Caruso 1987.

Study characteristics
Methods	Design: parallel Duration: 8 weeks Assessment: baseline, week 2, week 4, post‐intervention Country: Italy
Participants	Pain condition: fibromyalgia Population: adults with fibromyalgia Minimum pain intensity: NR Inclusion criteria Aged 25‐65 Affected by fibromyalgia Exclusion criteria: NR Total participants randomised: 60 Age in years (mean): 46 Gender: 52/60 were female Pain duration in years (mean): 5.7
Interventions	Placebo n = 30 Identical appearance and matched dosing Inert Dothiepin 75 mg n = 30 TCA Fixed dose
Outcomes	AEs Withdrawal
Missing data methods	NR
Funding source	Funding: NR
Conflicts of interest	NR
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Randomsiation methods not specified
Allocation concealment (selection bias)	Unclear risk	Allocation procedures not specified
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Double‐blind with matched dosing and identical appearance of tablets
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Self‐reported outcomes by blinded participants
Incomplete outcome data (attrition bias) All outcomes	High risk	Completer analysis only Attrition Total: 8/60 (13.3%) Placebo: 4/30 (13.3%) Dothiepin 75 mg: 4/30 (13.3%)
Selective reporting (reporting bias)	Unclear risk	No protocol or trial registration found
Other bias	Low risk	No other sources of bias were identified.