Although a recent study of testosterone therapy does not fulfill the need for large-scale, randomized, controlled studies of the treatment, “it is very informative in several ways,” writes Arthur L. Burnett, II, MD, MBA.
The topic of testosterone replacement therapy has engendered a great deal of interest in recent years, prompted in large part by concerns surrounding appropriate drug utilization and evidence of efficacy and safety. This matter received major attention 2 years when the FDA issued a statement on the appropriate indications and cardiovascular risks of testosterone replacement therapy. Many authorities including professional specialty societies entered the fray to help provide guidelines for practitioners implementing this therapy.
Some experts in the field have issued a resounding call for large-scale, randomized, controlled studies to address many of the controversies of testosterone supplement. A study discussed in the November 2016 issue of Urology Times does not fulfill this standard. However, it is very informative in several ways. This report shows that testosterone replacement therapy is safe in the long term (approximately 10 years) and may achieve not just health maintenance but also possibly health advantages.
The therapy was applied in a real-world setting to a population of biochemically hypogonadal men, providing appropriate testosterone replacement biochemically, beneficial outcomes both by objective (eg, prostate size, urinary residual volumes) and subjective (eg, urinary and sexual function questionnaire) indices, and no definite indication of adverse outcomes with regard to prostate and cardiovascular safety risks.
Thus, efficacy and safety outcomes are described in hypogonadal men receiving testosterone replacement therapy under rational indications and feasible therapeutic and monitoring circumstances. Moreover, the study is revealing with respect to the natural history of hypogonadism long term in a population of untreated hypogonadal men.
Indeed, more evidence is needed to fully satisfy critical opinion about the risk versus benefit assessment of testosterone replacement therapy. It is acknowledged that this study does not meet ideal experimental design standards, while also carrying limitations as a single-practice experience with retrospective analysis, selection bias, and possible placebo effects. It remains uncertain whether ideal studies will be forthcoming.
In the meantime, studies such as this lend valuable insights for practitioners in need of direction in their routine care of patients.
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