Sindrup 2003.
Study characteristics | ||
Methods | Design: cross‐over Duration: each cross‐over period lasted 4 weeks Assessment: baseline, post‐cross‐over period Country: Denmark |
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Participants | Pain condition: polyneuropathy Population: adults aged 20‐70 with painful polyneuropathy Minimum pain intensity: ≥ 4 on 0‐10 scale Inclusion criteria
Exclusion criteria
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) |
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Interventions | Placebo
Venlafaxine 225 mg
Imipramine 150 mg
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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. |