Chen Xiaoqin, Li Ying, Zheng Hui, Hu Kaming, Zhang Hongxing, Zhao Ling, Li Yan, Liu Lian, Mang Lingling, Yu Shuyuan
Chengdu University of Traditional Chinese Medicine Chengdu, Sichuan, China.
Contemp Clin Trials. 2009 Jul;30(4):347-53. doi: 10.1016/j.cct.2009.02.006. Epub 2009 Mar 10.
Acupuncture to treat Bell's palsy is one of the most commonly used methods in China. There are a variety of acupuncture treatment options to treat Bell's palsy in clinical practice. Since Bell's palsy has three different path-stages (acute stage, resting stage and restoration stage), so whether acupuncture is effective in the different path-stages and which acupuncture treatment is the best method are major issues in acupuncture clinical trials about Bell's palsy. In this article, we report the design and protocol of a large sample multi-center randomized controlled trial to treat Bell's palsy with acupuncture. There are five acupuncture groups, with four according to different path-stages and one not. In total, 900 patients with Bell's palsy are enrolled in this study. These patients are randomly assigned to receive one of the following four treatment groups according to different path-stages, i.e. 1) staging acupuncture group, 2) staging acupuncture and moxibustion group, 3) staging electro-acupuncture group, 4) staging acupuncture along yangming musculature group or non-staging acupuncture control group. The outcome measurements in this trial are the effect comparison achieved among these five groups in terms of House-Brackmann scale (Global Score and Regional Score), Facial Disability Index scale, Classification scale of Facial Paralysis, and WHOQOL-BREF scale before randomization (baseline phase) and after randomization. The result of this trial will certify the efficacy of using staging acupuncture and moxibustion to treat Bell's palsy, and to approach a best acupuncture treatment among these five different methods for treating Bell's palsy.
针灸治疗贝尔氏面瘫是中国最常用的方法之一。临床实践中有多种针灸治疗方案用于治疗贝尔氏面瘫。由于贝尔氏面瘫有三个不同的病程阶段（急性期、静止期和恢复期），因此针灸在不同病程阶段是否有效以及哪种针灸治疗是最佳方法，是贝尔氏面瘫针灸临床试验中的主要问题。在本文中，我们报告了一项用针灸治疗贝尔氏面瘫的大样本多中心随机对照试验的设计和方案。有五个针灸组，其中四个根据不同病程阶段设置，一个不按病程阶段设置。本研究共纳入900例贝尔氏面瘫患者。这些患者根据不同病程阶段被随机分配接受以下四个治疗组之一，即1）分期针灸组，2）分期针灸加艾灸组，3）分期电针组，4）沿阳明经筋分期针灸组或非分期针灸对照组。本试验的疗效评估指标是这五个组在随机分组前（基线期）和随机分组后，根据House-Brackmann量表（整体评分和区域评分）、面部残疾指数量表、面瘫分级量表和世界卫生组织生存质量简表所取得的疗效比较。本试验结果将验证分期针灸加艾灸治疗贝尔氏面瘫的疗效，并在这五种不同的贝尔氏面瘫治疗方法中探寻最佳的针灸治疗方案。
