Clinical Question: Is the combination of lactulose plus albumin more effective than lactulose alone for treatment of hepatic encephalopathy?
Background: Hepatic encephalopathy is caused by the effect of toxins that build up in the bloodstream when the liver is not able to perform its normal functions. Lactulose is primarily directed at the reduction of blood ammonia levels. Albumin is thought to minimize oxidative injury and improve circulatory dysfunction present in cirrhosis.
Study Design: Prospective, open-label, randomized controlled trial.
Setting: Tertiary care centers in India.
Synopsis: 120 patients with overt hepatic encephalopathy were randomized to treatment with lactulose plus albumin (1.5 gm/kg/day; n = 60), versus lactulose alone (n = 60). Patients with serum creatinine greater than 1.5 mg/dL on admission, active alcohol intake less than 4 weeks prior to presentation, other metabolic encephalopathies, or hepatocellular carcinoma were excluded. Treatment was continued up to a maximum of 10 days until complete resolution of hepatic encephalopathy as assessed independently by two expert hepatologists.
Of patients receiving lactulose plus albumin, 75% had complete reversal of hepatic encephalopathy within 10 days, compared with 53% of patients receiving lactulose alone (P = .03). Patients in lactulose plus albumin group had shorter hospital length-of-stay (6.4 vs. 8.6 days; P = .01). There was lower mortality at 10 days in the lactulose plus albumin group (18.3% vs. 31.6%; P = .04).
Limitations of the study include the noted exclusion factors, including presence of alcohol intake, limitation to a single country (India), and a relatively high mortality rate in both groups.
Bottom Line: Combination of lactulose plus albumin is more effective than lactulose alone at reversing hepatic encephalopathy and is also associated with decreased length-of-stay and mortality.
Reference: Sharma BC, Singh J, Srivastava S, et al. A randomized controlled trial comparing lactulose plus albumin with lactulose alone for treatment of hepatic encephalopathy. J Gastroenterol Hepatol. Published online Nov 25, 2016. doi: 10.1111/jgh.13666.
Dr. Huang is associate clinical professor in the division of hospital medicine, department of medicine, University of California, San Diego.