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The conflicting evidence of the relation between ß-carotene and lung cancer in humans serves as a poignant case study with respect to what types of evidence are sufficient to support or change a nutrition recommendation. This article is a review of the available evidence of the relation between ß-carotene and lung cancer, including data regarding ß-carotene intake (from diet and supplements), ß-carotene biochemical status, and vegetable and fruit consumption, and a discussion of the role of this evidence in making nutrition recommendations. More than 30 case-control and cohort studies were conducted over many years in various populations and indicated that people who eat more vegetables and fruit, foods rich in carotenoids, and carotenoids (ß-carotene in particular), as well as those with higher blood ß-carotene concentrations, have a lower risk of lung cancer than those who eat fewer such foods or have lower ß-carotene concentrations. In contrast, the intervention results from large, controlled trials of ß-carotene supplementation do not support the observed beneficial associations or a role for supplemental ß-carotene in lung cancer prevention; instead, they provide striking evidence for adverse effects (ie, excess lung cancer incidence and overall mortality) in smokers. The findings require that caution be exercised in recommending supplemental ß-carotene, particularly for smokers, and argue against changing the vegetable-fruit recommendations in the direction of greater nutrient specificity. This case study of ß-carotene and lung cancer stresses the importance of having results from at least one, and preferably more, large, randomized intervention trial before public health recommendations concerning micronutrient supplementation are considered.
Key Words: ß-Carotene carotenoids antioxidants lung cancer clinical trials epidemiology prevention
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