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

Sindrup 2003.

Study characteristics
Methods Design: cross‐over
Duration: each cross‐over period lasted 4 weeks
Assessment: baseline, post‐cross‐over period
Country: Denmark
Participants Pain condition: polyneuropathy
Population: adults aged 20‐70 with painful polyneuropathy
Minimum pain intensity: ≥ 4 on 0‐10 scale
Inclusion criteria
  • Aged 20‐70

  • Symptoms compatible with polyneuropathy present for > 6 months, polyneuropathy diagnosis confirmed by nerve conduction studies

  • Pain intensity median ≥ 4 on 0‐10 scale


Exclusion criteria
  • Other pain conditions and severe terminal illness


Total participants randomised: 40
Age in years (mean, range): 56 (31‐69)
Gender: 9/40 were female
Pain duration in months (mean, range): 51 (6‐300)
Interventions Placebo
  • Inert

  • Identical appearance and matched dosing

  • Double‐dummy design


Venlafaxine 225 mg
  • SNRI

  • Fixed dose, forced titration


Imipramine 150 mg
  • TCA

  • Fixed dose, forced titration

Outcomes AEs
Missing data methods Completer analysis
Funding source Non‐pharmaceutical: supported by the Danish National Research Council (NASTRA grant no. 42820) and the local research foundation at Odense University Hospital.
Conflicts of interest NR
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Assignment to one of the 6 possible treatment sequences was random via a computer‐generated randomisation code.
Allocation concealment (selection bias) Low risk "The study drugs were packed in boxes marked with patient number and treatment period. After the baseline period, the patients were numbered consecutively and were treated with the study drugs with the corresponding randomisation number. Sealed envelopes with treatment sequence for each patient were present at the study sites for emergency situations."
Blinding of participants and personnel (performance bias)
All outcomes Low risk Double‐dummy technique, matching study drugs and package appearance
Blinding of outcome assessment (detection bias)
All outcomes Low risk Self‐reported outcomes by blinded participants
Incomplete outcome data (attrition bias)
All outcomes High risk ITT with LOCF
Attrition
Total: 7/40 (17.5%)
Not clear in which arm withdrawals occurred
Selective reporting (reporting bias) Unclear risk No protocol or trial registration found
Other bias Low risk No other sources of bias were identified.