0.025% Capsaicin Gel for the Treatment of Painful Diabetic Neuropathy: A Randomized, Double-Blind, Crossover, Placebo-Controlled Trial
Background: Topical therapy may provide additional benefit in patients with painful diabetic neuropathy (PDN). This study was conducted to study the safety and efficacy of 0.025% capsaicin gel in this condition. Methods: A 20-week, double-blind, crossover, randomized, single-center study enrolled su...
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th-mahidol.326172018-10-19T12:36:14Z 0.025% Capsaicin Gel for the Treatment of Painful Diabetic Neuropathy: A Randomized, Double-Blind, Crossover, Placebo-Controlled Trial Kongkiat Kulkantrakorn Chakraphong Lorsuwansiri Pongsatorn Meesawatsom Thammasat University Mahidol University Medicine Background: Topical therapy may provide additional benefit in patients with painful diabetic neuropathy (PDN). This study was conducted to study the safety and efficacy of 0.025% capsaicin gel in this condition. Methods: A 20-week, double-blind, crossover, randomized, single-center study enrolled subjects with PDN. They received 0.025% capsaicin gel or placebo for 8 weeks, with a washout period of 4 weeks between the two treatments. Primary efficacy end point was percent change in visual analog scale (0-100 mm) of pain severity. Secondary outcomes were score change in Neuropathic Pain Scale (NPS), short-form McGill Pain Questionnaires (SF-MPQ), proportion of patients who had pain score reductions of 30% and 50%, and adverse event. Results: Of the 35 subjects screened, 33 were enrolled and 33 completed at least an 8-week treatment period. Intention-to-treat analysis showed no significant improvement in pain with capsaicin gel, compared with placebo with visual analog scale (VAS) score 28.8 mm vs. 34.6 mm (P = 0.53). No significant difference between the groups was found in SF-MPQ (7.4 vs. 7.71, P = 0.95), NPS (29.4 vs. 31.3, P = 0.81), and proportion of patients who had 30% or 50% pain relief. Capsaicin gel was well tolerated with minor skin reaction. Conclusions: 0.025% capsaicin gel is safe and well tolerated, but does not provide significant pain relief in patients with PDN. © 2012 The Authors Pain Practice © 2012 World Institute of Pain. 2018-10-19T05:36:14Z 2018-10-19T05:36:14Z 2013-01-01 Article Pain Practice. Vol.13, No.6 (2013), 497-503 10.1111/papr.12013 15332500 15307085 2-s2.0-84880045005 https://repository.li.mahidol.ac.th/handle/123456789/32617 Mahidol University SCOPUS https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=84880045005&origin=inward |
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Medicine Kongkiat Kulkantrakorn Chakraphong Lorsuwansiri Pongsatorn Meesawatsom 0.025% Capsaicin Gel for the Treatment of Painful Diabetic Neuropathy: A Randomized, Double-Blind, Crossover, Placebo-Controlled Trial |
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Background: Topical therapy may provide additional benefit in patients with painful diabetic neuropathy (PDN). This study was conducted to study the safety and efficacy of 0.025% capsaicin gel in this condition. Methods: A 20-week, double-blind, crossover, randomized, single-center study enrolled subjects with PDN. They received 0.025% capsaicin gel or placebo for 8 weeks, with a washout period of 4 weeks between the two treatments. Primary efficacy end point was percent change in visual analog scale (0-100 mm) of pain severity. Secondary outcomes were score change in Neuropathic Pain Scale (NPS), short-form McGill Pain Questionnaires (SF-MPQ), proportion of patients who had pain score reductions of 30% and 50%, and adverse event. Results: Of the 35 subjects screened, 33 were enrolled and 33 completed at least an 8-week treatment period. Intention-to-treat analysis showed no significant improvement in pain with capsaicin gel, compared with placebo with visual analog scale (VAS) score 28.8 mm vs. 34.6 mm (P = 0.53). No significant difference between the groups was found in SF-MPQ (7.4 vs. 7.71, P = 0.95), NPS (29.4 vs. 31.3, P = 0.81), and proportion of patients who had 30% or 50% pain relief. Capsaicin gel was well tolerated with minor skin reaction. Conclusions: 0.025% capsaicin gel is safe and well tolerated, but does not provide significant pain relief in patients with PDN. © 2012 The Authors Pain Practice © 2012 World Institute of Pain. |
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Thammasat University |
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Thammasat University Kongkiat Kulkantrakorn Chakraphong Lorsuwansiri Pongsatorn Meesawatsom |
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Article |
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Kongkiat Kulkantrakorn Chakraphong Lorsuwansiri Pongsatorn Meesawatsom |
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Kongkiat Kulkantrakorn |
title |
0.025% Capsaicin Gel for the Treatment of Painful Diabetic Neuropathy: A Randomized, Double-Blind, Crossover, Placebo-Controlled Trial |
title_short |
0.025% Capsaicin Gel for the Treatment of Painful Diabetic Neuropathy: A Randomized, Double-Blind, Crossover, Placebo-Controlled Trial |
title_full |
0.025% Capsaicin Gel for the Treatment of Painful Diabetic Neuropathy: A Randomized, Double-Blind, Crossover, Placebo-Controlled Trial |
title_fullStr |
0.025% Capsaicin Gel for the Treatment of Painful Diabetic Neuropathy: A Randomized, Double-Blind, Crossover, Placebo-Controlled Trial |
title_full_unstemmed |
0.025% Capsaicin Gel for the Treatment of Painful Diabetic Neuropathy: A Randomized, Double-Blind, Crossover, Placebo-Controlled Trial |
title_sort |
0.025% capsaicin gel for the treatment of painful diabetic neuropathy: a randomized, double-blind, crossover, placebo-controlled trial |
publishDate |
2018 |
url |
https://repository.li.mahidol.ac.th/handle/123456789/32617 |
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1763495290344570880 |