Highlights
- •A randomized trial in painful diabetic neuropathy comparing capsaicin to placebo for 8 weeks.
- •The efficacy of 0.075% capsaicin lotion was similar to placebo.
- •Capsaicin lotion was well tolerated but local skin reactions were common.
Abstract
Objective
A randomized, double-blinded, crossover, placebo controlled trial was conducted to
evaluate the efficacy and safety of 0.075% capsaicin lotion for treating painful diabetic
neuropathy (PDN).
Patients and methods
PDN subjects were randomized to receive 0.075% capsaicin/placebo for 8 weeks, then
crossing over to the other treatment after a 4-weeks washout period. Primary endpoint
was the change in visual analog scale score of pain severity. Secondary outcomes were
score changes in Neuropathic Pain Scale, short-form McGill Pain Questionnaires, and
proportions of patients with pain score reductions of 30% and 50%, and adverse events.
Results
A total of 42 subjects were enrolled, 27 completed at least an 8-week treatment period.
Intention-to-treat analysis showed no significant improvement in pain control with
capsaicin lotion compared with placebo for all pain measures and proportion of patients
who had 30% or 50% pain relief, respectively. Per protocol analysis were consistent.
Capsaicin lotion was well tolerated but local skin reactions were common.
Conclusion
In patients with PDN, the efficacy of 0.075% capsaicin lotion was similar to placebo
but was well tolerated. More work is needed to assess different capsaicin formulations.
Keywords
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Article info
Publication history
Published online: November 21, 2018
Accepted:
November 11,
2018
Received:
October 5,
2018
Identification
Copyright
© 2018 Elsevier Ltd. All rights reserved.
