Saw palmetto fruit extracts are widely used to treat lower urinary tract symptoms attributed to benign prostatic hyperplasia (BPH), but a new study shows that these extracts are no better than placebo at easing symptoms, according to investigators.

Between baseline and 72 weeks of a double-blind, placebo-controlled, randomized trial involving 369 men aged 45 years and older, mean American Urological Association Symptom Index scores fell from 14.42 points to 12.22 points with the use of saw palmetto extract and from 14.69 to 11.70 points with placebo.

Findings appear in the Journal of the American Medical Association (2011;306:1344-1351).

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In the study, men were randomly assigned to receive a daily dose of saw palmetto extract, beginning 320 mg, or matching placebo. After 24 weeks, the saw palmetto dosage was increased to 640 mg per day. After another 24 week, it was increased to 960 mg per day, which is triple the standard dose.

“Now we know that even very high doses of saw palmetto make absolutely no difference,” said study co-investigator Gerald Andriole, MD, Chief of Urologic Surgery at Washington University School of Medicine in St. Louis.