Saw palmetto for benign prostatic hyperplasia.
- 2006-02-09
- The New England journal of medicine 354(6)
- Stephen Bent
- Christopher Kane
- Katsuto Shinohara
- John Neuhaus
- Esther S Hudes
- Harley Goldberg
- Andrew L Avins
- PubMed: 16467543
- DOI: 10.1056/nejmoa053085
Study Design
- Type
- Randomized Controlled Trial (RCT)
- Sample size
- n = 225
- Population
- 225 men over the age of 49 years who had moderate-to-severe symptoms of benign prostatic hyperplasia
- Methods
- Double-blind trial, randomly assigned to one year of treatment with saw palmetto extract (160 mg twice a day) or placebo
- Blinding
- Double-blind
- Duration
- one year
- Funding
- Unclear
- Large Human Trial
- Highly Cited
Background
Saw palmetto is used by over 2 million men in the United States for the treatment of benign prostatic hyperplasia and is commonly recommended as an alternative to drugs approved by the Food and Drug Administration.Methods
In this double-blind trial, we randomly assigned 225 men over the age of 49 years who had moderate-to-severe symptoms of benign prostatic hyperplasia to one year of treatment with saw palmetto extract (160 mg twice a day) or placebo. The primary outcome measures were changes in the scores on the American Urological Association Symptom Index (AUASI) and the maximal urinary flow rate. Secondary outcome measures included changes in prostate size, residual urinary volume after voiding, quality of life, laboratory values, and the rate of reported adverse effects.Results
There was no significant difference between the saw palmetto and placebo groups in the change in AUASI scores (mean difference, 0.04 point; 95 percent confidence interval, -0.93 to 1.01), maximal urinary flow rate (mean difference, 0.43 ml per minute; 95 percent confidence interval, -0.52 to 1.38), prostate size, residual volume after voiding, quality of life, or serum prostate-specific antigen levels during the one-year study. The incidence of side effects was similar in the two groups.Conclusions
In this study, saw palmetto did not improve symptoms or objective measures of benign prostatic hyperplasia. (ClinicalTrials.gov number, NCT00037154.).Research Insights
There was no significant difference between the saw palmetto and placebo groups in the change in ... maximal urinary flow rate (mean difference, 0.43 ml per minute; 95 percent confidence interval, -0.52 to 1.38)
- Effect
- Neutral
- Effect size
- Small
- Dose
- 160 mg twice a day
There was no significant difference between the saw palmetto and placebo groups in the change in ... quality of life ... during the one-year study.
- Effect
- Neutral
- Effect size
- Small
- Dose
- 160 mg twice a day
There was no significant difference between the saw palmetto and placebo groups in the change in AUASI scores (mean difference, 0.04 point; 95 percent confidence interval, -0.93 to 1.01)
- Effect
- Neutral
- Effect size
- Small
- Dose
- 160 mg twice a day
There was no significant difference between the saw palmetto and placebo groups in the change in ... prostate size ... during the one-year study.
- Effect
- Neutral
- Effect size
- Small
- Dose
- 160 mg twice a day
There was no significant difference between the saw palmetto and placebo groups in the change in ... residual volume after voiding ... during the one-year study.
- Effect
- Neutral
- Effect size
- Small
- Dose
- 160 mg twice a day
There was no significant difference between the saw palmetto and placebo groups in the change in ... serum prostate-specific antigen levels during the one-year study.
- Effect
- Neutral
- Effect size
- Small
- Dose
- 160 mg twice a day
Adverse Events Reported
The incidence of side effects was similar in the two groups.
- Finding
- No significant difference
- Significant
- No