Safety and Toxicity of Saw palmetto in the Complementary and Alternative Medicine for Urological Symptoms (CAMUS) Trial
Avins AL, Lee JY, Meyers CM, Barry MJ; Complementary and Alternative Medicine for Urologic Symptoms (CAMUS) Study Group. J Urol. 2012 Oct 9. pii: S0022-5347(12)05181-6. doi: 10.1016/j.juro.2012.10.002. [Epub ahead of print]

Source

Northern California Kaiser-Permanente Division of Research, Oakland, CA; Departments of Medicine and Epidemiology & Biostatistics, University of California, San Francisco, San Francisco, CA. Electronic address: andrew.avins@ucsf.edu.

Abstract

PURPOSE:

Extracts of the saw palmetto berry are used by many men in the U.S. as self-treatment for lower urinary tract symptoms due to benign prostatic hyperplasia. While the most recent data from double-blind clinical trials do not support efficacy superior to that of placebo, there are few data on the toxicity of saw palmetto.

MATERIALS AND METHODS:

369 patients were randomized in the Complementary and Alternative Medicine for Urological Symptoms (CAMUS) trial; 357 participants are included in this modified intention-to-treat analysis. Participants were randomized to 320mg, 640mg, and 960mg daily of an ethanolic saw palmetto extract or an identical-appearing placebo, in an escalating manner at 6-month intervals, for a total of 18 months follow-up. Adverse-event assessments, vital signs, and blood and urine laboratory tests were obtained at regular intervals.

RESULTS:

There were no statistically significant differences between groups in rates of serious or non-serious adverse events, changes in vital signs, digital prostate exam findings, or study withdrawal rates. Overall, there were no significant inter-group differences in the occurrence of laboratory-test abnormalities; differences in individual laboratory tests were uncommon and small in magnitude. No evidence of significant dose-response phenomena were identified.

CONCLUSIONS:

The saw palmetto extract used in the CAMUS trial showed no evidence of toxicity at doses up to three times the usual clinical dose over a period of 18 months.