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健常女性におけるプロポリスエキス含有食品による排尿の悩み改善効果検証試験―プラセボ対照ランダム化二重盲検並行群間比較試験の再解析―
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JPY
Abstract
Background and Objective Nocturnal awakenings for voiding are among the most frequent urinary complaints and may impair the quality of life(QOL). Our recent clinical study demonstrated the ameliorating effect of the propolis extract(PP)–containing food consumption on urination frequency, without any significant difference in QOL. Focusing on nocturia, we reanalyzed the study data and evaluated the impact of PP on the QOL of healthy women with urinary frequency problems. Methods Previously, we conducted a randomized, double–blind, placebo–controlled, parallel–group study involving 88 healthy women who were aware of frequent urination. The participants were assigned to the PP and placebo groups, and each group was provided the test food daily for eight weeks. During the study period, participants recorded urination logs using a frequency volume chart, and their QOL and sleep status were assessed using questionnaires. Presently, the data were reanalyzed, focusing on the QOL of participants with nocturia, especially those whose urination frequency were less than twice at night. Results Compared to the placebo group, post hoc reanalysis revealed that the PP group had a statistically significant difference for“bother/concern”score in the N–QOL, which was used to evaluate the degree of difficulty in life caused by nocturia, regarding changes before and after the 8–week test food consumption. Conclusion The consumption of PP–containing food may improve the QOL of healthy women with urinary frequency problems. Limitations Future clinical trials with N–QOL as the primary endpoint should be conducted to confirm the reproducibility of this reanalysis.(UMIN–ID:UMIN000054877)(Jpn Pharmacol Ther 2024;52:61‒71)
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