Glémain 2002.

Study characteristics
Methods	Study design: parallel‐group randomized trial Study dates: not available Setting: outpatient, multicenter and national Country: France
Participants	Inclusion criteria: Men above 50 years old IPSS ≥ 13 LUTS Diagnosed BPH Qmax of 7 to 15 mL/s for a voided volume of at least 120 mL Exclusion criteria: History of surgical intervention in the bladder, prostate, or pelvic area PVR > 300 mL Ailments that could affect urination or the final evaluation (bladder disease, prostate cancer, urinary tract infection, urethral stricture) Stopping treatment for BPH for less than 15 days (for alpha‐blockers) or less than 1 month (for plant extract or finasteride) Hepatic insufficiency Cardiovascular or cerebrovascular event Neurological disease Allergy to alpha‐blockers Life‐threatening pathology Sample size: 329 randomized participants Age (years): Group 1 mean (SD): 64.4 (7.7) Group 2 mean (SD): 65.2 (7.9) IPSS score (baseline): Group 1 mean (SD): 16.3 (5.6) Group 2 mean (SD): 16.2 (5.2) Prostate size: Group 1 mean (SD): 38.6 (15) Group 2 mean (SD): 40.8 (16.5)
Interventions	Group 1 (n = 161): placebo orally after breakfast and dinner for 52 weeks Group 2 (n = 165): Serenoa repens 160 mg orally (Permixon) after breakfast and dinner for 52 weeks Co‐interventions: tamsulosin (Omix LP 0.4 mg) orally after breakfast
Outcomes	Urinary symptoms How measured: IPSS score Time points measured: 0, 4, 13, 26, 39, and 52 weeks Time points reported: 0, 4, 13, 26, 39, and 52 weeks Subgroups: none Quality of life How measured: IPSS‐QoL and UROLIFE BPH QoL9 Time points measured: 0, 4, 13, 26, 39, and 52 weeks Time points reported: 0, 4, 13, 26, 39, and 52 weeks Subgroups: none Adverse events How measured: not described (classified as serious/non‐serious) Time points measured: not available (possibly 52 weeks) Time points reported: not available (possibly 52 weeks) Subgroups: none Other outcomes measured in the trial: sexual function was assessed using the Brief Male Sexual Function Inventory (BMSFI), Qmax
Notes	Funding sources: not available Declarations of interest: not available