These studies demonstrated improvement in biochemical profiles , with a decline in or normalization of liver enzymes .
However , some concerns have been raised regarding the use of vitamin E in patients with NASH due to its adverse effects profile and lack of significant improvement in hepatic fibrosis .
There has been a growing interest in the role of vitamin E supplementation in the treatment and /or prevention of nonalcoholic fatty liver ( NAFLD ) .
Furthermore , histological assessment showed favorable outcomes in lobular inflammation and hepatic steatosis following treatment with vitamin E. Current guidelines regarding the use of vitamin E in the setting of NAFLD recommend that vitamin E-based treatment be restricted to biopsy-proven nondiabetic patients with NASH only .
Pioglitazone, vitamin E, or placebo for nonalcoholic steatohepatitis.
BACKGROUND Nonalcoholic steatohepatitis is a common liver disease that can progress to cirrhosis . Currently , there is no established treatment for this disease . METHODS We r and omly assigned 247 adults with nonalcoholic steatohepatitis and without diabetes to receive pioglitazone at a dose of 30 mg daily ( 80 subjects ) , vitamin E at a dose of 800 IU daily ( 84 subjects ) , or placebo ( 83 subjects ) , for 96 weeks . The primary outcome was an improvement in histologic features of nonalcoholic steatohepatitis , as assessed with the use of a composite of st and ardized scores for steatosis , lobular inflammation , hepatocellular ballooning , and fibrosis . Given the two planned primary comparisons , P values of less than 0.025 were considered to indicate statistical significance . RESULTS Vitamin E therapy , as compared with placebo , was associated with a significantly higher rate of improvement in nonalcoholic steatohepatitis ( 43 % vs. 19 % , P=0.001 ) , but the difference in the rate of improvement with pioglitazone as compared with placebo was not significant ( 34 % and 19 % , respectively ; P=0.04 ) . Serum alanine and aspartate aminotransferase levels were reduced with vitamin E and with pioglitazone , as compared with placebo ( P<0.001 for both comparisons ) , and both agents were associated with reductions in hepatic steatosis ( P=0.005 for vitamin E and P<0.001 for pioglitazone ) and lobular inflammation ( P=0.02 for vitamin E and P=0.004 for pioglitazone ) but not with improvement in fibrosis scores ( P=0.24 for vitamin E and P=0.12 for pioglitazone ) . Subjects who received pioglitazone gained more weight than did those who received vitamin E or placebo ; the rates of other side effects were similar among the three groups . CONCLUSIONS Vitamin E was superior to placebo for the treatment of nonalcoholic steatohepatitis in adults without diabetes . There was no benefit of pioglitazone over placebo for the primary outcome ; however , significant benefits of pioglitazone were observed for some of the secondary outcomes . ( Clinical Trials.gov number , NCT00063622 .
These studies demonstrated improvement in biochemical profiles , with a decline in or normalization of liver enzymes .
However , some concerns have been raised regarding the use of vitamin E in patients with NASH due to its adverse effects profile and lack of significant improvement in hepatic fibrosis .
There has been a growing interest in the role of vitamin E supplementation in the treatment and /or prevention of nonalcoholic fatty liver ( NAFLD ) .
Furthermore , histological assessment showed favorable outcomes in lobular inflammation and hepatic steatosis following treatment with vitamin E. Current guidelines regarding the use of vitamin E in the setting of NAFLD recommend that vitamin E-based treatment be restricted to biopsy-proven nondiabetic patients with NASH only .