6/29/23, 1:13 AM Rifaximin plus lactulose for hepatic encephalopathy Pathway Feedback Search Clinical Topics Home Studies Rifaximin plus lactulose for hepatic encephalopathy Rifaximin plus lactulose for hepatic encephalopathy Disease Hepatic encephalopathy Trial question What is the effect of rifaximin plus lactulose in patients with overt hepatic encephalopathy? Study design Single center Double blinded RCT Population Characteristics of study participants 26.0% female N = 120 74.0% male 120 patients (31 female, 89 male) Inclusion criteria: patients with overt hepatic encephalopathy Key exclusion criteria: serum creatinine > 1.5 mg/dl, active alcohol intake < 4 weeks before present episode, other metabolic encephalopathies, HCC, degenerative CNS disease or major psychiatric illness, and significant comorbidity Interventions N=63 lactulose and rifaximin (lactulose 30-60 mL TID plus rifaximin 1,200 mg/day) N=57 lactulose only (lactulose 30-60 mL TID plus placebo capsule) Primary outcome Complete reversal of hepatic encephalopathy https://web.pathway.md/studies/recldqmyg8lJLE6Yo 1/2 6/29/23, 1:13 AM Rifaximin plus lactulose for hepatic encephalopathy Pathway 76.0 % 76 57.0 % 50.8 38.0 % Significant increase 19.0 % NNT = 4 0.0 % Lactulose and rifaximin Lactulose only Significant increase in complete reversal of hepatic encephalopathy (76% vs. 50.8%; RR 1.5, 95% CI 0.48 to 2.52) Secondary outcomes Borderline significant decrease in death (23.8% vs. 49.1%; RR 0.48, 95% CI 0 to 0.96) Significant increase in hospital stay (5.8 vs. 8.2; AD 2.4, 95% CI 0.98 to 3.82) Safety outcomes No significant difference in gastrointestinal bleeding (4 vs. 4) and hepatorenal syndrome (4 vs. 7). Significant differences in sepsis (7 vs. 17, p = 0.01). Conclusion In patients with overt hepatic encephalopathy, lactulose and rifaximin were superior to lactulose only with respect to complete reversal of hepatic encephalopathy. Reference Sharma BC, Sharma P, Lunia MK et al. A randomized, double-blind, controlled trial comparing rifaximin plus lactulose with lactulose alone in treatment of overt hepatic encephalopathy. Am J Gastroenterol. 2013 Sep;108(9):1458-63. Open reference URL https://web.pathway.md/studies/recldqmyg8lJLE6Yo 2/2