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Cited by 269Hormonal and reproductive studiesNutrition and Health in AgingLiver Disease and Transplantation

Testosterone therapy increases muscle mass in men with cirrhosis and low testosterone: A randomised controlled trial

Sinclair, Marie, Grossmann, Mathis, Hoermann, Rudolf, Angus, Peter W., Gow, Paul J.·2016·Journal of Hepatology
DOI 10.1016/j.jhep.2016.06.007
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Abstract

Background & aims Low testosterone and sarcopenia are common in men with cirrhosis and both are associated with increased mortality. Whether testosterone therapy in cirrhosis improves muscle mass and other outcomes is unknown.Methods We conducted a 12-month, double-blinded, placebo-controlled trial of intramuscular testosterone undecanoate in 101 men with established cirrhosis and low serum testosterone (total testosterone <12nmol/L or free testosterone <230pmol/L) in a single tertiary centre. Body composition was assessed using dual-energy X-ray absorptiometry at baseline, 6 and 12months.Results At study completion, appendicular lean mass was significant higher in testosterone-treated subjects, with a mean adjusted difference (MAD) of +1.69kg, (CI +0.40; +2.97kg, p=0.021). Secondary outcomes included a substantially higher total lean mass in the active group (MAD +4.74kg, CI +1.75; +7.74kg, p=0.008), matched by reduced fat mass (MAD -4.34kg, CI -6.65; -2.04, p<0.001). Total bone mass increased (MAD +0.08kg, CI +0.01; +0.15kg, p=0.009) as did bone mineral density at the femoral neck (MAD +0.287points, CI +0.140; +0.434, p<0.001). Haemoglobin was higher with testosterone therapy (MAD +10.2g/L, CI +1.50; +18.9g/L, p=0.041) and percentage glycosylated haemoglobin (HbA1c) lower (MAD -0.35%, CI -0.05; -0.54, p=0.028). Mortality was non-significantly lower in testosterone-treated patients (16% vs. 25.5%, p=0.352). There was no increase in adverse events in testosterone-treated subjects.Conclusion Testosterone therapy in men with cirrhosis and low serum testosterone safely increases muscle mass, bone mass and haemoglobin, and reduces fat mass and HbA1c. This is the first evidence-based therapy for sarcopenia in cirrhosis and thus requires larger-scale investigation into its potential impact on mortality.Lay summary Both low testosterone and muscle wasting are associated with increased risk of death in men with severe liver disease. Administering testosterone to men with liver disease who have low testosterone levels significantly increases their muscle mass. In addition, testosterone has non-muscle beneficial effects which may be able to increase survival in this population.Clinical trial number Australian New Zealand Clinical Trials Registry trial number ACTRN 12614000526673.

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Authors
Sinclair, M., Grossmann, M., Hoermann, R., Angus, P. W., & Gow, P. J.
Affiliations
The University of Melbourne (AU)
Corresponding author
Sinclair, Marie
ORCID
Venue
Journal of Hepatology
Publisher
Elsevier BV
Published
2016-11
Volume
65
Issue
5
Pages
906-913
ISSN
0168-8278 (ISSN-L)
DOI
10.1016/j.jhep.2016.06.007
OpenAlex
W2423926234
Cited by
269
References
56
Citations by year
2026: 21 · 2025: 24 · 2024: 30 · 2023: 32 · 2022: 28 · 2021: 27 · 2020: 25 · 2019: 30 · 2018: 28 · 2017: 18 · 2016: 4
FWCI
26.78
Type
journal article
Language
en
Open access
closed
Licence
Locations
  • Journal of Hepatology (publishedVersion)
  • PubMed (publishedVersion)
Funders
  • Novartis
  • Bayer Schering
  • University of Melbourne
  • National Health and Medical Research Council (1024139)
Topics
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Hormonal and reproductive studies
  • Health Sciences › Medicine › Physiology › Nutrition and Health in Aging
  • Health Sciences › Medicine › Hepatology › Liver Disease and Transplantation
Keywords
testosterone replacement therapy, testosterone undecanoate, liver cirrhosis, androgen deficiency, sarcopenia, muscle mass, lean body mass, fat mass, bone mineral density, hemoglobin, HbA1c, mortality, men, body composition, sex hormones, adverse events, safety and tolerability, quality of life, quality-adjusted life years
MeSH terms
Australia, Body Composition, Humans, Liver Cirrhosis, Male, Testosterone, Absorptiometry, Photon, Muscle, Skeletal

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