M. Laccetti et al., Flumazenil in the treatment of acute hepatic encephalopathy in cirrhotic patients: a double blind randomized placebo controlled study, DIG LIVER D, 32(4), 2000, pp. 335-338
Aims. The aim of this study was to evaluate the effects of flumazenil on he
patic encephalopathy in patients with liver cirrhosis.
Patients and methods. in the double blind randomized, placebo controlled st
udy, 54 patients with hepatic encephalopathy grade III-IV were randomly ass
igned to receive either flumazenil 2 mg iv (group A) or placebo (group B);
conventional treatment with branched-chain amino acid, saline, glucose, and
lactulose was administered in both groups. A 24-hour observation period wa
s established. Clinical improvement was defined as a 3 point decrease in th
e Glasgow coma score at any time within 24 hours.
Results. Clinical improvement was obtained in 22/28 patients in group A and
in 14/26 in group B (p<0.05) improvement was observed within the first six
hours in 21/22 patients in group A and only in 3/14 in group B. Mortality
rate was not different between group A and B; however: all 6 non-responders
in group A and only 5 out of 12 in group B died within 24 hours. Among pat
ients with post-bleeding encephalopathy, 11 out of 17 in group A and only 2
out of 14 in group B improved (p<0.001).
Conclusions. Flumazenil may exert a beneficial effect in a subset of patien
ts with acute hepatic encephalopathy; encephalopathy associated with bleedi
ng is more likely to respond to flumazenil; responders to the treatment usu
ally improve within the first 6 hours while lack of response usually repres
ents a bad prognostic sign.