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

Max 1992.

Study characteristics
Methods Design: cross‐over
Duration: each cross‐over period was 6 weeks
Assessment: baseline and post‐cross‐over period
Country: USA
Participants Pain condition: diabetic peripheral neuropathy
Population: type 1 or 2 diabetic adults with diabetic peripheral neuropathy
Minimum pain intensity: no
Inclusion criteria
  • Daily pain of at least moderate severity, the quality and location of which were consistent with the peripheral neuropathy


Exclusion criteria
  • Other pain as severe as the diabetic peripheral neuropathy

  • Depression

  • Cardiovascular conditions


Total participants randomised: 54
Age in years (median, range): 58 (20‐84)
Gender: 21/54 were female
Pain duration in years (median, range): 3 (0.5‐12)
Interventions Desipramine 12.5‐150 mg
  • TCA

  • Forced titration to highest tolerated dose

  • Mean dose 111 mg/day (SD 39)


Amitriptyline 12.5‐150 mg
  • TCA

  • Forced titration to highest tolerated dose

  • Mean dose 105 mg/day (SD 37)

Outcomes Pain intensity
AEs
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 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 procedures e.g. study drug appearance
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Self‐reported outcomes from participants, but unsure of blinding process
Incomplete outcome data (attrition bias)
All outcomes High risk Completer analysis only
Attrition
Total: 16/54 (29.6%)
Attrition per arm NR
Selective reporting (reporting bias) Unclear risk No protocol or trial registration found
Other bias Unclear risk Complicated trial design between 2 studies. Of the 54 participants in the desipramine vs amitriptyline study only 29 were randomised into it.