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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, active placebo-controlled, cross-over. Analyses included all data available assuming that missing data were missing at random
Titration over 1 week of gabapentin at pre-study dose (up to 4800 mg daily), tramadol 50 mg “q.i.d.” (probably once daily in USA - officially 4 times daily), or diphenhydramine 50 mg “qhs” (qh = every hour, but more likely 4 × daily) as active placebo, then stable dose for 1 week (2 weeks in total); 1-week washout, then cross-over to next treatment
Participants Painful small fibre sensory neuropathy with gabapentin-sensitive pain that worsened with placebo, in a complete enrichment design. N = 18, mean age 59 years, 44% women.
Pain at randomisation > 3, initial mean pain score 4.9/10
Interventions Gabapentin 4800 mg daily (max)
Tramadol 200 mg daily (max)
Placebo
Stable pain medication other than gabapentin was continued
Paracetamol (325 mg tablets, dose not specified) allowed for rescue medication. If inadequate patient could take additional 400 mg gabapentin, up to 1200 mg daily
Outcomes ≥ 50 improvement in pain
≥ 30 improvement in pain
PGIC very much better
PGIC much or very much better
Withdrawals
Notes Oxford Quality Score: R = 2, DB = 2, W = 1, Total = 5
Risk of bias
Item Authors’ judgement Description
Allocation concealment? Yes Remote allocation
Blinding?
All outcomes
Yes “matching capsules”
Incomplete outcome data addressed?
Efficacy
Unclear Imputation not mentioned
Size
Efficacy
No 54 randomised to 3 groups. Gabapentin comparison with placebo 36 patients maximum
Study duration
Efficacy
No 2 weeks
Outcomes reported Yes At least 50% reduction in pain