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

Kaur 2011.

Study characteristics
Methods Design: cross‐over
Duration: 6 weeks
Assessment: baseline and post‐intervention
Country: India
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
  • Aged 18‐75

  • diabetic peripheral neuropathy for at least 1 month

  • ≥ 50 on 0‐100 pain intensity VAS


Exclusion criteria
  • Clinically significant physical or mental health comorbidities


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)
Interventions Amitriptyline 10‐50 mg
  • TCA

  • Flexible titration with fixed doses: started at 10 mg, with optional titration every 2 weeks to 25 mg, and then 50 mg


Duloxetine 20‐60 mg
  • SNRI

  • Flexible titration with fixed doses: started at 20 mg, with optional titration every 2 weeks to 40 mg, and then 60 mg

Outcomes Moderate pain relief
Substantial pain relief
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.