Department of Psychology , University of New Mexico, Albuquerque, New Mexico.
Department of Psychiatry , University of Pennsylvania, Philadelphia, Pennsylvania.
Alcohol Clin Exp Res. 2018 Dec;42(12):2453-2465. doi: 10.1111/acer.13897. Epub 2018 Nov 5.
Abstinence and no heavy drinking days are currently the only Food and Drug Administration-approved end points in clinical trials for alcohol use disorder (AUD). Many individuals who fail to meet these criteria may substantially reduce their drinking during treatment, and most individuals with AUD prefer drinking reduction goals. One- and two-level reductions in World Health Organization (WHO) drinking risk levels have been proposed as alternative end points that reflect reduced drinking and are associated with reductions in drinking consequences, improvements in mental health, and reduced risk of developing alcohol dependence. The current study examined the association between WHO drinking risk level reductions and improvements in physical health and quality of life in a sample of individuals with alcohol dependence.
Secondary data analysis of individuals with alcohol dependence (n = 1,142) enrolled in the longitudinal, prospective COMBINE study, a multi site randomized placebo-controlled clinical trial, examining the association between reductions in WHO drinking risk levels and change in blood pressure, liver enzyme levels, and self-reported quality of life following treatment for alcohol dependence.
One- and two-level reductions in WHO drinking risk level during treatment were associated with significant reductions in systolic blood pressure (p < 0.001), improvements in liver enzyme levels (all p < 0.01), and significantly better quality of life (p < 0.001).
One- and two-level reductions in WHO drinking risk levels predicted significant improvements in markers of physical health and quality of life, suggesting that the WHO drinking risk level reduction could be a meaningful surrogate marker of improvements in how a person "feels and functions" following treatment for alcohol dependence. The WHO drinking risk levels could be useful in medical practice for identifying drinking reduction targets that correspond with clinically significant improvements in health and quality of life.
目前,美国食品和药物管理局(FDA)批准的酒精使用障碍(AUD)临床试验的终点仅为禁欲和无大量饮酒日。许多不符合这些标准的人在治疗期间可能会大量减少饮酒,而大多数 AUD 患者更喜欢减少饮酒的目标。世界卫生组织(WHO)饮酒风险水平的一级和二级降低已被提议作为替代终点,反映了饮酒量的减少,与减少饮酒后果、改善心理健康和降低发展为酒精依赖的风险相关。本研究在酒精依赖个体样本中检验了 WHO 饮酒风险水平降低与身体健康和生活质量改善之间的关联。
对参加纵向、前瞻性 COMBINE 研究的酒精依赖个体(n=1142)进行二次数据分析,这是一项多地点随机安慰剂对照临床试验,研究了在治疗期间 WHO 饮酒风险水平降低与血压、肝酶水平和酒精依赖治疗后自我报告的生活质量变化之间的关系。
治疗期间 WHO 饮酒风险水平的一级和二级降低与收缩压显著降低(p<0.001)、肝酶水平改善(均 p<0.01)和生活质量显著提高(p<0.001)相关。
WHO 饮酒风险水平的一级和二级降低预测了身体健康和生活质量的显著改善,表明 WHO 饮酒风险水平降低可能是一个有意义的替代标志物,可以衡量一个人在治疗酒精依赖后“感觉和功能”的改善程度。WHO 饮酒风险水平在医疗实践中可能有助于确定与健康和生活质量的临床显著改善相对应的饮酒减少目标。