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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 Multisite study
Randomization: unclear
Patients blinded; providers blinded
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)
Interventions Control: placebo
Treatment: Prostagutt® forte (Serenoa repens and Urtica dioica) 20 drops thrice daily
Study duration: 6 weeks
Lost to follow up: none
Outcomes Physician rating of improvement
Peak urine flow
Bladder residual volume
Dropouts due to side effects: none
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