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. 2023 Jun 22;2023(6):CD001423. doi: 10.1002/14651858.CD001423.pub4

Ryu 2015.

Study characteristics
Methods Study design: randomized controlled trial
Study dates: March 2012 to March 2013
Setting: outpatient, single center, national
Country: Korea
Participants Inclusion criteria:
  • Men between 50 and 80 years old

  • IPSS > 10 points

  • Qmax 5 to 15 mL/s for a voided volume of at least 150 mL

  • Postvoiding volume < 150 mL

  • Prostate volume > 25 cm3

  • PSA < 4 ng/mL


Exclusion criteria:
  • History of bladder diseases such as:

    • micturition;

    • urethral stenosis;

    • prostate cancer;

    • pelvic radiotherapy;

    • repeated infection of urinary tract.

    • chronic bacterial prostatitis.

  • Patients with clinically significant cardiovascular disease

  • Hematuria

  • Insulin‐dependent diabetes mellitus

  • History of severe hepatic failure or abnormal liver function test

  • Known hypersensitivity to 1 of the study drugs

  • Medical history of BPH during the past 12 months


Sample size: 120 randomized participants
Age (years):
Group 1 mean (SD): 62.5 (1.21)
Group 2 mean (SD): 63.4 (1.44)
IPSS score (baseline):
Group 1 mean (SD): 19.6 (0.73)
Group 2 mean (SD): 20 (0.85)
Prostate size:
Group 1 mean (SD): 30.1 (0.93)
Group 2 mean (SD): 30.2 (0.67)
Interventions Group 1 (n = 60): Serenoa repens (Permixon) 320 mg/day for 12 months
Group 2 (n = 60): only the co‐intervention
Co‐interventions: tamsulosin 0.2 mg/day
Outcomes Urinary symptoms
  • How measured: IPSS score

  • Time points measured: 0, 6, and 12 months

  • Time points reported: 0, 6, and 12 months

  • Subgroups: none


Quality of life
  • How measured: LUTS‐related quality of life scores

  • Time points measured: 0, 6, and 12 months

  • Time points reported: 0, 6, and 12 months

  • Subgroups: none


Adverse events
  • How measured: not described

  • Time points measured: 0, 6, and 12 months

  • Time points reported: 12 months

  • Subgroups: none


Other outcomes measured in the trial: PSA and prostate volume, Qmax
Notes Funding sources: not available
Declarations of interest: not available