Safety and toxicity of saw palmetto in the CAMUS trial.

2012-10-09
The Journal of urology 189(4)
- Andrew L Avins
- Jeannette Y Lee
- Catherine M Meyers
- Michael J Barry

PubMed: 23063633
DOI: 10.1016/j.juro.2012.10.002

Study Design

Type: Randomized Controlled Trial (RCT)
Sample size: n = 369
Population: 369 patients were randomized in the CAMUS trial, of whom 357 were included in this modified intent to treat analysis
Methods: 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
Blinding: Double-blind
Duration: 18 months
Funding: Unclear

Large Human Trial

Purpose

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.

Materials and 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.

Research Insights

saw palmetto berry→Improved Lower Urinary Tract Symptoms
there are sparse data on saw palmetto toxicity
Effect
Neutral
Effect size
Small
Dose
320, 640 and 960 mg daily

Adverse Events Reported

saw palmetto berry→changes in vital signs
There were no statistically significant differences between the groups in the rates of serious or nonserious adverse events, changes in vital signs
Finding
No significant difference
Significant
No
saw palmetto berry→digital prostate examination findings
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
Finding
No significant difference
Significant
No
saw palmetto berry→laboratory test abnormalities
Overall, there were no significant intergroup differences in laboratory test abnormalities
Finding
No significant difference
Significant
No
saw palmetto berry→nonserious adverse events
There were no statistically significant differences between the groups in the rates of serious or nonserious adverse events
Finding
No significant difference
Significant
No
saw palmetto berry→serious adverse events
There were no statistically significant differences between the groups in the rates of serious or nonserious adverse events
Finding
No significant difference
Severity
Serious adverse event
Significant
No
saw palmetto berry→study withdrawal rates
or study withdrawal rates
Finding
No significant difference
Significant
No
saw palmetto berry→toxicity
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.
Finding
No significant difference
Significant
No