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

Vrethem 1997.

Study characteristics
Methods Design: cross‐over
Duration: each cross‐over period lasted 4 weeks
Assessment: baseline, mid‐intervention (8‐14 days), post‐cross‐over period
Country: Sweden
Participants Pain condition: polyneuropathy (diabetic and non‐diabetic)
Population: adults with painful polyneuropathy. 19 had diabetic polyneuropathy, 18 had non‐diabetic polyneuropathy
Minimum pain intensity: no
Inclusion criteria
  • Daily moderate or severe polyneuropathic pain for at least 6 months


Exclusion criteria
  • Patients with other neurologic diseases were excluded.


Total participants randomised: 37
Age in years (range): 35‐83
Gender: 19/37 were female
Pain duration in years (range): 6‐168
Interventions Placebo
  • Inert

  • Identical appearance

  • Double‐dummy design


Amitriptyline 75 mg
  • TCA

  • Fixed dose, forced titration


Maprotiline 75 mg
  • TeCA

  • Fixed dose, forced titration

Outcomes Pain intensity
Missing data methods NR
Funding source Non‐pharmaceutical: This work was supported by grants from The Medical Research Council, project no. 9058, The Swedish Association of Neurologically Disabled, The County Council of Ostergotland, and The University Hospital of Linkoping
Conflicts of interest NR
Notes This study reported results separately for participants with and without neuropathic pain caused by diabetes. Therefore, in the NMA we separated the study into 2 to include the 2 sets of results for both populations.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Randomisation methods NR
Allocation concealment (selection bias) Unclear risk Allocation procedures NR
Blinding of participants and personnel (performance bias)
All outcomes Low risk Double‐blind, identical study drugs, double‐dummy design
Blinding of outcome assessment (detection bias)
All outcomes Low risk Self‐reported outcomes from blinded participants
Incomplete outcome data (attrition bias)
All outcomes Unclear risk No clear information regarding withdrawal, no information regarding missing data methods
Attrition
Total: 4/37 (10.8%)
Attrition per arm NR
Selective reporting (reporting bias) Unclear risk No protocol or trial registration found
Other bias Low risk No other sources of bias were identified