Skip to main content
. 2023 May 10;2023(5):CD014682. doi: 10.1002/14651858.CD014682.pub2

Majdinasab 2019.

Study characteristics
Methods Design: parallel
Duration: 8 weeks
Assessment: baseline and post‐intervention
Country: Iran
Participants Pain condition: painful diabetic peripheral polyneuropathy
Population: adults with painful diabetic peripheral polyneuropathy
Minimum pain intensity: ≥ 40 on 0‐100 VAS
Inclusion criteria
  • Aged between 18‐75

  • Painful diabetic peripheral poly‐neuropathy from 1 month to 5 years

  • ≥ 40 on 0‐100 pain intensity VAS


Exclusion criteria
  • Severe illness in vital organs

  • Using medication to treat pain


Total participants randomised: 104
Age in years (mean): 60.3
Gender: 50/104 were female
Pain duration in years (mean): 3.75
Interventions Gabapentin 300‐900 mg
  • n = 52

  • Anticonvulsant

  • Flexible dose depending on tolerability

  • Identical appearance to duloxetine


Duloxetine 30‐60 mg
  • n = 52

  • SNRI

  • Flexible dose depending on tolerability

Outcomes Pain intensity
Sleep
AEs
Withdrawal
Missing data methods NR
Funding source Non‐pharmaceutical: "This study was funded by Ahvaz Jundishapur University of Medical Sciences (grant number IR.AJUMS.REC.1395.78)"
Conflicts of interest Dr Nastaran Majdinasab, Dr Hossein Kaveyani, and Dr Mojgan Azizi have received research grants from Ahvaz Jundishapur University of Medical Sciences (grant number IR.AJUMS.REC.1395.78). The authors report no other conflicts of interest in this work.
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Participants were randomised using the 4 block randomised method (equalised 4‐blocks).
Allocation concealment (selection bias) Low risk "The medications of this study were first made similar to each other by a doctor who had no role in the collection and analysis of data and then sufficient amounts were packed into packets A and B and were given to the researcher."
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Used identical drugs and placebos and packets but: "Before the commencement of the study, the side effects of the medications were explained to the patients " could then allow participants to know what they're experiencing and which medication it comes from.
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Self‐reported outcomes from participants, but unsure of blinding
Incomplete outcome data (attrition bias)
All outcomes Unclear risk Method of missing data not specified
Attrition
Total: 16/104 (15.4%)
Gabapentin 300‐900 mg: 11/52 (21.2%)
Duloxetine 30‐60 mg: 5/52 (9.6%)
Selective reporting (reporting bias) Unclear risk Protocol registered retrospectively
Other bias Unclear risk Errors in publication between tables