Backonja 2011.
Methods | Randomised, double‐blind, placebo‐controlled, parallel groups, enriched for tolerance (but not response), LOCF Open‐label titration with gabapentin from 300 mg at night to maximum 600 mg 3 times daily (1800 mg/d) over 4 days, maintained on maximum tolerated dose for 7 days, then randomised to double blind treatment with 600 mg gabapentin encarbil twice daily or placebo for 2 weeks |
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Participants | PHN. Pain > 3 months after healing of skin rash. PI at randomisation ≥ 40/100 N = 102 in double‐blind phase, and 116 in open‐label phase Mean age 65 years, 51% women Initial average daily pain score 6.1/10, and 4.5 before randomisation |
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Interventions | Gabapentin encarbil 1200 mg daily, n = 47 (equivalent to 624 mg gabapentin, given as divided dose) Placebo, n = 54 Antiepileptic medication discontinued ≥ 7 days before open label phase. Antidepressant and narcotic analgesics continued if stable > 1 month |
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Outcomes | ≥ 50% reduction in pain ≥ 30% reduction in pain PGIC much and very much improved Withdrawals Adverse events |
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Notes | Oxford Quality Score: R = 1, DB = 2, W = 1, Total = 4 XenoPort sponsored |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not described |
Allocation concealment (selection bias) | Unclear risk | Not reported |
Blinding (performance bias and detection bias) All outcomes | Low risk | "matching placebo" |
Incomplete outcome data (attrition bias) Efficacy | Unclear risk | LOCF imputation |
Size Efficacy | High risk | < 50 participants per treatment arm |