0.075% capsaicin lotion for the treatment of painful diabetic neuropathy: A randomized, double-blind, crossover, placebo-controlled trial.

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.

• Authors: Kongkiat Kulkantrakorn, Assawin Chomjit, Pasiri Sithinamsuwan, Thipaporn Tharavanij, Juthamas Suwankanoknark, Phunyada Napunnaphat
• Journal: Journal of clinical neuroscience : official journal of the Neurosurgical Society of Australasia (J Clin Neurosci) Vol. 62 Pg. 174-179 (Apr 2019) ISSN: 1532-2653 [Electronic] Scotland
• PMID: 30472337 (Publication Type: Journal Article, Randomized Controlled Trial)
• Copyright: Copyright © 2018 Elsevier Ltd. All rights reserved.

Chemical References

• Sensory System Agents
• Capsaicin

Topics

• Adult
• Capsaicin (administration & dosage)
• Cross-Over Studies
• Diabetic Neuropathies (drug therapy)
• Double-Blind Method
• Female
• Humans
• Male
• Middle Aged
• Neuralgia (drug therapy)
• Pain Management (methods)
• Sensory System Agents (administration & dosage)
• Skin Cream (therapeutic use)