Written by Jessica Patella, ND. Of 247 study participants, those 84 who received Vitamin E demonstrated a 43% statistically significant rate of improvement in non-alcoholic liver disease compared to a 19% rate of improvement in the placebo group.
Nonalcoholic Steatohepatitis (NASH) is a common liver disease that affects 2-5% of Americans (1). It is characterized by inflammation and fat in the liver and eventually can progress to cirrhosis. Currently there is no therapy of proven benefit for NASH, but current research gives some hope. Recently published in the New England Journal of Medicine, vitamin E was found to be beneficial in the treatment of NASH and pioglitazone may also be effective (2). Pioglitazone is a drug used to treat type 2 diabetes by decreasing insulin resistance (C19H20N2O3S.HCL). In the formula the numbers should be 1/2 space down and the period before HCL up 1/2 space.
The research focused on adults without diabetes that had been diagnosed with NASH via a liver biopsy (2). Steatohepatitis was categorized as absent, possible or definite (3). Disease activity was based on a standardized grading system for steatosis (fatty degeneration), lobular inflammation and hepatocellular ballooning (cell swelling and enlargement). Participants who met all eligibility criteria were randomly assigned to one of three groups for 96 weeks of treatment:
- Group 1: This group received the pharmaceutical drug pioglitazone (30mg once daily) and a vitamin E-like placebo
- Group 2: This group received vitamin E (800 IU d-alpha-tocopherol once daily) and a pioglitazone-like placebo
- Group 3: This group received a vitamin E-like placebo and a pioglitazone-like placebo (2).
Of the 247 participants that underwent randomization, 83 were assigned to receive placebo, 84 were assigned to receive vitamin E and 80 were assigned to receive pioglitazone. At the end of 96 weeks of treatment, the study drugs were discontinued and another liver biopsy was performed (2). The vitamin E group compared to the placebo group resulted in a significant rate of improvement in NASH (43% vs. 19%, p=0.001) but the pharmaceutical drug pioglitazone compared to the placebo did not reach a significant outcome.
Secondary outcomes were also run and both the vitamin E and pioglitazone groups had a significant reduction in steatosis (54%, 69% respectively) and lobular inflammation (54% and 60% respectively). Scores for hepatocellular ballooning were only improved with vitamin E (50% improvement). Fibrosis was not significantly improved with either vitamin E or pioglitazone (2).
It is likely that because of the severity of NASH that whichever drug is prescribed, it will likely need to be taken indefinitely. This draws a concern with the drug pioglitazone because of weight gain associated with the drug, which does not resolve even after discontinuing the drug (2).
In conclusion, treatment of nonalcoholic steatohepatitis in adults without diabetes with vitamin E was superior to placebo, and superior to ploglitazone in liver biopsy, heptocellular ballooning, potential weight gain and had similar benefits in other secondary outcomes.
Source: Sanyal, Arun J., et al. “Pioglitazone, vitamin E, or placebo for nonalcoholic steatohepatitis.” New England Journal of Medicine 362.18 (2010): 1675-1685.
© 2010 Massachusetts Medical Society
Posted August 6, 2010.
References:
- National Institute of diabetes and digestive and kidney disorders. “Nonalcoholic Steatohepatitis”
- Sanyal, A et al. Pioglitazone, Vitamin E, or Placebo for Nonalcoholic Steatohepatitis. N Engl J Med 2010; 362:1675-85.
- Kleiner, DE et al. Design and validation of histological scoring system for nonalcoholic fatty liver disease. Hepatology 2005; 41:1313-21
