Planning Grant for a Multi Center RCT of Moderate Alcohol Use on Chronic Disease

适度饮酒治疗慢性病的多中心随机对照试验计划拨款

• 批准号: 8757476
• 负责人: KENNETH Jay MUKAMAL
• 金额: $ 46.96万
• 依托单位: BETH ISRAEL DEACONESS MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-03-20 至 2016-02-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8757476
• 关键词: Accidents; Adherence; Adult; Affect; Africa; Alcohol abuse; Alcohol consumption; Alcoholism; Alcohols; Animals; Area; Asia; Atherosclerosis; Benefits and Risks; Beverages; Biological; Bone Density; Breast; Cardiovascular Diseases; Cardiovascular system; Cholelithiasis; Chronic Disease; Clinical; Clinical Trials; Clinical Trials Design; Clinical trial protocol document; Collaborations; Congestive Heart Failure; Coronary heart disease; Data; Development; Development Plans; Diabetes Mellitus; Disease; Documentation; Effectiveness; Elderly; Ensure; Epidemiologic Studies; Epidemiologist; Equilibrium; Estrogen Therapy; Estrogens; Ethanol; Europe; Face; Fibrinogen; Fracture; Future; Goals; Gold; Grant; Health; Health Care Seeking Behavior; Health Status; High Density Lipoprotein Cholesterol; Human; Hypertension; Influentials; Institutional Review Boards; Insulin Resistance; Intake; International; Intervention; Ischemic Stroke; Link; Malignant Neoplasms; Manuals; Methods; Monitor; Myocardial Infarction; National Institute on Alcohol Abuse and Alcoholism; Neurobiology; North America; Nutritional; Observational Study; Outcome; Outpatients; Participant; Pathway interactions; Patients; Pattern; Phase; Physicians; Postmenopause; Preparation; Protocols documentation; Psychiatrist; Randomized; Randomized Clinical Trials; Recommendation; Recruitment Activity; Research Infrastructure; Research Personnel; Residual state; Risk; Safety; Scientist; Site; Specimen; Stroke; Testing; Trauma; U-Series Cooperative Agreements; Woman; Women' s Health; Work; adiponectin; adjudicate; alcohol epidemiology; alcohol risk; cardiovascular disorder risk; cardiovascular risk factor; clinical practice; clinical research site; cost; data management; design; disorder prevention; drinking; experience; feeding; high risk drinking; improved; international center; malignant breast neoplasm; meetings; men; middle age; mortality; novel; operation; preference; public health relevance; randomized trial; repository; research study; response; sex; success

DESCRIPTION (provided by applicant): Moderate or low-risk alcohol consumption (defined by NIAAA as d4 drinks on any single day AND d14 drinks per week for men or d3 drinks on any single day AND d7 drinks per week for non-pregnant women) has been associated - despite its appellation - with a wide variety of health outcomes of the greatest import. Compared with abstainers or rare drinkers, moderate drinkers have been observed to have lower rates of coronary heart disease, congestive heart failure, ischemic stroke, diabetes, and cholelithiasis but higher rates of breast and possibly other cancers; relationships with fractures are less certain, although evidence suggests that moderate alcohol may simultaneously raise risk of trauma yet improve bone density. Perhaps most compellingly, moderate alcohol intake has been associated with a lower risk of all-cause mortality, chiefly reflecting its inverse associatio with cardiovascular mortality. Important limitations affect this body of evidence, however. Although large and consistent epidemiological studies have been conducted, strong concerns about residual confounding by both health status and health- seeking behavior exist. The existing experimental studies of alcohol are small and short and, while demonstrating plausible mechanisms by which moderate drinking would lower cardiometabolic risk, the lack of correspondence between similar studies of postmenopausal estrogen treatment and the randomized Women's Health Initiative clinical trial only heightens this concern. Given the widespread use of alcohol, the clear risks and costs of its overuse, the uncertain balance of risks and benefits of moderate use, and the complete lack of definitive clinical trial data, the urgent need for a clinical trial of moderate alcohol intake is unmistakable. In this Clinical Trial Planning Cooperative Agreement (U34) application, we propose to develop a multi-center, international, long-term, pragmatic randomized clinical trial of moderate drinking on the key clinical outcomes with which it has been associated - cardiovascular disease, cancer, diabetes, trauma, accidents, mortality, and progression to heavy or at-risk drinking. Building upon a team of established investigators and field centers with clinical trial and/or alcohol expertise (both i most cases) in North America, Asia, Europe, and Africa, we intend to develop a clinical trial protocol, recruit additional field centers, establish a data management network, and outline practical strategies for recruitment, intervention, monitoring, and outcome ascertainment across diverse settings. With a focus upon adults at higher cardiovascular risk to maximize efficiency, we will partner with NIAAA to develop a definitive clinical trial that can provide patients and clinicians worldwide with gold- standard advice about the effectiveness of moderate drinking in chronic disease prevention.

描述（由申请人提供）：中度或低风险酒精消费（NIAAA定义为男性在任何一天的d4饮酒量和每周d14饮酒量，或非妊娠女性在任何一天的d3饮酒量和每周d 7饮酒量）与各种最重要的健康结果相关-尽管其名称。与不饮酒者或很少饮酒者相比，适度饮酒者患冠心病、充血性心力衰竭、缺血性中风、糖尿病和胆石症的几率较低，但患乳腺癌和其他癌症的几率较高;与骨折的关系不太确定，尽管有证据表明适度饮酒可能同时增加创伤风险，但能提高骨密度。也许最令人信服的是，适度饮酒与全因死亡率的风险降低有关，主要反映了它与心血管死亡率的负相关。然而，重要的局限性影响了这一证据。尽管已经进行了大量和一致的流行病学研究，但仍然存在对健康状况和寻求健康行为的残余混杂的强烈关注。现有的酒精实验研究规模小，时间短，虽然证明适度饮酒会降低心脏代谢风险的合理机制，但绝经后雌激素治疗的类似研究与随机妇女健康倡议临床试验之间缺乏对应性只会加剧这种担忧。鉴于酒精的广泛使用，过度使用的明显风险和成本，适度使用的风险和收益的不确定平衡，以及完全缺乏明确的临床试验数据，对适度饮酒的临床试验的迫切需要是明确无误的。在该临床试验中 计划合作协议（U34）的应用，我们建议开发一个多中心，国际，长期，务实的随机临床试验，适度饮酒的关键临床结果与它相关-心血管疾病，癌症，糖尿病，创伤，事故，死亡率，并进展到重度或高危饮酒。在北美、亚洲、欧洲和非洲建立了一支由具有临床试验和/或酒精专业知识（大多数情况下都是）的研究者和现场中心组成的团队，我们打算制定临床试验方案，招募更多的现场中心，建立数据管理网络，并概述在不同环境下招募、干预、监测和结果确定的实用策略。我们将重点关注心血管风险较高的成年人，以最大限度地提高效率，我们将与NIAAA合作开发一项确定的临床试验，为全球患者和临床医生提供关于适度饮酒在慢性病预防中的有效性的黄金标准建议。