| Methods |
Multisite study
Randomization: computer‐generated randomization code
Blinding: patients, providers |
| Participants |
Geographic region: Nine European countries
Study setting: community
N = 1098
Baseline IPSS: Permixon® 15.7; finasteride 15.7
Baseline prostate volume: Permixon® 43.0 cc; finasteride 44.0 cc
Mean age (range): 64.5 (49 to 88) years
Race: White
Diagnostic criteria: BPH diagnosed by digital rectal exam (DRE); International Prostate Symptom Score (IPSS) > 6; maximum urinary flow between 4 to 15 mL/s (with a urine volume at least 150 mL, and a postvoid residue of < 200 mL); prostate size > 25 mL; serum prostate‐specific antigen (PSA) < 10 ng/mL (prostates less than or equal to 60 mL) or 15 ng/mL (prostates > 60 mL); good mental and physical condition. |
| Interventions |
Control: finasteride 5 mg (PROSCAR®) + placebo (morning) and two placebos (evening)
Treatment: Permixon® 160 mg + placebo twice daily
Study duration: 26 weeks
Lost to follow‐up: 13.4% |
| Outcomes |
Symptom improvement ‐ IPSS symptom score (0 to 35 points)
Quality of life score (0 to 6 points)
Sexual function score (0 to 20 points)
Peak urine flow
Mean urine flow
Total voided volume
Bladder residual volume
Prostate size (volume)
Serum PSA
Dropouts due to side effects: 4% (Permixon® n = 28, finasteride n = 14) |
| Notes |
Exclusions: Prostate cancer; bladder disease; abnormal liver function; diuretics or drugs with antiandrogenic or alpha‐receptor properties in the preceding 3 months; urogenital infections; disease potentially affecting micturition. |
| 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 |
"double‐blind" |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
not mentioned |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
adequate |
| Selective reporting (reporting bias) |
Low risk |
adequate |
| Other bias |
Low risk |
adequate |
