Moon Jee-Youn, Lee Pyung-Bok, Kim Yong-Chul, Lee Sang-Chul, Nahm Francis S, Choi Eunjoo
Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea.
Department of Anesthesiology and Pain Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Kyonggi, Republic of Korea.
Pain Physician. 2017 Feb;20(2):27-35.
Topical capsaicin therapy may be of benefit in providing pain relief in patients with peripheral neuropathy.
To investigate the efficacy and safety of 0.625% (50 µg/cm2) and 1.25% (100 µg/cm2) capsaicin patches (CPs) compared to conventional 0.075% capsaicin cream or placebo patches in patients suffering from peripheral neuropathy.
Early Phase II, multi-center, randomized, semi-double-blind, and placebo-controlled clinical trial.
Two medical college teaching hospitals.
Sixty patients were randomized to the 0.625% CP, 1.25% CP, placebo-controlled patch, or 0.075% capsaicin cream. The primary efficacy endpoint was the mean difference in the change of daily numerical rating scale (NRS) pain score. Secondary endpoints included values for the Daily Sleep Interference Scale, the percentage of patients achieving a >/= 30% or >/= 50% reduction in pain, and data for Global Impression Change (GIC) and EQ-5D.
Patients treated with the 0.625% CP and 0.075% capsaicin cream showed statistically significant improvements in pain after 6-weeks of test drug application. Daily sleep disorder scores were improved only for those patients applying the 0.075% capsaicin cream. For patient-derived GIC scores, the majority (11 of 12) of patients in the 0.625% CP group reported that their pain was improved. For the safety evaluation, 2 severe adverse events were reported for the 0.075% capsaicin cream group only. Repetitive patch application was related to minor skin problems such as a burning sensation, erythema, pruritus, and vesicles in 28 patients (46.67%).
The small sample size and relatively high dropout rates.
Our data indicate that the 0.625% CP may prove to be an effective and safe alternative with which to treat patients with peripheral neuropathy and could replace the high concentration (8%) CP. Further studies are now needed to definitively establish efficacy.Key words: Capsaicin, patch, CP, topical capsaicin, neuropathic pain, peripheral neuropathic pain, PNP, high concentration CPTrial Registration: ClinicalTrials.gov, NCT02228928.
局部应用辣椒素疗法可能有助于缓解周围神经病变患者的疼痛。
比较0.625%（50μg/cm²）和1.25%（100μg/cm²）辣椒素贴片（CP）与传统0.075%辣椒素乳膏或安慰剂贴片对周围神经病变患者的疗效和安全性。
II期早期、多中心、随机、半双盲、安慰剂对照临床试验。
两家医学院教学医院。
60例患者被随机分为0.625%CP组、1.25%CP组、安慰剂对照贴片组或0.075%辣椒素乳膏组。主要疗效终点是每日数字评定量表（NRS）疼痛评分变化的平均差值。次要终点包括每日睡眠干扰量表的值、疼痛减轻≥30%或≥50%的患者百分比，以及整体印象变化（GIC）和EQ-5D的数据。
应用0.625%CP和0.075%辣椒素乳膏治疗的患者在应用试验药物6周后疼痛有统计学显著改善。仅应用0.075%辣椒素乳膏的患者每日睡眠障碍评分有所改善。对于患者自评的GIC评分，0.625%CP组的大多数（12例中的11例）患者报告疼痛有所改善。在安全性评估方面，仅0.075%辣椒素乳膏组报告了2例严重不良事件。28例患者（46.67%）反复贴片应用与轻微皮肤问题有关，如烧灼感、红斑、瘙痒和水疱。
样本量小且脱落率相对较高。
我们的数据表明，0.625%CP可能是治疗周围神经病变患者的一种有效且安全的替代方法，并且可以替代高浓度（8%）CP。现在需要进一步研究来明确确定其疗效。关键词：辣椒素、贴片、CP、局部辣椒素、神经性疼痛、周围神经性疼痛、PNP、高浓度CP试验注册号：ClinicalTrials.gov，NCT02228928
