Lessons and Challenges from a 6-Month Randomized Pilot Study of Daily Ethanol Consumption: Research Methodology and Study Design.
Lessons and Challenges from a 6-Month Randomized Pilot Study of Daily Ethanol Consumption: Research Methodology and Study Design.
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DOI：
10.3945/cdn.117.000505
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发表时间：
2017-07
影响因子：
4.8
通讯作者：
Mittleman MA
中科院分区：
文献类型：
--
作者：
Mukamal KJ;Na B;Mu L;Mantzoros CS;Manning WJ;Mittleman MA
背景资料：观察性研究和交叉喂养研究表明，适度饮酒可能有利于心血管风险，但我们知道没有长期的随机试验已经验证了这一假设。 目的：我们在一项为期6个月的随机化先导性研究中评估了在心血管风险较高的成人中进行每日使用乙醇的疗效研究的可行性。 研究方法：在一项双盲、随机、对照平行设计试验中，我们筛选了67名年龄≥55岁的成年人，并随机分配45名参与者每天饮用150 mL含或不含10%谷物酒精的人工甜味饮料，持续6个月。参与者被要求不饮用其他酒精，每月返回接受饮料，并接受HDL胆固醇，肝功能测试和全血细胞计数的测量。 结果：在45名随机分配的参与者中，39人完成了试验;减员的主要原因是不便。没有参与者报告饮酒问题或发生任何严重不良事件或异常生化结果。然而，我们观察到酒精组和对照组之间的HDL胆固醇、HDL脂蛋白亚类、天冬氨酸转氨酶、丙氨酸转氨酶、γ-谷氨酰转移酶、平均红细胞体积或脂联素浓度无差异，表明依从性差。每个参与者都准确地识别了他们分配的饮料，大多数都非常确定。 结论：在这项关于每日饮酒的平行设计试点研究中，我们没有观察到酒精摄入标志物的预期变化，这表明对这种纯酒精干预的依从性较差。我们的研究结果表明，长期的酒精消费试验，如果他们在轻度饮酒者类似于这些进行，必须使用务实的设计，以最大的可行性。本研究在clinicaltrials.gov上注册为NCT 01377727。
Background: Observational studies and crossover feeding studies suggest that moderate alcohol use may benefit cardiovascular risk, but we know of no long-term randomized trials that have tested this hypothesis. Objective: We evaluated the feasibility of an efficacy study of daily ethanol use in a 6-mo randomized pilot study in adults at higher cardiovascular risk. Methods: In a double-blind, randomized, controlled parallel-design trial, we screened 67 adults aged ≥55 y and randomly assigned 45 participants to consume 150 mL of an artificially sweetened beverage with or without 10% grain alcohol daily for 6 mo. Participants were asked to consume no other alcohol and returned monthly to receive the beverage and undergo measurement of HDL cholesterol, liver function tests, and complete blood counts. Results: Of the 45 randomly assigned participants, 39 completed the trial; the primary reason cited for attrition was inconvenience. None of the participants reported problem drinking or developed any serious adverse events or abnormal biochemical findings. However, we observed no differences in concentrations of HDL cholesterol, HDL lipoprotein subclasses, aspartate aminotransferase, alanine aminotransferase, γ-glutamyltransferase, mean corpuscular volume, or adiponectin between the alcohol and control arms, suggesting that adherence was poor. Every participant accurately identified their assigned beverage, most with great certainty. Conclusions: In this parallel-design pilot study of daily alcohol use, we observed none of the expected changes in markers of alcohol intake, which suggests poor adherence to this pure alcohol intervention. Our results suggest that long-term trials of alcohol consumption, if they are conducted in light drinkers similar to these, must use pragmatic designs for maximal feasibility. This study was registered at clinicaltrials.gov as NCT01377727.