Complementary and Alternative Medicine for Urological Symptoms

The Complementary and Alternative Medicine for Urological Symptoms (CAMUS) study was a double-blind, placebo-controlled randomized clinical trial that investigated the efficacy of a widely available phytotherapy, saw palmetto extract, at up to 3 times the standard dose on lower urinary tract symptoms attributed to benign prostatic hyperplasia (BPH) in men. Although saw palmetto fruit extract is widely used for treating lower urinary tract symptoms attributed to BPH, a well-design National Institutes of Health supported clinical trial (Avins A et al. JAMA) failed to a benefit of this treatment compared to placebo. The CAMUS study enrolled males with a peak urinary flow rate of at least 4 mL/s and an American Urological Associate Symptom Index (AUASI) score of between 8 and 24 at screening visits. Participants were randomly assigned equally to receive one, two, and then three 320 mg gelcaps daily containing a standardized saw palmetto fruit extract with dose escalations at 24 and 48 weeks; or an identical number of placebo gelcaps escalated similarly. The primary outcome was the change in AUASI score from baseline to 72 weeks. Participants were closely monitored for adverse events. The study concluded that saw palmetto extract used at up to 3 times the standard daily dose had no greater effect than placebo on improving lower urinary symptoms or other outcomes related to BPH.