Electroacupuncture and carbamazepine for patients with trigeminal neuralgia: a randomized, controlled, 2 × 2 factorial trial.

IF 4.8 2区医学 Q1 CLINICAL NEUROLOGY Journal of Neurology Pub Date : 2024-08-01 Epub Date: 2024-05-31 DOI:10.1007/s00415-024-12433-x

Rongrong Li, Jing Sun, Kaitao Luo, Ning Luo, Ruohan Sun, Feng Gao, Yiyi Wang, Yunfan Xia, Xiaoyu Li, Lifang Chen, Ruijie Ma, Xiaomei Shao, Yi Liang, Jianqiao Fang

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Abstract

Background: Trigeminal neuralgia (TN) is difficult to treat due to its severe pain intensity and recurring episodes, which significantly impact quality of life.

Objectives: We aimed to assess the effectiveness of electroacupuncture (EA) in alleviating the pain intensity in TN, and to determine whether EA combined with low-dosage carbamazepine (CBZ) has a synergistic effect.

Methods: A multi-centre, randomized, 2 × 2 factorial trial was conducted. Participants who met the inclusion criteria received active EA or sham EA for 60 min, three times a week for four weeks; CBZ (300 mg per day) or placebo for four weeks. The primary outcome was the change in visual analog scale (VAS) score from baseline to weeks 2, 4, 16, and 28. Secondary outcomes included quality of life and adverse events.

Results: A total of 120 participants (75 females and 45 males; mean (SD) age, 58.5 (15.3) years) were included. The main effects of EA and CBZ were significant (P < 0.001), and there was a significant interaction was identified between the interventions (P = 0.041). Participants who received EA (mean difference [MD], -0.3 [95% CI, -0.40 to -0.20] at week 2; -1.6 [-1.70 to -1.50] at week 4; -1.1 [-1.31 to -0.89] at week 16; -0.8 [-1.01 to -0.59] at week 28), CBZ (MD, -0.6 [95% CI, -0.70 to -0.50] at week 2; -0.9 [-1.03 to -0.77] at week 4, -0.2 [-0.41 to 0.01] at week 16, 0.2 [-0.01 to 0.41] at week 28), and the combination of both (MD, -1.8 [95% CI, -1.90 to -1.70] at week 2; -3.7 [-3.83 to -3.57] at week 4, -3.4 [-3.61 to -3.19] at week 16, -2.9 [-3.11 to -2.69] at week 28) had a greater reduction in VAS score over the treatment phase than their respective control groups (sham EA, placebo, and sham EA plus placebo). EA-related adverse events (6/59, 10.17%) were lower than that of CBZ (15/59, 25.42%) during the whole phases.

Conclusions: EA or CBZ alone are effective treatments for TN, while the combination of EA and low-dosage CBZ exerts a greater benefit. These findings in this trial demonstrate that the combination of EA and low-dosage CBZ may be clinically effective under certain circumstances.

Trial registration: NCT03580317.

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电针和卡马西平治疗三叉神经痛患者：随机对照、2 × 2因子试验。

背景：三叉神经痛（TN三叉神经痛（TN）因其剧烈的疼痛强度和反复发作而难以治疗，严重影响患者的生活质量：我们旨在评估电针（EA）在减轻 TN 疼痛强度方面的有效性，并确定 EA 与低剂量卡马西平（CBZ）联用是否具有协同作用：方法：进行了一项多中心、随机、2 × 2因子试验。符合纳入标准的参与者接受活性 EA 或假性 EA 治疗，每周三次，每次 60 分钟，为期四周；接受 CBZ（每天 300 毫克）或安慰剂治疗，为期四周。主要结果是视觉模拟量表（VAS）评分从基线到第2周、第4周、第16周和第28周的变化。次要结果包括生活质量和不良反应：共纳入了 120 名参与者（女性 75 人，男性 45 人；平均（标清）年龄 58.5（15.3）岁）。EA和CBZ的主效应具有显著性（P 结论：EA和CBZ都是有效的治疗方法：单独使用EA或CBZ均可有效治疗TN，而EA和小剂量CBZ联合使用可产生更大疗效。本试验的这些结果表明，在某些情况下，EA和小剂量CBZ联合治疗可能会有临床疗效：试验注册：NCT03580317。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Journal of Neurology 医学-临床神经学

CiteScore

10.00

自引率

5.00%

发文量

558

审稿时长

1 months

期刊介绍： The Journal of Neurology is an international peer-reviewed journal which provides a source for publishing original communications and reviews on clinical neurology covering the whole field. In addition, Letters to the Editors serve as a forum for clinical cases and the exchange of ideas which highlight important new findings. A section on Neurological progress serves to summarise the major findings in certain fields of neurology. Commentaries on new developments in clinical neuroscience, which may be commissioned or submitted, are published as editorials. Every neurologist interested in the current diagnosis and treatment of neurological disorders needs access to the information contained in this valuable journal.