A daily dose of a specific Vitamin E can improve liver disease, nonalcoholic steatohepatitis (NASH), a new study has revealed.
In addition, Actos (pioglitazone), a drug used to treat diabetes, also improved many features of NASH but was associated with weight gain.
NASH is a chronic liver disease that is linked to weight gain and obesity and can lead to cirrhosis, or scarring, liver cancer and death. It resembles alcoholic liver disease but occurs in patients who drink little or no alcohol. NASH can occur in children, the elderly, normal-weight, and non-diabetic persons.
The disease is apparently caused by abnormal metabolism of fats, which increases levels of oxidants, compounds that transfer oxygen in the liver.
In the Pioglitazone or Vitamin E for NASH Study (PIVENS), investigators from the NASH Clinical Research Network (CRN) compared the two different treatments to placebo.
Vitamin E functions as an anti-oxidant while Actos improves the sensitivity of cells to insulin, a hormone that controls sugar and fat metabolism.
PIVENS is the largest placebo-controlled, randomized clinical trial of therapies ever conducted for NASH.
"This is an important landmark in the search for effective treatments for NASH," said Dr. Pat Robuck, the NASH CRN project scientist.
The PIVENS trial randomly assigned 247 adults with NASH and without diabetes into three groups.
Researchers reported that vitamin E and Actos helped certain patients with NASH.
After 96 weeks of treatment, vitamin E improved all features of NASH except the degree of cirrhosis in the liver.
Forty-three percent of participants treated with vitamin E met the primary endpoint of the trial compared to only 19 percent of those who received a placebo.
The primary endpoint was a composite of the scores for several features of NASH-retention of lipids, liver inflammation, and liver degeneration. The scores were used to assess disease activity.
While Actos improved liver inflammation and retention of lipids in 34 percent of individuals who received it, suggesting a benefit, the improvement fell short of being statistically significant.
Actos also led to an undesirable weight gain of 10 pounds over the 96-week trial. There was an early improvement in liver enzyme tests among participants receiving either Actos or vitamin E.
However, upon stopping the medications, the liver enzymes worsened again suggesting the need for long-term treatment.
"This study was conducted in people who had NASH but did not have diabetes. The benefits of either treatment in NASH patients who have diabetes remain unknown. Also, the study lasted only two years and the potential long-term benefits and risks of taking vitamin E or Actos in these doses are still uncertain," said Dr. Arun Sanyal, NASH CRN co-chair.
The results were published online in the New England Journal of Medicine.