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Suppressive Effects of a Supplement Containing Pomegranate Fruit—derived Punicalagin on Urinary Stress in Healthy Adult Women ―A Randomized, Double—blind, Placebo—controlled, Parallel—group Study―
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JPY
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)
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