Challenges of designing hepatic encephalopathy treatment trials

✍ Scribed by Madhusudhan R. Sanaka; Janus P. Ong; Kevin D. Mullen

• Publisher: John Wiley and Sons
• Year: 2003
• Tongue: English
• Weight: 61 KB
• Volume: 38
• Category: Article
• ISSN: 0270-9139
• DOI: 10.1002/hep.510380231

✦ Synopsis

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, doubledummy, 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.