Testosterone therapy increases muscle mass in men with cirrhosis
Sinclair M, et al. J Hepatol. 2016;doi:10.1016/j.jhep.2016.06.007.
June 20, 2016
Administering testosterone to men with cirrhosis and low testosterone safely and effectively increased muscle and bone mass, suggesting testosterone may increase survival for this patient population, according to results of a placebo-controlled trial.
“This trial demonstrates for the first time that testosterone therapy can safely increase muscle mass in men with cirrhosis who have low baseline testosterone levels and thus represents the first evidence-based therapy for sarcopenia in cirrhosis,” Marie Sinclair, MD, of the Liver Transplant Unit, Austin Health, Melbourne, Australia, and colleagues wrote.
The researchers at a single tertiary center randomly assigned 101 men with established cirrhosis and low serum testosterone either placebo (n = 51) or testosterone (n = 50) for 1 year. Body composition was measured at baseline, 6 and 12 months in each patient using dual-energy X-ray absorptiometry.
After 1 year, appendicular lean mass was higher in men treated with testosterone (mean adjusted difference [MAD] = 1.69 kg; 95% CI, 0.4-2.97). Men treated with testosterone also had a higher total lean mass (MAD = 4.74 kg; 95% CI, 1.75-7.74), matched by reduced fat mass (MAD = –4.34 kg; 95% CI, –6.65 to –2.04).
In addition, total bone mass (MAD = 0.08 kg; 95% CI, 0.01-0.15) and bone mineral density at the femoral neck (MAD = 0.287 points; 95% CI, 0.14-0.434) increased in patients treated with testosterone.
After testosterone therapy, hemoglobin was higher (MAD = 10.2 g/L; 95% CI, 1.5-18.9) and hemoglobin A1c was lower (MAD = –0.35%; 95% CI, –0.05 to –0.54).
Neither group experienced cardiovascular events, infection or bleeding at injection site, nor was there any increase in adverse events in the patients treated with testosterone.
Mortality was lower in men treated with testosterone. However, the researchers note that it was insignificantly lower compared with men treated with placebo (16% vs. 25.5%; P = .352).
The researchers concluded: “Both low testosterone and muscle wasting are associated with increased risk of death in men with severe liver disease. … Testosterone has non-muscle beneficial effects which may be able to increase survival in this population.” – by Melinda Stevens
Disclosure: Sinclair reports no relevant financial disclosures. Please see the full study for a list of all other researchers’ relevant financial disclosures.