UDCA & VIT E

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Clin Gastroenterol Hepatol. 2006 Dec;4(12):1537-43.

Randomized placebo-controlled trial

of ursodeoxycholic Acid with vitamin e in

nonalcoholic steatohepatitis.

Dufour JF, Oneta CM, Gonvers JJ, Bihl F, Cerny A, Cereda JM, Zala JF, Helbling B, Steuerwald M, Zimmermann A; Swiss Association for the Study of the Liver.

Institute of Clinical Pharmacology, University of Bern, Bern.

Background & Aims: Nonalcoholic steatohepatitis

(NASH) is a frequent liver disease that can progress to cirrhosis and for which

there is no recognized therapy. UDCA and vitamin E

have been considered separately as therapeutic options and have not been shown

to be effective. This study tested their combination. Methods: Patients with elevated aminotransferase

levels and drinking less than 40 g alcohol/week with biopsy-proven NASH were

randomly assigned to receive UDCA 12-15 mg.kg(-1).day(-1)

with vitamin E 400 IU twice a day (UDCA/Vit E), UDCA

with placebo (UDCA/P), or placebo/placebo (P/P). After

2 years, they underwent a second liver biopsy. Biopsy

specimens were collected, blinded, and scored by a single liver pathologist. Results: Forty eight patients were included, 15 in the

UDCA/Vit E group, 18 in the UDCA/P group, and 15 in

the P/P group; 8 patients dropped out, none because of side effects. Baseline parameters were not significantly different between

the 3 groups. Body mass index remained unchanged

during the study. Serum aspartate

aminotransferase (AST) and alanine

aminotransferase (ALT) levels diminished

significantly in the UDCA/Vit E group. Neither the AST nor the ALT levels improved in the P/P

group and only the ALT levels in the UDCA/P group. Histologically, the activity index was unchanged at the end

of the study in the P/P and UDCA/P groups, but it was significantly better in

the UDCA/Vit E group, mostly as a result of

regression of steatosis. Conclusions: Two years of treatment with UDCA

in combination with vitamin E improved laboratory values and hepatic steatosis of patients with NASH. Larger

trials are warranted.

PMID: 17162245 [PubMed - in process]