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

Heymann 2001.

Study characteristics
Methods Design: parallel
Duration: 8 weeks
Assessment: baseline and post‐intervention
Country: Brazil
Participants Pain condition: fibromyalgia
Population: women with fibromyalgia
Minimum pain intensity: no
Inclusion criteria
  • Women with fibromyalgia meeting the ACR criteria


Exclusion criteria
  • Physical health comorbidities

  • Use of nortriptyline or amitriptyline at any point


Total participants randomised: 118
Age in years (mean): 50.5
Gender: 118/118 were female
Pain duration in years (mean, SD): NR
Interventions Placebo
  • n = 40

  • Inert

  • Identical tablets, matched dosing


Amitriptyline 25 mg
  • n = 40

  • TCA

  • Fixed dose


Nortriptyline 25 mg
  • n = 38

  • TCA

  • Fixed dose

Outcomes Quality of life
SAEs
Withdrawal
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) Low risk Participants were randomised using random number tables
Allocation concealment (selection bias) Unclear risk Allocation procedures NR
Blinding of participants and personnel (performance bias)
All outcomes Low risk Double‐blind, all study drugs were identical in appearance and packaging
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 Much higher attrition in the placebo group than intervention groups. No missing data methods; report only completer analysis
Attrition
Total: 12/118 (10.2%)
Amitriptyline 25 mg: 3/40 (7.5%)
Nortriptyline 25 mg: 2/38 (5.3%)
Placebo: 7/40 (17.5%)
Selective reporting (reporting bias) Unclear risk No protocol or trial registration found
Other bias Low risk No other sources of bias were identified