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Comparison of rifaximin and lactitol in the treatment of acute hepatic
Comparison of rifaximin and lactitol in the treatment of acute hepatic
encephalopathy: results of a randomized, double-blind, double-
dummy, controlled clinical trialq, qq
Antoni Mas1,*, Juan Rode?s1, Lourdes Sunyer2, Lu??s Rodrigo3, Ramon Planas4,
Victor Vargas5, Llu??s Castells5, Dolores Rodr??guez-Mart??nez6, Conrado Ferna?ndez-Rodr??guez6,
Ignasi Coll7, Albert Pardo8,
the Hepatic Encephalopathy Cooperative Group from the Spanish Association for the Study of the Liver?
1Liver Unit, Institut de Malalties Digestives, Hospital Cl??nic, Institut d’Investigacions Biome?diques August Pi i Sunyer (IDIBAPS),
University of Barcelona, Barcelona, Spain
2Laboratorios Zambon S.A., Barcelona, Spain
3Hospital Central de Asturias, Oviedo, Spain
4Hospital Germans Trias i Pujol, Badalona, Spain
5Hospital Vall d’Hebro?n, Barcelona, Spain
6Hospital Xeral Cies, Vigo, Spain
7Hospital Mu?tua de Terrassa, Terrassa, Spain
8Hospital Universitario de Canarias, La Laguna, Tenerife, Spain
Background/Aims: The efficacy and safety of rifaximin in comparison with lactitol in the treatment of acute 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 the portal-systemic encephalo-
pathy (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 o
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