Vitamin E in the primary prevention of cardiovascular disease and cancer - The Women's Health Study: A randomized controlled trial
Vitamin E in the primary prevention of cardiovascular disease and cancer - The Women's Health Study: A randomized controlled trial
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DOI：
10.1001/jama.294.1.56
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发表时间：
2005-07-06
影响因子：
120.7
通讯作者：
Buring, JE
中科院分区：
文献类型：
--
作者：
Lee, IM;Cook, NR;Buring, JE
基础研究提供了合理的机制，观察性研究表明，表面健康的人，通过饮食或补充剂自行选择高摄入量的维生素E，降低了患心血管疾病和癌症的风险。随机试验通常不支持维生素E的益处，但很少有在最初健康的人群中进行的长期试验。目的探讨健康女性补充维生素E是否能降低心血管疾病和癌症的风险。在1992年至2004年间进行的妇女健康研究中，39876名年龄在45岁以上的明显健康的美国妇女被随机分配接受维生素E或安慰剂和阿司匹林或安慰剂，采用2 × 2因子设计，平均随访10.1年。隔天服用600国际单位的天然维生素E。主要结局指标主要结局是首次主要心血管事件（非致死性心肌梗死、非致死性卒中或心血管性死亡）和完全侵袭性癌症的复合终点。结果随访482例。维生素E组的主要心血管事件发生率为517例，安慰剂组为517例，风险降低了7%（相对风险[RR]， 0.93； 95%可信区间[CI]， 0.82-1.05； P= 0.26）。对心肌梗死（RR, 1.01; 95% Cl, 0.82-1.23； P= 0.96）或卒中（RR, 0.98; 95% Cl, 0.82-1.17； P= 0.82）以及缺血性或出血性卒中的发生率无显著影响。心血管死亡显著降低24% （RR, 0.76; 95% Cl, 0.59-0.98； P= 0.03）。对总癌症（维生素E组1437例，安慰剂组1428例；RR, 1.01; 95% Cl, 0.94-1.08； P= 0.87）、乳腺癌（RR, 1.00; 95% Cl, 0.90-1.12； P= 0.95）、肺癌（RR, 1.09; 95% Cl, 0.83-1.44； P= 0.52）或结肠癌（RR, 1.00; 95% Cl, 0.77-1.31； P= 0.99）的发病率无显著影响。癌症死亡率在两组之间也没有显著差异。维生素E对总死亡率无显著影响（维生素E组636例，安慰剂组615例；RR, 1.04; 95% Cl, 0.93-1.16； P= 0.53）。这项大型试验的数据表明，每隔一天服用600国际单位的天然维生素E对主要心血管事件或癌症没有总体益处，对健康女性的总死亡率没有影响，反而降低了心血管死亡率。这些数据不支持在健康女性中推荐补充维生素E来预防心血管疾病或癌症。
Context Basic research provides plausible mechanisms and observational studies suggest that apparently healthy persons, who self-select for high intakes of vitamin E through diet or supplements, have decreased risks of cardiovascular disease and cancer. Randomized trials do not generally support benefits of vitamin E, but there are few trials of long duration among initially healthy persons.Objective To test whether vitamin E supplementation decreases risks of cardiovascular disease and cancer among healthy women.Design, Setting, and Participants In the Women's Health Study conducted between 1992 and 2004, 39 876 apparently healthy US women aged at least 45 years were randomly assigned to receive vitamin E or placebo and aspirin or placebo, using a 2 X 2 factorial design, and were followed up for an average of 10.1 years.Intervention Administration of 600 IU of natural-source vitamin E on alternate days.Main Outcome Measures Primary outcomes were a composite end point of first major cardiovascular event (nonfatal myocardial infarction, nonfatal stroke, or cardiovascular death) and total invasive cancer.Results During follow-up, there were 482. major cardiovascular events in the vitamin E group and 517 in the placebo group, a nonsignificant 7% risk reduction (relative risk [RR], 0.93; 95% confidence interval [CI], 0.82-1.05; P=.26). There were no significant effects on the incidences of myocardial infarction (RR, 1.01; 95% Cl, 0.82-1.23; P=.96) or stroke (RR, 0.98; 95% Cl, 0.82-1.17; P=.82), as well as ischemic or hemorrhagic stroke. For cardiovascular death, there was a significant 24% reduction (RR, 0.76; 95% Cl, 0.59-0.98; P=.03). There was no significant effect on the incidences of total cancer (1437 cases in the vitamin E group and 1428 in the placebo group; RR, 1.01; 95% Cl, 0.94-1.08; P=.87) or breast (RR, 1.00; 95% Cl, 0.90-1.12; P=.95), lung (RR, 1.09; 95% Cl, 0.83-1.44; P=.52), or colon cancers (RR, 1.00; 95% Cl, 0.77-1.31; P=.99). Cancer deaths also did not differ significantly between groups. There was no significant effect of vitamin E on total mortality (636 in the vitamin E group and 615 in the placebo group; RR, 1.04; 95% Cl, 0.93-1.16; P=.53).Conclusions The data from this large trial indicated that 600 IU of natural-source vitamin E taken every other day provided no overall benefit for major cardiovascular events or cancer, did not affect total mortality, and decreased cardiovascular mortality in healthy women. These data do not support recommending vitamin E supplementation for cardiovascular disease or cancer prevention among healthy women.