Research and reports in urology · 2026
Fucoidan from Undaria pinnatifida Improves Benign Prostatic Hyperplasia Symptoms in Men: A Randomized, Double-Blind, Placebo-Controlled Study.
Клинический случайКлиническое исследованиеСтатьяНазвание и аннотация: Перевод в очереди
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Wimmer Barbara Caecilia, Dwan Corinna Anne, Bhalerao Sagar Sudhir, Gupta Chirag Govind, Vaze Sanjay Vishnu, Kshirsagar Shalaka Sharad
Аннотация
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.
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.