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

Johansson 1979.

Study characteristics
Methods Design: parallel
Duration: 4 weeks
Assessment: baseline and post‐intervention
Country: Sweden
Participants Pain condition: chronic pain conditions
Population: people hospitalised at the Department of Neurology, University of Umeå with chronic pain syndromes
Minimum pain intensity: no
Inclusion criteria
  • Pain syndromes of at least 6 months with a stable course

  • All possibilities of active treatment tried


Exclusion criteria: NR
Total participants randomised: 40
Age in years (range): 25‐65
Gender: 23/40 were female
Pain duration in years (mean, SD): NR
Interventions Placebo
  • n = 20

  • Inert

  • Matched dosing schedule


Zimelidine 200 mg
  • n = 20

  • SSRI

  • Fixed dose with forced titration

Outcomes Pain intensity
Withdrawal
Missing data methods Completer analysis
Funding source NR
Conflicts of interest NR
Notes Zimelidine has been banned worldwide due to serious, sometimes fatal, cases of central and/or peripheral neuropathy known as Guillain‐Barré syndrome and due to a peculiar hypersensitivity reaction involving many organs including skin exanthema, flu‐like symptoms, arthralgias, and sometimes eosinophilia. Additionally, zimelidine was found to cause an increase in suicidal ideation and/or attempts among depressive patients.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk "Patients were then according to a randomisation list given tablets of identical form, color and taste, containing either Zimelidine 25 mg or a placebo according to a fixed dose regimen"
Allocation concealment (selection bias) Unclear risk Allocation procedures not specified
Blinding of participants and personnel (performance bias)
All outcomes Low risk Double‐blind, matched dosing and appearance of study drugs
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 HIgh attrition in Zimeldine arm. Reported compeleter analysis only, with no missing data methods
Attrition
Total: 8/20 (40.0%)
Placebo: 3/11 (27.3%)
Zimeldine 200 mg: 5/9 (55.6%)
Selective reporting (reporting bias) Unclear risk No protocol found
Other bias Low risk No other sources of bias were identified.