Although data from double-blind studies suggest that saw palmetto is no more effective for treating BPH than placebo, many men still take extracts of this berry as self-treatment. To assess the toxicity of this dietary supplement, 357 men were randomized to receive either a dose-escalating regime of saw palmetto or placebo for 18 months. Even at high doses, no statistically significant differences were observed between the treated and control groups in terms of adverse effect profiles, changes in vital signs, or digital prostate examination findings.