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Capsaicin Patch for Diabetic Neuropathic Pain

Treatment showed statistically significant improvements in pain relief and sleep quality.

Currently in the United States, capsaicin patches are approved for the treatment of postherpetic neuralgia, however they are not approved for diabetic neuropathic pain. In previous studies, capsaicin 8% patches have demonstrated non-inferior efficacy to pregabalin in peripheral neuropathic pain, with faster onset of action, fewer systemic side effects, and greater treatment satisfaction. Therefore, researchers set out to evaluate the efficacy and safety of capsaicin 8% patch compared to placebo in patients with painful diabetic peripheral neuropathy.

Researchers conducted a phase III, multicenter, double-blinded, placebo-controlled, 12-week study, which included 369 patients with painful, distal, symmetrical, sensorimotor diabetic polyneuropathy, which lasted at least a year in duration. Patients either received capsaicin 8% patch or placebo patch to painful areas of the feet for 30 minutes. The patients had a mean pain duration of 5.8 years, HBA1c of 7.3%, and an average daily pain score of 6.5 (Brief Pain Inventory-Diabetic Neuropathy [BPI-DN]). The primary endpoint was percentage change in average daily pain score from baseline to between weeks 2-8. Secondary endpoints included weekly average daily pain, 30% responder rates, BPI-DN sleep interference score, and weekly sleep interference score.

The results showed that the average daily pain score was reduced more in the capsaicin group than in the placebo group (-27.4% vs -20.9%; P = .025). Sleep was also improved in those with the capsaicin patch, from baseline to between weeks 2 and 8 (P = .03) or for weeks 2 to 12 (P = .02). More patients in the capsaicin group achieved at least a 30% reduction in average daily pain score between baseline and weeks 2 to 12 (40.9% vs 31.7%; P = .05) compared to the placebo group. Patients favored the capsaicin patch as it was associated with higher treatment satisfaction at week 12. There were no difference in health-related quality of life between the groups; the most commonly reported adverse effect in the capsaicin group was a sensation of burning.

Overall, the capsaicin 8% patch showed statistically significant improvements in pain relief and sleep quality compared to placebo in patients with painful diabetic peripheral neuropathy. There were no new safety issues and the capsaicin 8% patch proved to be efficacious and safe.

Practice Pearls:

  • The average daily pain score was reduced more in the capsaicin group than in the placebo group (-27.4% vs -20.9%; P = .025). Sleep was also improved in those with the capsaicin patch.
  • There were no difference in health-related quality of life between the groups; the most commonly reported adverse effect in the capsaicin group was a sensation of burning.
  • Overall, the capsaicin 8% patch showed statistically significant improvements in pain relief and sleep quality compared to placebo in patients with painful diabetic peripheral neuropathy. There were no new safety issues and the capsaicin 8% patch proved to be efficacious and safe.

McCall, Becky. “Capsaicin Patch Approved in EU for Diabetic Neuropathy Pain.” Medscape Multispecialty. WebMD LLC. 21 Sep 2015. Web. 25 Sep 2015.