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

Bird 2000.

Study characteristics
Methods Design: parallel
Duration: 8 weeks
Assessment: baseline and post‐intervention
Countries: UK, Ireland, Germany, Italy, and Belgium
Participants Pain condition: RA
Population: adults with RA and depression
Minimum pain intensity: NR
Inclusion criteria
  • Aged 18‐70

  • RA for > 1 year

  • Diagnosis of mild, moderate, or severe depression

  • Had a total MADRS score of ≥ 16


Exclusion criteria
  • Severe comorbid physical conditions


Total participants randomised: 191
Age in years (mean): 54.8
Gender: 150/191 were female
Pain duration in years (mean, SD): NR
Interventions Paroxetine 20‐40 mg
  • n = 94

  • SSRI

  • Flexible dosing based on efficacy


Amitriptyline 75‐150 mg
  • n = 97

  • TCA

  • Flexible dosing based on efficacy

Outcomes Mood
PGIC
AEs
SAEs
Withdrawal
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.