Backonja 2008.
Study characteristics | ||
Methods | RCT, DB, multicentre, parallel groups, single application, 12‐week duration. Patch applied to painful area, up to 1000 cm2 Oral pain medication continued without change. Transdermal opioids (morphine equivalent ≤ 60 mg/day) permitted, but not topical analgesics Rescue medication: after application participants allowed hydrocodone/paracetamol (5/500 mg) for ≤ 5 days Pain assessed daily (average pain for last 24 hours). PGIC assessed at endpoint. Clinic visits at 4, 8, 12 weeks |
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Participants | Postherpetic neuropathy with at least moderate pain, ≥ 6 months since vesicle crusting. Exclusion: pain in/around facial area N = 402 M = 190, F = 212 Mean age: 71 years Baseline pain: 30 mm to 90 mm (mean 60 mm) |
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Interventions | (1) Capsaicin patch 8%, n = 206 (2) Control patch, n = 196 Topical local anaesthetic applied for 60 min, then patch applied for 60 min Control patch contained 0.04% capsaicin to mimic AEs |
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Outcomes | PI: 11‐point numeric pain rating scale (responder: ≥ 30% and ≥ 2‐point reduction from baseline) PGIC: 7‐point scale (responder: much and very much improved) AEs Withdrawals |
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Notes | Oxford Quality Score: R1, DB2, W1. Total = 4/5 | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not described |
Allocation concealment (selection bias) | Low risk | Remote treatment assignment, using unique number on printed labels affixed to outside of patch envelope |
Blinding (performance bias and detection bias) All outcomes | Low risk | Low concentration of capsaicin in "identically formulated" control patch to mimic local skin reaction of active treatment |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Modified (no details) LOCF analysis for primary outcome, but no imputation for weekly scores. All participants included for safety analysis |
Size | Low risk | 206 participants in capsaicin arm,196 participants in control arm |