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Clinical Trials |

Age-Related Cataract in a Randomized Trial of Vitamins E and C in Men

William G. Christen, ScD; Robert J. Glynn, ScD; Howard D. Sesso, ScD; Tobias Kurth, MD; Jean MacFadyen, BA; Vadim Bubes, PhD; Julie E. Buring, ScD; JoAnn E. Manson, MD; J. Michael Gaziano, MD
Arch Ophthalmol. 2010;128(11):1397-1405. doi:10.1001/archophthalmol.2010.266.
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Published online

Objective  To test whether supplementation with alternate-day vitamin E or daily vitamin C affects the incidence of age-related cataract in a large cohort of men.

Methods  In a randomized, double-masked, placebo-controlled trial, 11 545 apparently healthy US male physicians 50 years or older without a diagnosis of cataract at baseline were randomly assigned to receive 400 IU of vitamin E or placebo on alternate days and 500 mg of vitamin C or placebo daily.

Main Outcome Measure  Incident cataract responsible for a reduction in best-corrected visual acuity to 20/30 or worse based on self-report confirmed by medical record review.

Application to Clinical Practice  Long-term use of vitamin E and C supplements has no appreciable effect on cataract.

Results  After 8 years of treatment and follow-up, 1174 incident cataracts were confirmed. There were 579 cataracts in the vitamin E–treated group and 595 in the vitamin E placebo group (hazard ratio, 0.99; 95% confidence interval, 0.88-1.11). For vitamin C, there were 593 cataracts in the treated group and 581 in the placebo group (hazard ratio, 1.02; 95% confidence interval, 0.91-1.14).

Conclusion  Long-term alternate-day use of 400 IU of vitamin E and daily use of 500 mg of vitamin C had no notable beneficial or harmful effect on the risk of cataract.

Trial Registration  clinicaltrials.gov Identifier: NCT00270647

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Figures

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Figure 1.

Flow diagram of the vitamin E and vitamin C components of the Physicians' Health Study (PHS) II. A total of 3096 participants who had a diagnosis of cataract at baseline were excluded.

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Figure 2.

Venn diagram showing subtypes for 1160 participants with diagnosed cataract in the Physicians' Health Study II. Excludes 14 participants with missing subtype information. PSC indicates posterior subcapsular.

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Figure 3.

Cumulative incidence rates of cataract in the vitamin E (A) and vitamin C (B) groups in the Physicians' Health Study II.

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Figure 4.

Hazard ratios and 95% confidence intervals (CIs) of cataract and subtypes comparing the vitamin E alone, vitamin C alone, and vitamin E plus vitamin C groups with placebo (combined vitamin E and vitamin C placebo groups) in the Physicians' Health Study II adjusted for age, Physicians' Health Study cohort, and beta carotene and multivitamin treatment assignment. PSC indicates posterior subcapsular. *Test of the null hypothesis of no difference in treatment effect across treatment combinations. †With or without other subtypes. Dotted vertical line indicates the 1.0 hazard ratio.

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