Methods | Number of sites unknown Randomization: Identical packaging Patients blinded; providers blinded |
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Participants | Geographic region: Italy Study setting: community N = 60 Baseline IPSS: NA Baseline prostate volume: NA Mean age: NA Age range: 50 to 80 Race: White Diagnostic criteria: Men with symptomatic BPH confirmed on rectal examination |
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Interventions | Control 1: matching placebo Control 2: Pygeum africanum extract Treatment: Permixon® 320 mg daily Study duration: 4 weeks Lost to follow up: unclear |
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Outcomes | Patient self-rating Dysuria (pain on voiding) Urgency Tenesmus Difficult urination Post-voiding residue Pollachiuria Nocturia Dropouts due to side effects: none |
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Notes | Exclusions: Details not given | |
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 |
Yes | A - Adequate |
Free of selective reporting? | Yes | A - Adequate |
Free of other bias? | Yes | A - Adequate |