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

Ash 1999.

Study characteristics
Methods Design: parallel
Duration: 10 weeks
Assessment: baseline and post‐intervention
Country: UK
Participants Pain condition: RA
Population: women with RA and depression
Minimum pain intensity: NR
Inclusion criteria:
  • Patients with definite or classical RA as diagnosed per the ARA criteria

  • Aged between 18 and 70

  • Scored a) > 7 on the depression or anxiety subscales of HADS, b) total score of > 11 on HADS scale, or c) considered to be depressed on clincial assessment


Exclusion criteria
  • Experiencing an acute flare in RA symptoms

  • Taking oral steroids, antidepressants, or had received a steroid injection in the previous month


Total participants randomised: 48
Age in years (mean, SD): NR
Gender: 48/48 were female
Pain duration in years (mean, SD): NR
Interventions Dothiepin
  • n = 25

  • TCA

  • Flexible dosing dependent on tolerability and side‐effects


Placebo
  • n = 23

  • Identical appearance

  • Inert

Outcomes Pain intensity
Mood
Physical function
Withdrawal
Missing data methods ITT but does not state imputation methods
Funding source Pharmaceutical ‐ Boots
Conflicts of interest NR
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk States random allocation but no method given
Allocation concealment (selection bias) Unclear risk No information given
Blinding of participants and personnel (performance bias)
All outcomes Low risk Double‐blind with identical appearing antidepressants and placebo
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 Over 40% of participants did not compelte the study due to lack of effect or intolerable side effects.
Attrition:
Total: 21/48 (43.75%)
Placebo: 10/23 (43.5%)
Dothiepin 75 to 150 mg: 11/25 (44.0%)
Selective reporting (reporting bias) Unclear risk No protocol or trial registration found
Other bias Low risk No other sources of bias were identified.