薬理と治療

Abstract

Background　Chrysanthemum flowers contain luteolin as the principal flavonoid and are traditionally used for eye care in Taiwan. We previously demonstrated that luteolin-enriched chrysanthemum flower extract（CFE）reduced serum uric acid levels in humans. Luteolin has also been reported to exert diverse biological effects, particularly anti-allergic activity. Objective　We herein conducted a clinical trial on the effects of CFE on allergic symptoms in the eyes and nose in Japanese healthy subjects. Methods　This was a randomized, double-blind, placebo-controlled trial and CFE（100 mg） containing 10 mg of luteolin was used as the active sample in a capsule. We enrolled 44 healthy Japanese individuals with mild allergic symptoms in the nose and eyes. All subjects were randomly allocated to an active group（n＝22）or placebo group（n＝22）using a computerized random number generator. One active or placebo capsule was taken twice a day for 8 weeks between February and April 2021. Japanese rhino-conjunctivitis quality of life questionnaire （JRQLQ）scores and each questionnaire item were assessed after 4 and 8 weeks as the primary outcomes. Blood, urine, and body parameters were also examined to evaluate the safety of CFE. Results　Forty-two subjects completed the trial, and the per protocol set comprised 21 subjects in the CFE group and 21 subjects in the placebo group. JRQLQ scores for eye symptoms after the 8-week intervention were significantly lower in the CFE group than in the placebo group. Laboratory tests revealed no abnormalities to suggest any side effects of CFE. Conclusions　CFE（200 mg╱day）containing 20 mg of luteolin reduced allergic symptoms in the eyes. Therefore, CFE may be beneficial for attenuating hay fever symptoms. （UMIN000042583）