Vitamin, Mineral Combo Shows Promise for AMD

BETHESDA, Md.--A government-funded study concerning dietary supplements and eye health had media outlets such as CNN, The New York Times and The Washington Post posting positive stories about an industry it is usually not kind to. In a study appearing in the October Archives of Ophthalmology (119, 10:1417-36, 2001) (http://archopht.ama-assn.org), it was found that a high level of certain vitamins and minerals may not only reduce the risk of age-related macular degeneration (AMD), but also of the vision loss associated with it.

During a six-year, 11-center, double-masked clinical trial of 3,640 participants ages 55 to 80 years old, researchers found that a potent antioxidant combo may not only prevent age-related macular degeneration (AMD), but it may also prevent the loss of vision associated with this condition. In results from the Age-Related Eye Disease Study (AREDS) (www.nei.nih.gov/amd), sponsored by the National Institutes of Health's National Eye Institute (NEI), it was found that high levels of vitamins A, C and E, as well as zinc and copper reduced the risk for AMD by approximately 25 percent. Additionally, the supplements reduced the risk of vision loss by 19 percent. The researchers were quick to point out that this supplement is not a cure for AMD, nor will it restore vision already lost by AMD.

The supplement used in the study included 500 mg of vitamin C, 100 IU of vitamin E, 15 mg of beta-carotene, 80 mg of zinc oxide and 2 mg of copper as cupric oxide (copper was added because high levels of zinc have been linked to copper deficiency). As a comparison, the Recommended Daily Allowance (RDA) posted by the National Academy of Sciences is 90 mg/d for vitamin C (18 percent of what was used in the study), 15 IU/d of vitamin E (15 percent), 900 mcg/d of beta-carotene (6 percent), 11 mg/d of zinc (14 percent) and 900 mcg/d for copper (45 percent).

There were minor side effects from the treatment. Approximately 7.5 percent of those who received zinc experienced urinary tract problems that required hospitalization. The zinc group also reported anemia at a slightly higher rate than the non-zinc group. There was also an increased number of reports in the antioxidant supplemented subjects for yellowing skin-a common effect from large doses of beta-carotene.

"This is an exciting discovery because, for people at high risk for developing advanced AMD, these nutrients are the first effective treatment to slow the progression of the disease," said Paul Sieving, M.D., Ph.D., director of the NEI. "Currently, treatment for advanced AMD is quite limited. These nutrients will delay the progression to advanced AMD in people who are at high risk--those with intermediate AMD in one or both eyes, or those with advanced AMD in one eye already."

"The nutrients are not a cure for AMD, nor will they restore vision already lost from the disease," Sieving continued. "But, they will play a key role in helping people at high risk for developing advanced AMD keep their vision."

The study's investigators knew from the get-go that they were on the right track for testing these nutrients on people at risk for AMD. "Previous studies have suggested that people who have diets rich in green, leafy vegetables have a lower risk of developing AMD," said Frederick Ferris, M.D., director of clinical research at NEI and chairman of the AREDS. "However, the high levels of nutrients that were evaluated in the AREDS are very difficult to achieve from diet alone."

He added, "Almost two-thirds of AREDS participants chose to take a daily multivitamin in addition to their assigned study treatment. The AREDS also showed that, even with a daily multivitamin, people at high risk for developing advanced AMD can lower the risk of vision loss by adding a formulation with the same high levels of antioxidants and zinc used in the study." He told the news outlet, CNN, that as a medical treatment, this vitamin and mineral combination is a relatively inexpensive way to ward off AMD.

Susan Bressler, an ophthalmologist at Johns Hopkins Hospital and one of the leaders of the study told the Washington Post, "[The results in the study showed] a modest reduction, but given that there's no alternative and that this [treatment] is safe and nontoxic, even a modest reduction is a wonderful thing."

Bausch and Lomb (www.Bausch.com) collaborated in the AREDS and provided the supplement used in the study. In fact, the same time this story came out, Bausch released a press release that it had launched in the United States the product used in the study--Ocuvite PreserVision. This product is now available over-the counter and will be sold by major food, drug and mass retailers. "To be able to say definitively for the first time that this specific formulation of vitamins and minerals can actually preserve eye health and vision throughout the aging process in specific people is good news for the public," said Stephen Bartels, Ph.D., director of research at Bausch.

Although this study will be good news to many, others are quick to point out that there are other eye-healthy nutrients out there. Robert Abel, M.D., chairman of Kemin Foods' Lutein Information Bureau (www.luteininfo.com) advisory board, said that although vitamins and minerals may help AMD, so does lutein. "Studies are scientifically proving that the combination of the essential vitamins--and lutein--benefit aging Americans and people at risk for macular degeneration. As a matter of fact, there is demonstrable evidence in healthy and donor eyes that lutein plays a more important role than beta-carotene in retinal health."

Abel was not the only one touting the benefits of carotenoids. Daniel Perry, executive director of the Alliance for Aging Research (www.agingresearch.org), reported that the study might have shown the benefits of this supplement on AMD, but not on cataracts, another affliction of the aging population. He cited a 2000 study in the Journal of the American College of Nutrition (www.am-coll-nutr.org) that reported that lutein and zeaxanthin may not only reduce the risk for AMD, but also cataracts. "Although additional research studies on the relationships between diet, supplements and diseases of the eye are necessary, these new findings help to define nutritional solutions to reducing the risk for leading eye diseases."

Industry was also on hand to respond to this latest study. "The AREDS results on macular degeneration give us robust evidence that good nutrition, including proper supplement use, is an important tool in maintaining health," said Burton Kallman, Ph.D., director emeritus of science and quality assurance at the National Nutrition Foods Association (NNFA) (www.nnfa.org). "In addition to the human aspects of this evidence, the economic effects should not be overlooked. Preventing or delaying vision loss in millions of Americans in this manner will have an impact on reducing future health care costs."

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