Ye 2019.

Study characteristics
Methods	Study design: parallel‐group randomized trial Study dates: March 2014 to June 2016 Setting: outpatient, multicenter, national Country: China
Participants	Inclusion criteria: Men ≥ 45 years old Qmax ≥ 4 mL/s AUASI score ≥ 8 and ≤ 24 at 2 screening visits Participants on therapy with alpha‐adrenergic blockers, 5‐alpha‐reductase inhibitors, Chinese patent drug, and herbal medicine for BPH were withdrawn for 2 weeks Exclusion criteria: Refractory to medical treatment BPH complications IPSS of 20 to 35 Suspected or confirmed prostatic cancer, neurogenic bladder dysfunction, urethral stricture, congenital or anatomic abnormality of the genital organ, and a history of surgery or trauma that would affect the evaluation of the efficacy of the drug Diabetes mellitus, severe cardiovascular disease, sexually transmitted disease, malignant tumor, peptic ulcer, hemorrhagic disease, mental diseases, acrasia, alcohol dependence, and drug abuse Patients on drugs affecting the bladder or sexual function, those with insufficiency of liver or kidney, and those with a history of allergic reactions to the study drug or similar drugs Patients who participated in another clinical trial in the past 3 months Sample size: 354 Age (years): Group 1 mean (SD): 61.47 (± 5.20) Group 2 mean (SD): 60.32 (± 5.96) IPSS/AUASI score (baseline): Group 1 mean (SD): 14.42 (± 3.88) Group 2 mean (SD): 14.34 (± 4.08) Prostate size: Group 1: 37.01 (± 19.68) Group 2: 37.30 (± 25.40)
Interventions	Group 1 (n = 159): Serenoa repens extract 320 mg (160 mg twice daily soft capsule) manufactured by TAD Pharma GmbH Group 2 (n = 166): placebo 160 mg twice daily soft capsule
Outcomes	Urinary symptoms How measured: IPSS score Time points measured: 2, 4, 12, and 24 weeks Time points reported: 2, 4, 12, and 24 weeks Subgroups: none Quality of life How measured: IPSS QoL Time points measured: 2, 4, 12, and 24 weeks Time points reported: 2, 4, 12, and 24 weeks Subgroups: none Adverse events: How measured: narratively Time points measured: not available (possibly 2, 4, 12, and 24 weeks) Time points reported: not available Subgroups: none Other outcomes measured in the trial: voiding symptoms, prostate volume, urinary frequency, and total PSA level. Other parameters assessed were MSF‐4 score, IIEF, and Qmax.
Notes	Funding sources: Serenoa Repens was provided by TAD Pharma GmbH Declarations of interest: the authors report no conflicts of interest

AUASI: American Urological Association Symptom Index; BPH: benign prostatic hyperplasia; BUN: blood urea nitrogen; CFU: colony‐forming units; HCL: hydrochloride; IIEF: International Index of Erectile Function; IPSS: International Prostate Symptom Score; LUTS: lower urinary tract symptoms; MedDRA: Medical Dictionary for Regulatory Activities; MFR: maximum flow rate; MSF‐4: Male Sexual Function 4‐item; NIH‐CPSI: National Institutes of Health Chronic Prostatitis Symptom Index; PSA: prostate‐specific antigen; PVR: postvoid residual; Q_max: peak urinary flow; QoL: quality of life; SD: standard deviation; SEM: standard error of the mean