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Effect of provision of non-alcoholic beverages on alcohol consumption: a randomized controlled study
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 alcoh...
Autores principales: | , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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BioMed Central
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10544561/ https://www.ncbi.nlm.nih.gov/pubmed/37784187 http://dx.doi.org/10.1186/s12916-023-03085-1 |
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author | Yoshimoto, Hisashi Kawaida, Kyoko Dobashi, Shohei Saito, Go Owaki, Yukiko |
author_facet | Yoshimoto, Hisashi Kawaida, Kyoko Dobashi, Shohei Saito, Go Owaki, Yukiko |
author_sort | Yoshimoto, Hisashi |
collection | PubMed |
description | 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. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12916-023-03085-1. |
format | Online Article Text |
id | pubmed-10544561 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-105445612023-10-03 Effect of provision of non-alcoholic beverages on alcohol consumption: a randomized controlled study Yoshimoto, Hisashi Kawaida, Kyoko Dobashi, Shohei Saito, Go Owaki, Yukiko BMC Med Research Article 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. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12916-023-03085-1. BioMed Central 2023-10-02 /pmc/articles/PMC10544561/ /pubmed/37784187 http://dx.doi.org/10.1186/s12916-023-03085-1 Text en © The Author(s) 2023 https://creativecommons.org/licenses/by/4.0/Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data. |
spellingShingle | Research Article Yoshimoto, Hisashi Kawaida, Kyoko Dobashi, Shohei Saito, Go Owaki, Yukiko Effect of provision of non-alcoholic beverages on alcohol consumption: a randomized controlled study |
title | Effect of provision of non-alcoholic beverages on alcohol consumption: a randomized controlled study |
title_full | Effect of provision of non-alcoholic beverages on alcohol consumption: a randomized controlled study |
title_fullStr | Effect of provision of non-alcoholic beverages on alcohol consumption: a randomized controlled study |
title_full_unstemmed | Effect of provision of non-alcoholic beverages on alcohol consumption: a randomized controlled study |
title_short | Effect of provision of non-alcoholic beverages on alcohol consumption: a randomized controlled study |
title_sort | effect of provision of non-alcoholic beverages on alcohol consumption: a randomized controlled study |
topic | Research Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10544561/ https://www.ncbi.nlm.nih.gov/pubmed/37784187 http://dx.doi.org/10.1186/s12916-023-03085-1 |
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