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提供非酒精饮料对酒精消费的影响:一项随机对照研究。

Effect of provision of non-alcoholic beverages on alcohol consumption: a randomized controlled study.

机构信息

Research and Development Center for Lifestyle Innovation, University of Tsukuba, 1-2 Kasuga, Tsukuba, Ibaraki, 305-8550, Japan.

Department of Family Medicine, General Practice and Community Health, Institute of Medicine, University of Tsukuba, Tsukuba, Japan.

出版信息

BMC Med. 2023 Oct 2;21(1):379. doi: 10.1186/s12916-023-03085-1.

Abstract

BACKGROUND

The use of alcohol-flavored beverages not containing alcohol (hereinafter referred to as non-alcoholic beverages) is recommended to reduce alcohol consumption. However, it is unclear if this reduces excessive drinking.

OBJECTIVE

To verify whether non-alcoholic beverages impact the alcohol consumption of excessive drinkers.

STUDY DESIGN

Single-center, open-label, randomized, parallel-group study.

METHODS

Participants aged 20 years or older who were not diagnosed with alcoholism, who drank at least four times a week, and whose alcohol consumption on those days was at least 40 g in males and 20 g in females, were recruited. Participants were randomized into the intervention or control group by simple randomization using a random number table. In the intervention group, free non-alcoholic beverages were provided once every 4 weeks for 12 weeks (three times in total), and thereafter, the number of alcoholic and non-alcoholic beverages consumed were recorded for up to 20 weeks. The consumption of alcoholic and non-alcoholic beverages was calculated based on a drinking diary submitted with the previous 4 weeks of data. The primary endpoint was the change from baseline in total alcohol consumption during past 4 weeks at week 12. The participants were not blinded to group allocations.

RESULTS

Fifty-four participants (43.9%) were allocated to the intervention group and 69 (56.1%) to the control group. None of the participants in the intervention group dropped out, compared to two (1.6%) in the control group. The change in alcohol consumption was - 320.8 g (standard deviation [SD], 283.6) in the intervention group and - 76.9 g (SD, 272.6) in the control group at Week 12, indicating a significant difference (p < 0.001). Even at Week 20 (8 weeks after the completion of the intervention), the change was - 276.9 g (SD, 39.1) in the intervention group, which was significantly greater than - 126.1 g (SD, 41.3) in the control group (p < 0.001). The Spearman rank correlation coefficient between the change in non-alcoholic beverage consumption and alcohol consumption at Week 12 was significantly negative only in the intervention group (ρ =  - 0.500, p < 0.001). There were no reports of adverse events during the study.

CONCLUSIONS

Providing non-alcoholic beverages significantly reduced alcohol consumption, an effect that persisted for 8 weeks after the intervention.

TRIAL REGISTRATION

UMIN UMIN000047949. Registered 4 June 2022.

摘要

背景

建议使用不含酒精的酒精味饮料(以下简称无酒精饮料)来减少酒精摄入量。然而,目前尚不清楚这是否会减少过量饮酒。

目的

验证无酒精饮料是否会影响过量饮酒者的饮酒行为。

研究设计

单中心、开放标签、随机、平行组研究。

方法

招募年龄在 20 岁及以上、未被诊断为酗酒、每周饮酒至少 4 次且每日饮酒量男性至少 40g、女性至少 20g 的参与者。参与者通过简单随机数表按简单随机分组分为干预组或对照组。在干预组中,每 4 周提供一次免费的无酒精饮料,共 12 周(共 3 次),此后记录参与者在接下来的 20 周内摄入的酒精和无酒精饮料的量。根据提交的过去 4 周的饮酒日记计算酒精和无酒精饮料的摄入量。主要终点是第 12 周时过去 4 周内总饮酒量相对于基线的变化。参与者对分组分配不知情。

结果

54 名参与者(43.9%)被分配到干预组,69 名参与者(56.1%)被分配到对照组。干预组中没有参与者退出,而对照组中有 2 名参与者(1.6%)退出。干预组第 12 周时的饮酒量变化为-320.8g(标准差[SD],283.6),对照组为-76.9g(SD,272.6),差异具有统计学意义(p<0.001)。甚至在第 20 周(干预结束后 8 周),干预组的饮酒量变化仍为-276.9g(SD,39.1),明显大于对照组的-126.1g(SD,41.3)(p<0.001)。仅在干预组中,第 12 周时无酒精饮料摄入量变化与酒精摄入量之间的 Spearman 秩相关系数具有显著的负相关性(ρ=-0.500,p<0.001)。在研究期间未报告不良事件。

结论

提供无酒精饮料可显著减少酒精摄入量,且该效果在干预结束后 8 周仍持续存在。

试验注册

UMIN UMIN000047949。于 2022 年 6 月 4 日注册。

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