Barry 2011.

Methods	Multisite trial Randomization: 1:1 Participants, caregivers and investigators blinded
Participants	Geographic region: see 'Study setting' below Study setting: 11 N. American clinical sites N = 369 Baseline AUA: saw palmetto 14.4; placebo 14.7 Baseline prostate size: NR Mean age (range): 61.0 (NR) years Race: non‐Hispanic White 79.6%; Black 11.5%; Hispanic, Latino; other 9.0% Diagnostic criteria: peak urine flow of at least 4 mL/s; AUA 8 to 24 at 2 visits.
Interventions	Control: matching placebo Treatment: SR 320 mg once daily for 24 weeks, followed by 640 mg once daily for 24 weeks, followed by 960 mg once daily for 24 weeks Follow‐up: 72 weeks Lost to follow‐up: n = 12
Outcomes	AUA NIH CPSI (National Institute of Health, Chronic Prostatitis Symptom Index) Urinary symptom scale BPH Inpact Index IPSS QoL NIH CPSI QoL scale AUA Nocturia Peak urine flow Erectile/ejaculatory function ICS male incontinence
Notes	Exclusions Any prior invasive intervention for BPH. Phytotherapy for BPH or a 5‐alpha reductase inhibitor within 3 months. Alpha blocker within one month. Reported allergic reaction to SR. Taken phenylephrine, pseudoephedrine, tricyclic antidepressants, and anticholinergic or cholinergic medication within 4 weeks of the first screening visit, with the following exception: topical anticholinergic eye drops used for glaucoma. Taken an estrogen, androgen, or any drug producing androgen suppression, or anabolic steroids within 6 months. Known clinically significant renal impairment (i.e., creatinine greater than 2.0 mg/dL). ALT (SGPT), AST (SGOT) or GGT value greater than 3 times the upper limit of normal in the clinical center lab at SV1.0; confirmed on a second measurement. Prothrombin time greater than 3 seconds above the upper limit of normal, or more than 3 seconds above the control value in the clinical center at SV1.0; confirmed on a second measurement. ECG reading at the clinical center at SV1.0 suggesting active ischemia or recent myocardial infarction until appropriate consultation confirms the absence of an acute coronary syndrome. PSA level greater than 10 ng/ml at the first screening visit. Requires the daily use of a pad or device for incontinence, or ICSmaleIS score >14 at screening. Unstable medical condition within the past 3 months. History or current evidence of carcinoma of the prostate or bladder, pelvic radiation or surgery, urethral stricture, or prior surgery for bladder neck obstruction. Active urinary tract disease or has undergone cystoscopy or biopsy of the prostate within one month prior to the first screening visit or has an imminent need for urologic surgery. Known primary neurologic conditions such as multiple sclerosis or Parkinson's disease or other neurological diseases known to affect bladder function. Documented bacterial prostatitis within the past year. Two documented independent urinary tract infections of any type in the past year. Known severe bleeding disorder or need for ongoing therapeutic anticoagulation with coumadin or heparin. Cancer, which is not considered cured (except basal cell or squamous cell carcinoma of the skin). A potential participant is considered cured if there has been no evidence of cancer within five years of randomization. A history of bladder cancer or prostate cancer is exclusionary whether the participant is considered cured or not. Unable to follow protocol directions due to organic brain or psychiatric disease. History of alcoholism or any other substance abuse, which, in the opinion of the investigator, would affect compliance with the protocol. Any serious medical condition likely to impede successful completion of the study.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	computer generated
Allocation concealment (selection bias)	Low risk	adequate
Blinding of participants and personnel (performance bias) All outcomes	Low risk	adequate
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	not mentioned
Incomplete outcome data (attrition bias) All outcomes	Low risk	attrition documented
Selective reporting (reporting bias)	Low risk	adequate
Other bias	Low risk	adequate