title: Vitamin E treatment in patients with nonalcoholic steatohepatitis: A six-month, open-label study of sixteen patients.
abstract: BACKGROUND
  Free radicals have a pivotal role in the pathogenesis of nonalcoholic steatohepatitis (NASH). Decreasing oxidative stress might have beneficial effects on the biochemical and histologic progression of this disease.
  
  
  OBJECTIVE
  We aimed to determine the therapeutic effect of vitamin E, a potent antioxidant, on liver enzymes and histology in NASH.
  
  
  METHODS
  This 6-month, open-label study was conducted at the Departments of Gastroenterology and Pathology, Gazi University School of Medicine (Ankara, Turkey). Patients aged 18 to 70 years with biopsy-proven NASH were included in the study. All patients received vitamin E 800 U/d in 2 divided doses, orally (capsules) for 6 months. Patients were not advised to change their exercise or dietary habits. Body mass index (BMI) was calculated at months 0 (baseline) and 6. Histologic scoring of steatosis, necroinflammatory grade, and fibrosis stage was performed at 0 and 6 months. Liver enzyme activities (alanine aminotransferase [ALT], aspartate aminotransferase [AST], alkaline phosphatase [ALP], and gamma-glutamyltransferase [GGT]) were monitored monthly. Control biopsy specimens were obtained at the end of the treatment. All of the liver biopsies were read by a single pathologist (G.A.) who was blinded to the clinical, laboratory, and histopathologic data, as well as the sequence of liver biopsies. Assessments of compliance and tolerability of treatment were performed using a pill count and patient interview, respectively, at the end of each month.
  
  
  RESULTS
  Sixteen patients (12 men, 4 women; mean [SD] age, 45.5 [6.9] years [range, 37-60 years]) were enrolled. All patients completed 6 months of treatment. Mean BMI did not change significantly from baseline. Significant improvements in mean (SD) serum liver enzyme activities were observed at 6 months compared with baseline (ALT: 38.6 [16.3] U/L vs 84.8 [22.1] U/L, respectively, P = 0.001; AST: 29.8 [15.4] U/L vs 46.0 [16.0] U/L, respectively, P = 0.001; ALP: 154.6 [64.1] U/L vs 211.5 [70.4] U/L, respectively, P= 0.011; and GGT: 49.8 [38.5] U/L vs 64.7 [54.4] U/L, respectively, P = 0.002), as well as in total cholesterol level (176.2 [42.0] mg/dL vs 199.6 [60.6] mg/dL; P = 0.02). Posttreatment liver biopsy was available in 13 patients (81%). Significant improvements in the mean (SD) scores of steatosis (1.46 [0.66] vs 2.43 [0.62]; P = 0.002) and necroinflammatory grade (0.84 [0.24] vs 1.31 [0.51]; P= 0.006) were observed at 6 months compared with baseline, respectively. However, no significant change was noted in the mean (SD) score of fibrosis stage (0.77 [0.33] vs 1.12 [0.59], respectively). None of the patients reported any adverse effects.
  
  
  CONCLUSIONS
  In this small, 6-month, open-label study, vitamin E treatment was safe and well tolerated and led to potential biochemical and histologic improvements (except in fibrosis) in patients with NASH.
authors.affiliation: Departments of Gastroenterology, Gazi University School of Medicine, Ankara, Turkey.
authors.forename: Fahri
authors.initials: F
authors.lastname: Yakaryilmaz
authors.affiliation: Departments of Gastroenterology, Gazi University School of Medicine, Ankara, Turkey.
authors.forename: Sefa
authors.initials: S
authors.lastname: Guliter
authors.affiliation: Departments of Gastroenterology, Gazi University School of Medicine, Ankara, Turkey.
authors.forename: Seren
authors.initials: S
authors.lastname: Ozenirler
authors.affiliation: Pathology, Gazi University School of Medicine, Ankara, Turkey.
authors.forename: Ozlem
authors.initials: O
authors.lastname: Erdem
authors.affiliation: Pathology, Gazi University School of Medicine, Ankara, Turkey.
authors.forename: Gulen
authors.initials: G
authors.lastname: Akyol