It’s a good time to revisit the National Institute of Health (NIH) AREDS studies and recommendations for vitamin supplements to treat intermediate-stage dry macular degeneration.
“AREDS” stands for the Age-Related Eye Disease Study, a NIH clinical trial that enrolled more than 5,000 people with age-related macular degeneration (AMD). When it ended, in 2001, AREDS showed that a specific formula of nutritional supplements containing high doses of antioxidants and zinc could slow the disease in those who have intermediate AMD and those with advanced AMD in only one eye.
Results of a follow-up study known as AREDS2 were published in 2013. Importantly, it substituted the nutrients, lutein and zeaxanthin, for beta-carotene, because they are also effective for retina health, whereas beta-carotene is linked to an increased risk of lung cancer in smokers. Results showed that the AREDS2 combination reduced the risk of disease progression by as much as 19 percent and/or of vision loss by 25 percent. In patients with early (Category Two) AMD, the supplements did not slow the disease’s progression to intermediate AMD. AREDS2 was not designed to test the effectiveness of supplements in patients with very early (Category 1) AMD or in AMD prevention.
Currently the AREDS and AREDS2 formulas are the only available treatments proven to be effective for intermediate-to-severe dry AMD. Dozens of “eye vitamins” and “ocular supplements” containing these ingredients have been marketed for AMD and eye health in recent decades. These have become popular and even essential among consumers because the dosages recommended in AREDS/AREDS2, particularly of vitamin E and zinc, are higher than those in most multivitamin supplements and also higher than can be taken in consistently through diet alone. Multivitamin use appears to be safe alongside AREDS/AREDS2 supplements, according to NIH.
- 500 mg vitamin C
- 400 IU vitamin E
- 10 mg lutein
- 2 mg zeaxanthin
- 80 mg zinc
- 2 mg copper
Study Checks Ingredients in AREDS/AREDS2 Supplements
Now a new study suggests that many people with AMD may not be getting their treatment benefits—or their money’s worth—from their ocular vitamins. It turns out that many of the products being marketed may not contain identical ingredient dosages to the AREDS and AREDS2 formulas.
Evidence of this surfaced recently in a leading medical journal, Ophthalmology. In a small study, clinician-researchers at major medical centers compared the ingredients for 11 brand-name supplements against the AREDS and AREDS 2 recommendations and found that many of the products were lacking. They didn’t analyze the contents of each product, just compared ingredients and dosages listed on bottles and company websites.
Their results showed that:
- Of 11 popular supplements analyzed, only 4 products adhered to and 7 products deviated from AREDS or AREDS2 ingredients
- 4 products contained lower doses of all the AREDS or AREDS2 ingredients
- 4 products included additional vitamins, minerals and herbal extracts that are not part of the AREDS or AREDS2 formulas
- There were misleading claims associated with all 11 products
"With so many vitamins out there claiming to support eye health, it's very easy for patients to be misled into buying supplements that may not bring about the desired results," said Jennifer J. Yong, MD, lead investigator and a resident at Yale-New Haven Hospital-Waterbury Hospital.
Yong said it’s important that eye doctors tell patients to take only proven formulations matching guidelines established by AREDS and AREDS2. Also, while it has been proven that supplements help in mid-stage AMD, they have not been shown to prevent the onset of AMD or other eye conditions, such as cataracts.
Additional clinician-researchers participating in the study are based from Penn State College of Medicine, Providence VA Medical Center, and Warren Alpert Medical School of Brown University
The group’s findings were published online last month (Yong et al, Ophthalmology, November 20, 2014). They also appear in a news release on the American Academy of Ophthalmology website, and AAO has created a downloadable chart showing the results for the 11 products analyzed in this study.
Still Have Questions? The Answers are Here.
Q. Why wasn’t the consumer better protected in this situation?
A. Nutritional supplements differ from prescription drugs in that they are less rigorously overseen by the U.S. Food and Drug Administration (FDA) and do not require FDA approval to be marketed and sold in the United States. Some of these products’ shortcomings may result from their being formulated before the AREDS and AREDS2 recommendations were finalized; in other cases, they may not be labeled as exactly equivalent to AREDS/AREDS2, even though they lend that impression.
Q. Could taking these supplements be harmful?
A. U.S. law (eg, the Food, Drug and Cosmetic Act) requires that dietary supplements sold here are safe, meaning free of contaminants or unknown harmful substances. This may relieve some worries. However, for people with intermediate-stage macular degeneration, some harm could lie in what they do not do. If the formula you’re taking differs from the AREDS and AREDS2 recommendations, you might not be getting the benefit for your eyes that both you and your doctor were expecting and counting on. In this study, seven brands contained dosages that were lower than recommended—in several cases drastically so, less than half. Those formulations have not been proven to bring about the same results as seen in the AREDS and AREDS2 studies.
Q. How can I check to see if my pills have the right amounts?
A. There are several ways. First, you can check the list of brands that were analyzed in this study to see if yours is included. View the chart.
If you don’t see the product you use, then try reviewing its ingredients yourself. Check the label on your pill bottle and cross check the ingredients and dosages that are listed there against the AREDS2 recommendations (see box above). If you don’t have your pill bottle handy or can’t locate that information, ask a drugstore pharmacist to help you. You can also see if the ingredients and dosages are posted on the manufacturer’s website or try calling the company’s 800 number.
A third way to check is to bring your supplements with you on your next eye appointment. Have your doctor or someone on the staff check the ingredients and dosages against AREDS/AREDS2 recommendations.
Q. What’s the difference between AREDS and AREDS2, and does it matter which one I follow?
A. If you smoke and your AREDS supplement contains beta-carotene, that could be a health hazard. AREDS2 recommendations removed beta-carotene and replaced it with lutein and zeaxanthin, which provide the same level of benefit without risk to smokers. Conveniently, the AREDS2 formula (reprinted above) works for smokers and nonsmokers alike.
Q. How can I protect myself when I purchasing dietary supplements in the future?
A. Manufacturers and distributors are prohibited by law from making false or misleading claims about vitamins and dietary supplements, however, language sometimes can be tricky. For that reason, it’s best to consult with your doctor(s) about supplements you are taking, and/or to seek advice from other consumers and trusted websites and organizations. Don’t make health decisions based on advertising claims alone.
The information provided in this section is a public service of BrightFocus Foundation, and should not in any way substitute for the advice of a qualified healthcare professional, and is not intended to constitute medical advice. Although we take efforts to keep the medical information on our website updated, we cannot guarantee that the information on our website reflects the most up-to-date research. Please consult your physician for personalized medical advice; all medications and supplements should only be taken under medical supervision. BrightFocus Foundation does not endorse any medical product or therapy.
Some of the content in this section is adapted from other sources, which are clearly identified within each individual item of information.