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Systematic review and meta-analysis
Need for standardising adverse event reporting in testosterone trials
  1. Shehzad Basaria
  1. Section on Men's Health, Aging and Metabolism, Brigham & Women's Hospital, Boston, Massachusetts, USA
  1. Correspondence to: Dr Shehzad Basaria, Section on Men's Health, Aging and Metabolism, Brigham & Women's Hospital, 221 Longwood Avenue, 5th Floor, Boston, MA 02115, USA; sbasaria{at}

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Epidemiological studies neither establish causality nor exclude reverse causality. Therefore, randomised controlled trials (RCTs) provide an excellent platform to evaluate the efficacy as well as risks of an intervention. This also holds true for testosterone whose prescription sales have sky-rocketed over the last two decades.1 This increase is a result of a sophisticated marketing campaign that promotes testosterone as a ‘fountain of youth’ for late-onset hypogonadism, a condition with ever-evolving diagnostic criteria, modest benefits from testosterone replacement and uncertain risks.2 ,3 These uncertainties of testosterone therapy, particularly in ageing men, underscores the importance of reporting the efficacy as well as harm in testosterone trials.

The relationship between testosterone and cardiovascular disease (CVD) remains unclear. Population studies have largely shown an inverse association between testosterone levels and CVD.1 However, these studies do not establish causality. Similarly, men undergoing androgen …

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