Simpson 2001.
Methods | Randomised, double‐blind, placebo‐controlled, parallel groups, not obviously enriched (part 1 of study only) Titration over 4 weeks to maximum tolerated dose, then stable dose for 4 weeks (8 weeks in total) |
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Participants | PDN. Pain duration > 3 months before treatment, PI ≥ 40/100 at randomisation N = 60 Mean age 50 years, 40% women Initial pain score 6.5/10 |
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Interventions | Gabapentin 3600 mg daily (max), n = 30 Placebo, n = 30 |
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Outcomes | PGIC moderate or much improved Adverse events Withdrawals |
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Notes | Oxford Quality Score: R = 1, DB = 1, W = 1, Total = 3 No funding mentioned |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not reported |
Allocation concealment (selection bias) | Unclear risk | Not reported |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Not reported |
Incomplete outcome data (attrition bias) Efficacy | Unclear risk | Imputation not mentioned |
Size Efficacy | High risk | < 50 participants per treatment arm (30) |