Source: NEJM, February 2006;354(6):557-66.
Research: This double-blind trial randomly assigned 225 men over the age of 49 years, who had moderate-to-severe symptoms of BPH, to one year of treatment with saw palmetto extract (160 mg twice daily) or placebo. The primary outcome measures included changes in the scores on the American Urological Association Symptom Index (AUASI) and the maximal urinary flow rate. Secondary outcome measures included changes in prostate size, residual urinary volume after voiding, quality of life, laboratory values and the rates of reported adverse effects.
Results: The results of the trial suggested there were no significant differences between the saw palmetto and placebo groups in the change in AUASI scores, maximum urinary flow rate, prostate size, residual volume after voiding, quality of life, or serum prostate-specific antigen (PSA) levels. Therefore, the study authors concluded that saw palmetto was no more effective than placebo in treating symptoms of BPH.