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Randomized Controlled Trial
. 2015 Apr 28;21(16):4975-85.
doi: 10.3748/wjg.v21.i16.4975.

Metadoxine improves the three- and six-month survival rates in patients with severe alcoholic hepatitis

Fátima Higuera-de la Tijera  1 , Alfredo I Servín-Caamaño  1 , Aurora E Serralde-Zúñiga  1 , Javier Cruz-Herrera  1 , Eduardo Pérez-Torres  1 , Juan M Abdo-Francis  1 , Francisco Salas-Gordillo  1 , José L Pérez-Hernández  1
Affiliations
Randomized Controlled Trial

Metadoxine improves the three- and six-month survival rates in patients with severe alcoholic hepatitis

Fátima Higuera-de la Tijera et al. World J Gastroenterol. .

Abstract

Aim: To evaluate the impact of metadoxine (MTD) on the 3- and 6-mo survival of patients with severe alcoholic hepatitis (AH).

Methods: This study was an open-label clinical trial, performed at the "Hospital General de México, Dr. Eduardo Liceaga". We randomized 135 patients who met the criteria for severe AH into the following groups: 35 patients received prednisone (PDN) 40 mg/d, 35 patients received PDN+MTD 500 mg three times daily, 33 patients received pentoxifylline (PTX) 400 mg three times daily, and 32 patients received PTX+MTD 500 mg three times daily. The duration of the treatment for all of the groups was 30 d.

Results: In the groups treated with the MTD, the survival rate was higher at 3 mo (PTX+MTD 59.4% vs PTX 33.3%, P = 0.04; PDN+MTD 68.6% vs PDN 20%, P = 0.0001) and at 6 mo (PTX+MTD 50% vs PTX 18.2%, P = 0.01; PDN+MTD 48.6% vs PDN 20%, P = 0.003) than in the groups not treated with MTD. A relapse in alcohol intake was the primary independent factor predicting mortality at 6 mo. The patients receiving MTD maintained greater abstinence than those who did not receive it (74.5% vs 59.4%, P = 0.02).

Conclusion: MTD improves the 3- and 6-mo survival rates in patients with severe AH. Alcohol abstinence is a key factor for survival in these patients. The patients who received the combination therapy with MTD were more likely to maintain abstinence than those who received monotherapy with either PDN or PTX.

Trial registration: ClinicalTrials.gov NCT02161653.

Keywords: Alcohol abstinence; Alcoholic hepatitis; Metadoxine; Survival.

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Figures

Figure 1
Figure 1
Enrollment and outcomes.
Figure 2
Figure 2
Kaplan Meier curves showing the 3-mo survival according to the treatment groups. Pentoxifylline + Metadoxine 59.4% vs Pentoxifylline 33.3%, Log rank test P = 0.04; Prednisone + Metadoxine 68.6% vs Prednisone 20%, Log rank test P = 0.0001.
Figure 3
Figure 3
Kaplan Meier curves showing the 6-mo survival according to the treatment groups. Pentoxifyne + Metadoxine 50% vs Pentoxifylline 18.2%, Log rank test P = 0.01; Prednisone + Metadoxine 48.6% vs Prednisone 20%, Log rank test P = 0.003.
See this image and copyright information in PMC

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