Benefits
Prostate-related urinary symptoms and urine flow
In independent trials, saw palmetto was not superior to placebo: a one-year trial in 225 men found no difference in symptom scores or urine flow, and a 72-week trial in 369 men at up to triple dose found the same. Reviews pooling up to 32 randomized trials found little or no benefit for symptoms, flow or prostate size; only a pooled analysis of one other extract, Permixon, reported slightly fewer night-time voids and better flow.
Tolerability over a year or more
Across the pooled trials and the long independent trials, side effects on saw palmetto were similar to placebo, and no clearly attributable adverse effects were seen at up to three times the usual dose over 72 weeks. Good tolerability does not mean the extract improves urinary symptoms.
Mechanism of action
Proposed 5-alpha-reductase action
Saw palmetto is often said to act on 5-alpha-reductase, the enzyme that converts testosterone to DHT. In the placebo-controlled trials pooled by Cochrane and in a one-year independent trial, prostate size did not change more than on placebo, so any such action has not translated into a measurable effect in men.
Clinical trials
Systematic review of 32 randomized trials of saw palmetto in men with urinary symptoms consistent with BPH, lasting 4 to 72 weeks (Tacklind et al. 2012, Cochrane Database Syst Rev).
5,666 men with lower urinary tract symptoms consistent with benign prostatic hyperplasia.
In two high-quality long-term trials, saw palmetto was not superior to placebo for symptom scores; peak urine flow, night-time urination and prostate size also did not improve. The authors concluded that saw palmetto, even at double and triple doses, did not improve urinary flow measures or prostate size.
Double-blind, randomized trial of saw palmetto extract 160 mg twice a day or placebo for one year (Bent et al. 2006, N Engl J Med).
225 men over 49 years old with moderate to severe symptoms of benign prostatic hyperplasia.
No significant difference from placebo in symptom score change, peak urine flow, prostate size, leftover urine, quality of life or PSA. Side effects were similar in both groups.
Double-blind, multicenter, placebo-controlled randomized trial at 11 North American sites; saw palmetto extract at 320 mg/day, raised to 640 and then 960 mg/day at 24 and 48 weeks (Barry et al. 2011, JAMA).
369 men aged 45 or older with moderate urinary symptoms attributed to benign prostatic hyperplasia.
Symptom scores fell 2.20 points with saw palmetto and 2.99 points with placebo; the 0.79-point difference favored placebo. Saw palmetto was no more effective than placebo for any secondary outcome, including night-time urination and urine flow, and no clearly attributable adverse effects were identified.