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. Author manuscript; available in PMC: 2014 Sep 22.
Published in final edited form as: Cochrane Database Syst Rev. 2011 Mar 16;(3):CD007938. doi: 10.1002/14651858.CD007938.pub2
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
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
Outcomes No dichotomous data for efficacy or harm
Withdrawals
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