Gordh 2008.
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 relief at 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. PI at randomisation > 30/100 N = 120 (efficacy analysis based on 98 who completed both treatment periods) Mean age 49 years, 53% women Initial pain intensity 53/100 |
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Interventions | Gabapentin 2400 mg daily (max) Placebo Mean daily dose of gabapentin 2243 mg ± 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 Sponsored by Parke‐Davis AB, later Pfizer AB |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomisation list was generated by the Clinical Pharmaceutical Operation Center in Freiburg |
Allocation concealment (selection bias) | Low risk | Central, remote allocation, "sealed code envelope" |
Blinding (performance bias and detection bias) All outcomes | Low risk | "capsules that were identical in appearance" |
Incomplete outcome data (attrition bias) Efficacy | Unclear risk | Imputation not mentioned |
Size Efficacy | Unclear risk | 50‐200 participants per treatment arm (98 completed both periods and included in efficacy analysis) |