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

Ventafridda 1987.

Study characteristics
Methods Design: parallel
Duration: 15 days
Assessment: baseline and post‐intervention
Country: Italy
Participants Pain condition: chronic pain syndromes from deafferentation and with oncological pain with deafferentation component
Population: adults aged 34‐79 with cancer pain and other painful syndromes with deafferentation component
Minimum pain intensity: no
Inclusion criteria
  • Chronic pain from: phantom limb, cancer, post‐herpetic neuralgia, traumatic nerve lesion, post‐radiation nerve lesion

  • Pain lasting at least 6 months


Exclusion criteria
  • Glaucoma, myasthenia, hypertrophic prostate, serious cardiopathia and stomach ulcer


Total participants randomised: 45
Age in years (range) 34‐79
Gender: NR
Pain duration in years (mean, SD): NR
Interventions Amitriptyline 75 mg
  • n = 22

  • TCA

  • Fixed dose, forced titration over 3 days


Trazodone 225 mg
  • n = 23

  • SARI

  • Fixed dose, forced titration over 3 days

  • Identical appearance to amitriptyline

Outcomes Withdrawal
Missing data methods Completer‐only analysis
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 NR
Allocation concealment (selection bias) Unclear risk Allocation procedures NR
Blinding of participants and personnel (performance bias)
All outcomes Low risk Double‐blind, identical appearance of study drugs
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 Completer analysis with ~30% dropout
Attrition
Total: 14/45 (31.1%)
Amitriptyline 75 mg: 4/22 (18.2%)
Trazodone 225 mg: 10/23 (43.5%)
Selective reporting (reporting bias) Unclear risk No protocol or trial registration found
Other bias Unclear risk Unclear ‐ data other than withdrawal not presented in any useable way, no tables only figures