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在一项随机双盲安慰剂对照脑成像研究中,当用于治疗慢性背痛时,5%利多卡因贴剂的疗效并不优于安慰剂。

Lidocaine patch (5%) is no more potent than placebo in treating chronic back pain when tested in a randomised double blind placebo controlled brain imaging study.

机构信息

Department of Physiology, Northwestern University, Feinberg School of Medicine, Chicago, Illinois 60611, USA.

出版信息

Mol Pain. 2012 Apr 24;8:29. doi: 10.1186/1744-8069-8-29.

Abstract

BACKGROUND

The 5% Lidocaine patch is used for treating chronic neuropathic pain conditions such as chronic back pain (CBP), diabetic neuropathy and complex regional pain syndrome, but is effective in a variable proportion of patients. Our lab has reported that this treatment reduces CBP intensity and associated brain activations when tested in an open labelled preliminary study. Notably, effectiveness of the 5% Lidocaine patch has not been tested against placebo for treating CBP. In this study, effectiveness of the 5% Lidocaine patch was compared with placebo in 30 CBP patients in a randomised double-blind study where 15 patients received 5% Lidocaine patches and the remaining patients received placebo patches. Functional MRI was used to identify brain activity for fluctuations of spontaneous pain, at baseline and at two time points after start of treatment (6 hours and 2 weeks).

RESULTS

There was no significant difference between the treatment groups in either pain intensity, sensory and affective qualities of pain or in pain related brain activation at any time point. However, 50% patients in both the Lidocaine and placebo arms reported a greater than 50% decrease in pain suggesting a marked placebo effect. When tested against an untreated CBP group at similar time points, the patch treated subjects showed significantly greater decrease in pain compared to the untreated group (n = 15).

CONCLUSIONS

These findings suggest that although the 5% Lidocaine is not better than placebo in its effectiveness for treating pain, the patch itself induces a potent placebo effect in a significant proportion of CBP patients.

摘要

背景

5%利多卡因贴剂用于治疗慢性神经性疼痛病症,如慢性腰痛(CBP)、糖尿病性神经病变和复杂性区域疼痛综合征,但在一部分患者中有效。我们实验室曾报告,在一项开放性初步研究中,这种治疗方法可降低 CBP 强度和相关的大脑激活。值得注意的是,尚未针对安慰剂测试 5%利多卡因贴剂治疗 CBP 的效果。在这项研究中,我们在一项随机双盲研究中比较了 30 名 CBP 患者使用 5%利多卡因贴剂与安慰剂的效果,其中 15 名患者接受 5%利多卡因贴剂,其余患者接受安慰剂贴剂。功能性磁共振成像用于识别自发疼痛波动的大脑活动,在基线和治疗开始后 6 小时和 2 周两个时间点进行。

结果

在任何时间点,治疗组在疼痛强度、疼痛的感觉和情感质量或与疼痛相关的大脑激活方面均无显著差异。然而,利多卡因和安慰剂组各有 50%的患者报告疼痛减轻超过 50%,表明存在明显的安慰剂效应。在与相似时间点的未经治疗的 CBP 组进行比较时,贴剂治疗组的疼痛减轻程度明显大于未治疗组(n = 15)。

结论

这些发现表明,尽管 5%利多卡因在治疗疼痛方面并不优于安慰剂,但贴剂本身在很大一部分 CBP 患者中会引起强烈的安慰剂效应。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bd33/3475108/c616eb94d8e4/1744-8069-8-29-1.jpg

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