Original articleRandomized Placebo-Controlled Trial of Ursodeoxycholic Acid With Vitamin E in Nonalcoholic Steatohepatitis
Section snippets
Study Design
Patients 18–75 years of age with a persistent elevation of serum ALT levels of at least 1.5 times the upper limit of normal for at least 6 months and a weekly alcohol consumption of less than 40 g confirmed by the patient and eventually by someone close to the patient were eligible if they had a liver biopsy performed no more than 6 months before inclusion showing macrovesicular steatosis of more than 10% of the hepatocytes, hepatocellular injury (ballooning, dropout), and lobular inflammation.
Results
Between January 1, 1999 and December 31, 2002, 48 patients from 7 different Swiss centers were included in the study. The demographic characteristics (age, gender, body mass index [BMI], ongoing therapy for arterial hypertension, and diabetes mellitus) were not significantly different between the 3 groups (Table 1). The mean serum levels of ALT and AST were elevated in the 3 groups at baseline and not significantly different. None of the 6 histologic parameters was significantly different among
Discussion
This double-blind, randomized, placebo-controlled study found that UDCA 12–15 mg · kg−1 · day−1 in combination with vitamin E 400 IU twice daily improves serum aminotransferase levels and liver histology of patients with NASH. This combination had beneficial effects, which could not be reached with UDCA monotherapy. With this therapeutic association the average of the serum AST and ALT levels reached normal range, and their decrease was significant. This was not the case in the P/P group or in the
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