AREDS 2 Supplement Claims Premature?

Research is evolving on the role antioxidant vitamin supplementation may play in slowing the progression of age-related macular degeneration (AMD); however, are the claims getting ahead of the science? Harriet Hall, M.D., specifically drew attention to advertising by Bausch & Lomb in this area, in a posting for Science Based Medicine, an online endeavor aiming to explore issues and controversies in the relationship between science and medicine;" it noted its physician contributors examine health care ideas and claims with a skeptical view.

She noted the evidence for the efficacy of antioxidants in the area of AMD primarily comes from the Age-Related Eye Disease Study (AREDS), which examined the impact of vitamin C, vitamin E, beta-carotene, zinc and copper. Supplementation had a statistically significant effect, with patients taking the supplement dropping their chance of developing vision loss from advanced AMD by 6 percent from those on a placebo.

Bausch & Lomb, which supplied the supplement for the AREDS study, offers a product called PreserVision Eye Vitamin AREDS Formula, based on the study formulation. Its new product, the AREDS 2 Formula, omits the beta-carotene and adds omega-3 fatty acids, lutein and zeaxanthinthe combination being studied in the AREDS 2 study, which is underway and being overseen by the National Institutes of Health (NIH).

However, Hall suggested the new formula may be promising more than it can deliver, as the AREDS 2 trial results wont be available until 2013. Further, she noted the product was recalled in the United States for reformulation after some patients had difficulty swallowing the softgels; it is expected back on shelves soon. Her concerns also included the fact that B&L sells other products with lower amounts of the vitamins and minerals used in the AREDS trial, and that the new formula is touted as the latest scientific advancement in eye vitamin therapy."

Instead, she suggested caution is warranted in promoting antioxidant supplements to patients with moderate to severe AMD, as the evidence stems from a single trial that has not been replicated, which showed only a modest effect.