Please use this identifier to cite or link to this item: http://ahro.austin.org.au/austinjspui/handle/1/17791
Title: Symptomatic response to testosterone treatment in dieting obese men with low testosterone levels in a randomized, placebo-controlled clinical trial.
Authors: Ng Tang Fui, Mark;Hoermann, Rudolf;Prendergast, Luke A;Zajac, Jeffrey D;Grossmann, Mathis
Affiliation: Department of Medicine, Austin Health, The University of Melbourne, Heidelberg, Victoria, Australia
Department of Endocrinology, Austin Health, Heidelberg, Victoria, Australia
Department of Mathematics and Statistics, La Trobe University, Bundoora, Victoria, Australia
Issue Date: Mar-2017
EDate: 2016-12-28
Citation: International journal of obesity (2005) 2017; 41(3): 420-426
Abstract: Obese men commonly have reductions in circulating testosterone and report symptoms consistent with androgen deficiency. We hypothesized that testosterone treatment improves constitutional and sexual symptoms over and above the effects of weight loss alone. We conducted a pre-specified analysis of a randomized double-blind, placebo-controlled trial at a tertiary referral center. About 100 obese men (body mass index (BMI)⩾30 kg m-2) with a repeated total testosterone level ⩽12 nmol l-1 and a median age of 53 years (interquartile range 47-60) receiving 10 weeks of a very-low-energy diet (VLED) followed by 46 weeks of weight maintenance were randomly assigned at baseline to 56 weeks of intramuscular testosterone undecanoate (n=49, cases) or matching placebo (n=51, controls). Pre-specified outcomes were the between-group differences in Aging Male Symptoms scale (AMS) and international index of erectile function (IIEF-5) questionnaires. Eighty-two men completed the study. At study end, cases showed significant symptomatic improvement in AMS score, compared with controls, and improvement was more marked in men with more severe baseline symptoms (mean adjusted difference (MAD) per unit of change in AMS score -0.34 (95% confidence interval (CI) -0.65, -0.02), P=0.04). This corresponds to improvements of 11% and 20% from baseline scores of 40 and 60, respectively, with higher scores denoting more severe symptoms. Men with erectile dysfunction (IIEF-5⩽20) had improved erectile function with testosterone treatment. Cases and controls lost the same weight after VLED (testosterone -12.0 kg; placebo -13.5 kg, P=0.40) and maintained this at study end (testosterone -11.4 kg; placebo -10.9 kg, P=0.80). The improvement in AMS following VLED was not different between the groups (-0.05 (95% CI -0.28, 0.17), P=0.65). In otherwise healthy obese men with mild to moderate symptoms and modest reductions in testosterone levels, testosterone treatment improved androgen deficiency symptoms over and above the improvement associated with weight loss alone, and more severely symptomatic men achieved a greater benefit.
URI: http://ahro.austin.org.au/austinjspui/handle/1/17791
DOI: 10.1038/ijo.2016.242
ORCID: 0000-0001-8261-3457
PubMed URL: 28028318
Type: Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Appears in Collections:Journal articles

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