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NEI Statement

Review Supports Vitamin E Dosage in AREDS

December 14, 2004

Following recent media stories concerning high dosages of vitamin E, the National Eye Institute has reviewed the 2001 findings of the Age-Related Eye Disease Study (AREDS), a study of nearly 5,000 patients with varying stages of age-related macular degeneration (AMD) a leading cause of vision loss. Both the AREDS results regarding the risks and benefits of taking vitamin E and the results of multiple other published studies of vitamin E were reviewed.

A paper to be published in the January 2005 edition of the Annals of Internal Medicine will report that taking high-dose vitamin E supplements does not lower the risk of death, and there might be a small increase in the risk of death. The material in this paper was recently presented at a meeting of the American College of Physicians in New Orleans and this presentation has received much attention from the media. The authors of the paper analyzed combined data from 19 clinical trials that had tested vitamin E as a possible treatment for different diseases. One of the trials included in the analysis was the AREDS. In the AREDS, scientists found that people at high risk of developing advanced stages of AMD could lower their risk of the disease by about 25 percent when treated with a high-dose combination of vitamin C, vitamin E, beta-carotene, and zinc.

After careful study and interpretation of the data from the paper in Annals of Internal Medicine, the NEI researchers have concluded that taking a recommended 400 international units (IU) of vitamin E each day, as part of the AREDS formulation, does not increase the risk of death of persons at risk for advanced AMD.

"If the reason for taking vitamin E is to decrease mortality, we agree with the authors of this new study that there does not seem to be any benefit of vitamin E for most patients and there might be some harm at very high doses of 500 IU or more," Emily Chew, M.D., deputy director of the Division of Epidemiology and Clinical Research at NEI. "However if you are at high risk for developing AMD, there is a benefit in taking the AREDS formulation that includes vitamin E. Different patients have different needs and it is important to discuss with your doctor whether this formulation is right for you," says Dr. Chew.

In the new study, the data seem to show that people taking particularly high doses of vitamin E (500 IU to 2000 IU) may have a slightly increased risk of death. However, taking 400 IU vitamin E per day did not increase the risk of death in a total of 15,000 patients studied in several different clinical trials.

For additional information on the AREDS, please visit www.nei.nih.gov/amd.

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Citations

• Miller ER 3rd, Pastor-Barriuso R, Dalal D, Riemersma RA, Appel LJ, Guallar E. Meta-Analysis: High-Dosage Vitamin E Supplementation May Increase All-Cause Mortality. Ann Intern Med. 2004 Nov 10. [Epub ahead of print]. PubMed