Beta carotene supplementation and age-related maculopathy in a randomized trial of US physicians.
OBJECTIVE
To test whether beta carotene supplementation affects the incidence of age-related maculopathy (ARM) in a large-scale randomized trial.


METHODS
Randomized, double-masked, placebo-controlled trial among 22 071 apparently healthy US male physicians aged 40 to 84 years. Participants were randomly assigned to receive beta carotene (50 mg every other day) or placebo. Main Outcome Measure Incident ARM responsible for a reduction in best-corrected visual acuity to 20/30 or worse.


RESULTS
After 12 years of treatment and follow-up, there were 162 cases of ARM in the beta carotene group vs 170 cases in the placebo group (relative risk [RR], 0.96; 95% confidence interval [CI], 0.78-1.20). The results were similar for the secondary end points of ARM with or without vision loss (275 vs 274 cases; RR, 1.01; 95% CI, 0.86-1.20) and advanced ARM (63 vs 66 cases; RR, 0.97; 95% CI, 0.69-1.37).


CONCLUSIONS
These randomized data relative to 12 years of treatment among a large population of apparently healthy men indicate that beta carotene supplementation has no beneficial or harmful effect on the incidence of ARM. Long-term supplemental use of beta carotene neither decreases nor increases the risk of ARM.
Christen
William G
WG
Division of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital, 900 Commonwealth Ave E, Boston, MA 02215-1204, USA. wchristen@rics.bwh.harvard.edu
Manson
Joann E
JE
Glynn
Robert J
RJ
Gaziano
J Michael
JM
Chew
Emily Y
EY
Buring
Julie E
JE
Hennekens
Charles H
CH
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage; D001241:Aspirin / Q000008:administration & dosage; D002318:Cardiovascular Diseases / Q000517:prevention & control; D004311:Double-Blind Method; D006801:Humans; D015994:Incidence; D008268:Macular Degeneration / Q000453:epidemiology*; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000517:prevention & control; D010820:Physicians; D014481:United States / Q000453:epidemiology; D014792:Visual Acuity; D014815:Vitamins / Q000008:administration & dosage*; D019207:beta Carotene / Q000008:administration & dosage*
D000894:Anti-Inflammatory Agents, Non-Steroidal; D014815:Vitamins; D019207:beta Carotene; D001241:Aspirin