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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, cross-over, not enriched. No imputation method mentioned
Titration over 3 days to 900 mg, then fixed dose for remainder of 6-week period; 3 week washout, then cross-over
Participants Painful diabetic neuropathy 1 to 5 years, pain ≥ moderate for over 3 months. N = 40, mean age 62 years, 23% women. Pain intensity at randomisation ≥ 40/100, initial pain intensity not reported
Interventions Gabapentin 900 mg, n = 19 (first phase)
Placebo, n = 21 (first phase)
Medication for diabetes control remained stable during study. Stable doses of NSAID or narcotics allowed
Outcomes Pain relief at end of treatment (4-point global score) moderate or excellent
Adverse events
Notes Oxford Quality Score: R = 1, DB = 1, W = 0, Total = 3
Sponsored by Warner Lambert/Parke-Davis
Note: no separate data for first period, small group sizes, non standard global scale
Risk of bias
Item Authors’ judgement Description
Allocation concealment? Unclear Not reported
Blinding?
All outcomes
Unclear Not reported
Incomplete outcome data addressed?
Efficacy
Unclear Imputation not mentioned
Size
Efficacy
No 40 randomised
Study duration
Efficacy
Unclear 6-week period
Outcomes reported Unclear Moderate or excellent pain relief