| Methods |
Dual site and surrounding community
Randomization: computer generated
Blinding: patients, providers |
| Participants |
Geographic region: Northern California
Study setting: VA Hospital/Kaiser Permanente and community
N = 225
Baseline AUA: SR 15.7; placebo 15.0
Baseline prostate volume: SR 34.7 cc; placebo 33.9 cc
Mean age (range): 63.0 (NR) years
Race: White 82%; Black 5%; Asian/Pacific Islander 7%; Hispanic 5%; other 1%
Diagnostic criteria: moderate‐to‐severe symptoms of BPH (AUA ≥ 8); Peak urine flow < 15 mL/s |
| Interventions |
Control: matching placebo
Treatment: Sabal extract 160 mg twice daily
Study duration: 12 months
Lost to follow‐up: n = 9 |
| Outcomes |
AUA symptom score
BPH Impact Index
Peak urine flow |
| Notes |
Exclusions: < 49 years old; less than moderate symptoms of BPH (AUA < 8); peak urine flow < 4 mL/s or residual volume > 250 mL after voiding; history of prostate cancer; surgery for BPH; urethral stricture; neurogenic bladder; creatinine > 2 mg/dL; PSA > 4 ng/dL; medications known to affect urination; severe concomitant disease. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
stated |
| Allocation concealment (selection bias) |
Low risk |
adequate |
| Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
likely |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
not stated |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
adequate |
| Selective reporting (reporting bias) |
Low risk |
adequate |
| Other bias |
Low risk |
adequate |
