Methods | Randomised, double-blind, placebo-controlled, 3-way cross-over, not enriched. No imputation method mentioned Titration over 4 weeks to pain control, limit of tolerability, or maximum amitriptyline 150 mg daily, gabapentin 3600 mg daily, then stable dose for remainder of 8-week period; 1-week washout then cross-over Analysis for completers only |
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Participants | SCI at any level and degree of completeness. N = 38, only 22 patients completed all three cross-overs. Mean age 43 years, 9% women. Pain duration before treatment > 6 months, PI at randomisation > 5/10, initial pain intensity 5.6/10 | |
Interventions | Amitriptyline 150 mg daily (max) Gabapentin 3600 mg daily (max) Placebo (diphenhydramine) 75 mg daily Oxycodone + paracetamol 5/325 mg (max 8 tablets daily) allowed for rescue medication |
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Outcomes | No dichotomous data for efficacy or harm Withdrawals |
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Notes | Oxford Quality Score: R = 2, DB = 2, W = 1, Total = 5 | |
Risk of bias | ||
Item | Authors’ judgement | Description |
Allocation concealment? | Yes | Prepared, packaged and labelled by remote, commercial compounding pharmacy |
Blinding? All outcomes |
Yes | “identical capsules” |
Incomplete outcome data addressed? Efficacy |
No | Completers only |
Size Efficacy |
No | 38 randomised |
Study duration Efficacy |
Yes | 8-week period |
Outcomes reported | No | No dichotomous data |