薬理と治療

Abstract

Objective　This study aimed to investigate the effects of consuming food containing champignon extract（CME）on halitosis（bad breath）and its related concerns in healthy Japanese adults. Methods　This study was a randomized, double–blind, placebo–controlled, parallel–comparison study involving 66 subjects who met the eligibility criteria. The subjects were assigned to the CME group（n＝33; three tablets of CME［240 mg of CME per day］for 8 weeks）or placebo group（n＝33; placebo once daily for 8 weeks）using a random number generator. The assessment items were subjective symptoms（using a Keio Self–Rating Questionnaire for patients complaining of foul breath, visual analogue scale, and the Profile of Mood States 2nd Edition）, volatile sulfur compounds in the mouth, tongue coating score, oral moisture, and salivary volume at rest. The primary outcome was the total score of the Keio Self–Rating Questionnaire after 8 weeks. Furthermore, safety evaluations for test foods were conducted. Results　The total number of subjects analyzed according to the protocol set was 63 subjects （CME group, 32; placebo group, 31）. After 8 weeks, the total score of the Keio Self–Rating Questionnaire and its changes from baseline were significantly lower in the CME group than in the placebo group. No clinically significant changes caused by the continued consumption of the test food were observed. Conclusions　The 8–week consumption of CME–containing foods was confirmed to improve halitosis（bad breath）in healthy Japanese adults. Trial registration　UMIN000046201 Foundation　Greenhouse Co., Ltd.（Jpn Pharmacol Ther 2023；51：687‒701）