Author(s): Goulenok C, Bernard B, Cadranel JF, Thabut D, Di Martino V, , Goulenok C, Bernard B, Cadranel JF, Thabut D, Di Martino V,
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Abstract 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 < 0.001; Der Simonian: mean rate difference, 29\%; 95\% confidence interval, 17-41; P < 0.001). The mean percentages of patients with electroencephalographic improvement were 19\% in treated groups and 2\% in placebo groups. This difference was significant only with the Peto method (odds ratio=5.8; 95\% confidence interval, 3.4-9.7; P < 0.001). The sensitivity analysis showed similar results. CONCLUSIONS: This meta-analysis shows that flumazenil induces clinical and electroencephalographic improvement of hepatic encephalopathy in patients with cirrhosis.
This article was published in Aliment Pharmacol Ther
and referenced in Journal of Liver