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. 2023 May 10;2023(5):CD014682. doi: 10.1002/14651858.CD014682.pub2

Masand 2009.

Study characteristics
Methods Design: parallel
Duration: 12 weeks
Assessment: baseline and post‐intervention
Country: USA
Participants Pain condition: IBS
Population: adults aged 18‐75 with IBS
Minimum pain intensity: no
Inclusion criteria
  • Confirmed diagnosis of IBS by use of Rome II diagnostic criteria for over 1 year


Exclusion criteria
  • Physical and mental health comorbidies


Total participants randomised: 72
Age in years (mean): 49.0
Gender: 63/72 were female
Pain duration in years (mean, SD): NR
Interventions Placebo
  • n = 36

  • Inert

  • Dosing matched to antidepressant arm


Paroxetine 12.5‐50 mg
  • n = 36

  • SSRI

  • Forced titration to maximum tolerated dose

Outcomes SAEs
Withdrawal
Missing data methods ITT with LOCF
Funding source Pharmaceutical: This study was supported by a collaborative research grant from GlaxoSmithKline.
Conflicts of interest Dr Masand is a consultant for Bristol‐Myers Squibb Company, Cephalon, Inc., Eli Lilly and Company, Forest Pharmaceutical Laboratories Inc., GlaxoSmithKline, Janssen Pharmaceutica, Jazz Pharmaceuticals, Organon, Inc., Pfizer Inc., U.S. Pharmaceuticals Group., Targacept Inc., and Wyeth Pharmaceuticals. He is on the speaker's bureau of Astra‐Zeneca, Bristol‐Myers Squibb Company, Forest Pharmaceutical Laboratories, Inc., GlaxoSmithKline, Janssen Pharmaceutica, Pfizer Inc., U.S. Pharmaceuticals Group., and Wyeth Pharmaceuticals. He has received research support from AstraZeneca Pharmaceuticals, Bristol‐Myers Squibb Company, Cephalon, Inc.., Eli Lilly and Company, Forest Pharmaceutical Laboratories Inc., GlaxoSmithKline, Ortho McNeil Pharmaceutical, Inc., Janssen Pharmaceutica, and Wyeth Pharmaceuticals, and is an employee of i3CME.
Dr Patkar is a consultant for Bristol‐Myers Squibb Company, GlaxoSmithKline, and Reckitt Benckiser; he is on the speaker's bureau of Bristol‐Myers Squibb Company, GlaxoSmithKline, and Reckitt Benckiser, and has received research support from National Institutes of Health, AstraZeneca Pharmaceuticals, Bristol‐Myers Squibb Company, Forest Pharmaceuticals, Inc., GlaxoSmithKline, Janssen Pharmaceutica, McNeil Consumer and Specialty Inc., Organon, Inc., Jazz Pharmaceuticals, and Pfizer Inc., U.S. Pharmaceuticals Group.
Dr Pae has received research support from GlaxoSmithKline.
Mr. Krulewicz is an employee of GlaxoSmithKline and owns common stock in the company.
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Randomisation methods not described
Allocation concealment (selection bias) Low risk Participants were allocated using an Interactive Voice Response System
Blinding of participants and personnel (performance bias)
All outcomes Low risk Double‐blind, matching drug appearance and identical dosing schedules
Blinding of outcome assessment (detection bias)
All outcomes Low risk Self‐reported outcomes from blinded participants
Incomplete outcome data (attrition bias)
All outcomes High risk ITT with LOCF
Attrition
Total: 14/72 (19.4%)
Placebo: 8/36 (22.2%)
Paroxetine 12.5‐50 mg: 6/36 (16.7%)
Selective reporting (reporting bias) High risk Trial registry lists quality of life and IBS symptoms as outcomes but these are NR. Beck Depression Index and Beck Anxiety Index are NR for all participants, divided into samples with or without history of anxiety and depression.
Other bias Low risk No other sources of bias were identified