薬理と治療

Abstract

Objective　Our preceding pilot study showed that the pomegranate fruit extract achieved improvements in quality of life（QOL）deterioration caused by a desire to void and urination problems in women with high daytime urinary frequency. To clarify these issues, the present randomized, double-blind, placebo-controlled, parallel-group study was conducted to investigate the effects of a supplement containing pomegranate fruit-derived punicalagin（PP）on QOL among healthy women who reported mental stress such asʻfeeling botheredʼorʻtoilet anxietyʼ caused by desire to void in daily life. Methods　Forty-two eligible subjects were randomized to receive 69 mg PP or placebo daily for 8 weeks. Efficacy on urinary stress was evaluated based on the Short Form-8（SF-8）comprehensive health-related QOL questionnaire, Overactive Bladder questionnaire（OAB-q）and a visual analogue scale（VAS）. To assess urination function and frequent feelings of urinary urgency, a urination diary was also kept. Results　Analysis of the fully evaluable population revealed that two items of the SF-8（social functioning［SF］; and mental component summary［MCS］）showed significantly improved percentage change at Week 8 in the Group PP compared to the placebo group（Group P）. Furthermore, stratified analysis showed a significant improvement in percentage change for three items of the SF-8（SF; role emotional ［RE］; and MCS）and frequency of desire to void at Week 8 in the Group PP compared to the Group P. During treatment, no PP-induced adverse effects were observed. Conclusion　The results showed that PP intake is effective in significantly alleviating the stress caused by toilet anxiety（fear of a sudden desire to void）, and appears free from safety concerns. （UMIN-CTR: UMIN000039084）