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

Razazian 2014.

Study characteristics
Methods Design: parallel
Duration: 4 weeks
Assessment: baseline, 2 days, 7 days, 14 days, 1 week post‐intervention
Country: Iran
Participants Pain condition: diabetic polyneuropathy
Population: adults with diabetic polyneuropathy referred to diabetic clinic
Minimum pain intensity: ≥ 40 on 0‐100 scale
Inclusion criteria
  • Diagnosis of metabolically stable type 1 or 2 diabetes with diabetic polyneuropathy according to the Boulton 2005 criteria

  • History of neuropathic pain for at least 3 months

  • Pain intensity of ≥ 40 on 0‐100 scale


Exclusion criteria
  • Any other pain condition, severe medical conditions including severe depression and psychotic disorders


Total participants randomised: 257
Age in years (mean, SD): 56.3 (10.4)
Gender: 156/257 were female
Pain duration in months (mean, SD): 23.5 (2.5)
Interventions Carbamazepine 400 mg
  • n = 85

  • Anticonvulsant

  • Fixed dose


Pregabalin 150 mg
  • n = 86

  • Anticonvulsant

  • Fixed dose


Venlafaxine 150 mg
  • n = 86

  • SNRI

  • Fixed dose

Outcomes Moderate pain relief
Substantial pain relief
Sleep
Mood
AEs
SAEs
Withdrawal
Missing data methods NR
Funding source Non‐pharmaceutical: Kermanshah Univesity Of Medical Science
Conflicts of interest NR
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Participants were randomised via a computer‐generated randomisation schedule
Allocation concealment (selection bias) Low risk Investigators and participants were blinded to the treatments by preprinted medication code labels.
Blinding of participants and personnel (performance bias)
All outcomes High risk States double‐blind but drugs not identical and dosage schedule differs between participants: venlafaxine taken as tablet twice daily, pregabalin as capsule once daily and carbamazepine twice daily as tablet
Blinding of outcome assessment (detection bias)
All outcomes High risk Self‐reported outcomes from participants, but not strict blinding procedures
Incomplete outcome data (attrition bias)
All outcomes High risk No methods for dealing with missing data specified, think they present completer analysis.
Attrition
Total: 33/257 (12.8%)
Carbamazepine 400 mg: 7/85 (8.2%)
Pregabalin 150 mg: 9/86 (10.5%)
Venlafaxine 150 mg: 17/86 (19.8%)
Selective reporting (reporting bias) High risk Protocol not very clear, mention reporting 30th day as outcome time point but in article it's the 35th day. Did not mention work interference as outcome but have included it in paper, mention primary outcome will be measured with "PPI" and VAS but seems that PPI NR in article. Protocol registered on IRCT while recruiting participants, only 2 outcomes specified.
Other bias High risk Significant difference in VAS pain between groups at baseline