Calderon 2011.

Study characteristics
Methods	Design: parallel Duration: 7 weeks Assessment: baseline, post‐intervention, follow‐up (4 weeks after post‐intervention) Country: Brazil
Participants	Pain condition: orofacial pain Population: women with temporomandibular disorders Minimum pain intensity: ≥ 40 mm on a 0‐100 mm VAS Inclusion criteria Women aged between 17 and 55 Orofacial pain for > 6 months Pain occurring daily or almost daily Pain ≥ 40 on a 0‐100 mm VAS Exclusion criteria Physical and mental health comorbidities Total participants randomised: 47 Age in years (mean, range): 35.6 (17‐52) Gender: 47/47 were female Pain duration in months (mean, range): 72.35 (6‐384)
Interventions	Placebo n = 13 Inert Placebo + CBT n = 11 Inert placebo Weekly 90‐min CBT sessions for 7 weeks Amitriptyline 25 mg n = 11 TCA Fixed dose with no titration Amitriptyline 25 mg + CBT n = 12 TCA ‐ antidepressant Weekly 90‐min CBT sessions for 7 weeks
Outcomes	Withdrawal
Missing data methods	Completer‐only analysis
Funding source	Non‐pharmaceutical ‐ Ministry of Education in Brazil
Conflicts of interest	NR
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Participants were randomised using the website www.randomization.com
Allocation concealment (selection bias)	Unclear risk	Allocation procedures not specified
Blinding of participants and personnel (performance bias) All outcomes	High risk	Due to nature of CBT group participants cannot be blinded. When comparing the placebo versus amitriptyline group(s) there was no description of whether pills were matched.
Blinding of outcome assessment (detection bias) All outcomes	High risk	Self‐reported outcomes from unblinded participants
Incomplete outcome data (attrition bias) All outcomes	High risk	No clear explanation of reasons for withdrawal and from which group, not clear on handling missing data or group sizes in outcomes Attrition Total: 10/47 (21.3%) Placebo: 2/13 (15.4%) CBT: 2/11 (18.2%) Amitriptyline 25 mg: 2/11 (18.2%) CBT + amitriptyline 25 mg: 4/12 (33.3%)
Selective reporting (reporting bias)	Unclear risk	No trial registration or protocol found
Other bias	Low risk	No other sources of bias were identified.