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

Rowbotham 2004.

Study characteristics
Methods Design: parallel
Duration: 6 weeks
Assessment: baseline and post‐intervention
Country: USA
Participants Pain condition: diabetic peripheral neuropathy
Population: type 1 or 2 diabetic adults with diabetic peripheral neuropathy
Minimum pain intensity: ≥ 40 on 0‐10 scale
Inclusion criteria
  • Metabolically stable type 1 or 2 diabetes were eligible if they had symptomatic peripheral neuropathy due only to diabetes and daily pain at moderate intensity for at least 3 months


Exclusion criteria
  • Physical and mental health comorbidities


Total participants randomised: 245
Age in years (mean): 59
Gender: 99/245 were female
Pain duration in weeks (mean): 252.6
Interventions Placebo
  • n = 81

  • Inert

  • Identical appearance, double‐dummy design


Venlafaxine 75 mg
  • n = 82

  • SNRI

  • Fixed dose


Venlafaxine 150/225 mg
  • n = 82

  • SNRI

  • Flexible dose: 150 mg/day ‐ 225 mg/day depending on clinical response and tolerance.

Outcomes Substantial pain relief
AEs
SAEs
Withdrawal
Missing data methods ITT with LOCF
Funding source Pharmaceutical: support for this study was provided by Wyeth Research, Collegeville, Pennsylvania.
Conflicts of interest NR
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 Blinded bottles and capsules, identical dosing schedules between groups
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: 43/245 (17.6%)
Placebo: 12/81 (14.8%)
Venlafaxine 75 mg: 13/82 (15.9%)
Venlafaxine 150‐225 mg: 18/82 (22.0%)
Selective reporting (reporting bias) Unclear risk No protocol or trial registration found
Other bias Low risk No other sources of bias were identified.