Safety and toxicity of saw palmetto in the CAMUS trial.
OBJECTIVE
Extracts of the saw palmetto berry are used by many men in the United States 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 sparse data on saw palmetto toxicity.


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


RESULTS
There were no statistically significant differences between the groups in the rates of serious or nonserious adverse events, changes in vital signs, digital prostate examination findings or study withdrawal rates. Overall, there were no significant intergroup differences in laboratory test abnormalities, while differences in individual laboratory tests were rare and small in magnitude. No evidence of significant dose-response phenomena was identified.


CONCLUSIONS
The saw palmetto extract used in the CAMUS trial showed no evidence of toxicity at doses up to 3 times the usual clinical dose during an 18-month period.
Northern California Kaiser-Permanente Division of Research, Oakland and Departments of Medicine and Epidemiology and Biostatistics, University of California, San Francisco, San Francisco, California 94612, USA. andrew.avins@ucsf.edu
Andrew L
AL
Avins
Jeannette Y
JY
Lee
Catherine M
CM
Meyers
Michael J
MJ
Barry
D000368:Aged; D006801:Humans; D059411:Lower Urinary Tract Symptoms / Q000188:drug therapy*; D008875:Middle Aged; D008517:Phytotherapy; D010936:Plant Extracts / Q000009:adverse effects* / Q000633:toxicity; D028024:Serenoa
D010936:Plant Extracts; C040972:saw palmetto extract