Effect of α-Tocopherol (Vitamin E) and β-Carotene Supplementation on the Incidence of Intermittent Claudication in Male Smokers

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Abstract
Abstract We examined the primary preventive effect of vitamin E (α-tocopherol) and β-carotene supplementation on intermittent claudication. The subjects—participants in the Alpha-Tocopherol, Beta-Carotene Cancer Prevention Study—were male smokers aged 50 to 69 years who were randomly assigned to receive 50 mg of α-tocopherol daily, 20 mg of β-carotene daily, both, or placebo. At baseline, there were 26 289 men with no history or symptoms of intermittent claudication. The Rose questionnaire on intermittent claudication was administered annually to discover incident cases. We observed 2704 cases of first occurrence of typical intermittent claudication during a median follow-up time of 4.0 years. Compared with placebo, the adjusted relative risk for typical intermittent claudication among those who received α-tocopherol only was 1.11 (95% confidence interval, 1.00-1.24); among those who received α-tocopherol and β-carotene, 1.02 (0.91-1.13); and among those who received β-carotene only, 1.02 (0.92-1.14). When we compared the α-tocopherol–supplemented subjects with those who received no α-tocopherol, the adjusted relative risk for typical intermittent claudication was 1.05 (0.98-1.14), and for β-carotene–supplemented subjects compared with those who did not receive β-carotene, the relative risk was 0.96 (0.89-1.04). In conclusion, no primary preventive effect on intermittent claudication was observed among middle-aged male smokers who were supplemented with α-tocopherol, β-carotene, or both.

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