Methods	Multicentre, randomised, double-blind, placebo-controlled, parallel-group, not enriched, LOCF Titration to maximum tolerated dose or 3600 mg daily over 4 weeks, then stable dose for 4 weeks (8 weeks in total)
Participants	Painful diabetic neuropathy. N = 165, mean age 53 years, 40% women. Pain duration > 3 months before treatment, PI ≥40/100 at randomisation, initial mean pain score 6.4/10
Interventions	Gabapentin 3600 mg daily (max), n = 84 Placebo, n = 81 Medication for diabetes control remained stable during study. Paracetamol (max 3 g daily) allowed
Outcomes	PGIC much or moderately improved ≥ 50% reduction in pain (CTR) PGIC much improved (CTR) PGIC moderately or much improved (CTR) Adverse events Withdrawals
Notes	Oxford Quality Score: R = 2, DB = 2, W = 1, Total = 5 Parke-Davies/Pfizer sponsored
Risk of bias
Item	Authors’ judgement	Description
Allocation concealment?	Unclear	Not reported
Blinding? All outcomes	Yes	“supplied in identical capsules in blinded fashion”. “All participants were supplied with an equal number of capsules”
Incomplete outcome data addressed? Efficacy	Unclear	LOCF
Size Efficacy	Unclear	165
Study duration Efficacy	Yes	8 weeks
Outcomes reported	Yes	At least 50% reduction in pain