High-dose capsaicin improves patient-reported outcomes in neuropathic pain

In patients with peripheral neuropathic pain (PNP), a highly concentrated capsaicin cutaneous patch (HCCP) had better patient-reported results than daily pregabalin, according to study results published in Pain Physician.

PNP affects both the physical and psychological aspects of the functioning of this patient population. Data on patient-reported results is essential to help clinicians make decisions about treatment options. However, there is little data on patient-reported outcomes comparing treatment options for this population.

The aim of the current study was to directly compare the effectiveness of HCCP with pregabalin in the treatment of peripheral neuropathic pain over a period of 8 weeks using data from the ELEVATE study, an open-label, randomized, multicenter study.

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The ELEVATE study enrolled patients (N = 559) with probable or definite PNP due to peripheral nerve injury, non-diabetic painful peripheral polyneuropathy, or postherpetic neuralgia at 92 locations in 22 countries. Patients were randomized to receive 179 mg capsaicin HCCP (n = 282) or 75 mg oral pregabalin (n = 277) for 8 weeks. The patch was applied to the painful area for up to 60 minutes (30 minutes for the feet). The results were assessed using 5 self-reported instruments.

The median participants in the HCCP and pregabalin cohorts were 57 (range 20–81) and 57 (range 19–80) years old, 56.4% and 56.0% were women, 45.4% and 46.2%, respectively % had probable PNP and the median time symptoms were 1.1 (range 0–36.2) and 1.0 (range 0–19.3) years, respectively.

Compared to baseline, HCCP recipients reported greater changes in results on the cognitive functional scale of the Medical Outcomes Study after 8 weeks (standardized difference 35.9; 95% CI 16.7-65.2; P <0.0001). In particular, HCCP recipients were more likely to report improvements on the questions: Difficulty engaging in activities (odds ratio [OR], 1.91; 95% CI 1.31-2.79, difficulty thinking and solving problems (OR 1.62; 95% CI 1.11-2.28), slow reaction time (OR 1.60; 95- % CI 1.07-2.41) and confusion about activities (OR 1.51; 95% CI 1.02-2.25).

For the medication treatment satisfaction questionnaire, HCCP recipients reported greater satisfaction with the components of the side effects (standardized difference 125.0; 95% CI 84.0-177.3; P <0.0001), global satisfaction (standardized difference 7.80 ; 95% CI 1.0-24.4; P = 0.0003) and efficacy (standardized difference 3.79; 95% CI 0-17.3; P = 0.029).

Other patient-reported results were similar between groups.

This study was limited by its short duration, open design, and subjective patient-reported results.

These data suggested that a single treatment with a high-dose capsaicin HCCP might be a viable treatment option for some patients with PNP.

“While HCCP has been approved in the United States for the treatment of PNP in diabetic and PHN patients, these observations provide information about how patients perceive the effects of various PNP treatments,” the researchers concluded.

Disclosure: Several authors stated links to industry. For a full list of the details, see the original article.


Viel E, Eerdekens M, Kandaswamy P. Effects of treatment on patient-reported outcomes in peripheral neuropathic pain: Comparison of a single intervention of topical high-concentration capsaicin with daily oral pregabalin. Pain doctor. 2021; 24 (6): 453-463

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