Effects of a Combination of Beta Carotene and Vitamin A on Lung Cancer and Cardiovascular Disease
Gilbert S. Omenn, M.D., Ph.D., Gary E. Goodman, M.D., M.S., Mark D. Thornquist, Ph.D., John Balmes, M.D., Mark R. Cullen, M.D., Andrew Glass, M.D., James P. Keogh, M.D., Frank L. Meyskens, M.D., Barbara Valanis, Dr.P.H., James H. Williams, M.D., Scott Barnhart, M.D., M.P.H., and Samuel Hammar, M.D.
Background Lung cancer and cardiovascular disease are majorcauses of death in the United States. It has been proposed thatcarotenoids and retinoids are agents that may prevent thesedisorders.
Methods We conducted a multicenter, randomized, double-blind,placebo-controlled primary prevention trial — the Beta-Caroteneand Retinol Efficacy Trial — involving a total of 18,314smokers, former smokers, and workers exposed to asbestos. Theeffects of a combination of 30 mg of beta carotene per day and25,000 IU of retinol (vitamin A) in the form of retinyl palmitateper day on the primary end point, the incidence of lung cancer,were compared with those of placebo.
Results A total of 388 new cases of lung cancer were diagnosedduring the 73,135 person-years of follow-up (mean length offollow-up, 4.0 years). The active-treatment group had a relativerisk of lung cancer of 1.28 (95 percent confidence interval,1.04 to 1.57; P = 0.02), as compared with the placebo group.There were no statistically significant differences in the risksof other types of cancer. In the active-treatment group, therelative risk of death from any cause was 1.17 (95 percent confidenceinterval, 1.03 to 1.33); of death from lung cancer, 1.46 (95percent confidence interval, 1.07 to 2.00); and of death fromcardiovascular disease, 1.26 (95 percent confidence interval,0.99 to 1.61). On the basis of these findings, the randomizedtrial was stopped 21 months earlier than planned; follow-upwill continue for another 5 years.
Conclusions After an average of four years of supplementation,the combination of beta carotene and vitamin A had no benefitand may have had an adverse effect on the incidence of lungcancer and on the risk of death from lung cancer, cardiovasculardisease, and any cause in smokers and workers exposed to asbestos.
Source Information
From the Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle (G.S.O., G.E.G., M.D.T., S.B.); the Departments of Environmental Health and Medicine, University of Washington, Seattle (G.S.O., G.E.G., S.B., S.H.); the Swedish Hospital Tumor Institute, Seattle (G.E.G.); the Department of Medicine, University of California at San Francisco, San Francisco (J.B.); the Department of Medicine, Yale University, New Haven, Conn. (M.R.C.); Kaiser Permanente Center for Health Research, Portland, Oreg. (A.G., B.V.); the Department of Medicine, University of Maryland, Baltimore (J.P.K.); and the Department of Medicine and Cancer Center, University of California at Irvine, Orange (F.L.M., J.H.W.).
Address reprint requests to Dr. Omenn at the Fred Hutchinson Cancer Research Center, Division of Public Health Sciences, 1124 Columbia–MP859, Seattle, WA 98104.
Antioxidant Vitamins, Cancer, and Cardiovascular Disease
Doering W., Pietrzik K., DeGrand D., Krinsky N. I., Peacocke M., Russell R. M., Hennekens C. H., Buring J. E., Peto R., Omenn G. S., Kushi L. H., Mink P. J., Folsom A. R., Greenberg E. R., Sporn M. B.
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N Engl J Med 1996;
335:1065-1069, Oct 3, 1996.
Correspondence
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