Abstract：
BACKGROUND: Peripheral facial palsy (PFP) results in weakness or paralysis of the affected side of the face. In Korea, there is a high demand for Korean medicine treatment for PFP. The clinical practice guidelines (CPGs) of Korean medicine for facial palsy were developed; however, there remains insufficient evidence to support the effectiveness and safety of Korean medicine treatment. Thus, this study aimed to evaluate the effectiveness and safety of Korean medicine treatment based on the CPGs in patients with acute PFP.
METHODS: This is a multicenter, prospective, observational study. The participants will be recruited from one Korean medicine hospital and eight Korean medicine clinics. The participants will receive Korean medicine treatments based on the CPGs, fill in survey questionnaires, and undergo electrophysiologic testing. The changes in House-Brackmann (H-B) grade, movement of the lip and eye, symptoms related to or accompanied by facial palsy, Facial Disability Index, EuroQol 5-dimension 5-level (EQ-5D-5L), and EuroQol Visual Analogue Scale (EQ-VAS), and the results of electromyography (EMG), electroneurography (ENoG), and Blink Reflex test will be analyzed. For the safety analysis, adverse events will be recorded, and for the feasibility analysis, the results of the Was It Worth It questionnaire will be assessed.
CONCLUSIONS: We expect to draw real-world clinical data on the effectiveness and safety of Korean medicine treatment based on the CPGs in patients with acute PFP from this study. It would be the basis for complementing and improving the CPGs and provide the basis of clinical and policy decision-making.
BACKGROUND: This study was approved by the Institutional Review Board of Kyung Hee University Korean Medicine Hospital (2021-06-005-001), and registered with the Korean Clinical Trial Registry (CRIS), Republic of Korea (KCT0006562).
METHODS: This is a multicenter, prospective, observational study. The participants will be recruited from one Korean medicine hospital and eight Korean medicine clinics. The participants will receive Korean medicine treatments based on the CPGs, fill in survey questionnaires, and undergo electrophysiologic testing. The changes in House-Brackmann (H-B) grade, movement of the lip and eye, symptoms related to or accompanied by facial palsy, Facial Disability Index, EuroQol 5-dimension 5-level (EQ-5D-5L), and EuroQol Visual Analogue Scale (EQ-VAS), and the results of electromyography (EMG), electroneurography (ENoG), and Blink Reflex test will be analyzed. For the safety analysis, adverse events will be recorded, and for the feasibility analysis, the results of the Was It Worth It questionnaire will be assessed.
CONCLUSIONS: We expect to draw real-world clinical data on the effectiveness and safety of Korean medicine treatment based on the CPGs in patients with acute PFP from this study. It would be the basis for complementing and improving the CPGs and provide the basis of clinical and policy decision-making.
BACKGROUND: This study was approved by the Institutional Review Board of Kyung Hee University Korean Medicine Hospital (2021-06-005-001), and registered with the Korean Clinical Trial Registry (CRIS), Republic of Korea (KCT0006562).
摘要：
背景：周围性面神经麻痹（PFP）导致患侧面部无力或瘫痪。在韩国,对韩国药物治疗PFP的需求很高。制定了韩国面神经麻痹医学的临床实践指南(CPGs)；然而，仍然没有足够的证据支持韩国药物治疗的有效性和安全性.因此，本研究旨在评估基于CPGs的韩国药物治疗急性PFP的有效性和安全性.
方法：这是一个多中心，prospective,观察性研究。参与者将从一家韩国医学医院和八家韩国医学诊所招募。参与者将接受基于CPG的韩国医学治疗，填写调查问卷，并接受电生理测试。House-Brackmann(H-B)等级的变化，嘴唇和眼睛的运动，与面部麻痹相关或伴有面部麻痹的症状，面部残疾指数,EuroQol5维5级（EQ-5D-5L），和EuroQol视觉模拟量表（EQ-VAS），和肌电图（EMG）的结果，神经电描记术(EnoG)，和闪烁反射测试将被分析。对于安全分析，将记录不良事件，对于可行性分析，将评估“是否值得”问卷的结果。
结论：我们希望根据本研究的急性PFP患者的CPG，得出韩国药物治疗有效性和安全性的真实临床数据。这将是补充和改进CPG的基础，并为临床和政策决策提供依据。
背景：本研究获得了庆熙大学韩国医学医院机构审查委员会的批准（2021-06-005-001），并在韩国临床试验注册中心（CRIS）注册，大韩民国(KCT0006562)。
方法：这是一个多中心，prospective,观察性研究。参与者将从一家韩国医学医院和八家韩国医学诊所招募。参与者将接受基于CPG的韩国医学治疗，填写调查问卷，并接受电生理测试。House-Brackmann(H-B)等级的变化，嘴唇和眼睛的运动，与面部麻痹相关或伴有面部麻痹的症状，面部残疾指数,EuroQol5维5级（EQ-5D-5L），和EuroQol视觉模拟量表（EQ-VAS），和肌电图（EMG）的结果，神经电描记术(EnoG)，和闪烁反射测试将被分析。对于安全分析，将记录不良事件，对于可行性分析，将评估“是否值得”问卷的结果。
结论：我们希望根据本研究的急性PFP患者的CPG，得出韩国药物治疗有效性和安全性的真实临床数据。这将是补充和改进CPG的基础，并为临床和政策决策提供依据。
背景：本研究获得了庆熙大学韩国医学医院机构审查委员会的批准（2021-06-005-001），并在韩国临床试验注册中心（CRIS）注册，大韩民国(KCT0006562)。
