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The aim of the present study was to investigate the effects of 12‐week consumption of saw palmetto fruit extract (320 mg per day) on urination issues. A total of 44 Japanese men aged 40–69 years who experienced urination issues and awaken ≥2 times at night to urinate participated in a randomized, double‐blind, placebo‐controlled study between June and December 2017. All subjects were randomly allocated into a saw palmetto fruit extract group (SP group, n = 22) or a placebo group (P group, n = 22) using a computerized random number generator. Each group took their assigned one capsule every day for 12 weeks. Subjective symptoms and impact on daily life were assessed using the international prostate symptom score (IPSS) as a primary outcome, King's health questionnaire (KHQ), and overactive bladder symptom score. A safety evaluation was also performed. A total of 20 subjects in each group were analyzed. There was a significant group–time interaction for total IPSS. The SP group also showed a significant decrease in IPSS at 8 weeks compared with the P group, suggesting reduced subjective symptoms related to urination issues. We observed no adverse effects. The consumption of saw palmetto fruit extract capsule for 12 weeks relieved subjective symptoms related to urination, which suggests improvement of the issue in healthy Japanese men. [ABSTRACT FROM AUTHOR]

The aim of the present study was to investigate the effects of the consumption of saw palmetto fruit extract capsule on urination issues. Japanese men whose age ranged from 40 to 69 years (n = 44) who were experiencing urination issues and nocturia two times or more per night participated in a randomized, double-blind, parallel-group, placebo-controlled study. With the use of a computerized random-number generator, all subjects were randomly allocated into either a saw palmetto fruit extract group (SP group, n=22) or a placebo group (P group, n = 22). Participants in each group took either one capsule of saw palmetto fruit extract or one placebo capsule per day for 12 weeks. Urination issues were assessed using questionnaires before intake and at 4, 8, and 12 weeks after intake, and safety evaluations were carried out before intake and at 12 weeks after intake. The SP group showed significantly lower changes on the International Prostate Symptom Score at 8 weeks compared with the P group (P = 0.007). Moreover, the changes in the personal limitation and the physical limitation in the Kings' Health Questionnaire were significantly decreased at 4 weeks in the SP group compared with those in the P group (P = 0.033, P = 0.038, respectively). Therefore, we conclude that consumption of saw palmetto fruit extract capsule improves urination issues. Furthermore, safety evaluations showed no medical changes, and no adverse events were observed. [ABSTRACT FROM AUTHOR]