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

Shang 2012.

Study characteristics
Methods Study design: randomized controlled, parallel‐group trial
Setting/country: multi‐institution, China
Dates study conducted: May 2011 to May 2012
Participants Inclusion criteria:
  • Age 20–50 years

  • Matches with PE diagnostic criteria

  • Disease duration > 3 months

  • Signed informed consent


Exclusion criteria:
  • IELT > 2 minutes

  • Genitourinary system has inflammation, such as prostatitis, urethritis, epididymitis, seminal vesiculitis, etc

  • Heart, liver, kidney and nervous system and other primary diseases

  • ED

  • Alcohol, drugs or psychotropic substance abuse

  • Serious relationship problems

  • Taking other treatments for PE drugs during treatment

  • Did not take the medicine on time, halfway out, irregular sexual life, loss of contact and loss of follow‐up

  • Psychotherapy or behavioral therapy is not allowed during the study period or within 3 months prior to the screening visit

  • Participants who had participated in investigative studies have also been excluded

  • Treatment with certain prescription or non‐prescription medications (including any psychoactive drugs)


Number of participants randomized: 80
Group 1 (citalopram 20 mg daily):
  • Number of participants randomized: 40

  • Age (mean): 39.1 (SD 2.5) years

  • Baseline IELT (mean): 0.91 (SD 0.18) minutes


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

  • Age (mean): 37.8 (SD 2.8) years

  • Baseline IELT (mean): 0.95 (SD 0.17) minutes

Interventions Group 1: paroxetine 20 mg daily orally
Group 2: soda tablets as a placebo orally
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, 2 and 4 weeks


Safety outcomes:
  • Heart, liver and kidney function

  • How measured: blood and urine test

  • Time points measured: at baseline, 4 weeks

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 Unclear risk Did not explicitly state whether investigators were blinded; participants appeared to be blinded.
Blinding of outcome assessment (detection bias)
Participant‐reported outcomes Low risk Participants appeared to be appropriately blinded.
Quote: "In the control group, oral placebo medication is the same colour and size as treatment group containing starch complexes."
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 All participants included in analysis.
Selective reporting (reporting bias) Unclear risk No protocol available.
Other bias Low risk No additional sources of bias identified.