, and the Vitality Trial.
The participants were then either asked to use testosterone gel or a placebo, which was a fake gel without hormone. Such trials were recommended by the Institute of Medicine (now the National Academy of Medicine) as a key step before considering possible larger and longer trials that would be needed to assess long-term risks and benefits of testosterone treatment for older men.
Some men with serious medical conditions that deplete their bodies of testosterone use the hormone as therapy and that practice are not in question, researchers said. The results could encourage large numbers of men to take the drug without knowing answers about safety, Dr. Joel Finkelstein, a professor at Harvard, told The New York Times. The benefits were modest and tended to wane with time, noted Dr. Eric Orwoll of the Oregon Health and Science University in an accompanying editorial. However, they found no significant difference in energy levels.
SNYDER: Testosterone improved selectivity and improved sexual desire and improved erectile function.
Stevens who at 63 would not be considered a candidate for the therapy according to the trial findings, said the hormone helped him feel better.
Advertisement
AbbVie’s AndroGel; Eli Lilly’s Axiron; Pfizer’s Depo-Testosterone; Actavis’ Androderm; Valeant Pharmaceuticals’ Android and Endo Pharmaceuticals’ Fortesta are some of the leading prescription testosterone treatments.
