A randomized controlled pilot study of Pentoxifylline in patients with non-alcoholic steatohepatitis (NASH).
OBJECTIVE
Tumor necrosis factor-alpha (TNF-alpha) is implicated in non-alcoholic steatohepatitis (NASH). Pentoxifylline inhibits TNF-alpha. We wanted to evaluate the efficacy of Pentoxifylline on NASH patients.


METHODS
Patients with biopsy proven NASH and persistently elevated alanine aminotransferase (ALT) greater than 1.5 times the upper limit of normal were randomized to 3 months of treatment with a step 1 American Heart Association diet and daily exercise with Pentoxifylline or placebo. Liver function tests, serum lipids and TNF-alpha, Interleukin 6 (IL-6), and plasma hyaluronic acid were measured at baseline, at weeks 6 and 12. Categorical data were analyzed by Fisher's exact test while independent sample t-test and Mann-Whitney test were used for continuous data.


RESULTS
Eleven patients were randomized into the Pentoxifylline and nine to the placebo group. After 3 months of treatment body mass index (BMI), ALT and aspartate aminotransferase (AST) decreased significantly in both groups. There was no difference between the two groups in reduction of BMI (P = 0.897). There was significantly greater reduction in AST in the Pentoxifylline group (P = 0.038). There was a trend toward lower ALT level (P = 0.065) in the Pentoxifylline group. TNF-alpha and IL-6 decreased significantly in both groups after treatment, but there was no significant difference between the two groups.


CONCLUSIONS
Three months of Pentoxifylline treatment in combination with diet and exercise results in significantly greater reduction in AST levels in patients with NASH as compared with controls.
Lee
Yin-Mei
YM
Department of Gastroenterology/Hepatology, National University Hospital, 5 Lower Kent Ridge Road, Singapore, 119074, Singapore, mdcleeym@nus.edu.sg.
Sutedja
Dede S
DS
Wai
Chun-Tao
CT
Dan
Yock-Young
YY
Aung
Myat-Oo
MO
Zhou
Lei
L
Cheng
Chee-Leong
CL
Wee
Aileen
A
Lim
Seng-Gee
SG