ArticleHepatology international2026
Effect of testosterone addition to nutrition and exercise on muscle mass in men with cirrhosis: the next trial.
Article in Hepatology international, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
backgroundNutrition supplementation and exercise are the current approaches for managing sarcopenia in patients with cirrhosis. There are limited data on benefits, if any, of supplementing testosterone in cirrhosis with sarcopenia and frailty.
methods127 patients with cirrhosis and sarcopenia were randomized to receive either nutrition and structured exercise with intramuscular testosterone undecanoate 1000 mg administered at 0, 6, 12, 16, 20, and 24 weeks (NExT group, n = 64) or only structured exercise and nutrition (NEx group, n = 63). Of these, 102 patients completed the 24-week study period as per protocol (NExT, n = 50; NEx, n = 52). The primary endpoint was a ≥ 10% increase in appendicular skeletal muscle index (ASMI) at 24 weeks, assessed by dual-energy X-ray absorptiometry (DEXA).
resultsThe mean age, MELD (median 14), CTP score (Child A 15.7%, Child B 64.7%, Child C 19.6%) were comparable between groups. On intention-to-treat analysis, a ≥ 10% increase in ASMI was achieved in 41/64 (64.1%) patients in the NExT group compared with 16/63 (25.3%) in the NEx group (p < 0.001). Similar findings were observed in the per-protocol analysis (33/50 [66%] vs. 13/52 [25%]; p < 0.001). A greater proportion of patients in the NExT group demonstrated improvement in hand-grip strength (92% vs. 67.3%, p = 0.002), 6-min walk distance (82% vs. 63.5%, p = 0.04), and reduction in serum ammonia (64% vs. 25%, p = 0.01). Liver frailty index improved significantly in the NExT group compared with the NEx group at 24 weeks (3.98 ± 0.27 to 3.32 ± 0.21 vs. 3.93 ± 0.24 to 3.68 ± 0.22, respectively; p = 0.01). Hospitalization rates were lower in the NExT group (18% vs. 34.6%, p = 0.05), with no apparent major adverse-events with testosterone use.
conclusionThe addition of testosterone therapy to nutrition and structured exercise protocols significantly improves the appendicular muscle mass, reduces frailty and need of rehospitalization in cirrhosis patients with sarcopenia and frailty.
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