Hizli 2007.

Study characteristics
Methods	Study design: open‐label prospective study Study dates: May 2005 to November 2005 Setting: outpatient, multicenter, national Country: Turkey
Participants	Inclusion criteria: IPSS ≥ 10 Qmax 5 to 15 mL/s PVR ≤ 150 mL Prostate volume ≥ 25 cm3 PSA ≤ 4 ng/mL Exclusion criteria: History of bladder disease likely to affect micturition Urethral stenosis Prostate cancer Pelvic radiotherapy Repeated infection of the urinary tract or chronic bacterial prostatitis, or any other disease that causes urinary problems Men with clinically significant cardiovascular disease Hematuria Insulin‐dependent diabetes mellitus A history of severe hepatic failure or abnormal liver function tests Concomitant medication Hypersensitivity to 1 of the study drugs Having participated in another clinical trial in the previous 3 months Sample size: 60 randomized participants Age (years): Group 1 mean (SD): 58.9 (5.7) Group 2 mean (SD): 56.8 (7.8) Group 3 mean (SD): 60.2 (6.3) IPSS score (baseline): Group 1 mean (SD): 16.2 (4.7) Group 2 mean (SD): 18.0 (4.9) Group 3 mean (SD): 15.6 (3.2) Prostate size: Group 1 mean (SD): 38.6 (11.6) Group 2 mean (SD): 35.2 (10.3) Group 3 mean (SD): 31.2 (4.2)
Interventions	Group 1 (n = 20): tamsulosin 0.4 mg once a day for 6 months Group 2 (n = 20): Serenoa repens (Permixon) 320 mg once a day for 6 months is the lipidosterolic extract of Serenoa repens Group 3 (n = 20): Serenoa repens 320 mg plus tamsulosin 0.4 mg once a day for 6 months Co‐interventions: tamsulosin (for comparison of group 2 and 3)
Outcomes	Urinary symptoms How measured: IPSS Time points measured: 2, 4, and 6 months Time points reported: 2, 4, and 6 months Subgroups: none Quality of life How measured: IPSS‐QoL Time points measured: 2, 4, and 6 months Time points reported: 2, 4, and 6 months Subgroups: none Adverse events How measured: not described Time points measured: during the 6‐month treatment period Time points reported: during the 6‐month treatment period Subgroups: none Other outcomes measured in the trial: PSA, Qmax, and acute urinary retention
Notes	Funding sources: not available Declarations of interest: not available