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Swan Song for Beta Carotene . .
The Physicians' Health Study (PHS), a randomized, double-blind, placebo-controlled trial to evaluate the role of aspirin and beta carotene in the primary prevention of cardiovascular disease and cancer, terminated recently and provided the final results of the beta carotene component. The trial enrolled 22,071 male physicians in 1982, aged 40 to 84 years. On alternate days participants received either aspirin, beta carotene (50 mg), both, or neither. The aspirin phase of the trial was terminated early because of a statistically significant (44%) reduction in the risk of MI in the aspirin group. The beta carotene component continued until the scheduled termination of the trial at the end of 1995.
Subjects received an average 12 years of treatment and follow-up. Beta carotene was not associated with a significant difference in the rate of MI, stroke, deaths due to cardiovascular disease, or deaths due to all causes. The relative risk for all important cardiovascular events was 1.00 (95% CI, 0.91 to 1.09), demonstrating no hint of a benefit associated with beta carotene. There was also no significant association with the rate of malignant neoplasms. Comment: This important trial, which had revealed very significant information about the benefit of aspirin in preventing MI, now yields as important a negative finding on beta carotene. While the trial did not find a harm associated with beta carotene, supplementation with this micronutrient, accounting for tens of millions of dollars of spending annually, is not supported by the findings of this trial. As stated in the editorial, the money spent on this supplement "should now be diverted to more useful purposes."
— HM Krumholz
Published in Journal Watch Cardiology June 1, 1996
Citation(s):
Hennekens CH et al. Lack of effect of long-term supplementation with beta carotene on the incidence of malignant neoplasms and cardiovascular disease. N Engl J Med 1996 May 02 334 1145-1149.
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Greenberg ER and Sporn MB. Antioxidant vitamins, cancer, and cardiovascular disease. N Engl J Med 1996 May 02 334 1189-1190.
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