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Previous nonblinded studies suggest that probiotics plus lactulose may be effective in preventing recurrent hepatic encephalopathy (HE; NEJM JW Gastroenterol Aug 10 2012). Could probiotics alone be effective?
To find out, investigators randomized 130 patients with cirrhosis and a previous HE episode to receive the probiotic VSL#3 or placebo daily for 6 months in a double-blinded, industry-funded study. Other HE medications such as lactulose and rifaximin were stopped a week prior to randomization. The primary endpoint was recurrent HE, and secondary endpoints were hospitalizations due to HE and liver disease severity.
The rate of HE breakthrough was lower in the VSL#3 group compared with the placebo group, but the difference did not reach sta…