A Randomised Double-Blind Trial of Pentoxifylline Alone versus Pentoxifylline Plus N Acetyl Cysteine in the Treatment of Severe Alcoholic Hepatitis in a Tertiary Care Hospital in Mysore, Karnataka

Author(s): Anurag Lavekar1, Deepak Suvarna2, Aradya V.3, Nandeesh P.4, Vijayakumar R.5, Rithesh Reddy6

Proven therapeutic options for treating severe alcoholic hepatitis are limited. The
study was conducted to compare pentoxifylline alone versus combination of
Pentoxifylline plus N acetylcysteine in severe alcoholic hepatitis patients.
A randomised, parallel, double blind, active controlled trial was conducted in
which, 240 cases were considered for analysis and were divided into two study
groups i.e. tablet pentoxifylline alone versus tablet pentoxifylline plus tablet N
acetylcysteine. The pentoxifylline group received 400 mg thrice daily for one
month and the other group received tablet pentoxifylline 400 mg thrice daily with
tablet N–acetyl cysteine 600 mg twice daily for one month. Enrolled patients were
called for follow up at one and three months. The parameters were compared
between the two study groups statistically and the results were obtained.
Forty-nine (20.4 %) patients expired in 3 months, out of which 35 (14.5 %)
expired at the end of 1st month. There was no significant difference in survival
between two groups at the end of one and three months (P = 0.58 and 0.10
respectively). Although liver function test (LFT), PT-INR (prothrombin timeinternational
normalised ratio) improved significantly from baseline in both the
groups (P < 0.0001), no significant difference was observed between the two
groups. Prevalence of hepatic encephalopathy was significantly low in
pentoxifylline plus N-acetylcysteine group at one and three months (P = 0.04 and
0.02 respectively).
Addition of N acetyl cysteine to pentoxifylline helps in reducing hepatic
encephalopathy in patients with severe alcoholic hepatitis; however, it does not
improve the short-term survival.