Clinical effect of phytosterol-enriched saw palmetto extract on urinary function in healthy middle-aged and older males: a double-blind, placebo-controlled randomized comparative study
Abstract
Background: Saw palmetto extract (SPE) is one of the most widely used supplements for benign prostatic hyperplasia (BPH) due to its pharmacological effects. β-sitosterol-enriched saw palmetto oil (VISPO™) contains more than 3% β-sitosterol and 85% total fatty acids and has been shown to improve symptoms in patients with BPH. Lower urinary tract symptoms (LUTS) require primary preventive measures in countries with accelerated population aging, including Japan. VISPO™ is expected to be effective against the early symptoms of LUTS. However, the effect of VISPO™ on urinary function in healthy individuals has not been elucidated.
Objective: This clinical study evaluated the efficacy and tolerability of VISPO™ in the management of urinary complaints among healthy middle-aged and older men who did not require treatment.
Methods: We conducted a randomized, double-blind, placebo-controlled trial that included 54 male participants who were assigned to consume VISPO™ or placebo (olive oil) capsules for 12 weeks. Biometric data, uroflowmetry results, and salivary hormone levels were assessed at weeks 1 and 12. Urinary function and quality of life were assessed at weeks 1, 4, 8, and 12 using the International Prostate Symptom Score (IPSS), Overactive Bladder Symptom Score (OABSS), Core Lower Urinary Tract Symptom Score (CLSS), and WHOQOL-26.
Results: Two-way analysis of variance revealed that IPSS and OABSS were significantly lower in the VISPO™ group that in the placebo group. However,…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 54 participants or records.
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