Effect of Increasing Doses of Saw Palmetto Extract on Lower Urinary Tract Symptoms

Abstract

Context Saw palmetto fruit extracts are widely used for treating lower urinary tract symptoms attributed to benign prostatic hyperplasia. However, recent clinical trials have questioned their efficacy, at least at standard doses (320 mg daily). Objective To determine the effect of a saw palmetto extract at up to three times the standard dose on lower urinary tract symptoms attributed to benign prostatic hyperplasia. Design Multicenter placebo-controlled randomized trial conducted from June, 2008 through October, 2010. Setting Eleven North American clinical sites. Participants Were men at least 45 years old, with a peak urinary flow rate ≥ 4 ml/sec, an AUA Symptom Index (AUASI) score ≥ 8 and ≤ 24, and no exclusions. Interventions One, two, and then three 320 mg daily doses of saw palmetto extract or placebo, with dose increases at 24 and 48 weeks. Main Outcome Measures Primary outcome was the difference in AUASI score from baseline to 72 weeks. Secondary outcomes were measures of urinary bother; nocturia; uroflow; postvoid residual; prostate-specific antigen; participants’ global assessments; and indices of sexual function, continence, sleep quality, and prostatitis symptoms. Results From baseline to 72 weeks, mean AUASI scores decreased from 14.4 to 12.2 points with saw palmetto and from 14.7 to 11.7 points with placebo. The group mean difference in AUASI score change from baseline to 72 weeks between the saw palmetto and placebo groups was 0.79 points favoring placebo (bound of the 95% confidence interval most favorable to saw palmetto was 1.77 points, one-sided P=0.91). Saw palmetto was no more effective than placebo for any secondary outcome. No attributable side effects were identified. Conclusions Increasing doses of a saw palmetto fruit extract did not reduce lower urinary tract symptoms more than placebo. (CAMUS study number NCT00603304 http://www.ClinicalTrials.gov)

Nocturia: Current Levels of Evidence and Recommendations From the International Consultation on Male Lower Urinary Tract Symptoms

“…Barry et al 36 conducted an RCT of 369 men with nocturia who were treated with saw palmetto or placebo. No difference in nocturia outcomes was seen at 24-or 48-week follow-up (LOE 2).…”

Effects of Serenoa repens Alcohol Extract on Benign Prostate Hyperplasia

“…EAU guidelines state that this herbal extracts significantly reduce nocturia in comparison with placebo [17]. On the contrary, some authors described that Serenoa repens extracts have not shown more effectiveness than placebo in the treatment of BPH [24][25][26]. However, more recent data favor the use of Serenoa repens extracts in milder BPH cases with promising results [27].…”

Integrative review on the non‐invasive management of lower urinary tract symptoms in men following treatments for pelvic malignancies

“…However, a placebo‐controlled study of 369 men has demonstrated no differences in reduction of LUTs between Saw Palmetto and placebo 122.…”