Methods | Multisite study Randomization: unclear Patients blinded; providers blinded |
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Participants | Geographic region: Croatia Study setting: community N = 30 Baseline IPSS: NA Baseline prostate volume: NA Mean age: 65.0 Age range: 40 to 82 Race: White Diagnostic criteria: BPH, stage I–II (Vahlensieck) |
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Interventions | Control: placebo Treatment: Prostagutt® forte (Serenoa repens and Urtica dioica) 20 drops thrice daily Study duration: 6 weeks Lost to follow up: none |
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Outcomes | Physician rating of improvement Peak urine flow Bladder residual volume Dropouts due to side effects: none |
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Notes | Exclusions: Stage IV prostate adenoma; bacterial prostatitis; cystitis; urethritis | |
Risk of bias | ||
Item | Authors’ judgement | Description |
Adequate sequence generation? | Unclear | B |
Allocation concealment? | Unclear | B |
Blinding? All outcomes |
Yes | A - Adequate |
Incomplete outcome data addressed? All outcomes |
Unclear | B |
Free of selective reporting? | Unclear | A - Adequate |
Free of other bias? | Unclear | A - Adequate |