薬理と治療

Abstract

Objectives　This study aimed to investigate the effects of an eight-week consumption of saw palmetto fruit extract（SP）on urination issues. Methods　A total of 44 Japanese men aged ≥40 years who woke ≥ twice at night to urinate participated in a randomized, double-blind, placebo-controlled study between December 2018 and April 2019. All subjects were randomly allocated into an SP group（n＝22）or a placebo group（P group, n＝22）using a computerized random-number generator. Each group took their assigned singular capsule（320 mg of SP or placebo）every day for eight weeks. Subjective symptoms and impacts on daily life were assessed using IPSS total score as a primary outcome and other subjective symptoms［Overactive Bladder Symptom Score（OABSS）and a questionnaire survey］. The ultrasonography of the post-void residual volume of urine and a safety evaluation were also performed. Results　All the subjects completed the trial and were analyzed. The simple main effect of the group was marginally significant in the measured values and changes in IPSS（P＜0.10）. At eight weeks in post hoc analysis, the IPSS of the SP group showed a significant decrease compared with that of the P group（P＜0.05）, suggesting reduced subjective symptoms related to urination issues. No safety concerns were noted. Conclusions　Consumption of one SP capsule for eight weeks relieved subjective symptoms related to urination, suggesting the improvement of urination issues in healthy Japanese men. Trial registration　UMIN-CTR: UMIN000035036 Funding　BGG Japan Co., Ltd.