Morgia 2014.

Study characteristics
Methods	Study design: parallel‐group randomized trial Study dates: March 2011 to March 2012 Setting: outpatient, multicenter and national Country: Italy
Participants	Inclusion criteria: Age between 55 and 80 years old Digital rectal examination negative for prostate nodules PSA ≤ 4 ng/mL IPSS ≥ 12 Prostate volume ≤ 60 cm3 (assessed by ultrasound) Qmax ≤ 15 mL/s Postvoid residual urine < 150 mL Exclusion criteria: Prostate cancer Previous bladder cancer Diabetes mellitus Neurogenic disorders Severe liver disease History of orthostatic hypotension or syncope Symptomatic urinary tract infection Anti‐androgens Antidepressants (neuroleptics, anticholinergics) therapy Recent treatment with alpha blocker (within 1 month) or phytotherapy including saw palmetto extract (within 3 months) Previous medical therapy with 5‐alpha‐reductase inhibitors or surgical treatment for LUTS/BPH Patients with catheters or with an episode of acute retention of urine in the last 4 weeks Sample size: 225 randomized participants Age (years): Group 1 median (range): 65 (56 to 76) Group 2 median (range): 66 (56 to 79) IPSS score (baseline): Group 1 median (range): 20 (12 to 35) Group 2 median (range): 19 (12 to 33) Prostate size: Group 1 median (range): 45 (20 to 60) Group 2 median (range): 45 (20 to 60)
Interventions	Group 1 (n = 75): Serenoa repens 320 mg, selenium, lycopene (Profluss) for 1 year Group 2 (n = 79): placebo for 1 year Co‐interventions: tamsulosin 0.4 mg
Outcomes	Urinary symptoms How measured: IPSS Time points measured: 0, 1, 3, 6, and 12 months Time points reported: 6 and 12 months Subgroups: none Quality of life How measured: IPSS‐QoL Time points measured: 0, 1, 3, 6, and 12 months Time points reported: 6 and 12 months Subgroups: none Adverse events How measured: not described Time points measured: along the 12‐month trial Time points reported: 12 months Subgroups: none Other outcomes measured in the trial: International Index of Erectile Function (IIEF‐5), PVR, prostate volume, PSA and Ejaculation Questionnaire (EjQ), Qmax
Notes	Funding sources: Konpharma provided support for this study Declarations of interest: the authors declare no conflicts of interest. This study has been designed and conducted independently.