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

Gong 2011.

Study characteristics
Methods Study design: randomized controlled, parallel‐group trial
Setting/country: Outpatient/Department of Urology, The affiliated hospital of Chuanbei Medical University, Nanchong, China
Dates study conducted: NR
Participants Inclusion criteria:
  • Met the PE diagnostic criteria

  • Had a fixed sexual partner

  • Sexual partners have a willingness to co‐operate

  • No other complications


Exclusion criteria:
  • NR


Number of participants randomized: 80
Group 1 (paroxetine):
  • Number of participants randomized: 40

  • Age (mean): 26.8 (SD 5.5) years

  • Baseline IELT (mean): 0.89 (SD 0.21) minutes


Group 2 (placebo):
  • Number of participants randomized: 40

  • Age (mean): 29.2 (SD 6.7) years

  • Baseline IELT (mean): 0.97 (SD 0.18) minutes

Interventions Group 1: paroxetine 20 mg daily orally
Group 2: oral soda tablets as a placebo
Outcomes Primary outcomes:
  • IELT/sexual satisfaction

  • How measured: stopwatch/sexual intercourse satisfaction score quantified as 1–10 points (1 = very dissatisfied, 10 = very satisfied)

  • Time points measured: at baseline, 30 days


Safety outcomes:
  • NR

Funding sources NR
Declarations of interest NR
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Methods not described.
Allocation concealment (selection bias) Unclear risk Methods not described.
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Not explicitly stated whether personnel were blinded; participants appeared to be blinded.
Blinding of outcome assessment (detection bias)
Participant‐reported outcomes Low risk Participants likely blinded through the use of placebo.
Blinding of outcome assessment (detection bias)
Investigator‐assessed outcomes Unclear risk Not explicitly described.
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 Quote: "All patients were followed up for 6 to 10 weeks."
Selective reporting (reporting bias) Unclear risk No protocol available.
Other bias Low risk No additional sources of bias identified.