Methods | Randomised, double-blind, active controlled, parallel-group, no enrichment Dose escalation every 2 weeks until adequate pain relief obtained or limit of tolerability, to maximum nortriptyline 150 mg daily or gabapentin 2700 mg daily by 4 weeks, then stable dose for 5 weeks (9 weeks in total) |
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Participants | Postherpetic neuralgia. N = 76, mean age 54 years, 50% women. Pain > 2 months after healing of skin rash. PI at randomisation ≥ 40/100, initial average daily pain score 5.7/10 | |
Interventions | Gabapentin 2700 mg daily (max), n = 38 Nortriptyline 150 mg daily (max), n = 38 Of ‘responders’ ~80% gabapentin took 2700 mg daily, ~66% nortriptyline took 75 mg daily |
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Outcomes | ≥ 50% pain relief over baseline pain ≥ 50% pain relief over (VAS) Adverse events Withdrawals |
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Notes | Oxford Quality Score: R = 2, DB = 2, W = 1, Total = 5 Sponsored Pfizer/independent |
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Risk of bias | ||
Item | Authors’ judgement | Description |
Allocation concealment? | Yes | “code supplied in sealed envelopes, opened at time of enrolment”, “drugs dispensed in sealed envelopes” |
Blinding? All outcomes |
Yes | “drugs placed in identical capsules”, “matching placebo of nortriptyline” to blind different dosing schedules |
Incomplete outcome data addressed? Efficacy |
Unclear | Imputation not mentioned |
Size Efficacy |
Unclear | 76 randomised |
Study duration Efficacy |
Yes | 9 weeks |
Outcomes reported | Yes | At least 50% reduction in pain |