High-Dose Capsaicin Improves Patient-Reported Outcomes in Neuropathic Pain

In an open-label, randomized, noninferiority trial, researchers compared patient-reported outcomes, defined as secondary objectives in the ELEVATE trial, after a single treatment with high-concentration capsaicin cutaneous patch to daily oral pregabalin for 8 weeks.

For patients with peripheral neuropathic pain (PNP), a high-concentration capsaicin-containing cutaneous patch (HCCP) had more favorable patient-reported outcomes than daily pregabalin, according to study results published in Pain Physician.

PNP affects both physical and psychological aspects of functioning for this patient population. Data on patient self-reported outcomes is essential to aid clinicians in decision-making when it comes to treatment options. However, data on patient-reported outcomes when comparing treatment options for this population is scarce.

The objective of the current study was to directly compare the efficacy of HCCP with pregabalin in the treatment of peripheral neuropathic pain for 8 weeks using data from the ELEVATE trial, an open-label, randomized multicenter study.

The ELEVATE trial recruited patients (N=559) with probable or definite PNP due to peripheral nerve injury, non-diabetic painful peripheral polyneuropathy, or postherpetic neuralgia at 92 sites 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 for up to 60 minutes (30 minutes for feet) to the painful area. Outcomes were assessed using 5 self-reported instruments.

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

Compared with baseline, HCCP recipients reported greater changes to Medical Outcomes Study Cognitive Functioning Scale scores at 8 weeks (standardized difference, 35.9; 95% CI, 16.7-65.2; P <.0001). Specifically, HCCP recipients were more likely to report improvements to the questions: difficulty doing activities (odds ratio [OR], 1.91; 95% CI, 1.31-2.79), difficulty reasoning 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 over activities (OR, 1.51; 95% CI, 1.02-2.25).

For the Treatment Satisfaction Questionnaire for Medication instrument, HCCP recipients reported more satisfaction to the components of side effects (standardized difference, 125.0; 95% CI, 84.0-177.3; P <.0001), global satisfaction (standardized difference, 7.80; 95% CI, 1.0-24.4; P =.0003), and effectiveness (standardized difference, 3.79; 95% CI, 0-17.3; P =.029).

Other patient-reported outcomes were similar between groups.

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

These data suggested that a 1-time treatment with a high-dose capsaicin HCCP may be a viable treatment option for some patients with PNP.

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

Disclosure: Multiple authors declared affiliations with industry. Please refer to the original article for a full list of disclosures.


Viel E, Eerdekens M, Kandaswamy P. Treatment Impact on Patient-Reported Outcomes in Peripheral Neuropathic Pain: Comparing Single Intervention With Topical High-Concentration Capsaicin to Daily Oral Pregabalin. Pain Physician. 2021;24(6):453-463