Flumazenil vs. placebo in hepatic encephalopathy in patients with cirrhosis: a meta‐analysis

Background: Randomized controlled trials testing flumazenil in hepatic encephalopathy have shown conflicting results. Aim: To compare flumazenil and placebo in hepatic encephalopathy in patients with cirrhosis. Methods: An overview of randomized controlled trials comparing flumazenil and placebo in...

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Bibliographic Details
Published in:Alimentary pharmacology & therapeutics 2002-03, Vol.16 (3), p.361-372
Main Authors: Goulenok, C., Bernard, B., Cadranel, J. F., Thabut, D., Di Martino, V., Opolon, P., Poynard, T.
Format: Article
Language:English
Subjects:
Biological and medical sciences
Coma - complications
Coma - drug therapy
Coma - physiopathology
Double-Blind Method
Electroencephalography
Female
Flumazenil - therapeutic use
Gabaergic and benzodiazepinic system
Hepatic Encephalopathy - complications
Hepatic Encephalopathy - drug therapy
Hepatic Encephalopathy - physiopathology
Humans
Liver Cirrhosis - complications
Liver Cirrhosis - physiopathology
Male
Medical sciences
Neuropharmacology
Neurotransmitters. Neurotransmission. Receptors
Odds Ratio
Patient Selection
Pharmacology. Drug treatments
Placebos
Randomized Controlled Trials as Topic
Research Design
Surveys and Questionnaires
Treatment Outcome
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Summary:Background: Randomized controlled trials testing flumazenil in hepatic encephalopathy have shown conflicting results. Aim: To compare flumazenil and placebo in hepatic encephalopathy in patients with cirrhosis. Methods: An overview of randomized controlled trials comparing flumazenil and placebo in hepatic encephalopathy in patients with cirrhosis was performed. For each end‐point, heterogeneity and treatment efficacy were assessed by Peto and Der Simonian methods. As most trials were crossover in nature, a sensitivity analysis was performed including the two treatment periods. Results: Six double‐blind randomized controlled trials, including 641 patients (326 treated with flumazenil and 315 with placebo), were identified. The treatment duration ranged from 5 min to 3 days. Heterogeneity tests between control groups were not significant. The mean percentages of patients with clinical improvement (five trials) were 27% in treated groups and 3% in placebo groups. This difference was significant by both methods (Peto: odds ratio=6.15; 95% confidence interval, 4.0–9.5; P 
ISSN:0269-2813
1365-2036
DOI:10.1046/j.1365-2036.2002.01191.x