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

Simpson 2008.

Study characteristics
Methods RCT, DB, multicentre, parallel groups, single application, 12‐week duration. Patches applied to both feet, up to maximum 1000 cm2
Oral pain medication continued without change. No topical analgesics
During application participants allowed oral oxycodone solution (1 mg/mL) or equivalent, after application allowed hydrocodone/paracetamol (5/500 mg) for ≤ 7 days
Pain assessed daily (average pain for last 24 hours). PGIC assessed at 12 weeks. Clinic visits at 4, 8, 12 weeks
Participants HIV‐associated distal sensory polyneuropathy with ≥ 2 months' moderate to severe pain in both feet
N = 307
M = 286, F = 21
Mean age: 48 years (range 29 to 74)
Baseline pain: 30 mm to 90 mm (mean ~ 60 mm)
Interventions (1) Capsaicin patch 8% 30 min, n = 72
(2) Capsaicin patch 8% 60 min, n = 78
(3) Capsaicin patch 8% 90 min, n = 75
(4) Control patch, n = 82
Topical local anaesthetic applied for 60 min, then patch applied for 30, 60, or 90 min
Control patch contained 0.04% capsaicin to mimic AEs
Outcomes PI: 11‐point numeric pain rating scale (responder: ≥ 30% reduction from baseline)
PGIC: 7‐point scale (responder: much and very much improved)
AEs
Withdrawals
Notes Oxford Quality Score: R1, DB1, W1. Total = 3/5
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Method of randomisation not described
Allocation concealment (selection bias) Unclear risk Not described
Blinding (performance bias and detection bias)
All outcomes Low risk Control patch contained a low concentration of capsaicin to mimic local skin reaction of active treatment. Although it does not say "identical" or use similar wording, we judged this to be low risk
Incomplete outcome data (attrition bias)
All outcomes Low risk BOCF or 'no improvement' imputed for missing values for dichotomous data analyses
Size Unclear risk 50 to 200 participants per treatment arm