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Challenges of designing hepatic encephalopathy treatment trials
Author(s) -
Sanaka Madhusudhan R.,
Ong Janus P.,
Mullen Kevin D.
Publication year - 2003
Publication title -
hepatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 5.488
H-Index - 361
eISSN - 1527-3350
pISSN - 0270-9139
DOI - 10.1002/hep.510380231
Subject(s) - rifaximin , hepatic encephalopathy , medicine , cirrhosis , randomized controlled trial , gastroenterology , encephalopathy , hepatology , antibiotics , microbiology and biotechnology , biology
Background/Aims: The efficacy and safety of rifaximin in comparison with lactitol in the treatment of hepatic encephalopathy was assessed in a prospective randomized, double‐blind, double‐dummy, controlled trial. Methods: A total of 103 patients with grade I‐III acute hepatic encephalopathy were randomized to receive rifaximin (50 patients, 1200 mg/day) or lactitol (53 patients, 60 g/day) for 5‐10 days. Changes in portal‐systemic encephalopathy (PSE) index on entry and at the end of the study were used to evaluate the efficacy of the two therapies. Results: Both groups were comparable before treatment with regard to demographic data and characteristics of the hepatic encephalopathy episode. The global efficacy of both therapies was similar: 81.6% in the rifaximin group and 80.4% in the lactitol group showed improvement or total regression of the episode. A significantly better evolution of the PSE index was observed in the rifaximin group, due to a greater effect of rifaximin in two components of the index: EEG abnormalities and ammonia levels. No serious events related to either treatment were found during the study. Conclusions: Rifaximin may be considered a useful and safe alternative therapy to lactitol in the treatment of acute hepatic encephalopathy in cirrhosis.