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. 2017 Jan 13;2017(1):CD007393. doi: 10.1002/14651858.CD007393.pub4

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
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)
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
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
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