RIFAXIMIN, A NONABSORBABLE RIFAMYCIN, FOR THE TREATMENT OF HEPATIC-ENCEPHALOPATHY - A DOUBLE-BLIND, RANDOMIZED TRIAL

The aim of this study was to evaluate the efficacy and tolerability of irifaximin, a non-absorbable intestinal antibiotic, in comparison to neomycin in the short-and long-term treatment of hepatic encephalopath y (HE). Forty-nine patients with a definite diagnosis of cirrhosis wer e included in this double-blind, randomised, controlled trial. Patient s were randomly assigned to one of the following treatments: (1) rifax imin 400 mg three limes daily, (2) neomycin 1 g three times daily. Bot h drugs were administrated ovally as tablets during 14 consecutive day s each month, for a period of six months. The neuropsychiatric signs a nd blood ammonia levels were examined before starting the treatment, a nd every 30 days, until the final assessment. In all patients a progre ssive and important reduction in HE grade was observed, and no statist ically significant difference between the two treatments was detected. In both groups the disturbances in speech, memory, behaviour and mood , gait, asterixis, writing and serial subtraction of 7s and five-point ed star tests all showed the highest proportion of improvement. During the study blood ammonia levels decreased in both the rifaximin and in the neomycin groups, and again no statistically significant differenc e was found between groups. Our findings confirm, therefore, the usefu lness of rifaximin in the treatment of HE, supporting its use as a fir st-choice antibiotic, particularly in patients intolerant to neomycin or with impaired renal function.