Abstract
Saw palmetto extract (SPE) is the most commonly used supplement for the treatment of lower urinary tract symptoms (LUTS), but most evidence is for those with LUTS, and little data is verifying its effectiveness for those who do not have the disease but are troubled by symptoms. The purpose of this study was to examine the effect of SPE on the improvement of urinary frequency problems that present stress due to urinary urgency in daily life, among healthy Japanese adults aged ≥50 years who are not diagnosed with benign prostatic hyperplasia or overactive bladder. They were randomly assigned to the SPE group or placebo group (34 participants per group) using a computerized random number generator. Each participant was instructed to take one capsule containing SPE (320 mg) or placebo every day for 12 weeks. Subjective symptoms were assessed using the overactive bladder questionnaire, and the score of symptom bother by frequent urination during the daytime hours was set as the primary outcome. The other outcomes were subjective urinary symptoms and urinary frequencies. The final efficacy analysis dataset was per protocol set, and 33 participants in each group were analyzed. After SPE intervention for 12 weeks, the score of symptom bother by frequent urination during the daytime hours was significantly improved and the daytime frequency of urination assessed using the urinary log was significantly decreased. The consumption of SPE improved urinary frequency-related quality of life such as bother of urinary symptoms in healthy Japanese adults (UMIN000045334).