Lack of Effect of Long-Term Supplementation with Beta Carotene on the Incidence of Malignant Neoplasms and Cardiovascular Disease
Charles H. Hennekens, M.D., Julie E. Buring, Sc.D., JoAnn E. Manson, M.D., Meir Stampfer, M.D., Bernard Rosner, Ph.D., Nancy R. Cook, Sc.D., Charlene Belanger, M.A., Frances LaMotte, B.S., J. Michael Gaziano, M.D., Paul M. Ridker, M.D., Walter Willett, M.D., and Richard Peto, F.R.S.
Background Observational studies suggest that people who consumemore fruits and vegetables containing beta carotene have somewhatlower risks of cancer and cardiovascular disease, and earlierbasic research suggested plausible mechanisms. Because largerandomized trials of long duration were necessary to test thishypothesis directly, we conducted a trial of beta carotene supplementation.
Methods In a randomized, double-blind, placebo-controlled trialof beta carotene (50 mg on alternate days), we enrolled 22,071male physicians, 40 to 84 years of age, in the United States;11 percent were current smokers and 39 percent were former smokersat the beginning of the study in 1982. By December 31, 1995,the scheduled end of the study, fewer than 1 percent had beenlost to follow-up, and compliance was 78 percent in the groupthat received beta carotene.
Results Among 11,036 physicians randomly assigned to receivebeta carotene and 11,035 assigned to receive placebo, therewere virtually no early or late differences in the overall incidenceof malignant neoplasms or cardiovascular disease, or in overallmortality. In the beta carotene group, 1273 men had any malignantneoplasm (except nonmelanoma skin cancer), as compared with1293 in the placebo group (relative risk, 0.98; 95 percent confidenceinterval, 0.91 to 1.06). There were also no significant differencesin the number of cases of lung cancer (82 in the beta carotenegroup vs. 88 in the placebo group); the number of deaths fromcancer (386 vs. 380), deaths from any cause (979 vs. 968), ordeaths from cardiovascular disease (338 vs. 313); the numberof men with myocardial infarction (468 vs. 489); the numberwith stroke (367 vs. 382); or the number with any one of theprevious three end points (967 vs. 972). Among current and formersmokers, there were also no significant early or late differencesin any of these end points.
Conclusions In this trial among healthy men, 12 years of supplementationwith beta carotene produced neither benefit nor harm in termsof the incidence of malignant neoplasms, cardiovascular disease,or death from all causes.
Source Information
From the Divisions of Preventive Medicine (C.H.H., J.E.B., J.E.M., N.R.C., C.B., F.L., J.M.G., P.M.R.) and Cardiovascular Medicine (J.M.G., P.M.R.) and the Channing Laboratory (M.S., B.R., W.W.), Department of Medicine, Brigham and Women's Hospital; the Department of Ambulatory Care and Prevention, Harvard Medical School (C.H.H., J.E.B., N.R.C.); and the Departments of Epidemiology (C.H.H., J.E.B., M.S., W.W.), Biostatistics (B.R.), and Nutrition (M.S., W.W.), Harvard School of Public Health — all in Boston; and the Imperial Cancer Research Fund Clinical Trial Service Unit, University of Oxford, Oxford, England (R.P.).
Address reprint requests to Dr. Hennekens at 900 Commonwealth Ave. E., Boston, MA 02215.
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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Full Text
N Engl J Med 1996;
335:1065-1069, Oct 3, 1996.
Correspondence
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(2004). The Beta-Carotene and Retinol Efficacy Trial: Incidence of Lung Cancer and Cardiovascular Disease Mortality During 6-Year Follow-up After Stopping {beta}-Carotene and Retinol Supplements. JNCI J Natl Cancer Inst
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Schabath, M. B., Grossman, H. B., Delclos, G. L., Hernandez, L. M., Day, R. S., Davis, B. R., Lerner, S. P., Spitz, M. R., Wu, X.
(2004). Dietary Carotenoids and Genetic Instability Modify Bladder Cancer Risk. J. Nutr.
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Liu, R. H.
(2004). Potential Synergy of Phytochemicals in Cancer Prevention: Mechanism of Action. J. Nutr.
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Hercberg, S., Galan, P., Preziosi, P., Bertrais, S., Mennen, L., Malvy, D., Roussel, A.-M., Favier, A., Briancon, S.
(2004). The SU.VI.MAX Study: A Randomized, Placebo-Controlled Trial of the Health Effects of Antioxidant Vitamins and Minerals. Arch Intern Med
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Yuan, J.-M., Ross, R. K., Gao, Y.-T., Qu, Y.-H., Chu, X.-D., Yu, M. C.
(2004). Prediagnostic Levels of Serum Micronutrients in Relation to Risk of Gastric Cancer in Shanghai, China. Cancer Epidemiol. Biomarkers Prev.
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Khuri, F. R., Lotan, R.
(2004). Retinoids in Lung Cancer: Friend, Foe, or Fellow Traveler?. JCO
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Moos, P. J., Edes, K., Mullally, J. E., Fitzpatrick, F. A.
(2004). Curcumin impairs tumor suppressor p53 function in colon cancer cells. Carcinogenesis
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Keith, R. L., Miller, Y. E., Hudish, T. M., Girod, C. E., Sotto-Santiago, S., Franklin, W. A., Nemenoff, R. A., March, T. H., Nana-Sinkam, S. P., Geraci, M. W.
(2004). Pulmonary Prostacyclin Synthase Overexpression Chemoprevents Tobacco Smoke Lung Carcinogenesis in Mice. Cancer Res.
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Kris-Etherton, P. M., Lichtenstein, A. H., Howard, B. V., Steinberg, D., Witztum, J. L., for the Nutrition Committee of the American Heart,
(2004). Antioxidant Vitamin Supplements and Cardiovascular Disease. Circulation
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Zureik, M., Galan, P., Bertrais, S., Mennen, L., Czernichow, S., Blacher, J., Ducimetiere, P., Hercberg, S.
(2004). Effects of Long-Term Daily Low-Dose Supplementation With Antioxidant Vitamins and Minerals on Structure and Function of Large Arteries. Arterioscler. Thromb. Vasc. Bio.
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Tornwall, M. E., Virtamo, J., Korhonen, P. A., Virtanen, M. J., Albanes, D., Huttunen, J. K.
(2004). Postintervention Effect of Alpha Tocopherol and Beta Carotene on Different Strokes: A 6-Year Follow-Up of the Alpha Tocopherol, Beta Carotene Cancer Prevention Study. Stroke
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Eidelman, R. S., Hollar, D., Hebert, P. R., Lamas, G. A., Hennekens, C. H.
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