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

Hammody 2015.

Study characteristics
Methods Design: parallel
Duration: 12 weeks
Assessment: baseline, week 4, week 8, post‐intervention
Country: Iraq
Participants Pain condition: fibromyalgia
Population: adults with fibromyalgia
Minimum pain intensity: no
Inclusion criteria
  • Patients with fibromyalgia fulfilling the Wolfe 2010 criteria


Exclusion criteria
  • Inflammatory conditions and cardiovascular problems


Total participants randomised: 123
Age in years (mean, SD): NR
Gender: NR
Pain duration in years (mean, SD): NR
Interventions Pregabalin 75 mg
  • n = 62

  • Anticonvulsant

  • Fixed dose, no titration


Amitriptyline 25 mg
  • n = 61

  • TCA

  • Fixed dose, no titration

Outcomes Pain intensity
Quality of life
Missing data methods NR
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 procedures not specified
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk States double‐blind, but no information regarding blinding procedures
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Self‐reported outcomes from participants, but unsure of blinding procedures
Incomplete outcome data (attrition bias)
All outcomes High risk High attrition, analysis of per‐protocol population
Attrition
Total: 45/123 (36.6%)
Attrition per arm NR
Selective reporting (reporting bias) Unclear risk No protocol or trial registration found
Other bias High risk Poorly reported ‐ mistakes throughout document, figures not really adding up and tables wrongly titled