Alcoholic hepatitis represents one of the more serious forms of alcoholic liver disease.
Critically ill patients with alcoholic hepatitis have high morbidity and mortality rate.
Because of data suggesting that the pathogenic mechanisms in alcoholic hepatitis involve
cytokine release and the perpetuation of injury by immunologic process, corticosteroid has
been extensively evaluated in the treatment of alcoholic hepatitis. Although there are
discrepancies in literature as several randomized trials and meta-analyses have reached
contradictory results, corticosteroid for a subset of patients with severe alcoholic
hepatitis, defined as a discriminant function ≥ 32, who also have no concomitant
gastrointestinal bleeding, active infection, renal failure, and pancreatitis, has been
recommended. This latter point emphasizes the important of meticulous selection to avoid the
side effects of corticosteroid. Thus, the beneficial effects seems confined to a highly
selected minority group in which the inhibitory effect of corticosteroid on liver
inflammation is not outweighed by side effects such as weakened defense against infection,
anti-anabolic effects, and possible ulcer-promoting effects causing gastrointestinal
bleeding, which may be deleterious in these critically ill patients.
Newer understanding of the role of the role of TNF-α expression and receptor activity in
alcoholic liver injury has prompted to an examination of TNF inhibition as an alternative to
corticosteroid for severe alcoholic hepatitis. Pentoxifylline, a nonspecific TNF inhibitor,
recently has been demonstrated in a randomized trial to improve survival in the therapy of
severe alcoholic hepatitis. In particular, the survival benefit of pentoxifylline appears to
be related to a significant reduction in development of hepatorenal syndrome. These results
are promising, and support the need to further evaluate the potential of this new therapeutic
There is a need for head to head comparison of corticosteroid and pentoxifylline in severe
alcoholic hepatitis. At the time the current study was designed (2008), corticosteroid was
first-line treatment for severe alcoholic hepatitis. This study was designed to demonstrate
that the effect of pentoxifylline was similar (i.e., not inferior) to that of prednisolone,
an active form of prednisone. The aim of the present study was thus to compare the effects of
pentoxifylline and prednisolone on the short-term mortality.