Testosterone treatment combined with exercise to improve muscle strength, physical function and quality of life in men affected by inclusion body myositis: A randomised, double-blind, placebo-controlled, crossover trial

作者：Sophia G. Connor, Timothy J. Fairchild, Yvonne C. Learmonth, Kelly Beer, Ian Cooper, Glenn Boardman, Shaun Y. M. Teo, Behnaz Shatahmasseb, Rui Zhang, Krystyne Hiscock, Jérôme D. Coudert, Bu B. Yeap, Merrilee Needham · 发表于：PLoS ONE · 年份：2023 · DOI：10.1371/journal.pone.0283394 · 被引用次数：17 · 研究领域：Inflammatory Myopathies and Dermatomyositis、Exercise and Physiological Responses、Muscle Physiology and Disorders

INTRODUCTION: Inclusion body myositis (IBM) is the most commonly acquired skeletal muscle disease of older adults involving both autoimmune attack and muscle degeneration. As exercise training can improve outcomes in IBM, this study assessed whether a combination of testosterone supplementation and exercise training would improve muscle strength, physical function and quality of life in men affected by IBM, more than exercise alone. METHODS: This pilot study was a single site randomised, double-blind, placebo-controlled, crossover study. Testosterone (exercise and testosterone cream) and placebo (exercise and placebo cream) were each delivered for 12 weeks, with a two-week wash-out between the two periods. The primary outcome measure was improvement in quadriceps isokinetic muscle strength. Secondary outcomes included assessment of isokinetic peak flexion force, walk capacity and patient reported outcomes, and other tests, comparing results between the placebo and testosterone arms. A 12-month Open Label Extension (OLE) was offered using the same outcome measures collected at 6 and 12-months. RESULTS: 14 men completed the trial. There were no significant improvements in quadriceps extension strength or lean body mass, nor any of the secondary outcomes. Improvement in the RAND Short Form 36 patient reported outcome questionnaire 'emotional wellbeing' sub-category was reported during the testosterone arm compared to the placebo arm (mean difference [95% CI]: 6.0 points, [95% CI...