| Methods |
Double blinded:
yes. |
| Participants |
N=209 French men with symptomatic BPH, age > 50, IPSS 10 or >, PUF < 15 ml/s, residual volume < 150 ml. Mean age: 66 years.
Lost to follow‐up: 26 (11.1%). |
| Interventions |
Treatment 1: P. africanum extract (Tadenan) 50 mg x 2 daily (n=101).
Treatment 2: P. africanum extract (Tadenan) 100 mg daily (n=108).
Treatment duration: 60 days. |
| Outcomes |
Symptom score (IPSS); peak urine flow. Adverse events. |
| Notes |
235 men were randomized, 223 completed the comparative phase, but only 209 men were valid for per‐protocol analysis. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Unclear risk |
B ‐ Unclear |
