Wang Zhidan, Zhang Jie, Zhang Zhen, Liu Yue, Ren Shuang, Sun Hao, Meng Di, Liu Ruoshi, Zhang Yang
Department of Traditional Chinese Medicine, The First Hospital of China Medical University, Shenyang, China.
Department of Ultrasound, The First Hospital of China Medical University, Shenyang, China.
Front Neurol. 2024 Apr 16;15:1327206. doi: 10.3389/fneur.2024.1327206. eCollection 2024.
Bell's palsy is an acute peripheral facial neuropathy, which is one of the most common causes of facial palsy of lower motor neurons. Facial nerve swelling is commonly observed in Bell's palsy. Acupuncture therapy has been widely used in the treatment of Bell's palsy. However, whether acupuncture can be effectively used in the acute stage is still controversial. There are no clinical trials conducted previously to evaluate the effect of acupuncture on facial nerve edema in Bell's palsy patients. The study aims to evaluate the potential efficacy of different acupuncture modalities on Bell's palsy patients in the acute phase, its effect on facial nerve edema, and to preliminarily explore its possible mechanism.
In this randomized, controlled trial, 165 Bell's palsy patients with unilateral onset within 3 days will be recruited and randomly assigned to either the electroacupuncture group ( = 33), the acupuncture group ( = 33), the sham acupuncture group ( = 33), the blank control group ( = 33), or the acupuncture control group ( = 33) in a 1:1:1:1:1 ratio. The participants will receive 4 weeks of treatment and 8 weeks of follow-up. The five groups of participants will receive the following treatments: A: Electroacupuncture + Medication (prednisone acetate tablets, mecobalamin tablets, and vitamin B1 tablets); B: Acupuncture + Medication; C: Sham Acupuncture + Medication; D: Medication only; and E: Acupuncture only. The primary outcome will be the effectiveness rate of different acupuncture modalities in improving facial nerve function after the intervention period. The secondary outcomes will be the recovery speed, the diameter of the facial nerve, the echo intensity and thickness of facial muscles, blood flow parameters of the facial artery, the serum inflammatory level, safety evaluation, and adverse events. Preliminary exploration of its mechanism of action occurs through inflammation and immune response. The difference between groups will be assessed using repeated measure analysis of covariance (ANCOVA) and trend chi-square.
The trial will evaluate the efficacy and facial nerve edema of acupuncture for Bell's palsy patients in the acute phase and preliminarily explore its possible mechanism. The results thus may provide evidence for clinical application.
https://www.chictr.org.cn/bin/project/edit?pid=133211, identifier ChiCTR2100050815.
贝尔面瘫是一种急性周围性面神经病变，是下运动神经元性面瘫最常见的病因之一。贝尔面瘫患者常可见面神经肿胀。针灸疗法已广泛应用于贝尔面瘫的治疗。然而，针灸在急性期是否能有效应用仍存在争议。此前尚无临床试验评估针灸对贝尔面瘫患者面神经水肿的影响。本研究旨在评估不同针灸方式对急性期贝尔面瘫患者的潜在疗效、其对面神经水肿的影响，并初步探索其可能机制。
在这项随机对照试验中，将招募165例发病3天内单侧发病的贝尔面瘫患者，并按1:1:1:1:1的比例随机分为电针组（n = 33）、针刺组（n = 33）、假针刺组（n = 33）、空白对照组（n = 33）或针刺对照组（n = 33）。参与者将接受4周治疗和8周随访。五组参与者将接受以下治疗：A：电针 + 药物（醋酸泼尼松片、甲钴胺片和维生素B1片）；B：针刺 + 药物；C：假针刺 + 药物；D：仅药物治疗；E：仅针刺治疗。主要结局将是干预期后不同针灸方式改善面神经功能的有效率。次要结局将是恢复速度、面神经直径、面部肌肉的回声强度和厚度、面动脉血流参数、血清炎症水平、安全性评估及不良事件。通过炎症和免疫反应对其作用机制进行初步探索。组间差异将采用重复测量协方差分析（ANCOVA）和趋势卡方检验进行评估。
本试验将评估针灸对急性期贝尔面瘫患者的疗效及面神经水肿情况，并初步探索其可能机制。研究结果可为临床应用提供依据。
https://www.chictr.org.cn/bin/project/edit?pid=133211，标识符ChiCTR2100050815 。
