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

Carette 1986.

Study characteristics
Methods Design: parallel
Duration: baseline and post‐intervention
Assessment: 9 weeks
Country: Canada
Participants Pain condition: primary fibrositis/fibromyalgia
Population: people with fibromyalgia
Minimum pain intensity: NR
Inclusion criteria
  • Widespread pain lasting > 3 months

  • Local tenderness at 12 out of 14 specified sites


Exclusion criteria
  • History of heart conditions

  • Treated with amitriptyline in the previous year


Total participants randomised: 70
Age in years (mean): 41
Gender: 54/70 were female
Pain duration in months (mean): 84
Interventions Placebo
  • n = 36

  • Identical appearance

  • Inert


Amitriptyline 10‐50 mg
  • n = 34

  • TCA

  • Forced titration to fixed doses dependent upon tolerability

Outcomes Pain intensity
AEs
Withdrawal
Missing data methods Completer analysis only
Funding source Non‐pharmaceutical ‐ Arthritis Grant
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 High risk Although the study used double‐blind procedures, the authors noted that 70% of the amitriptyline participants experienced side effects that, in some cases, unblinded participants and research staff.
Blinding of outcome assessment (detection bias)
All outcomes High risk Self‐reported outcomes from participants who may have been unblinded
Incomplete outcome data (attrition bias)
All outcomes High risk Completer analysis only
Attrition
Total: 11/70 (15.7%)
Placebo: 4/32 (11.1%)
Amitriptyline 10‐50 mg: 7/27 (20.6%)
Selective reporting (reporting bias) Unclear risk No protocol or trial registration found
Other bias Low risk No other sources of bias were identified.