| Methods |
Single‐site study.
Randomization: noted but method not described.
Patients blinded: Providers blinded:
Lost to follow‐up: 15% |
| Participants |
Geographic region: UK
Study setting: community
n = 62
Age range: 53‐81 mean: 67.0
Race: White
Diagnostic criteria: "prostatism", full urodynamic assessments, Trucut needle biopsy performed to confirm benign hyperplasia. |
| Interventions |
Control: matching placebo
Treatment: Beta‐sitosterol (WA184) 0.15 mg bid
Average follow‐up: 24 weeks |
| Outcomes |
Peak urine flow (mL/s)
Bladder residual volume (mL)
Maximum detrusor pressure at peak flow (cm H2O)
Prostate volume (mL)
Dropouts due to side effects: none |
| Notes |
Exclusions: prostate cancer; gastrointestinal or hepatobiliary disease; patients in whom overwhelming indications for surgical relief of outflow obstruction existed. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Unclear risk |
B ‐ Unclear |
