Abstract

Cunningham and Toma have published an article entitled “Why Is Androgen Replacement in Males Controversial?” (1) in this issue of JCEM. This represents a new look at an old controversy. The article reviews the status of testosterone treatment in older men and serves as an extension to previously published guidelines on hypogonadism by Bhasin et al. (2) and recommendations published by Wang et al. (3) on late-onset hypogonadism. There are many causes for controversy in the practice of medicine, not the least of which is insufficiency of high-grade, evidence-based data. This is likely to occur when a medication was established in clinical use before the modern era of pharmaceutical regulation. This new review describes the insufficiency of evidence-based data to be certain that the benefit-to-risk ratio justifies testosterone treatment in older men, whereas taking the position that androgen replacement therapy in younger and middle-aged men is well established. The authors do acknowledge, as do the above guidelines (2), that relatively few large-scale, double-blind, placebo-controlled, multiple end point studies had been performed on testosterone treatment in men of any age. This position was also taken by the Institute of Medicine (4). Most of the data come from relatively small-size studies and meta-analyses of small- or medium-size databases (5,6,7,8).

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