title: Flumazenil therapy for hepatic encephalopathy in cirrhotic patients: a double-blind pragmatic randomized, placebo study.
abstract: OBJECTIVE
  To evaluate the effects of flumazenil on hepatic encephalopathy in patients with cirrhosis.
  
  
  METHODS
  Double-blind randomized study.
  
  
  METHODS
  Liver intensive care unit over a 2-year period.
  
  
  METHODS
  Fourteen patients with cirrhosis (median age 54 years, range 41-73 years), comprising 10 men and four women enrolled during 18 episodes of hepatic encephalopathy.
  
  
  METHODS
  Placebo or flumazenil (1 mg at 0.1 mg/min infusion rate) was infused in coded vials. The patients' hepatic encephalopathy was graded clinically and by electroencephalography (EEG).
  
  
  RESULTS
  In eight episodes of hepatic encephalopathy the placebo was infused first and no improvement occurred (0%). During 12 episodes of hepatic encephalopathy, flumazenil was administered and the EEG recording improved within 7 min (range 4-47 min; 12 out of 18 cases; 66 versus 0% for flumazenil versus placebo, respectively; P < 0.01); a modest clinical improvement in hepatic encephalopathy was observed within 83 min (range 30-340 min). The amount of flumazenil infused averaged 0.7 mg (range 0.4-1 mg).
  
  
  CONCLUSIONS
  The infusion of 0.4-1 mg flumazenil results in a modest but rapid improvement in the EEG grading of hepatic encephalopathy and to a moderate but delayed improvement in the clinical grade of hepatic encephalopathy.
authors.affiliation: Department of Hepato-Gastroenterology, Hospital Pitié-Salpétrière, Paris, France.
authors.forename: J F
authors.initials: JF
authors.lastname: Cadranel
authors.forename: M
authors.initials: M
authors.lastname: el Younsi
authors.forename: B
authors.initials: B
authors.lastname: Pidoux
authors.forename: P
authors.initials: P
authors.lastname: Zylberberg
authors.forename: Y
authors.initials: Y
authors.lastname: Benhamou
authors.forename: D
authors.initials: D
authors.lastname: Valla
authors.forename: P
authors.initials: P
authors.lastname: Opolon
mesh_terms: D000328:Adult; D000368:Aged; D004311:Double-Blind Method; D005260:Female; D005442:Flumazenil / Q000008:administration & dosage / Q000627:therapeutic use*; D006501:Hepatic Encephalopathy / Q000188:drug therapy* / Q000209:etiology; D006801:Humans; D007263:Infusions, Parenteral; D008103:Liver Cirrhosis / Q000150:complications*; D008297:Male; D008875:Middle Aged
chemical_list: D005442:Flumazenil