Methods | Multicentre, randomised, double-blind, placebo-controlled, cross-over, not enriched. No imputation method mentioned Titration over 2 weeks from 300 mg to maximum pain reliefat a tolerable dose or 2400 mg daily, then stable dose for 3 weeks (5 weeks total); 3-week washout, then cross-over |
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Participants | Peripheral nerve injury with pain ≥ 6 months. N = 120, mean age 49 years, 53% women. PI at randomisation > 30/100, initial pain intensity 53/100 Efficacy analysis based on 98 who completed both treatment periods |
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Interventions | Gabapentin 2400 mg daily (max) Placebo Mean daily dose of gabapentin 2243 ± 402 mg Paracetamol ± codeine and dextropropoxyphene permitted as rescue medication Analgesics and NSAIDs used by ~50% during study |
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Outcomes | ≥ 50% pain relief (weekly mean pain score) ≥ 30% pain relief Marked pain relief (5-point scale) Marked or moderate pain relief (5-point scale) Adverse events Withdrawals |
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Notes | Oxford Quality Score: R = 2, DB = 2, W = 1, Total = 5 | |
Risk of bias | ||
Item | Authors’ judgement | Description |
Allocation concealment? | Yes | Central, remote allocation, “sealed code envelope” |
Blinding? All outcomes |
Yes | “capsules that were identical in appearance” |
Incomplete outcome data addressed? Efficacy |
Unclear | Imputation not mentioned |
Size Efficacy |
Unclear | 120 randomised |
Study duration Efficacy |
Unclear | 5-week period |
Outcomes reported | Yes | At least 50% reduction in pain |