Hasin Deborah S, Wall Melanie, Witkiewitz Katie, Kranzler Henry R, Falk Daniel, Litten Raye, Mann Karl, O'Malley Stephanie S, Scodes Jennifer, Robinson Rebecca L, Anton Raymond
Columbia University, New York, NY, USA; New York State Psychiatric Institute, New York, NY, USA.
Columbia University, New York, NY, USA; New York State Psychiatric Institute, New York, NY, USA.
Lancet Psychiatry. 2017 Jun;4(6):469-476. doi: 10.1016/S2215-0366(17)30130-X. Epub 2017 Apr 26.
Alcohol dependence is often untreated. Although abstinence is often the aim of treatment, many drinkers prefer drinking reduction goals. Therefore, if supported by evidence of benefit, drinking reduction goals could broaden the appeal of treatment. Regulatory agencies are considering non-abstinent outcomes as efficacy indicators in clinical trials, including reduction in WHO drinking risk levels-very high, high, moderate, and low-defined in terms of mean ethanol consumption (in grams) per day. We aimed to study the relationship between reductions in WHO drinking risk levels and subsequent reduction in the risk of alcohol dependence.
In this population-based cohort study, we included data from 22 005 drinkers who were interviewed in 2001-02 (Wave 1) and re-interviewed 3 years later (2004-05; Wave 2) in the US National Epidemiologic Survey on Alcohol and Related Conditions. Alcohol consumption (WHO drinking risk levels) and alcohol dependence (at least three of seven DSM-IV criteria in the previous 12 months) were assessed at both waves. We used logistic regression to test the relationship between change in WHO drinking risk levels between Waves 1 and 2, and alcohol dependence at Wave 2.
At Wave 1, 2·5% (weighted proportion) of the respondents were very-high-risk drinkers, 2·5% were high-risk drinkers, 4·8% were moderate-risk drinkers, and most (90·2%) were low-risk drinkers. Reduction in WHO drinking risk level predicted significantly lower odds of alcohol dependence at Wave 2, particularly among very-high-risk drinkers (adjusted odds ratios 0·27 [95% CI 0·18-0·41] for reduction by one level, 0·17 [0·10-0·27] for two levels, and 0·07 [0·05-0·10] for three levels) and high-risk drinkers (0·64 [0·54-0·75] for one level and 0·12 [0·09-0·15] for two levels), and among those with alcohol dependence at Wave 1 (0·29 [0·15-0·57] for one level, 0·06 [0·04-0·10] for two levels, and 0·04 [0·03-0·06] for three levels in very-high-risk drinkers).
Our results support the use of reductions in WHO drinking risk levels as an efficacy outcome in clinical trials. Because these risk levels can be readily translated into standard drink equivalents per day of different countries, the WHO risk levels could also be used internationally to guide treatment goals and clinical recommendations on drinking reduction.
US National Institute on Alcohol Abuse and Alcoholism, New York State Psychiatric Institute, the Alcohol Clinical Trials Initiative.
酒精依赖常常得不到治疗。尽管戒酒通常是治疗的目标,但许多饮酒者更倾向于降低饮酒量的目标。因此,如果有获益证据支持,降低饮酒量目标可能会扩大治疗的吸引力。监管机构正在考虑将非戒酒结果作为临床试验中的疗效指标,包括降低世界卫生组织(WHO)饮酒风险水平——根据每日平均乙醇摄入量(克)定义的极高、高、中、低风险水平。我们旨在研究WHO饮酒风险水平的降低与随后酒精依赖风险降低之间的关系。
在这项基于人群的队列研究中,我们纳入了2001 - 2002年(第1波)接受访谈且3年后(2004 - 2005年;第2波)在美国国家酒精及相关疾病流行病学调查中再次接受访谈的22005名饮酒者的数据。在两波调查中均评估了饮酒量(WHO饮酒风险水平)和酒精依赖(在过去12个月内符合《精神疾病诊断与统计手册》第四版(DSM - IV)七项标准中的至少三项)。我们使用逻辑回归来检验第1波和第2波之间WHO饮酒风险水平的变化与第2波时的酒精依赖之间的关系。
在第1波时,2.5%(加权比例)的受访者为极高风险饮酒者,2.5%为高风险饮酒者,4.8%为中度风险饮酒者,大多数(90.2%)为低风险饮酒者。WHO饮酒风险水平的降低预示着第2波时酒精依赖的几率显著降低,特别是在极高风险饮酒者中(降低一个水平的调整优势比为0.27 [95%可信区间0.18 - 0.41],降低两个水平为0.17 [0.10 - 0.27],降低三个水平为0.07 [0.05 - 0.10])和高风险饮酒者中(降低一个水平为0.64 [0.54 - 0.75],降低两个水平为0.12 [0.09 - 0.15]),以及在第1波时有酒精依赖的人群中(极高风险饮酒者降低一个水平为0.29 [0.15 - 0.57],降低两个水平为0.06 [0.04 - 0.10],降低三个水平为0.04 [0.03 - 0.06])。
我们的结果支持将WHO饮酒风险水平的降低作为临床试验中的疗效结果。由于这些风险水平可以很容易地转化为不同国家每天的标准饮酒当量,WHO风险水平也可在国际上用于指导饮酒量降低的治疗目标和临床建议。
美国国家酒精滥用与酒精中毒研究所、纽约州精神病研究所、酒精临床试验倡议组织。