Baseline characteristics of participants in the women's health study
Baseline characteristics of participants in the women's health study
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DOI：
10.1089/152460900318911
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发表时间：
2000-01-01
期刊：
影响因子：
--
通讯作者：
Buring, JE
中科院分区：
文献类型：
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作者：
Rexrode, KM;Lee, IM;Buring, JE
女性健康研究（WHS）是一项随机、双盲、安慰剂对照试验，旨在评估低剂量阿司匹林和维生素E在女性心血管疾病和癌症一级预防中的获益和风险平衡。共有39，876名女性卫生专业人员，年龄在45岁或以上，没有心血管疾病或癌症（非黑色素瘤皮肤癌除外）病史，以2 × 2析因设计随机分配到四个治疗组之一：活性阿司匹林和维生素E安慰剂，阿司匹林安慰剂和活性维生素E，两种活性药物，或两种安慰剂。随机化过程是成功的，大量基线人口统计学、生活方式和病史特征在4个治疗组中分布均匀。已知潜在混杂因素的相似分布以及大样本量提供了可靠的证据，即未测量或未知的潜在混杂因素也均匀分布。正如临床试验所预期的那样，研究中的女性在某些方面比普通人群更健康，但她们的肥胖率，高血压和胆固醇升高的比率非常相似。通过足够的治疗和随访时间，本试验将提供关于阿司匹林和维生素E补充剂在女性心血管疾病和癌症一级预防中的获益和风险平衡的重要和相关信息。
The Women's Health Study (WHS) is a randomized, double-blind, placebo-controlled trial designed to evaluate the balance of benefits and risks of low-dose aspirin and vitamin E in the primary prevention of cardiovascular disease and cancer in women. A total of 39,876 female health professionals, age 45 years or older and without a history of cardiovascular disease or cancer (other than nonmelanoma skin cancer), were randomized in a 2 x 2 factorial design to one of four treatment groups: active aspirin and vitamin E placebo, aspirin placebo and active vitamin E, both active agents, or both placebos. The process of randomization was successful, as evidenced by the equal distribution of a large number of baseline demographic, lifestyle, and hearth history characteristics among the four treatment groups. Similar distribution of known potential confounders, as well as the large sample size, provides reassuring evidence that unmeasured or unknown potential confounders are also equally distributed. As expected in a clinical trial, the women in the study are healthier in some respects than the general population, but they have very comparable rates of obesity, hypertension, and elevated cholesterol. With adequate duration of treatment and follow-up, this trial will provide important and relevant information on the balance of benefits and risks of aspirin and vitamin E supplementation in the primary prevention of cardiovascular disease and cancer in women.