| Methods |
Single‐site study
Randomization: table of random numbers
Blinding: patients |
| Participants |
Geographic region: USA
Study setting: community
N = 44
Baseline IPSS: Saw palmetto herbal blend 18.4; placebo 16.4
Baseline prostate volume: Saw palmetto herbal blend 58.5 cc; placebo 55.6 cc
Mean age (range): 64 (45 to 80) years
Race: White 73%, Black 7%, Asian 11%
Diagnostic criteria: moderate to severe BPH with enlarged prostate (DRE), IPSS score of 9 or greater, PSA < 15 ng/mL, prostate volume 30 cc or greater. |
| Interventions |
Control: placebo
Treatment: Saw palmetto herbal blend (saw palmetto 106 mg, nettle root extract 80 mg, pumpkin seed oil extract 160 mg, vitamin A 190 mg) thrice daily
Study duration: 6 months
Lost to follow‐up: 7% |
| Outcomes |
Symptom improvement ‐ IPSS symptom score
Peak urine flow
Post‐void residual volume
PSA
Prostate volume
Dropouts due to side effects: None |
| Notes |
Exclusions: concurrent use of α‐blockers; use of finasteride, phytotherapy within last 18 months or α‐blockers within last month; chronic prostatitis; previous bladder or prostate surgery; neurogenic bladder |
| 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 |
adequate |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
not mentioned |
| Incomplete outcome data (attrition bias)
All outcomes |
High risk |
per protocol analysis |
| Selective reporting (reporting bias) |
Low risk |
adequate |
| Other bias |
Low risk |
adequate |
