A Verification Study on the Improvement of Urination Issues with Ingestion of Saw Palmetto Fruit Extract: A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study

摘要

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 for12 weeks. Urination issues were assessed using questionnaires before intake and at 4, 8, and12 weeks after intake, and safety evaluations were carried out before intake and at12 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.