An efficacy evaluation of the oral administration metadoxine in Korean alcoholic liver patients: A randomized, placebo-controlled trial

Background: To investigate the effectiveness of metadoxine(pyridoxol L-2 pyrrolidone-5-carboxylate) in the treatment of Korean alcoholic patients with liver diseases. Method: A randomized, placebo-controlled trial involving 36 chronic active alcoholic liver disease patients diagnosed by clinical, biochemical and ultrasonographic findings. Patients were treated with 1000mg/day of metadoxine(n=24) or placebo(n=12) for 2 months. Patients were clinically and biochemically evaluated every month. Abdominal ultrasonography was performed at the diagnosis. Results: At the end of the study there was a significant improvement in the liver function tests in both groups. However, the changes were more rapid and greater in patients treated with metadoxine. Almost all patients in both groups continued drinking through the study. Though alcohol intake was lower than initially and similar in both groups. Conclusion: In patients with alcoholic liver, metadoxine accelerates the normalization of liver function tests even in those who do not completely abstain from alcohol intake. We concluded that the metadoxine could be useful in the treatment of the alcoholic liver disease in Korea.