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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-period cross-over, no enrichment. No imputation method mentioned
Titration to target doses or limit of tolerability over 24 days, then stable dose for 1 week, and tapered dose for 1 week (6 weeks in total); 6-day washout and cross-over to next treatment
Participants PDN and PHN. N = 56, median age 64 years, 40% women. Pain ≥ moderate for 6 months, initial mean pain score 5.4/10
Interventions Gabapentin 3600 mg daily (max)
Nortriptyline 100 mg daily (max)
Gabapentin plus nortriptyline 3600 mg/100 mg daily (max)
Mean (SE) maximum tolerated doses: gabapentin alone 2433 ± 106 mg, nortriptyline alone 62 ± 3.6 mg, gabapentin + nortriptyline 2180 ± 108 + 50 ± 3.5 mg
Outcomes Pain relief (average)
Withdrawals
Adverse events
Notes Oxford Quality Score: R = 2, DB = 2, W = 1, Total = 5
Risk of bias
Item Authors’ judgement Description
Allocation concealment? Yes “concealed allocation”
Blinding?
All outcomes
Yes “double dummy”
Incomplete outcome data addressed?
Efficacy
Unclear Imputation not mentioned
Size
Efficacy
No Reporting on < 50 completing 2 periods
Study duration
Efficacy
Unclear 5-week period on treatment
Outcomes reported No No dichotomous data