Sarzi Puttini 1988.

Study characteristics
Methods	Design: parallel Duration: 4 weeks Assessment: baseline and post‐intervention Country: Italy
Participants	Pain condition: RA Population: adults with RA and with or without depression Minimum pain intensity: ≥ 50 on 0‐100 scale Inclusion criteria Classical or definite active RA, diagnosed according to the ARA criteria Pain intensity ≥ 50 on 0‐100 scale Exclusion criteria: NR Total participants randomised: 60 Age in years (mean, SD): NR Gender: 52/60 were female Pain duration in years (mean, SD): NR
Interventions	Placebo n = 30 Inert Dothiepin 75 mg n = 30 TCA Fixed dose
Outcomes	Study provided no useable data
Missing data methods	Completer analysis
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 methods not specified
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Says matched dosing schedules but not other information given
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Self‐reported outcomes from participants but unsure of blinding
Incomplete outcome data (attrition bias) All outcomes	High risk	Completer analysis only Attrition Total: 10/60 (16.7%) Attrition per arm NR
Selective reporting (reporting bias)	Unclear risk	No protocol or trial registration found
Other bias	Low risk	No other sources of bias were identified