Morello 1999.
Study characteristics | ||
Methods | Design: cross‐over Duration: cross‐over periods were 6 weeks Assessment: baseline and post‐intervention Country: USA |
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Participants | Pain condition: diabetic peripheral neuropathy Population: type 1 and 2 diabetic veterans with diabetic peripheral neuropathy pain Minimum pain intensity: no Inclusion criteria
Exclusion criteria
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) |
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Interventions | Gabapentin 900‐1800 mg
Amitriptyline 25‐75 mg
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Outcomes | Pain intensity AEs Withdrawal |
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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 |