Barry 2011.

Study characteristics
Methods	Study design: parallel‐group randomized trial Study dates: June 2008 to October 2010 Setting: multicenter, outpatient, national Country: USA
Participants	Inclusion criteria: Men ≥ 45 years old Qmax ≥ 4 mL/s AUASI scores ≥ 8 and ≤ 24 at 2 screening visits Exclusion criteria: Prior invasive treatment for BPH Recent alpha‐blocker (alpha‐blocker (1 month), 5‐alpha reductase inhibitor (3 months), or phytotherapy including saw palmetto extract (3 months) treatment; recent treatment with other medications affecting LUTS Creatinine > 2.0 mg/dL Liver function tests more than 3 times normal Coagulopathy or anticoagulation Recent unstable medical conditions Neurologic conditions affecting urination Recent prostatitis or repeated urinary tract infections Prostate or bladder cancer or a PSA level > 10 ng/mL Recent or planned genitourinary instrumentation Severe incontinence Recent diuretic initiation or dose change Medical conditions likely to prevent completion Sample size: 369 randomized participants Age (years): Group 1 mean (SD): 61.25 (8.72) Group 2 mean (SD): 60.7 (8.08) IPSS/AUASI score (baseline): Group 1 mean (SD): 14.42 (4.29) Group 2 mean (SD): 14.69 (4.75) Prostate size: Group 1: not available Group 2: not available
Interventions	Group 1 (n = 176): one, two, and then three 320 mg chocolate‐colored gelcaps daily containing a standardized saw palmetto fruit extract with dose escalations at 24 and 48 weeks. Saw palmetto extract used was standardized to a reference chromatogram (with 85% to 95% fatty acids as marker substances). The phytotherapy used in this trial was a proprietary lipidic ethanolic extract of ripe, dried saw palmetto berries, Serenoa repens (W.Bartram) Small (Arecaceae), manufactured by Rottapharm/Madaus, Cologne, Germany and sold as PROSTAURGENIN UNO capsules. Group 2 (n = 181): an identical number of placebo gelcaps escalated similarly Co‐interventions: none
Outcomes	Urinary symptoms How measured: AUASI score Time points measured: 12, 24, 36, 48, 60, and 72 weeks Time points reported: 72 weeks Subgroups: age (61 years) and AUASI baseline score (16) Quality of life How measured: IPSS‐QoL/BPH impact index Time points measured: 12, 24, 36, 48, 60, and 72 weeks Time points reported: 72 weeks Subgroups: none Adverse events How measured: blood counts, basic blood chemistries, coagulation tests, electrocardiogram, and urinalysis Time points measured: 4 weeks after each dose increase and at the end of the study, and 30 days of treatment discontinuation Time points reported: 72 weeks Subgroups: none Other outcomes measured in the trial: Qmax, a global assessment of improvement, PVR, PSA, erectile and ejaculatory function, incontinence, sleep quality, NIH‐CPSI
Notes	Funding sources: this study was funded by co‐operative agreements from the National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases: U01 DK63795, U01 DK63797, U01 DK63825, U01 DK63835, U01 DK63866, U01 DK63833, U01 DK63862, U01 DK63840, U01 DK63883, U01 DK63831, U01 DK63778, and U01 DK63788. Support was also provided by the National Center for Complementary and Alternative Medicine and the Office of Dietary Supplements, NIH. Rottapharm/Madaus, Cologne, Germany donated the saw palmetto fruit extract and matching placebo. Declarations of interest: Rottapharm/Madaus had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; and preparation or approval of the manuscript. Rottapaharm/Madaus provided nonbinding comments to the authors on a draft of the manuscript. Individual authors: Barry serves on the Board of and receives salary support as President of the not‐for‐profit (501[3]c) Foundation for Informed Medical Decision Making (http://www.fimdm.org), which develops content for patient education programs. The foundation has an arrangement with a for‐profit company, Health Dialog, to co‐produce and market these programs to healthcare organizations. Nickel reports receiving consultation funds from GlaxoSmithKline, Pfizer, Watson, Astellas, Ferring, Taris, Triton, Farr Labs, Trillium, Cernelle, and Johnson & Johnson; has provided expert testimony for GlaxoSmithKline; and has received payment for development of educational presentations from the Canadian Urological Association. Crawford reports receiving payment for lectures from Ferring Pharmaceuticals. Andriole reports receiving consultation funds from Amgen, Bayer, Caris, France Foundation, GenProbe, GlaxoSmithKline, Steba Biotech, Ortho‐Clinical Diagnostics, and Ferring Pharmaceuticals, and has received royalties from “Up to Date.” He reports receiving payment for the development of educational presentations from Amgen, and has stock/stock options in Envisioneering Medical, Viking Medical, Augmenix, and Cambridge Endo. Dr Andriole reports receiving travel/accommodations/meeting expenses from Amgen, Augmenix, Bayer, Cambridge Endo, Caris, France Foundation, GenProbe, Myriad Genetics, Steba Biotech, and Ortho Clinical Diagnostics. Naslund reports receiving payment for lectures from Glaxo and Sanofi as well as payment for the development of educational presentations for the France Foundation. Lee reports that funds were paid to her institution for consultancy to Merck. McVary reports receiving consultancy funds from Lilly/ICOS, Allergan, NIDDK, Watson Pharmaceuticals, and NeoTract, as well as payment for lectures from GlaxoSmithKline.