Johansson 1979.
Study characteristics | ||
Methods | Design: parallel Duration: 4 weeks Assessment: baseline and post‐intervention Country: Sweden |
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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
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 |
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Interventions | Placebo
Zimelidine 200 mg
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Outcomes | Pain intensity Withdrawal |
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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. |