Masand 2009.
Study characteristics | ||
Methods | Design: parallel Duration: 12 weeks Assessment: baseline and post‐intervention Country: USA |
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Participants | Pain condition: IBS Population: adults aged 18‐75 with IBS Minimum pain intensity: no Inclusion criteria
Exclusion criteria
Total participants randomised: 72 Age in years (mean): 49.0 Gender: 63/72 were female Pain duration in years (mean, SD): NR |
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Interventions | Placebo
Paroxetine 12.5‐50 mg
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Outcomes | SAEs Withdrawal |
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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. |
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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 |