METADOXINE ACCELERATES FATTY LIVER RECOVERY IN ALCOHOLIC PATIENTS - RESULTS OF A RANDOMIZED DOUBLE-BLIND, PLACEBO-CONTROL TRIAL

Background/Aims: Our aim was to investigate the effectiveness of metad oxine (pyridoxol L, 2 pyrrolidone-5-carboxylate) in the treatment of a lcoholic fatty liver, Methods: A double-blind randomized multicenter t rial involving 136 chronic active alcoholic patients diagnosed with fa tty liver by clinical, biochemical and ultrasonographic criteria was p erformed, Patients were treated with 1500 mg/day of metadoxine (n = 69 ) or placebo (n = 67) for 3 months, Patients were clinically and bioch emically evaluated every month, Ultrasonography was performed before a nd after treatment, Results: At the end of the study there was a signi ficant improvement in the liver function tests in both groups. However , the changes were more rapid and greater in patients treated with met adoxine, in whom significant changes in serum levels of bilirubin, ami notransferases and gammaglutamyl transpeptidase were already observed after 1 month of treatment, and normalization of these parameters was observed at the end, After treatment, the percentage of patients with ultrasonographic signs of steatosis was significantly lower in the met adoxine group (28% vs 70%, p<0.01) and the degree of steatosis was als o lower in this group, Sixteen patients treated with metadoxine and 15 with placebo continued drinking, Alcohol intake was lower than initia lly, and similar in both groups, In the metadoxine group, the biochemi cal changes were similar in both the abstinent and the nonabstinent pa tients, In contrast, in the placebo group the improvement in the liver function tests was significantly higher in abstinents, Among patients who continued drinking, the prevalence (45% vs 92%, p<0.05) and the d egree of steatosis were also significantly lower in patients treated w ith metadoxine. Conclusions: In patients with alcoholic fatty liver, m etadoxine accelerates the normalization of liver function tests and th e ultrasonographic changes, even in those who do not completely abstai n from alcohol intake, Thus, metadoxine could be useful in the treatme nt of the early stages of alcoholic liver disease.