Backonja 1998.
Methods | Multicentre, randomised, double‐blind, placebo‐controlled, parallel groups, 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 | PDN. Pain duration > 3 months before treatment, PI ≥ 40/100 at randomisation N = 165 Mean age 53 years, 40% women 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 | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated random code |
Allocation concealment (selection bias) | Unclear risk | Not reported |
Blinding (performance bias and detection bias) All outcomes | Low risk | "supplied in identical capsules in blinded fashion". "All participants were supplied with an equal number of capsules". |
Incomplete outcome data (attrition bias) Efficacy | Unclear risk | LOCF imputation |
Size Efficacy | Unclear risk | 50‐200 participants per treatment arm (81, 84) |