Both treatments were significantly more effective than placebo.
Hepatic encephalopathy (HE) is a common complication of hepatic cirrhosis. Lactulose has been effective in treating patients with acute or recurrent HE, but data supporting its use are lacking. Probiotics might also be beneficial for these patients, by altering gut flora to reduce ammonia production, although few studies have evaluated probiotics in this setting.
Now, investigators have conducted an open-label, randomized, controlled trial to evaluate the efficacy of lactulose and probiotics in 235 consecutive cirrhotic patients at a single hospital in India who had recovered from HE and had not received any HE medication. Patients were randomized to lactulose (30 mL 3 times daily), probiotics (1 capsule containing 112.5 billion viable lyophilized bacteria 3 times daily), or placebo. The primary endpoint was development of overt HE, according to West Haven criteria.
During 12-month follow-up, recurrent HE developed in more patients receiving placebo (37) than lactulose (18; P=0.001) or probiotics (22; P=0.02). Rates of hospitalization and death from causes other than HE were similar among the three groups.
Comment: Although unblinded, this study was large and well executed. It demonstrated that lactulose and probiotics are similarly effective in secondary prophylaxis of HE. Whether all probiotics would be as effective is unclear, but we now potentially have other therapeutic options for preventing recurrent HE in addition to rifaximin plus lactulose (JW Gastroenterol Mar 24 2010).
Published in Journal Watch Gastroenterology August 10, 2012
Agrawal A et al. Secondary prophylaxis of hepatic encephalopathy in cirrhosis: An open-label, randomized controlled trial of lactulose, probiotics, and no therapy. Am J Gastroenterol 2012 Jul; 107:1043.
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