The Third Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, China.
Jiaxing Hospital of Traditional Chinese Medicine, Jiaxing, China.
J Neurol. 2024 Aug;271(8):5122-5136. doi: 10.1007/s00415-024-12433-x. Epub 2024 May 31.
Trigeminal neuralgia (TN) is difficult to treat due to its severe pain intensity and recurring episodes, which significantly impact quality of life.
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.
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.
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.
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.
NCT03580317.
三叉神经痛（TN）由于其剧烈的疼痛强度和反复发作，导致治疗难度大，严重影响生活质量。
评估电针（EA）缓解 TN 疼痛强度的有效性，并确定低剂量卡马西平（CBZ）与 EA 联合是否具有协同作用。
这是一项多中心、随机、2×2 析因试验。符合纳入标准的参与者接受为期 4 周的电针或假电针治疗，每周 3 次，每次 60 分钟；接受 CBZ（300mg/天）或安慰剂治疗，持续 4 周。主要结局是从基线到第 2、4、16 和 28 周时视觉模拟量表（VAS）评分的变化。次要结局包括生活质量和不良事件。
共有 120 名参与者（75 名女性和 45 名男性；平均（SD）年龄 58.5（15.3）岁）被纳入。EA 和 CBZ 的主要作用均有统计学意义（P<0.001），且干预措施之间存在显著的交互作用（P=0.041）。接受 EA（平均差值[MD]，第 2 周-0.3[95%CI，-0.40 至-0.20]；第 4 周-1.6[-1.70 至-1.50]；第 16 周-1.1[-1.31 至-0.89]；第 28 周-0.8[-1.01 至-0.59]）、CBZ（MD，第 2 周-0.6[95%CI，-0.70 至-0.50]；第 4 周-0.9[-1.03 至-0.77]；第 16 周-0.2[-0.41 至 0.01]；第 28 周 0.2[-0.01 至 0.41]）和两者联合治疗（MD，第 2 周-1.8[95%CI，-1.90 至-1.70]；第 4 周-3.7[-3.83 至-3.57]；第 16 周-3.4[-3.61 至-3.19]；第 28 周-2.9[-3.11 至-2.69]）的 VAS 评分在治疗阶段均比各自的对照组（假电针、安慰剂和假电针加安慰剂）有更大的降低。在整个治疗阶段，EA 相关的不良事件（6/59，10.17%）低于 CBZ（15/59，25.42%）。
EA 或 CBZ 单独治疗 TN 均有效，而 EA 与低剂量 CBZ 联合则具有更大的益处。本试验的结果表明，在某些情况下，EA 与低剂量 CBZ 的联合可能具有临床疗效。
NCT03580317。
