The effect of vitamin E and beta carotene on the incidence of lung cancer and other cancers in male smokers.
The effect of vitamin E and beta carotene on the incidence of lung cancer and other cancers in male smokers.
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DOI：
10.1056/nejm199404143301501
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发表时间：
1994-04-14
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背景技术背景：流行病学证据表明，饮食中富含类胡萝卜素的水果和蔬菜，以及高血清维生素E水平，（α-生育酚）和β-胡萝卜素与肺癌风险降低有关。我们进行了一项随机、双盲、安慰剂对照的一级预防试验，以确定每天补充α-生育酚、β-胡萝卜素、或者两者都能降低肺癌和其他癌症的发病率。来自芬兰西南部的29，133名50至69岁的男性吸烟者被随机分配到四种方案中的一种：α-生育酚（每天50毫克），β-胡萝卜素（每天20毫克），α-生育酚和β-胡萝卜素，或安慰剂。随访持续5 ~ 8年。结果：在试验期间诊断的876例新肺癌病例中，接受α-生育酚治疗的男性发病率没有降低（与未接受α-生育酚治疗的男性相比，发病率变化为-2%，95%可信区间为-14%~12%）。出乎意料的是，我们观察到接受β-胡萝卜素的男性肺癌发病率高于未接受β-胡萝卜素的男性（发病率变化为18%; 95%置信区间为3%至36%）。我们没有发现证据表明α-生育酚和β-胡萝卜素之间的相互作用与肺癌的发病率。接受α-生育酚治疗的患者中诊断出前列腺癌的病例比未接受α-生育酚治疗的患者少。β-胡萝卜素对肺癌以外的其他癌症的发病率几乎没有影响。α-生育酚对总死亡率没有明显的影响，尽管在接受这种补充剂的男性中观察到出血性中风的死亡人数多于那些没有接受这种补充剂的男性。总死亡率高8%（95%的置信区间，1%至16%）的参与者中接受β-胡萝卜素比那些谁没有，主要是因为有更多的死亡肺癌和缺血性心脏病。结论：我们发现，在男性吸烟者中肺癌的发病率没有减少五至八年后，膳食补充α-生育酚或β-胡萝卜素。事实上，这项试验提出了这些补充剂实际上可能有害和有益的影响的可能性。
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.