Fucoidan from Undaria pinnatifida Improves Benign Prostatic Hyperplasia Symptoms in Men: A Randomized, Double-Blind, Placebo-Controlled Study.

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 (p=0.0314) at day 90. Urinary flow rate improved and PVR decreased in both groups; however, between-group differences, including PSA, were not statistically significant. Importantly, UPF was well tolerated.

CONCLUSION

UPF supplementation was associated with statistically and clinically significant IPSS improvement, including voiding and storage composite scores, and enhanced prostate-related quality of life when compared to placebo. Secondary outcomes did not differ significantly between groups, and the duration (90 days) limits long-term interpretation. UPF appears safe and potentially beneficial for managing moderate BPH symptoms.