| Methods |
Multisite or single‐site: NR
Randomization: computer number table
Blinding: patients, providers |
| Participants |
Geographic region: USA
Study setting: community
N = 85
Baseline IPSS: SR 16.7; placebo 15.8
Baseline prostate volume: NR
Mean age (range): 65.0 (≥ 45) years
Race: NR
Diagnostic criteria: IPSS score ≥ 8 |
| Interventions |
Control: placebo
Treatment: SR 160 mg twice daily
Study duration: 6 months
Lost to follow‐up: 7% (SR n = 2, placebo n = 4) |
| Outcomes |
Symptom improvement ‐ IPSS symptom score
Quality of Life score
Peak urine flow
Dropouts due to side effects: 1% (SR n = 1) |
| Notes |
Exclusions: prostate surgery; history of prostate cancer or urethral stricture; treated with finasteride, saw palmetto or other alternative therapy (past 6 months); or treated with alpha‐blocker (within 1 month). |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
adequate |
| Allocation concealment (selection bias) |
Low risk |
adequate |
| Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
adequate |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
unclear |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
adequate |
| Selective reporting (reporting bias) |
Low risk |
adequate |
| Other bias |
Low risk |
adequate |
