A few years back, a big clinical trial showed that certain nutritional supplements could slow the progression of macular degeneration and reduce the risk of vision loss. “There was great interest among patients,” recalled Ingrid Scott, an ophthalmologist at the Penn State College of Medicine. “This was big news.”
Age-related macular degeneration is the leading cause of severe vision impairment and blindness in older Americans. For the great majority of those who have it, there’s no effective treatment. And it generally worsens with time. “Patients with age-related macular degeneration are extremely motivated to do whatever they can,” Dr. Scott said.
The trial showed that one thing they could do was to take a specific formula of vitamins, minerals and other nutrients. Manufacturers quickly responded with a host of over-the-counter pills making a host of claims. Now, my drugstore and supermarket — and yours — have shelves of products that supposedly help people with macular degeneration and other supplements that “promote” or “maintain” or “protect” eye health.
Do they? Dr. Scott and her colleagues recently reviewed the ingredients and found reasons to proceed with caution.
First, a primer.
The clinical trial called AREDS (Age-Related Eye Disease Study), conducted at 11 medical centers around the country by the National Eye Institute, found that a supplement could reduce the risk of worsening macular degeneration and severe vision loss by 25 percent over six years. The effective formula: a high-dose combination of vitamins C and E, beta carotene and zinc oxide, with a dash of copper.
“But the benefits of the nutrients only apply to certain stages of the disease,” Dr. Scott pointed out. “The formula could slow the progression in patients with either intermediate age-related macular degeneration or with advanced macular degeneration in only one eye.”
It didn’t work for people with milder forms of the disease, or with advanced age-related macular degeneration in both eyes. It didn’t prevent people from getting the disease in the first place. It didn’t cure anybody. But it was the best doctors could offer most patients with macular degeneration, apart from lifestyle modifications like stopping smoking.
Last year, a follow-up study called AREDS 2 examined a formula without beta carotene (because it’s associated with higher lung cancer rates in smokers), replacing it with the nutrients lutein and zeaxanthin and lowering the zinc content. The revised formula worked just as well.
So you’ll find those key initials, AREDS and AREDS 2, on a number of supplements sold in stores these days. Patients with moderate macular degeneration or advanced degeneration in one eye can take either, though smokers should go with AREDS 2.
But when Dr. Scott and her fellow researchers looked carefully at the supplements’ ingredients, in a study just published in the journal Ophthalmology, they found that most best-selling products didn’t follow the proven AREDS formula.
Some contained the right ingredients but not the right doses. Some added other stuff (selenium, B vitamins, grapeseed extract) that hasn’t been shown to slow macular degeneration and might actually reduce the effectiveness of the ingredients that do work. Of the 11 supplements that market research shows were top-sellers, only four duplicated the AREDS formula.
Moreover, most manufacturers didn’t bother to point out that the AREDS results don’t pertain to everyone with macular degeneration, and that therefore some consumers won’t benefit from these products.
(You can read more on the National Eye Institute’s fact sheet and patient FAQ.)
Manufacturers can get away with this because such products aren’t considered drugs. The Food and Drug Administration doesn’t test or approve supplements. “It may surprise people to know that dietary supplements are not evaluated or regulated at all for efficacy or safety,” Dr. Scott said.
When manufacturers say products that don’t use the AREDS formulas “protect” or “support” your eyes, “these claims are very vague,” Dr. Scott said. “There’s insufficient data to support them.”
That puts the onus on health professionals to prescribe specific brands that contain the proven formulas, and on consumers to shop carefully. These supplements don’t come cheap: At my local CVS, you’d pay $ 26.99 for the 90-pill size of PreserVision Eye Vitamin AREDS Formula Soft Gels. Taken as directed, you’ll pay $ 220 or so a year — out of pocket, of course, because Medicare Part D doesn’t cover supplements. But at least that’s one of the products that duplicated the AREDS formula, Dr. Scott and her colleagues reported.
Alternatively, you could pay $ 19.99 for 100 tablets of ICAPS Eye Vitamin Lutein & Zeaxanthin Formula at my local supermarket. Taking four a day as recommended, you’ll spend nearly $ 300 a year, but you won’t get the proper formula. The researchers found that it was one of the products with amounts of AREDS ingredients lower than those used in the studies proving they work.
So I’m passing along the findings of Dr. Scott and her colleagues, which are based not on laboratory analyses, just on what the manufacturers themselves said on product websites and packages. The report didn’t include Walmart products.
These four products duplicated the AREDS or AREDS2 formulas:
- PreserVision Eye Vitamin AREDS Formula tablets
- PreserVision Eye Vitamin AREDS Formula soft gels
- PreserVision AREDS2 Formula soft gels
- ICAPS Eye Vitamin AREDS Formula
Other best-selling supplements didn’t follow the AREDS formulae, including Eye Science Macular Health Formula, several products from Ocuvite and other ICAPS formulations. They had lower doses of the proven ingredients, or included substances not shown to be effective in these large-scale clinical trials.