A nationwide randomized, double-blind, placebo-controlled physicians’ trial of loxoprofen for the treatment of fatigue, headache, and nausea after hangovers

Hara, Masahiko; Hayashi, Kenichi; Kitamura, Tetsuhisa; Honda, Michitaka; Tamaki, Masatake

doi:https://doi.org/10.1016/j.alcohol.2019.10.006

A nationwide randomized, double-blind, placebo-controlled physicians’ trial of loxoprofen for the treatment of fatigue, headache, and nausea after hangovers

Hara, Masahiko; Hayashi, Kenichi; Kitamura, Tetsuhisa et al.

Alcohol, 2020, 84, 21-25

Number of Access:725（2025-10-22 07:40 Counts）

Identifier to cite or link to this item: https://hdl.handle.net/11094/78374

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Title	A nationwide randomized, double-blind, placebo-controlled physicians’ trial of loxoprofen for the treatment of fatigue, headache, and nausea after hangovers
Creator	CreatorName Hara, Masahiko
	NRID 1000070617274 1000070617274 CreatorName Hayashi, Kenichi
	NRID 1000030639810 1000030639810 ORCID 0000-0003-0107-0580 0000-0003-0107-0580 researchmap permalink Kitamura_T Kitamura_T Scopus Author ID 22234282700 22234282700 CreatorName Kitamura, Tetsuhisa
	NRID 1000030641956 1000030641956 CreatorName Honda, Michitaka
	CreatorName Tamaki, Masatake
Subject	Hangover
	Headache
	Loxoprofen
	Randomized controlled trial
Description	Masahiko Hara, Kenichi Hayashi, Tetsuhisa Kitamura, Michitaka Honda, Masatake Tamaki, A nationwide randomized, double-blind, placebo-controlled physicians’ trial of loxoprofen for the treatment of fatigue, headache, and nausea after hangovers, Alcohol, Volume 84, 2020, Pages 21-25, ISSN 0741-8329, https://doi.org/10.1016/j.alcohol.2019.10.006.
Abstract	Hangovers are associated with negative economic consequences due to decreased job performance or frequent visits to physicians. Thus, a new strategy for the alleviation of hangover-related symptoms is needed to avoid this detriment to society. The purpose of this nationwide randomized, double-blind, placebo-controlled physicians’ trial was to evaluate the efficacy of loxoprofen sodium for the alleviation of fatigue, headache, and nausea after hangover. A total of 229 participants were randomized to receive loxoprofen sodium (60 mg once orally) or placebo. The study was closed when the first 150 participants (n = 74 in the loxoprofen vs. n = 76 in the placebo groups) experienced hangovers. The primary endpoint was set as the difference in severity of general fatigue before and 3 h after taking the test drugs and was evaluated using a visual analogue scale. Secondary endpoints included difference in severity of headache, nausea, and incidence of adverse events. The study participants were 34 (interquartile range; 30-39) years old, 92.0% were men, and both groups were comparable for baseline characteristics. The alleviation of general fatigue did not differ statistically between the loxoprofen and placebo groups (24 [14-49] vs. 19 [9-35], p = 0.07). However, the alleviation of headache was statistically greater in the loxoprofen group (25 [10-50] vs. 10 [2-30], adjusted difference 14, 95% confidence interval 8-21, p < 0.001), whereas, there was no difference in nausea (7 [0-27] vs. 10 [0-24], p = 0.68). The incidence of adverse symptoms such as epigastric discomfort was also comparable between groups (2.7% vs. 3.9%, p = 0.25). Loxoprofen sodium was effective for relieving headaches after hangovers but did not alleviate general fatigue or nausea.
Publisher	Elsevier Inc.
Source Title	Alcohol
Volume (Issue)	84
Page	21-25
Date of Issued	2020-05
Language	English
Handle URL	https://hdl.handle.net/11094/78374
PISSN	07418329
eISSN	18736823
NCID	AA10631615
Relation.isIdenticalTo	DOI (Publisher Version) https://doi.org/10.1016/j.alcohol.2019.10.006
Relation.isIdenticalTo	PMID 31689482
Access Rights	open access
CopyRight	© 2019 The Authors. Published by Elsevier Inc. This article is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.
oaire:version	Version of Record
Category	学術雑誌論文 Journal Article

Resource Type	journal article
Local Type	Journal Article
DCMI Type	Text
DCTERMS.bibliographicCitation	Alcohol. 2020, 84, p. 21-25
DC.title	A nationwide randomized, double-blind, placebo-controlled physicians’ trial of loxoprofen for the treatment of fatigue, headache, and nausea after hangovers
DC.creator	Hara, Masahiko
	Hayashi, Kenichi
	Kitamura, Tetsuhisa
	Honda, Michitaka
	Tamaki, Masatake
DC.publisher	Elsevier Inc.
DC.language' scheme='DCTERMS.RFC1766	English
DC.type' scheme='DCTERMS.DCMIType	Text
DCTERMS.issued' scheme='DCTERMS.W3CDTF	2020-05
DC.identifier	https://doi.org/10.1016/j.alcohol.2019.10.006
DC.subject	Hangover
	Headache
	Loxoprofen
	Randomized controlled trial
DC.description	Masahiko Hara, Kenichi Hayashi, Tetsuhisa Kitamura, Michitaka Honda, Masatake Tamaki, A nationwide randomized, double-blind, placebo-controlled physicians’ trial of loxoprofen for the treatment of fatigue, headache, and nausea after hangovers, Alcohol, Volume 84, 2020, Pages 21-25, ISSN 0741-8329, https://doi.org/10.1016/j.alcohol.2019.10.006.
DCTERMS.abstract	Hangovers are associated with negative economic consequences due to decreased job performance or frequent visits to physicians. Thus, a new strategy for the alleviation of hangover-related symptoms is needed to avoid this detriment to society. The purpose of this nationwide randomized, double-blind, placebo-controlled physicians’ trial was to evaluate the efficacy of loxoprofen sodium for the alleviation of fatigue, headache, and nausea after hangover. A total of 229 participants were randomized to receive loxoprofen sodium (60 mg once orally) or placebo. The study was closed when the first 150 participants (n = 74 in the loxoprofen vs. n = 76 in the placebo groups) experienced hangovers. The primary endpoint was set as the difference in severity of general fatigue before and 3 h after taking the test drugs and was evaluated using a visual analogue scale. Secondary endpoints included difference in severity of headache, nausea, and incidence of adverse events. The study participants were 34 (interquartile range; 30-39) years old, 92.0% were men, and both groups were comparable for baseline characteristics. The alleviation of general fatigue did not differ statistically between the loxoprofen and placebo groups (24 [14-49] vs. 19 [9-35], p = 0.07). However, the alleviation of headache was statistically greater in the loxoprofen group (25 [10-50] vs. 10 [2-30], adjusted difference 14, 95% confidence interval 8-21, p < 0.001), whereas, there was no difference in nausea (7 [0-27] vs. 10 [0-24], p = 0.68). The incidence of adverse symptoms such as epigastric discomfort was also comparable between groups (2.7% vs. 3.9%, p = 0.25). Loxoprofen sodium was effective for relieving headaches after hangovers but did not alleviate general fatigue or nausea.
DC.rights	© 2019 The Authors. Published by Elsevier Inc. This article is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.
DC.format	78374
citation_title	A nationwide randomized, double-blind, placebo-controlled physicians’ trial of loxoprofen for the treatment of fatigue, headache, and nausea after hangovers
citation_author	Hara, Masahiko
	Hayashi, Kenichi
	Kitamura, Tetsuhisa
	Honda, Michitaka
	Tamaki, Masatake
citation_publisher	Elsevier Inc.
citation_language	English
citation_date	2020-05
citation_journal_title	Alcohol
citation_volume	84
citation_firstpage	21
citation_lastpage	25
citation_doi	https://doi.org/10.1016/j.alcohol.2019.10.006
citation_pmid	31689482
citation_public_url	https://hdl.handle.net/11094/78374

A nationwide randomized, double-blind, placebo-controlled physicians’ trial of loxoprofen for the treatment of fatigue, headache, and nausea after hangovers

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