Kulkantrakorn Kongkiat, Chomjit Assawin, Sithinamsuwan Pasiri, Tharavanij Thipaporn, Suwankanoknark Juthamas, Napunnaphat Phunyada
Division of Neurology, Department of Internal Medicine, Thammasat University, Pathumthani, Thailand; Center of Excellence for Diabetic Foot Care, Thammasat University Hospital, Pathumthani, Thailand.
Division of Neurology, Department of Internal Medicine, Thammasat University, Pathumthani, Thailand.
J Clin Neurosci. 2019 Apr;62:174-179. doi: 10.1016/j.jocn.2018.11.036. Epub 2018 Nov 22.
A randomized, double-blinded, crossover, placebo controlled trial was conducted to evaluate the efficacy and safety of 0.075% capsaicin lotion for treating painful diabetic neuropathy (PDN).
PDN subjects were randomized to receive 0.075% capsaicin/placebo for 8 weeks, then crossing over to the other treatment after a 4-weeks washout period. Primary endpoint was the change in visual analog scale score of pain severity. Secondary outcomes were score changes in Neuropathic Pain Scale, short-form McGill Pain Questionnaires, and proportions of patients with pain score reductions of 30% and 50%, and adverse events.
A total of 42 subjects were enrolled, 27 completed at least an 8-week treatment period. Intention-to-treat analysis showed no significant improvement in pain control with capsaicin lotion compared with placebo for all pain measures and proportion of patients who had 30% or 50% pain relief, respectively. Per protocol analysis were consistent. Capsaicin lotion was well tolerated but local skin reactions were common.
In patients with PDN, the efficacy of 0.075% capsaicin lotion was similar to placebo but was well tolerated. More work is needed to assess different capsaicin formulations.
开展一项随机、双盲、交叉、安慰剂对照试验，以评估0.075%辣椒素洗剂治疗糖尿病性周围神经病变性疼痛（PDN）的疗效和安全性。
将PDN受试者随机分组，接受0.075%辣椒素/安慰剂治疗8周，然后在4周的洗脱期后交叉接受另一种治疗。主要终点是疼痛严重程度视觉模拟量表评分的变化。次要结局是神经病理性疼痛量表、简式麦吉尔疼痛问卷的评分变化，以及疼痛评分降低30%和50%的患者比例和不良事件。
共纳入42名受试者，27名完成了至少8周的治疗期。意向性分析显示，与安慰剂相比，辣椒素洗剂在所有疼痛测量指标以及疼痛缓解30%或50%的患者比例方面，疼痛控制均无显著改善。符合方案分析结果一致。辣椒素洗剂耐受性良好，但局部皮肤反应常见。
在PDN患者中，0.075%辣椒素洗剂的疗效与安慰剂相似，但耐受性良好。需要开展更多工作来评估不同的辣椒素制剂。
