| Methods |
Multisite study (13 centres).
Randomization: Numbered or coded identical containers administered according to a randomization sequence.
Patients blinded: Providers blinded:
Lost to follow‐up: 12% |
| Participants |
Geographic region: Germany
Study setting: community
n = 177
Age range: 50‐80 (inclusion age range) mean: 65.4
Race: White
Diagnostic criteria: BPH confirmed with DRE. IPSS of at least or > than 6 points. Residual urinary volume 30‐150 mL. Peak flow less than/equal to 15 mL/s, at a voiding volume of at least or > than 150 mL. |
| Interventions |
Control: matching placebo
Treatment: Beta‐sitosterol 65 mg bid (derived from species Hypoxis, Pinus or Picea)
Average follow‐up: 24 weeks |
| Outcomes |
IPSS symptom score (points).
Quality of life score (points).
Peak urine flow (mL/s)
Bladder residual volume (mL)
Dropouts due to side effects: |
| Notes |
Exclusions (major): IPSS < 6 points; Prostate cancer; PSA > 10 ng/mL; bacterial prostatitis; urinary infection; history of acute urinary retention; history of surgical prostatic intervention; need for surgical intervention in case of urethral stricture or bladder diverticulae; bladder stones; IDDM; severe cardiopulmonary disease; concomitant prostatotropic treatment. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Low risk |
A ‐ Adequate |
