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 |
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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
Exclusion criteria
Total participants randomised: 37 Age in years (range): 35‐83 Gender: 19/37 were female Pain duration in years (range): 6‐168 |
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Interventions | Placebo
Amitriptyline 75 mg
Maprotiline 75 mg
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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 |