Gorson 1999.
Methods | Randomised, double‐blind, placebo‐controlled, cross‐over, not enriched. No imputation method mentioned Titration over 3 days to 900 mg, then fixed dose for remainder of 6‐week period; 3 week washout, then cross‐over |
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Participants | PDN 1‐5 years, pain ≥ moderate for over 3 months. Pain intensity at randomisation ≥ 40/100 N = 40 Mean age 62 years, 23% women Initial pain intensity not reported |
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Interventions | Gabapentin 900 mg, n = 19 (first phase) Placebo, n = 21 (first phase) Medication for diabetes control remained stable during study. Stable doses of NSAID or narcotics allowed |
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Outcomes | Pain relief at end of treatment (4‐point global score) moderate or excellent Adverse events |
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Notes | Oxford Quality Score: R = 1, DB = 1, W = 0, Total = 3 Sponsored by Warner Lambert/Parke‐Davis Note: no separate data for first period, small group sizes, non standard global scale |
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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 (19, 21) |