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 |
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Participants | Pain condition: diabetic peripheral neuropathy Population: type 1 or 2 diabetic adults with diabetic peripheral neuropathy Minimum pain intensity: no Inclusion criteria
Exclusion criteria
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) |
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Interventions | Desipramine 12.5‐150 mg
Amitriptyline 12.5‐150 mg
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Outcomes | Pain intensity AEs |
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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. |