薬理と治療

Abstract

Background　Ursolic acid in seaberry exhibits many biological activities. It has been shown to suppress carbachol-induced bladder muscle contraction and TGF-β-induced bladder smooth muscle cell contraction in collagen gel. We previously performed a clinical trial of ursolic acid in Japanese subjects with mild urinary dysfunction. The findings obtained showed that an 8-week treatment with ursolic acid（0.36 mg/day）improved several Kingʼs Health Questionnaire （KHQ）scores, including“Does your bladder problem make you depressed?”. A significant improvement was observed in the overactive bladder syndrome score（OABSS）for the item “How often do you have a sudden desire to urinate, which is difficult to defer?”. However, that study included healthy Japanese subjects with higher OABSS who were suspected as patients. Objective　To adopt the study to the Food with Function Claims system in Japan, we performed a stratified analysis by excluding healthy subjects suspected as patients according to the guidelines of the system. Methods　We excluded subjects who scored 2 points or more to the question“How often do you have a sudden desire to urinate, which is difficult to defer?”for OABSS and 3 points or more for total OABSS. The intervention period was 8 weeks, and urinary symptoms were evaluated by KHQ and OABSS. Results　The results of the stratified analysis showed that the daily intake of ursolic acid （0.36 mg╱day）for 8 weeks improved scores for“Impact of incontinence” and “Emotions”in KHQ. Improvements were also observed in several items related to urinary anxiety by the same dosing protocol. In OABSS, the score for urinary urgency was improved by the 8-week administration of ursolic acid（0.36 mg╱day）. Conclusions　The intake of ursolic acid（0.36 mg╱day for 8 weeks）improved several emotional parameters related to urinary dysfunction. Therefore, ursolic acid in seaberry is useful for reducing moderate urinary symptoms in healthy Japanese subjects. （UMIN000023486）