Bird 2000.
Study characteristics | ||
Methods | Design: parallel Duration: 8 weeks Assessment: baseline and post‐intervention Countries: UK, Ireland, Germany, Italy, and Belgium |
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Participants | Pain condition: RA Population: adults with RA and depression Minimum pain intensity: NR Inclusion criteria
Exclusion criteria
Total participants randomised: 191 Age in years (mean): 54.8 Gender: 150/191 were female Pain duration in years (mean, SD): NR |
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Interventions | Paroxetine 20‐40 mg
Amitriptyline 75‐150 mg
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Outcomes | Mood PGIC AEs SAEs Withdrawal |
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Missing data methods | ITT but imputation method not specified | |
Funding source | Pharmaceutical ‐ educational grant from SmithKline Beecham | |
Conflicts of interest | NR | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | No information given |
Allocation concealment (selection bias) | Unclear risk | No information given |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double‐blinded ‐ double‐dummy dosing schedule |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Self‐reported outcomes from blinded participants |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | States ITT but no information regarding imputation method given Attrition Total: 37/191 (19.4%) Paroxetine 20‐40 mg: 18/95 (18.9%) Amitriptyline 75‐150 mg: 20/105 (19.0%) |
Selective reporting (reporting bias) | Unclear risk | No protocol or trial registration found |
Other bias | Low risk | No other sources of bias were identified. |