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

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

Research output: Contribution to journalArticle

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.

Original languageEnglish
Pages (from-to)21-25
Number of pages5
JournalAlcohol
Volume84
DOIs
Publication statusPublished - 2020 May

Keywords

  • Hangover
  • Headache
  • Loxoprofen
  • Randomized controlled trial

ASJC Scopus subject areas

  • Health(social science)
  • Biochemistry
  • Toxicology
  • Neurology
  • Behavioral Neuroscience

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