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. 2014 Sep;4(5):810-6.
doi: 10.4103/2141-9248.141562.

Pentoxifylline Plus Prednisolone versus Pentoxifylline Only for Severe Alcoholic Hepatitis: A Randomized Controlled Clinical Trial

Bk De  1 , Sk Mandal  1 , D Sau  1 , S Mani  1 , S Chatterjee  1 , Ss Mondal  1 , K Bhattacharya  1 , K Sil  1 , R Bhattacharya  1
Affiliations

Pentoxifylline Plus Prednisolone versus Pentoxifylline Only for Severe Alcoholic Hepatitis: A Randomized Controlled Clinical Trial

Bk De et al. Ann Med Health Sci Res. 2014 Sep.

Abstract

Background: Prednisolone and pentoxifylline (PTX) have been shown to be individually useful in severe alcoholic hepatitis with Maddrey discriminant function (MDF) score ≥32. Previous report suggests that PTX is probably superior to prednisolone alone. However the efficacy of PTX and prednisolone combination over PTX alone in the management of acute alcoholic hepatitis (MDF score ≥32) is yet unrevealed.

Aim: The present study was initiated to find out the efficacy of combined pentoxifylline and prednisolone versus PTX alone in acute alcoholic hepatitis in respect of short and intermediate term outcomes.

Subjects and methods: A total of 124 patients with severe alcoholic hepatitis (MDF score ≥ 32) initially were evaluated. 62 patients who fulfilled the inclusion and exclusion criteria were randomized and divided into 2 groups. Group 1 received PTX only, whereas Group 2 received PTX plus Prednisolone. The total duration of follow-up was 12 months. Student's t-test, Chi-square test, the Kaplan-Meier methods were used for statistical analysis.

Results: A total of 60 patients, 30 in each group were available for final analysis. In Group-1, 6 patients expired at the end of 1 year (5 within 3 months and another after 3 months). In Group 2, 10 patients expired at the end of 1 year (9 within 3 months and another after 3 months). Though survival probability is higher among Group 1 patients but the difference is not statistically significant.

Conclusion: The combination of PTX plus Prednisolone yields no additional benefit in terms of mortality and morbidity from that of PTX monotherapy.

Keywords: Alcoholic hepatitis; Maddrey discriminant function score; Pentoxifylline; Prednisolone.

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Conflict of interest statement

Conflict of Interest: None declared.

Figures

Figure 1
Figure 1
Survival curves (Kaplan-Meier life table analysis) of patients receiving pentoxifylline (PTX) (Group – 1) as compared to patients receiving PTX plus prednisolone (Group – 2), at the end of 3 months of therapy
Figure 2
Figure 2
Survival curves (Kaplan-Meier life table analysis) of patients receiving pentoxifylline (PTX) (Group – 1) as compared to patients receiving PTX plus prednisolone (Group – 2), at the end of 1 year of therapy
See this image and copyright information in PMC

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