Rifaximin plus lactulose in 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
74.0% male
N = 120
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
76%
50.8%
76.0 %
57.0 %
38.0 %
19.0 %
0.0 %
Lactulose and
rifaximin
Lactulose
only
Significant
increase ▲
NNT = 3
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.
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