Improved sensory function after treatment with high-concentration capsaicin patches over 12 months
Aims: To evaluate whether repeated treatment with high-concentration (179 mg/8%) capsaicin patches improves sensory nerve function in people with painful diabetic peripheral neuropathy.
Methods: This post-hoc analysis of the phase III, open-label, randomized, controlled PACE study included two subsets of the original study population with painful diabetic peripheral neuropathy. Participants received between one and seven 30-minute treatments with capsaicin 8% patches over 52 weeks in addition to standard of care (SOC), and were compared with a study arm receiving SOC alone. Although the original PACE study also included a treatment arm receiving 60-minute capsaicin treatment plus SOC, this arm was not included in the present analysis. The first subset was analysed descriptively only, whereas the second, smaller subset included only participants with reduced function across all sensory modalities assessed (cold, heat, sharpness, and vibration perception) and was subjected to statistical analysis. A composite clinical score “Brief Sensory Pain Examination” (BSPE), derived from a battery of bedside tests, was created for this analysis.
Results: According to the BSPE scoring, numerically more participants improved than worsened over the course of the study. Positive shifts in sensory function also became more frequent with increasing treatment duration. These observations were not statistically tested. In the subset of 177 individuals with reduced sensory function at baseline, the capsaicin-treated group (n=88) showed improvements in heat, sharpness, and vibration perception compared with the SOC group.
Conclusions: Repeated treatment with high-concentration capsaicin patches may improve peripheral sensory nerve function at the treated areas in addition to symptomatic pain relief. This may reflect restoration of protective sensation to a certain degree and could potentially reduce the risk of diabetic foot complications.
Comments: This post-hoc analysis of the PACE study suggests that repeated treatment with high-concentration capsaicin patches may improve sensory nerve function in some individuals with painful diabetic peripheral neuropathy. As a potentially disease-modifying property, this warrants further investigation in adequately powered, double-blind clinical trials However, the subgroup subjected to statistical analysis was highly selected compared with the original PACE study population, and potential confounders, including glycaemic control, were not addressed. Furthermore, the BSPE scoring system is not an established measure of neuropathic deficits. These limitations reduce the robustness of the findings and their clinical interpretation.
Gidon J Bönhof
Reference. Katz NP, Allen S, Carnevale A, Marcondes L, Simpson DM. Effect of Capsaicin (8%) Topical System on Sensory Function in Patients With Diabetic Peripheral Neuropathy: Analysis of the PACE Study. Muscle Nerve. 2026 Jun;73(6):1109-1117. doi: 10.1002/mus.70237. Epub 2026 Apr 3. PMID: 41932827; PMCID: PMC13138354.
