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. Author manuscript; available in PMC: 2011 May 10.
Published in final edited form as: Cochrane Database Syst Rev. 2009 Apr 15;(2):CD001423. doi: 10.1002/14651858.CD001423.pub2
Methods Number of sites unknown
Randomization: Identical packaging
Patients blinded; providers blinded
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
Interventions Control 1: matching placebo
Control 2: Pygeum africanum extract
Treatment: Permixon® 320 mg daily
Study duration: 4 weeks
Lost to follow up: unclear
Outcomes Patient self-rating
Dysuria (pain on voiding)
Urgency
Tenesmus
Difficult urination
Post-voiding residue
Pollachiuria
Nocturia
Dropouts due to side effects: none
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