Smith 2005.
Methods | Randomised, double‐blind, placebo‐controlled, cross‐over, no enrichment. No imputation method mentioned Titration in 300 mg increments every 2‐3 days until pain intensity of 0 or uncomfortable side effects, or maximum 3600 mg daily, then stable dose for remainder of 6‐week treatment period, followed by titration off medication in week 7; 5‐week washout, then cross‐over |
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Participants | Phantom limb pain and residual limb pain. Time since amputation ≥ 6 months, PI before randomisation > 3/10 N = 24 Mean age 52 years, 25% women Initial pain intensity 4.4/10 |
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Interventions | Gabapentin 3600 mg daily (max), (19/24 took max dose) Placebo |
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Outcomes | Meaningful decrease in pain (5‐point scale) | |
Notes | Oxford Quality Score: R = 2, DB = 2, W = 0, Total = 4 No funding mentioned |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated random numbers |
Allocation concealment (selection bias) | Unclear risk | Not described |
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 | High risk | < 50 participants per treatment arm (24) |