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

Metzker 1996.

Study characteristics
Methods Study design: double‐blind, parallel‐group randomized trial
Study dates: not available
Setting: inpatient, single center, national
Country: Germany
Participants Inclusion criteria:
  • BPH stage 1 to 2 according to Alken

  • Minimum volume of urination > 150 mL

  • Qmax 20 mL/s


Exclusion criteria:
  • Age < 50

  • Need for the instrumental intervention of the lower urinary tract except for single catheterization

  • Symptomatic urinary tract infection

  • Concomitant medication that could interfere with the evaluation of efficacy

  • Another serious organic disease


Sample size: 40 randomized participants
Age (years):
Group 1 mean (SD): 66.0 (52.4 to 84.0)
Group 2 mean (SD): 65.1 (52.8 to 80.6)
IPSS score (baseline):
Group 1 mean (SD): 18.6 (15.0 to 22.2)
Group 2 mean (SD): 19.0 (15.1 to 22.9)
Prostate size: not available
Interventions Group 1 (n = 20): Sabal‐Urtica (Prostagutt forte) capsule twice a day for 1 year. 1 capsule of Prostagutt forte contains: WS 1473 extract of saw palmetto fruits, 160 mg and WS 1031 dry extract of nettle root, 120 mg.
Group 2 (n = 20): placebo capsule twice a day for 1 year
Co‐interventions: none
Outcomes Urinary symptoms
  • How measured: IPSS

  • Time points measured: day 0 and 24 and 48 weeks

  • Time points reported: day 0 and 24 and 48 weeks

  • Subgroups: none


Quality of life
  • How measured: AUASI

  • Time points measured: day 0 and 24 weeks

  • Time points reported: day 0 and 24 weeks (narrative)

  • Subgroups: none


Adverse events
  • How measured: not reported

  • Time points measured: day 0 and 24 weeks

  • Time points reported: cumulative at 24 weeks (narrative)

  • Subgroups: none


Other outcomes measured in the trial: blood pressure, Qmax, residual volume
Notes Funding sources: not available
Conflicts of interest: not available
After 24 weeks, all men were offered the interventional treatment (no control group).