Vahedi 2005.
Study characteristics | ||
Methods | Design: parallel Duration: 12 weeks Assessment: baseline, post‐intervention, follow‐up (4 weeks post‐intervention) Country: Iran |
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Participants | Pain condition: IBS Population: people with pain and constipation‐predominant IBS Minimum pain intensity: no Inclusion criteria
Exclusion criteria
Total participants randomised: 44 Age in years (mean, SD): 34.9 (10.0) Gender: 27/44 were female Pain duration in years (mean, SD): NR |
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Interventions | Placebo
Fluoxetine 20 mg
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Outcomes | Withdrawal | |
Missing data methods | No participants withdrew | |
Funding source | Non‐pharmaceutical: This study was supported by a grant from the Digestive Disease Research Center of Tehran University of Medical Sciences. | |
Conflicts of interest | NR | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Patients were randomly assigned according to a computer‐generated randomisation table |
Allocation concealment (selection bias) | Unclear risk | Allocation procedures NR |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double‐blind, identical study drugs, matched dosing |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Self‐reported outcomes by blinded participants |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No participants withdrew |
Selective reporting (reporting bias) | Unclear risk | No protocol or trial registration found |
Other bias | Low risk | No other sources of bias were identified. |