Marks 2000.

Study characteristics
Methods	Study design: parallel‐group randomized trial Study dates: September 1997 to January 1998 Setting: outpatient Country: USA
Participants	Inclusion criteria: Men aged 45 to 80 years Clinical diagnosis of BPH based on moderate to severe symptoms and palpation of an enlarged prostate gland on rectal examination at the screening visit IPSS 9 or more Question 5 rating of 1 or more 2 of any of questions 1 to 4, 6 or 7 rating of 3 or more PSA < 15 ng/mL Prostate volume 30 cm3 or more Exclusion criteria: History of: allergy to saw palmetto; any illness or condition that may confound the results of the study or pose additional risk to the patient; treatment with any investigational drug; drug or alcohol abuse or dependence; bladder surgery or procedure for BPH; neurogenic bladder; chronic prostatitis or repeat urinary tract infection; recurrent acute urinary retention episodes. Concurrent use of a‐adrenergic receptor antagonists and/or any hormonal therapy that may affect the prostate and use of finasteride or prostate phytotherapy Evidence of urethral stricture or radiotherapy to the pelvis Sample size: 44 participants Age (years): Group 1 mean (SD): 65.1 (8.1) Group 2 mean (SD): 62.9 (9.3) IPSS score (baseline): Group 1 mean (SD): 18.1 (7.2) Group 2 mean (SD): 16.6 (5.3) Prostate size (cm3): Group 1 mean (SD): 58.5 (29.8) Group 2 mean (SD): 55.6 (26.7)
Interventions	Group 1 (n = 21): saw palmetto berry lipoidal extract and other herbs (nettle root extract 80 mg; pumpkin seed oil extract 160 mg; lemon extract 33 mg; vitamin A 190 international units), 106 mg, 3 times daily with meals, orally for 6 months Group 2 (n = 23): placebo capsules (glycerin, yellow wax, lecithin, and soybean oil), 3 times daily with meals, orally for 6 months Co‐interventions: none
Outcomes	Urinary symptoms How measured: IPSS, uroflowmetry, and bladder scan Time points measured: 6, 12, 18, and 24 weeks Time points reported: 6, 12, 18, and 24 weeks Subgroups: none Quality of life How measured: quality of life index Time points measured: 6, 12, 18, and 24 weeks Time points reported: none (measured but not reported) Subgroups: none Adverse events How measured: a panel of 26 standard blood test Time points measured: complete follow‐up Time points reported: complete follow‐up Subgroups: none Other outcomes: postvoid residual urine volume, total serum PSA, free serum PSA, % free PSA, testosterone, dihydrotestosterone, estradiol, whole prostate volume, transition zone prostate volume, Qmax, urinary retention
Notes	Funding sources: supported by an unrestricted educational grant from the Nutrilite Division of Amway Corp., Buena Park, California. Financial interest and/or other relationship with Nutrilite Division of Amway Corp. Declarations of interest: saw palmetto extract capsules were provided and blinding was done by the Nutrilite Division of Amway Corp., Buena Park, California