Abstract：
BACKGROUND: Trigeminal neuralgia (TN) is difficult to treat due to its severe pain intensity and recurring episodes, which significantly impact quality of life.
OBJECTIVE: 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.
BACKGROUND: NCT03580317.
OBJECTIVE: 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.
BACKGROUND: NCT03580317.
摘要：
背景：三叉神经痛（TN）由于其严重的疼痛强度和反复发作而难以治疗，显著影响生活质量。
目的：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）联合使用是否具有协同作用。
方法：多中心，随机化，进行2×2阶乘试验。符合纳入标准的参与者接受主动EA或假EA60分钟，每周三次，共四周；CBZ（每天300mg）或安慰剂，共四周。主要结果是从基线到第2、4、16和28周的视觉模拟量表（VAS）评分的变化。次要结果包括生活质量和不良事件。
结果：共有120名参与者（75名女性和45名男性；平均（SD）年龄，包括58.5（15.3）年）。EA和CBZ的主效应显著(P<0.001)。干预措施之间存在显著的交互作用(P=0.041).接受EA的参与者(平均差[MD]，第2周为-0.3[95%CI，-0.40至-0.20]；第4周为-1.6[-1.70至-1.50]；第16周为-1.1[-1.31至-0.89]；第28周为-0.8[-1.01至-0.59]），CBZ(MD,第2周为-0.6[95%CI，-0.70至-0.50]；第4周为-0.9[-1.03至-0.77]，第16周为-0.2[-0.41至0.01]，第28周为0.2[-0.01至0.41]），以及两者的组合(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]）在治疗阶段的VAS评分降低幅度大于其各自的对照组（EA，安慰剂,和假EA加安慰剂)。在整个阶段，EA相关的不良事件（6/59，10.17％）低于CBZ（15/59，25.42％）。
结论：单用EA或CBZ是治疗TN的有效方法，而EA和低剂量CBZ的组合发挥更大的益处。本试验中的这些发现表明，EA和低剂量CBZ的组合在某些情况下可能是临床有效的。
背景：NCT03580317。
目的：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）联合使用是否具有协同作用。
方法：多中心，随机化，进行2×2阶乘试验。符合纳入标准的参与者接受主动EA或假EA60分钟，每周三次，共四周；CBZ（每天300mg）或安慰剂，共四周。主要结果是从基线到第2、4、16和28周的视觉模拟量表（VAS）评分的变化。次要结果包括生活质量和不良事件。
结果：共有120名参与者（75名女性和45名男性；平均（SD）年龄，包括58.5（15.3）年）。EA和CBZ的主效应显著(P<0.001)。干预措施之间存在显著的交互作用(P=0.041).接受EA的参与者(平均差[MD]，第2周为-0.3[95%CI，-0.40至-0.20]；第4周为-1.6[-1.70至-1.50]；第16周为-1.1[-1.31至-0.89]；第28周为-0.8[-1.01至-0.59]），CBZ(MD,第2周为-0.6[95%CI，-0.70至-0.50]；第4周为-0.9[-1.03至-0.77]，第16周为-0.2[-0.41至0.01]，第28周为0.2[-0.01至0.41]），以及两者的组合(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]）在治疗阶段的VAS评分降低幅度大于其各自的对照组（EA，安慰剂,和假EA加安慰剂)。在整个阶段，EA相关的不良事件（6/59，10.17％）低于CBZ（15/59，25.42％）。
结论：单用EA或CBZ是治疗TN的有效方法，而EA和低剂量CBZ的组合发挥更大的益处。本试验中的这些发现表明，EA和低剂量CBZ的组合在某些情况下可能是临床有效的。
背景：NCT03580317。
