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

Morello 1999.

Study characteristics
Methods Design: cross‐over
Duration: cross‐over periods were 6 weeks
Assessment: baseline and post‐intervention
Country: USA
Participants Pain condition: diabetic peripheral neuropathy
Population: type 1 and 2 diabetic veterans with diabetic peripheral neuropathy pain
Minimum pain intensity: no
Inclusion criteria
  • Chronic daily pain for > 3months, during which both the quality and location were consistent with diabetic peripheral neuropathy pain, as diagnosed by a neurologist


Exclusion criteria
  • Physical and mental health comorbidities


Total participants randomised: 25
Age in years (mean, SD): 60.4 (10.8)
Gender: 1/25 were female
Pain duration in years (mean, SD): 5.7 (4.2)
Interventions Gabapentin 900‐1800 mg
  • Anticonvulsant

  • Flexible dosing dependent upon tolerance

  • Mean dose after titration: 1565 mg/day


Amitriptyline 25‐75 mg
  • TCA

  • Flexible dosing dependent upon tolerance

  • Mean dose after titration: 59 mg/day

Outcomes Pain intensity
AEs
Withdrawal
Missing data methods Completer analysis only
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 procedure not specified
Blinding of participants and personnel (performance bias)
All outcomes Low risk Double‐blind medications, same dosing schedules and appearance
Blinding of outcome assessment (detection bias)
All outcomes Low risk Self‐reported outcomes by blinded participants
Incomplete outcome data (attrition bias)
All outcomes High risk Completer‐only analysis
Attrition
Total: 4/25 (16.0%)
Gabapentin 900‐1800 mg: 2/25 (8.0%)
Amitriptyline 25‐75 mg: 2/25 (8.0%)
Selective reporting (reporting bias) Unclear risk No protocol or trial registration found
Other bias High risk Post hoc power analysis and report needing sample of 280 to detect effect, they have 25 participants randomised