Hepatic encephalopathy ( HE ) is associated with poor prognosis in cirrhosis. Drugs used in the treatment of hepatic encephalopathy are primarily directed at the reduction of the blood ammonia levels.
Rifaximin ( Normix, Xifaxan ) and Lactulose have shown to be effective in hepatic encephalopathy.
Researchers have evaluated the efficacy and safety of Rifaximin plus Lactulose versus Lactulose alone for treatment of overt hepatic encephalopathy.
In this prospective double-blind randomized controlled trial, 120 patients with overt hepatic encephalopathy were randomized into two groups: ( group A Lactulose plus Rifaximin 1,200 mg/day; n=63 ) and group B ( Lactulose plus placebo; n=57 ).
The primary endpoint was complete reversal of hepatic encephalopathy and the secondary end points were mortality and hospital stay.
A total of 120 patients ( mean age 39.4±9.6 years; male/female ratio 89:31 ) were included in the study. 37 ( 30.8% ) patients were in Child-Turcotte-Pugh ( CTP ) class B and 83 ( 69.2% ) were in CTP class C.
Mean CTP score was 9.7±2.8 and the MELD ( model for end-stage liver disease ) score was 24.6±4.2. At the time of admission, 22 patients ( 18.3% ) had grade 2, 40 ( 33.3% ) had grade 3, and 58 ( 48.3% ) had grade 4 hepatic encephalopathy.
Of the patients, 48 ( 76% ) in group A compared with 29 ( 50.8% ) in group B had complete reversal of hepatic encephalopathy ( P less than 0.004 ).
There was a significant decrease in mortality after treatment with Lactulose plus Rifaximin versus Lactulose and placebo ( 23.8% vs 49.1%, P less than 0.05 ).
There were significantly more deaths in group B because of sepsis ( group A vs group B: 7:17, P=0.01 ).
There were no differences because of gastrointestinal bleed ( group A vs group B: 4:4, P=nonsignificant [ NS ] ) and hepatorenal syndrome ( group A vs group B: 4:7, P=NS ).
Patients in the Lactulose plus Rifaximin group had shorter hospital stay ( 5.8±3.4 vs 8.2±4.6 days, P=0.001 ).
The study has revealed that combination of Lactulose plus Rifaximin is more effective than Lactulose alone in the treatment of overt hepatic encephalopathy. ( Xagena )
Sharma BC et al, Am J Gastroenterol 2013; 108: 1458-1463