[Sodium benzoate in portal-systemic-encephalopathy-induced blood ammonia normalization and clinical improvement. Interim report of a double-blind multicenter trial].

To investigate the therapeutic efficacy of sodium benzoate (SB) in a cirrotic population with chronic portal systemic encepalopathy (PSE), we performed a double blind, randomised, multicentric, clinical trial, comparing SB versus a standard therapy of lactitol (LA). To perform the study blind, syrups containing the two drugs were prepared. To date 27 patients have been studied. Of these, 12 received SB (5.6 g/day) and 15 received LA (29 g/day). Standard PSE parameters were assessed and hippurate urinary excretion was measured before and after the trial. For the SB group, basal and final PSE index were 0.39 +/- 0.16 and 0.17 +/- 0.1 respectively (p < 0.001). The Group on LA had a PSE index of 0.40 + 0.1 and 0.23 +/- 0.18 (basal and final respectively) (p < 0.001). The final hippurate excretion for SB group was 2498.9 mg/24 h. The hippurate excretion for the LA group suffer no changes (traces). No serious side effects were observed with either therapy. We suggested that SB is a safe, efficacious and comfortable alternate treatment for PSE.