Fucoidan from Undaria pinnatifida Improves Benign Prostatic Hyperplasia Symptoms in Men: A Randomized, Double-Blind, Placebo-Controlled Study
Abstract
Purpose: Benign Prostatic Hyperplasia (BPH) is a common non-malignant prostate enlargement that contributes to bladder outlet obstruction and lower urinary tract symptoms in men as they age. Patients and Methods: In this 90-day study, ninety-five men aged 45– 80 years with clinically and radiologically confirmed moderate BPH [International Prostate Symptom Score (IPSS) between 8– 19] were randomly allocated (1:1) to receive either Undaria pinnatifida fucoidan (UPF) or placebo. Prostate health was evaluated using the validated IPSS (total and composite sub-scores) on days 30, 60 and 90. Potential clinically meaningful IPSS reductions were assessed as Minimum Clinically Important Difference (MCID). Urinary flow rate, post-void residual volume (PVR) and prostate-specific antigen were also assessed. Results: By day 60, the UPF group showed significant improvement in total IPSS score compared to placebo (p=0.0234), with further improvements by day 90 (p=0.0015). The mean reduction in total IPSS score from baseline to day 90 was − 3.40 in the UPF group versus − 0.93 in the placebo group. Voiding (p=0.0006) and storage (p=0.0150), sub-scores improved significantly by day 90 in the UPF group. Quality of life related to urinary symptoms improved continuously by day 60 and 90 (both p< 0.05 vs placebo). A higher proportion of UPF-treated participants achieved MCID ≥ 2 (60.0%) and ≥ 3 points (51.1%) compared to placebo (42.2% and 28.9%), with statistical significance for ≥ 3 points…
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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.
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