Researchers from France conducted a meta-analysis to compare flumazenil and placebo in hepatic encephalopathy in patients with cirrhosis.
For each end-point, both 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 2 treatment periods.
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 minutes to 3 days.
|Patients with clinical improvement:|
| Alimentary Pharmacology & Therapeutics |
Heterogeneity tests between control groups were not significant.
The mean percentages of patients with clinical improvement (5 trials) were 27% in treated groups and 3% in placebo groups. This difference was significant by both methods (Peto: odds ratio = 6.2; Der Simonian: mean rate difference, 29%).
The team found that 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).
The sensitivity analysis showed similar results.
Author C. Goulenok, of the Pitié Salpêtrière Hospital, Paris, concluded on behalf of colleagues, "This meta-analysis shows that flumazenil induces clinical and electroencephalographic improvement of hepatic encephalopathy in patients with cirrhosis."