Cited by 4,737Antioxidant Activity and Oxidative StressHead and Neck Cancer StudiesLung Cancer Diagnosis and Treatment

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The Effect of Vitamin E and Beta Carotene on the Incidence of Lung Cancer and Other Cancers in Male Smokers

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The Alpha-Tocopherol Beta Carotene Cancer Prevention Study Group·1994·New England Journal of Medicine

DOI 10.1056/nejm199404143301501

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Abstract

BACKGROUND: Epidemiologic evidence indicates that diets high in carotenoid-rich fruits and vegetables, as well as high serum levels of vitamin E (alpha-tocopherol) and beta carotene, are associated with a reduced risk of lung cancer. METHODS: We performed a randomized, double-blind, placebo-controlled primary-prevention trial to determine whether daily supplementation with alpha-tocopherol, beta carotene, or both would reduce the incidence of lung cancer and other cancers. A total of 29,133 male smokers 50 to 69 years of age from southwestern Finland were randomly assigned to one of four regimens: alpha-tocopherol (50 mg per day) alone, beta carotene (20 mg per day) alone, both alpha-tocopherol and beta carotene, or placebo. Follow-up continued for five to eight years. RESULTS: Among the 876 new cases of lung cancer diagnosed during the trial, no reduction in incidence was observed among the men who received alpha-tocopherol (change in incidence as compared with those who did not, -2 percent; 95 percent confidence interval, -14 to 12 percent). Unexpectedly, we observed a higher incidence of lung cancer among the men who received beta carotene than among those who did not (change in incidence, 18 percent; 95 percent confidence interval, 3 to 36 percent). We found no evidence of an interaction between alpha-tocopherol and beta carotene with respect to the incidence of lung cancer. Fewer cases of prostate cancer were diagnosed among those who received alpha-tocopherol than among those who did not. Beta carotene had little or no effect on the incidence of cancer other than lung cancer. Alpha-tocopherol had no apparent effect on total mortality, although more deaths from hemorrhagic stroke were observed among the men who received this supplement than among those who did not. Total mortality was 8 percent higher (95 percent confidence interval, 1 to 16 percent) among the participants who received beta carotene than among those who did not, primarily because there were more deaths from lung cancer and ischemic heart disease. CONCLUSIONS: We found no reduction in the incidence of lung cancer among male smokers after five to eight years of dietary supplementation with alpha-tocopherol or beta carotene. In fact, this trial raises the possibility that these supplements may actually have harmful as well as beneficial effects.

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Authors: The Alpha-Tocopherol Beta Carotene Cancer Prevention Study Group
Corresponding author: The Alpha-Tocopherol Beta Carotene Cancer Prevention Study Group
Venue: New England Journal of Medicine
Publisher: Massachusetts Medical Society
Published: 1994-04-14
Volume: 330
Issue: 15
Pages: 1029-1035
ISSN: 0028-4793 (ISSN-L)
1533-4406
DOI: 10.1056/nejm199404143301501
OpenAlex: W1525444530
Cited by: 4,737
References: 27
Citations by year: 2026: 63 · 2025: 51 · 2024: 63 · 2023: 72 · 2022: 104 · 2021: 87 · 2020: 94 · 2019: 77 · 2018: 83 · 2017: 95 · 2016: 91 · 2015: 105 · 2014: 135 · 2013: 120 · 2012: 160
FWCI: 154.01
Type: journal article
Language: en
Open access: bronze
doi.org
Locations: New England Journal of Medicine (publishedVersion)
PubMed (publishedVersion)
Funders: National Institutes of Health (n01cn045165-030)
National Cancer Institute (N01 CN 45165)
Topics: Health Sciences › Medicine › Biochemistry (medical) › Antioxidant Activity and Oxidative Stress
Health Sciences › Medicine › Otorhinolaryngology › Head and Neck Cancer Studies
Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Diagnosis and Treatment
Keywords: vitamin E, alpha-tocopherol, beta-carotene, lung cancer, cancer prevention, smokers, dietary supplementation, prostate cancer, hemorrhagic stroke, all-cause mortality, ischemic heart disease
MeSH terms: Aged, Carotenoids, Cause of Death, Double-Blind Method, Finland, Humans, Lung Neoplasms, Male, Middle Aged, Smoking, Vitamin E, Incidence, beta Carotene

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The Effect of Vitamin E and Beta Carotene on the Incidence of Lung Cancer and Other Cancers in Male Smokers

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