Vranken 2011.
Methods | Stratified, randomised, double‐blind, placebo‐controlled, parallel group study of patients with severe central neuropathic pain of more than 6 months duration from cerebrovascular or spinal cord lesions | |
Participants | 48 participants aged 18 years or older with > 6 month severe neuropathic pain from cord or cerebrovascular cause, > 6 on visual analogue scale (VAS) (10 points), which started after sustaining the lesion and with the distribution of pain concomitant with the somatosensory system involvement. The trial allowed other medication if doses were stable for 6 weeks, except other antidepressants, which had to be stopped more than 30 days prior to receiving study medication | |
Interventions | Duloxetine or placebo for 8 weeks. Duloxetine 60 mg at start. Increased if participants did not meet criteria of > 1.8 points improvement on VAS. At week 8 and study end 15 participants on 120 mg and 8 participants on 60 mg | |
Outcomes | Primary outcome
Secondary outcomes
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Simple computerised random sampling (clorandm.exe) assigned study codes N = 1 to the placebo or duloxetine arm. Consecutive participants who met inclusion criteria were randomly assigned to treatment with flexible dose placebo or flexible dose duloxetine |
Allocation concealment (selection bias) | Low risk | The association between type of treatment and study code was only known to the Department of Epidemiology, Biostatistics and Bioinformatics and the hospital pharmacy department |
Blinding (performance bias and detection bias) All outcomes | Low risk | |
Incomplete outcome data (attrition bias) All outcomes | Low risk | |
Selective reporting (reporting bias) | Low risk | |
Other bias | Low risk |