Primary prophylaxis of overt hepatic encephalopathy in patients with cirrhosis: an open labeled randomized controlled trial of lactulose versus no lactulose
Journal of Gastroenterology and Hepatology,  Clinical Article

Sharma P et al. – Lactulose is effective for primary prevention of overt hepatic encephalopathy in patients with cirrhosis.

Methods
  • Consecutive cirrhotic patients who never had an episode of overt HE were randomized to receive lactulose (Gp-L) or no lactulose (Gp-NL).
  • All patients were assessed by psychometry [(number connection test (NCT-A and B), figure connection test if illiterate (FCT-A and B), digit symbol test (DST), serial dot test (SDT), line tracing test (LTT)] and critical flicker frequency test (CFF) at inclusion and after 3 months.
  • These patients were followed every month for 12 months for development of overt HE.

Results
  • Of 250 patients screened, 120(48%) meeting the inclusion criteria were randomized to Gp-L(n=60) and Gp-NL(n=60).
  • Twenty (19%) of 105 patients followed for 12 mo developed an episode of overt HE.
  • Six (11%) of 55 in the lactulose (Gp-L) group and 14(28%) of 50 in the Gp-NL (p=0.02) developed overt HE.
  • Ten (20%) of 50 patients in Gp-NL and 5(9%) of 55 patients in Gp-L group died, p=0.16.
  • Number of patients with minimal hepatic encephalopathy (MHE) were comparable in two groups at baseline (Gp-L vs Gp-NL, 32:36, p=0.29).
  • Lactulose improved MHE in 66% of patients in Gp-L.
  • Taking a cutoff <38Hz sensitivity and specificity of CFF in predicting HE were 52% and 77% at baseline and 52% and 82% at 3 month of treatment.
  • On multivariate analysis Child's score and presence of MHE at baseline were significantly associated with development of overt HE.

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