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Randomized Controlled Trial
. 2018 Apr;22(4):700-706.
doi: 10.1002/ejp.1155. Epub 2017 Dec 1.

Superiority of capsaicin 8% patch versus oral pregabalin on dynamic mechanical allodynia in patients with peripheral neuropathic pain

G Cruccu  1 , T J Nurmikko  2 , E Ernault  3 , F K Riaz  4 , W T McBride  5 , M Haanpää  6
Affiliations
Randomized Controlled Trial

Superiority of capsaicin 8% patch versus oral pregabalin on dynamic mechanical allodynia in patients with peripheral neuropathic pain

G Cruccu et al. Eur J Pain. 2018 Apr.

Abstract

Background: Dynamic Mechanical Allodynia (DMA) is a typical symptom of neuropathic pain (NP). In a recent study, the capsaicin 8% patch was noninferior to pregabalin in overall peripheral NP relief. In this study, we report the comparison of the two treatments in relieving DMA.

Methods: In a randomized, open-label, head-to-head, 8-week study, 488 patients with peripheral NP were treated with the capsaicin 8% patch (one application) or an optimized dose of pregabalin. Assessments included the area and intensity of DMA, and the number of patients achieving complete resolution of DMA.

Results: At baseline, 253 patients in the capsaicin 8% patch group and 235 patients in the pregabalin group had DMA. From baseline to end of study, the change in DMA intensity was significantly in favour of the capsaicin 8% patch versus pregabalin [-0.63 (95% CI: -1.04, -0.23; p = 0.002)]. Similarly, the capsaicin 8% patch was superior to pregabalin in reducing the area of DMA [-39.5 cm2 (95% CI: -69.1, -10.0; p = 0.009)] from baseline to end of study. Overall, a greater proportion of patients had a complete resolution of allodynia with capsaicin 8% patch treatment compared with pregabalin treatment (24.1% vs. 12.3%; p = 0.001) at end of study.

Conclusion: Capsaicin 8% treatment was superior to pregabalin in reducing the intensity and area of DMA, and in the number of patients with complete resolution of DMA.

Significance: The superiority of a topical treatment over pregabalin in relieving DMA supports the view that both peripheral and central sensitization can mediate allodynia.

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Figures

Figure 1
Figure 1
Mean change in intensity of dynamic mechanical allodynia from baseline to Week 8/EoS (BOCF). BOCF, baseline observation carried forward; EoS, end of study; LS, least squares; n, number of all patients with allodynia at baseline; NPRS, Numeric Pain Rating Scale.
Figure 2
Figure 2
Mean change in area of dynamic mechanical allodynia from baseline to Week 8/EoS (BOCF). BOCF, baseline observation carried forward; EoS, end of study; LS, least squares; n, number of all patients with allodynia at baseline.
See this image and copyright information in PMC

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