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

Gao 2010.

Study characteristics
Methods Design: parallel
Duration: 12 weeks
Assessment: baseline and post‐intervention
Country: China
Participants Pain condition: diabetic peripheral neuropathy
Population: adults with diabetic peripheral neuropathy
Minimum pain intensity: ≥ 4 on 0‐10 VAS
Inclusion criteria
  • ≥ 4 on 0‐10 pain intensity VAS

  • Daily pain for ≥ 6 months

  • 3 on the clinical portion of the MNSI


Exclusion criteria
  • Unstable glycemic control, any other medical condition that could compromise participation

  • Risk for suicide


Total participants randomised: 215
Age in years (mean): 59.3
Gender: 14/215 were female
Pain duration in years (mean): 3.2
Interventions Placebo
  • n = 109

  • Inert

  • Matched to antidepressant


Duloxetine 60 to 120 mg
  • n = 106

  • SNRI

  • Flexible dosing dependent on efficacy and tolerance

Outcomes Pain intensity
Sleep
Mood
Quality of life
Moderate pain relief
Substantial pain relief
PGIC
AEs
SAEs
Withdrawal
Missing data methods ITT with LOCF
Funding source Pharmaceutical: Eli Lilly and Boehringer Ingelheim Pharmaceuticals
Conflicts of interest Drs Vladimir Skljarevski, Durisala Desaiah, Zhang Shu‐yu, and Zhang Qi are employees and stockholders of Eli Lilly and Company. All other authors from China were the investigators and received funding from Eli Lilly and Company for conducting this study.
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Randomisation methods not specified
Allocation concealment (selection bias) Unclear risk Allocation procedures not specified
Blinding of participants and personnel (performance bias)
All outcomes Low risk Double‐blind with identical placebo and matched dosing schedule
Blinding of outcome assessment (detection bias)
All outcomes Low risk Self‐reported outcomes from blinded participants
Incomplete outcome data (attrition bias)
All outcomes High risk ITT with LOCF
Attrition
Total: 36/215 (16.7%)
Placebo: 17/109 (15.6%)
Duloxetine 60‐120 mg: 19/106 (17.9%)
Selective reporting (reporting bias) Low risk All outcomes registered prospectively on clinicaltrials.gov
Other bias Low risk No other sources of bias identified