A randomized controlled trial of L-taurine for fatigue in decompensated cirrhosis

Background: Fatigue affects 60%–80% of patients with cirrhosis, yet no universally effective pharmacologic therapy exists. Taurine, an amino sulfonic acid with antioxidant and membrane-stabilizing properties, may address metabolic mechanisms underlying fatigue. We hypothesized that L -taurine supplementation would significantly reduce fatigue severity compared to standard care in patients with decompensated cirrhosis. Methods: This single-center, parallel-arm, open-label randomized controlled trial enrolled adults with decompensated cirrhosis (Child-Turcotte-Pugh score 7–13) and clinically significant fatigue (Fatigue Assessment Scale score >22) at a tertiary care center in South India. Participants were randomized via block randomization to L -taurine (1000 mg/d) plus standard care or standard care alone for 12 weeks. The primary outcome was the change in the Fatigue Assessment Scale score. Analysis of covariance examined treatment-by-anaemia interactions. Effect sizes were calculated using Cohen’s d . Results: Of 220 randomized patients, 202 completed the study (standard care: n=100; taurine: n=102). The mean FAS change was −6.83±8.70 (standard care) versus −8.08±7.95 (taurine), with no significant difference (mean difference −1.25; 95% CI: −3.55 to 1.05; p =0.288; Cohen’s d =−0.15). However, a significant treatment-by-anemia interaction was observed ( p =0.009). In patients without anemia (n=41), taurine produced a large treatment effect (−11.90±4.04 vs. −4.57±9.23; p =0.002; Cohen’s d =−1.02), whereas patients with anemia (n=161) showed no benefit ( p =0.832). Adverse events occurred in 11.8% of patients treated with taurine, all of which were mild. Conclusions: L -taurine did not improve fatigue in unselected patients with decompensated cirrhosis. A post hoc subgroup analysis suggested potential benefit in patients without anemia; however, given the open-label design, small subgroup size, post hoc nature of the analysis, and the inherent limitations of unblinded patient-reported outcomes, this finding should be considered hypothesis-generating. A confirmatory, placebo-controlled trial enrolling patients without anemia is warranted (Clinical Trials Registry India number CTRI/2023/06/054455).