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

Macfarlane 1986.

Study characteristics
Methods Design: parallel
Duration: 12 weeks
Assessment: baseline and post‐intervention
Country: Canada
Participants Pain condition: RA
Population: adults with RA and elevated self‐reported depression
Minimum pain intensity: no
Inclusion criteria
  • ‘Definite’ or ‘classical’ RA as defined by the ARA

  • All of the patients had a score exceeding 50 on the ‘self‐rating depression scale’ described by Zung 1965


Exclusion criteria: NR
Total participants randomised: 36
Age in years (mean, SD): 59.15
Gender: 27/36 were female
Pain duration in years (mean, SD): NR
Interventions Placebo
  • n = 18

  • Inert

  • Identical tablets


Trimipramine 75 mg
  • n = 18

  • TCA

  • Fixed titration schedule to 75 mg, but if participants experienced side effects they could reduce the dose

Outcomes Pain intensity
Mood
Withdrawal
Missing data methods NR
Funding source NR
Conflicts of interest NR
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Randomisation methods not specified
Allocation concealment (selection bias) Unclear risk Allocation procedure not specified
Blinding of participants and personnel (performance bias)
All outcomes Low risk Double‐blind, identical study drugs
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 No information on handling missing data, report 9 participants withdrew in the text but 10 in the table
Attrition
Total: 9/36 (25.0%)
Placebo: 4/18 (22.2%)
Trimipramine 25‐75 mg: 5/18 (27.8%)
Selective reporting (reporting bias) Unclear risk No protocol or trial registration found
Other bias Unclear risk Not a lot of information on methods, short publication so not enough information to assess whether a further risk of bias exists