Bent 2006.

Study characteristics
Methods	Study design: parallel group randomized trial Study dates: July 2001 to May 2004 Setting: multicenter, outpatient, national Country: USA
Participants	Inclusion criteria: Men > 49 years old AUASI ≥ 8 Qmax < 15 mL/s Exclusion criteria: Qmax < 4 mL/s Residual volume > 250 mL History of: prostate cancer; surgery for BPH; urethral stricture; neurological bladder. Creatinine > 2.0 mg/dL PSA > 4.0 ng/dL Users of medications known to affect urination Severe concomitant disease Sample size: 225 participants Age (years): Group 1 mean (SD): 62.9 (8.0) Group 2 mean (SD): 63.0 (7.4) AUASI score (baseline): Group 1 mean (SD): 15.7 (5.7) Group 2 mean (SD): 15.0 (5.3) Prostate size (mL): Group 1 mean (SD): 34.7 (13.9) Group 2 mean (SD): 33.9 (15.2)
Interventions	Group 1 (n = 112): saw palmetto carbon dioxide extract capsules, 160 mg twice daily orally for 14 months Group 2 (n = 113): placebo capsules twice a day orally for 14 months Co‐interventions: none
Outcomes	Urinary symptoms How measured: AUASI Time points measured: 1, 3, 6, 9, and 12 months Time points reported: 1, 3, 6, 9, and 12 months Subgroups: AUASI score (20) and PSA levels (1.4 ng/dL) Quality of life How measured: BPH Impact Index/36‐Item Short‐Form Health Survey (SF‐36) Time points measured: 1, 3, 6, 9, and 12 months Time points reported: 1, 3, 6, 9, and 12 months Subgroups: none Adverse events How measured: not described (classified as serious/non‐serious) Time points measured: possibly at 12‐month follow‐up Time points reported: possibly at 12‐month follow‐up Subgroups: none Other outcomes measured in the trial: Qmax, prostate size, PVR, PSA, creatinine, testosterone, and other laboratory values
Notes	Funding sources: supported by a grant (1 RO1 DK56199‐01, to Dr Avins) from the National Institute of Diabetes and Digestive and Kidney Diseases and a grant (1 K08 ATO1338‐01, to Dr Bent) from the National Center for Complementary and Alternative Medicine Declarations of interest: Dr Kane reports receiving consulting fees from American Medical Systems and Intuitive Surgical and lecture fees from Merck and TAP. Dr Shinohara reports having received lecture fees from GlaxoSmithKline and Pfizer. Dr Avins reports receiving grant support from Merck.