| Methods |
Number of sites unknown
Randomization: unclear
Blinding: patients, providers |
| Participants |
Geographic regions: Germany/Italy
Study setting: community
N = 101
Baseline IPSS: Sabal extract 9.6; placebo 8.9
Baseline prostate volume: Sabal extract 34.5 cc; placebo 31.7 cc
Mean age (range): 66.1 (NR (no record)) years
Race: White
Diagnostic criteria: confirmed diagnosis of BPH with enlargement of the prostate, symptoms of obstruction and a maximum flow of < 15 mL/s |
| Interventions |
Control: matching placebo
Treatment: Sabal extract (LG166/S) 160 mg twice daily
Study duration: 6 months
Lost to follow‐up: n = 3(?) |
| Outcomes |
IPSS symptom score
Peak urine flow
Prostate volume
Sexual function
Dropouts due to side effects: n = 0 |
| Notes |
Exclusions: patients treated for BPH within 1 month of the trial start; prostate cancer; acute urinary tract infection; chronic prostatitis; neurogenic bladder. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
not stated |
| Allocation concealment (selection bias) |
Unclear risk |
not stated |
| Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
"double blinded" |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
not stated |
| Incomplete outcome data (attrition bias)
All outcomes |
High risk |
per protocol outcomes |
| Selective reporting (reporting bias) |
Low risk |
outcomes not selectively reported |
| Other bias |
Low risk |
arms were assessed equally |
