Li Xiaoyan, Chen Chunlan, Zhao Chuang, Li Zunyuan, Liang Wei, Liu Zhidan
Department of Acupuncture, Baoshan Hospital of Integrated Traditional Chinese Medicine and Western Medicine, Shanghai, 201999, Shanghai, China.
Department of Acupuncture, Shuguang Hospital Baoshan Branch, Shanghai University of Traditional Chinese Medicine, Shanghai, 201203, China.
Trials. 2018 Jun 11;19(1):316. doi: 10.1186/s13063-018-2699-z.
Hypophasis is one of the most frequently observed sequelae of patients with Bell's palsy, who have not recovered completely, creating a clinical difficulty for physicians. Acupuncture therapy has been widely used to treat Bell's palsy as a reasonable resolution for management of symptoms such as hypophasis. The number of acupuncture points (acu-points) is frequently selected in the approach of acupuncture therapy; however, whether these had high efficiency has not been proved. According to the literature review, Bi'nao was useful for treating eye and eye lipid diseases, which could be proved only by some successful cases. Thus, a randomized controlled trial was designed to evaluate the efficiency of the acu-point Bi'nao.
METHODS/DESIGN: Participants with hypophasis as the major symptom are selected among patients with Bell's palsy and randomly allocated into one of the three groups at a 1:1:1 allocation ratio. All participants receive conventional acupuncture therapy; however, those assigned to the real acupuncture group will be given added acupuncture therapy on the acu-point Bi'nao, while those assigned to the sham acupuncture group were given extra acupuncture therapy on the sham Bi'nao as a placebo. The efficacy of the acupuncture therapy on the acu-point Bi'nao for hypophasis will be evaluated by Eye Crack Width Measurement (ECWM) and Eyelid Strength Assessment (ESA) before and after therapy.
This is the first study assessing the safety and efficiency of Bi'nao in treating the hypophasis of patients with Bell's palsy that might support the application of this acupuncture therapy. However, evaluating hypophasis is challenging, and, thus, ECWM and ESA were applied to measure the eyelid movement.
Chinese Clinical Trials Registry, ChiCTR-INR-17012955 . Registered on 12 October 2017.
下唇下垂是贝尔面瘫患者最常见的后遗症之一，这些患者未能完全康复，给医生带来了临床难题。针灸疗法已被广泛用于治疗贝尔面瘫，作为解决如下唇下垂等症状的合理方法。在针灸治疗中经常会选择多个穴位；然而，这些穴位是否具有高效性尚未得到证实。根据文献综述，臂臑穴对治疗眼部及眼部脂质疾病有用，但仅通过一些成功案例得到了证实。因此，设计了一项随机对照试验来评估臂臑穴的疗效。
方法/设计：从贝尔面瘫患者中选择以下唇下垂为主要症状的参与者，并以1:1:1的分配比例随机分配到三组中的一组。所有参与者都接受传统针灸治疗；然而，分配到真针灸组的参与者将在臂臑穴上加用针灸治疗，而分配到假针灸组的参与者将在假臂臑穴上加用额外的针灸治疗作为安慰剂。将通过治疗前后的睑裂宽度测量（ECWM）和眼睑力量评估（ESA）来评估针对下唇下垂的臂臑穴针灸治疗的疗效。
这是第一项评估臂臑穴治疗贝尔面瘫患者下唇下垂的安全性和有效性的研究，可能会支持这种针灸疗法的应用。然而，评估下唇下垂具有挑战性，因此，应用ECWM和ESA来测量眼睑运动。
中国临床试验注册中心，ChiCTR-INR-17012955。于2017年10月12日注册。
