Comparison of rifaximin and lactitol in the treatment of acute hepatic encephalopathy: results of a randomized, double-blind, double-dummy, controlled clinical trial.
OBJECTIVE
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 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 adverse 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.
Mas
Antoni
A
Liver Unit, Institut de Malalties Digestives, Hospital Clínic, Institut d'Investigacions Biomèdiques August Pi i Sunyer, University of Barcelona, Barcelona, Spain. amas@medicina.ub.es
Rodés
Juan
J
Sunyer
Lourdes
L
Rodrigo
Luís
L
Planas
Ramon
R
Vargas
Victor
V
Castells
Lluís
L
Rodríguez-Martínez
Dolores
D
Fernández-Rodríguez
Conrado
C
Coll
Ignasi
I
Pardo
Albert
A
D000208:Acute Disease; D000641:Ammonia / Q000097:blood; D000890:Anti-Infective Agents / Q000627:therapeutic use*; D004311:Double-Blind Method; D004569:Electroencephalography; D005260:Female; D006501:Hepatic Encephalopathy / Q000097:blood / Q000188:drug therapy* / Q000503:physiopathology; D006801:Humans; D008297:Male; D008875:Middle Aged; D012008:Recurrence; D012294:Rifamycins / Q000627:therapeutic use*; D000078262:Rifaximin; D012720:Severity of Illness Index; D013402:Sugar Alcohols / Q000627:therapeutic use*; D016896:Treatment Outcome
D000890:Anti-Infective Agents; D012294:Rifamycins; D013402:Sugar Alcohols; D000641:Ammonia; C014635:lactitol; D000078262:Rifaximin