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Older men often use an extract of fruit from the saw palmetto tree as an alternative treatment for lower urinary tract symptoms (LUTS) caused by benign prostatic hyperplasia. Various hormonal, inflammatory, and cellular mechanisms of action have been proposed. However, benefits found in earlier studies and meta-analyses have been countered by negative findings in more recent trials. To assess the value of much-higher-than-usual saw palmetto doses, 369 men were randomized to daily placebo or saw palmetto (320 mg, with escalations to 640 mg at 24 weeks and to 960 mg at 48 weeks). The men (age, ≥45; mean age, 61) had moderately impaired urinary flow and a range of standardized LUTS scores.
In an intent-to-treat analysis of the 306 men who compl…