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

Joharchi 2019.

Study characteristics
Methods Design: parallel
Duration: 12 weeks
Assessment: baseline, 4 weeks, 8 weeks, post‐intervention
Country: Iran
Participants Pain condition: diabetic peripheral neuropathy
Population: type 2 diabetic adults aged ≥ 40 and ≤ 65 with diabetic peripheral neuropathic pain
Minimum pain intensity: ≥ 40 on 0‐100 VAS
Inclusion criteria
  • Aged 40‐65

  • Diabetes duration ≥ 5 years

  • Diabetic peripheral neuropathy diagnosis

  • Diabetic peripheral neuropathy severity ≥ 40 on 100 VAS with a duration of ≥ 12 months


Exclusion criteria
  • Severe physical and mental health comorbidities


Total participants randomised: 180
Age in years (mean): 54.48
Gender: 109/180 were female
Pain duration in years (mean): 3.8
Interventions Duloxetine 30‐60 mg
  • n = 90

  • SNRI

  • Flexible dose dependent upon efficacy and tolerability

  • Mean dose: 42.5 mg/day


Pregabalin 150‐300 mg
  • n = 90

  • Anticonvulsant

  • Flexible dose dependent upon efficacy and tolerability

  • Mean dose: 235.5 mg/day

Outcomes Pain intensity
AEs
Withdrawal
Missing data methods Completer analysis
Funding source Non‐pharmaceutical: part of a PhD project ‐ financially supported by “Research Department of theSchool of Medicine Shahid Beheshti University of Medical Sciences(SBUMS)” (Grant No 13/587).
Conflicts of interest The authors declare that they have no COI.
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Randomisation methods not specified: Just states "randomly divided into 2 groups"
Allocation concealment (selection bias) Unclear risk Allocation procedures not described
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Used "similar" capsules but participants in pregabalin arm took 2 capsules a day compared to 1 a day for duloxetine
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Self‐reported outcomes from blinded participants, unsure of blinding procedures
Incomplete outcome data (attrition bias)
All outcomes High risk Higher attirition in duloxetine group than pregabalin, completer analysis only
Attrition
Total: 36/180 (20.0%)
Duloxetine 30‐60 mg: 24/90 (26.7%)
Pregabalin 150‐300 mg: 12/90 (13.3%)
Selective reporting (reporting bias) Low risk Protocol registered prospectively to study with outcome measures
Other bias Low risk No other sources of bias were identified.