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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 …

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  • Correction notice This article has been corrected since it was published Online First. The competing interests have been amended from ‘None.’ to the current text.

  • Competing interests The author has declared prior financial activities outside the submitted work, relationships during the past 36 months with Eli Lilly, and Abbvie and Clarus Pharmaceuticals. The Editor notes that The Endocrine Society reported a study led by Dr. Basaria in 2013 supported by Abbott Pharmaceuticals ( and published that Dr. Basaria reports financial relationships with Novartis, GlaxoSmithKline, Solvay Pharmaceuticals, Merck and Ligand Pharmaceuticals His study in the N Engl J Med was supported in part by Auxilium Pharmaceuticals (DOI: 10.1056/NEJMoa1000485).