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Findings from this multicenter, NEI and NIH sponsored study were reported in the October 2001 issue of Archives of Ophthalmology. The study followed 3,640 participants, aged 55-80, for an average of 6.3 years.
Patients were initially enrolled in four AMD categories based on the size and extent of retinal drusen and level of visual acuity decline (Table 1), and were randomly assigned to one of four treatment arms:
While the investigators acknowledged the importance of lutein and zeaxanthin
for macular health, these carotenoids were not available for use in supplements when the study began. Instead, the investigators chose beta-carotene, which was then being studied for
heart disease and cancer.
AMD Categories In AREDS
Category 1: few small or no drusen
Category 2: several small drusen or a few medium-sized drusen in one or both eyes, or pigment abnormalities
Category 3: many medium-sized drusen or one or more large drusen in one or both eyes
Category 4: advanced AMD in one eye, or vision loss due to AMD in one eye only
Although the antioxidant and zinc supplements each appeared to offer some protection, the benefits of supplementation were
greatest for those patients who received the antioxidant and zinc combination, and who were in the highest-risk category groups.
Supplementation with combined antioxidants and zinc significantly reduced the risk of progression to advanced AMD in these groups
by 25%. A significant risk reduction in vision loss was also seen in the higher-risk groups taking both zinc and antioxidants, with
an odds reduction of 27% (Table 2).
Very few patients with less severe AMD went on to develop advanced cases. Therefore the study was unable to detect whether the
zinc and antioxidant combination might delay or prevent progression in subjects at an earlier stage. However, when the researchers
included the less severe category (category 2) with the more advanced categories (3 and 4), the combined supplements showed an odds reduction in the visual acuity outcome that approached statistical
significance (Table 2).
Most of the participants experienced few side effects. People in the zinc groups had more frequent urinary-tract related problems
than placebo-takers (7.5% vs. 5%), although it's not clear whether zinc played a role in their occurrence. Another caveat is that high
dose beta-carotene is contra-indicated for smokers and recent ex-smokers. The AREDS trial confirmed
the general safety and benefit of these high-potency nutrients in preserving vision among well-nourished, older people with intermediate to more advanced AMD.
Effect of Treatment on Risk of Visual Acuity Loss Score Greater or Equal to 15 Letters from baseline
Participants in AMD Categories 2, 3 & 4 (n=3597)
Participants in AMD Categories 3 and 4 (n=2549)
OR (99% CL)
Antioxidants vs. placebo
zinc vs. placebo
Antioxidant + zinc - Combination vs. Placebo
*Significant at p≤.01
Click here to read the full text of the AREDS clinical trial on the Archives of Opthalmology website.
Age-Related Eye Disease Study Research Group. A Randomized, Placebo-Controlled, Clinical Trial of High-Dose Supplementation with Vitamins C and E, Beta Carotene, and Zinc for Age-Related Macular Degeneration
and Vision Loss. Arch Ophthalmol 119:1417-36, 2001.
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