Saw palmetto for the treatment of men with lower urinary tract symptoms
Barry MJ, Meleth S, Lee JY, Kreder KJ, Avins AL, Nickel JC, Roehrborn CG, Crawford ED, Foster HE Jr, Kaplan SA, McCullough A, Andriole GL, Naslund MJ, Williams OD, Kusek JW, Meyers CM, Betz JM, Cantor A, McVary KT
Published in New England Journal of Medicine
Abstract
High-quality randomized trial testing escalating doses (320mg to 960mg daily) of saw palmetto extract. Found no benefit over placebo at tested doses, though extract quality and form may be critical factors.
Methodology
Multicentre, randomised, double-blind, placebo-controlled dose-escalation trial with AUASI as the primary endpoint over 72 weeks.
Key Findings
In the CAMUS trial, 369 men with moderate lower urinary tract symptoms received saw palmetto extract escalated from 320 to 960 mg/day or placebo for 72 weeks. AUASI symptom scores improved similarly in both arms (-2.20 vs -2.99 points), with no benefit on flow rate, post-void residual or quality of life at any dose.
Conclusions
At up to three times the standard dose, saw palmetto was no better than placebo for BPH symptoms — the most rigorous test to date and a decisive negative result.
Limitations
Single extract preparation (ethanolic Serenoa repens), predominantly moderate-severity symptoms, and results may not generalise to other proprietary lipidosterolic extracts.
Supplements Studied
In the CAMUS trial, 369 men with moderate lower urinary tract symptoms received saw palmetto extract escalated from 320 to 960 mg/day or placebo for 72 weeks. AUASI symptom scores improved similarly in both arms (-2.20 vs -2.99 points), with no benefit on flow rate, post-void residual or quality of life at any dose.
Study Details
Access Study
Disclosures
Funding
US National Institutes of Health (NIDDK and NCCAM); no manufacturer funding
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