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. 2021 Mar 21;2021(3):CD012799. doi: 10.1002/14651858.CD012799.pub2

Ahn 1996.

Study characteristics
Methods Study design: randomized controlled, parallel‐group trial
Setting/country: Department of Urology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea
Dates study conducted: NR
Participants Inclusion criteria:
  • Heterosexual sexually active men with PE

  • Age 18–75 years

  • PE defined as IELT ≤ 2 minutes after vaginal intromission in half of the intercourse


Exclusion criteria:
  • ED

  • Alcohol and drug abuse

  • Physical illness

  • Use of psychoactive drugs


Number of participants randomized: 23
Group 1 (fluoxetine)
  • Number of participants randomized: 12

  • Age (mean): 39.8 (range 34–48) years


Group 2 (placebo)
  • Number of participants randomized: 11

  • Age (mean): 41.8 (range 31–61) years

Interventions Group 1: fluoxetine 20 mg daily for first 1 week and 40 mg daily for remaining 5 weeks after breakfast
Group 2: multivitamin as placebo daily
Outcomes Primary outcomes:
  • IELT

  • How measured: NR

  • Time points measured: 0, 3, 6 weeks


Safety outcomes:
  • Adverse effects

  • How measured: reported

  • Time points measured: anytime

Funding sources NR
Declarations of interest NR
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Not described.
Allocation concealment (selection bias) Unclear risk Not described.
Blinding of participants and personnel (performance bias)
All outcomes Low risk Quote: "participants and investigator were blinded for the randomization," "randomized placebo controlled trial."
Blinding of outcome assessment (detection bias)
Participant‐reported outcomes Low risk Quote: "participants and investigator were blinded for the randomization," "randomized placebo controlled trial."
Blinding of outcome assessment (detection bias)
Investigator‐assessed outcomes Low risk Quote: "investigator were blinded for the randomization."
Blinding of outcome assessment (detection bias)
IELT Low risk Objective measurement that was unlikely to be influenced by blinding.
Incomplete outcome data (attrition bias)
All outcomes Low risk All participants included in analysis.
Selective reporting (reporting bias) Unclear risk Unpublished protocol/prespecified outcomes (intercourse frequency, libido) in method were not or were partially reported in the results.
Other bias Low risk No additional sources of bias identified.