Lack of effect of long-term supplementation with beta carotene on the incidence of malignant neoplasms and cardiovascular disease
Lack of effect of long-term supplementation with beta carotene on the incidence of malignant neoplasms and cardiovascular disease
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DOI：
10.1056/nejm199605023341801
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发表时间：
1996-05-02
影响因子：
158.5
通讯作者：
Peto, R
中科院分区：
文献类型：
--
作者：
Hennekens, CH;Buring, JE;Peto, R
背景。观察性研究表明，食用更多含有 β 胡萝卜素的水果和蔬菜的人患癌症和心血管疾病的风险较低，早期的基础研究表明了合理的机制。由于需要进行长期的大型随机试验来直接检验这一假设，因此我们进行了一项补充 β 胡萝卜素的试验。方法。在一项 β 胡萝卜素（隔日 50 毫克）的随机、双盲、安慰剂对照试验中，我们招募了 22,071 名美国 40 至 84 岁的男性医生；在 1982 年研究开始时，11% 是当前吸烟者，39% 是前吸烟者。到 1995 年 12 月 31 日，即研究预定结束时，只有不到 1% 的人失访，接受 β 胡萝卜素组的依从性为 78%。结果。在 11,036 名被随机分配接受 β 胡萝卜素治疗的医生和 11,035 名被分配接受安慰剂的医生中，恶性肿瘤或心血管疾病的总体发病率或总体死亡率实际上没有早期或晚期差异。在 β 胡萝卜素组中，有 1273 名男性患有任何恶性肿瘤（非黑色素瘤皮肤癌除外），而安慰剂组有 1293 名男性（相对风险，0.98；95% 置信区间，0.91 至 1.06）。肺癌病例数也没有显着差异（β-胡萝卜素组为 82 例，安慰剂组为 88 例）；癌症死亡人数（386 比 380）、任何原因死亡人数（979 比 968）或心血管疾病死亡人数（338 比 313）；患有心肌梗塞的男性人数（468 比 489）；有中风的人数（367 比 382）；或具有前三个终点之一的数字（967 与 972）。在当前和以前的吸烟者中，这些终点中的任何一个都没有显着的早期或晚期差异。结论。在这项针对健康男性的试验中，补充 12 年 β 胡萝卜素对于恶性肿瘤、心血管疾病或全因死亡的发生率既没有带来好处，也没有带来坏处。 (C) 1996 年，马萨诸塞州医学会。
Background. Observational studies suggest that people who consume more fruits and vegetables containing beta carotene have somewhat lower risks of cancer and cardiovascular disease, and earlier basic research suggested plausible mechanisms. Because large randomized trials of long duration were necessary to test this hypothesis directly, we conducted a trial of beta carotene supplementation.Methods. In a randomized, double-blind, placebo-controlled trial of beta carotene (50 mg on alternate days), we enrolled 22,071 male physicians, 40 to 84 years of age, in the United States; 11 percent were current smokers and 39 percent were former smokers at the beginning of the study in 1982. By December 31, 1995, the scheduled end of the study, fewer than 1 percent had been lost to follow-up, and compliance was 78 percent in the group that received beta carotene.Results. Among 11,036 physicians randomly assigned to receive beta carotene and 11,035 assigned to receive placebo, there were virtually no early or late differences in the overall incidence of malignant neoplasms or cardiovascular disease, or in overall mortality. In the beta carotene group, 1273 men had any malignant neoplasm (except nonmelanoma skin cancer), as compared with 1293 in the placebo group (relative risk, 0.98; 95 percent confidence interval, 0.91 to 1.06). There were also no significant differences in the number of cases of lung cancer (82 in the beta carotene group vs. 88 in the placebo group); the number of deaths from cancer (386 vs. 380), deaths from any cause (979 vs. 968), or deaths from cardiovascular disease (338 vs. 313); the number of men with myocardial infarction (468 vs. 489); the number with stroke (367 vs. 382); or the number with any one of the previous three end points (967 vs. 972). Among current and former smokers, there were also no significant early or late differences in any of these end points.Conclusions. In this trial among healthy men, 12 years of supplementation with beta carotene produced neither benefit nor harm in terms of the incidence of malignant neoplasms, cardiovascular disease, or death from all causes. (C) 1996, Massachusetts Medical Society.