But only effective in less than half of cases, study finds
WEDNESDAY, April 28 (HealthDay News) -- A new study has identified vitamin E as a treatment that can provide relief for many of the estimated 10 million Americans who have the most common chronic liver disease.
"This clearly shows that vitamin E is effective for treatment of patients with nonalcoholic steatohepatitis who don't have active diabetes," said study author Dr. Arun J. Sanyal, chairman of the division of gastroenterology, hepatology and nutrition at Virginia Commonwealth University. A report on the trial is published in the April 28 online edition of the New England Journal of Medicine.
A second drug tested in the trial, the diabetes medication pioglitazone (Actos), provided some relief but did not meet the benchmarks set in the study, Sanyal added.
The trial did not test the two treatments head-to-head. Instead, each was tested against a placebo, an inactive substance. Those treatments were chosen for the trial because older studies indicated that insulin resistance was an important aspect of the condition, which is less formally called nonalcoholic fatty liver disease, while oxidative stress also plays an important role, Sanyal said. Actos reduces insulin resistance, while vitamin E is an antioxidant.
The study indicates that perhaps 43 percent of people with the condition who do not have diabetes will be helped by daily doses of vitamin E, Sanyal said. While some medications have shown promise in early tests, there is no drug approved by the U.S. Food and Drug Administration for treatment of nonalcoholic fatty liver disease.
The build-up of fatty deposits in the liver, which are caused by the condition, often creates only minor health problems. But the disease can progress to cirrhosis, and a life-threatening deterioration of liver function.
The 96-week study included 247 adults with the condition, none of whom had diabetes. Some patients were given 30 milligrams a day of Actos, some were given 800 International Units of vitamin E daily and others were given a placebo. A significant rate of improvement in markers of the disease, such as inflammation, was seen in 43 percent of those getting vitamin E, compared to 19 percent of those getting placebo. Similar improvement was seen in 34 percent of those getting Actos, compared to 19 percent of those getting placebo, a difference that was not statistically significant.
Actos might be a viable treatment for some people with fatty liver disease, but the study found its use was associated with significant weight gain that continued throughout the study, Sanyal said.
And vitamin E "should not be regarded as a panacea," he said. "It doesn't mean that everyone should start popping vitamin E."
Because of the high percentage of people who did not respond to vitamin E, that treatment should be done only under a doctor's supervision, with follow-ups to determine whether the treatment is working, Sanyal said.
And while no adverse side effects of the vitamin E regimen were seen, the small size of the study and its relatively short duration do not provide definitive evidence against such problems occurring, he said.
"Vitamin E will be a weapon in the arsenal that doctors have to treat patients with nonalcoholic steatohepatitis," said Patricia R. Robuck, a senior advisor at the U.S. National Institute of Diabetes and Digestive and Kidney Diseases, "but there are important cautions to be observed."
The trial included only "a relatively healthy population with no diabetes and no cardiovascular disease," Robuck said. "For those people, it can be an important treatment. But should everyone start taking vitamin E? Absolutely not. It should be done under a doctor's care and with careful supervision."
To learn more about fatty liver disease, visit the American Liver Foundation.
SOURCES: Arun J. Sanyal, M.D., chairman, division of gastroenterology, hepatology and nutrition, Virginia Commonwealth University, Richmond, Va.; Patricia R. Robuck, Ph.D., senior advisor, U.S. National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, Md.; April 28, 2010, New England Journal of Medicine, online
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