Kaur 2011.
Study characteristics | ||
Methods | Design: cross‐over Duration: 6 weeks Assessment: baseline and post‐intervention Country: India |
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Participants | Pain condition: diabetic peripheral neuropathy Population: adults with type 2 diabetes and diabetic peripheral neuropathy Minimum pain intensity: ≥ 50 on 0‐100 VAS Inclusion criteria
Exclusion criteria
Total participants randomised: 65 Age in years (median, IQR): 52.5 (48.2–62) Gender: 31/65 were female Pain duration in years (median IQR): 8 (6–36) |
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Interventions | Amitriptyline 10‐50 mg
Duloxetine 20‐60 mg
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Outcomes | Moderate pain relief Substantial pain relief |
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Missing data methods | Unclear regarding methods | |
Funding source | NR | |
Conflicts of interest | No potential conflicts of interest relevant to this study were reported | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Participants were randomised using computer‐generated randomisation of blocks of 4 |
Allocation concealment (selection bias) | Low risk | The drug packets were administered to patients serially according to the patient’s reporting sequence. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Says double‐blind but no information given regarding procedure e.g. appearance of tablets |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Self‐reported outcomes by participants but not enough information given regarding blinding |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Unclear reporting of withdrawals and analysis. State ITT analysis but only including those 58 who completed the study Attrition Total: 7/65 (10.8%) Attrition per arm NR |
Selective reporting (reporting bias) | Unclear risk | No protocol or trial registration found |
Other bias | Low risk | No other sources of bias were identified. |