Shang Kai, Ma Xin, Liu Hui-Lin, Jing Yuan-Yuan, Zeng Lin, Li Nan, Zhou De-An, Wei Jia, Zhang Chen
Acupuncture and Moxibustion Department, Beijing Hospital of Traditional Chinese Medicine affiliated with Capital Medical University, No.23, Mei shu guan hou jie Road, Beijing, 100010, China.
Otorhinolaryngology Department, Peking University People's Hospital, No.11, Xi zhi men nan da jie Road, Beijing, 100044, China.
Trials. 2018 Jul 4;19(1):356. doi: 10.1186/s13063-018-2737-x.
Idiopathic sudden sensorineural hearing loss (ISSNHL) is a common form of deafness. Acupuncture has been used as a salvage therapy for ISSNHL in China since 200 BCE. However, the efficacy of acupuncture has not been confirmed in strictly controlled trials. We designed a randomized controlled clinical trial to evaluate the efficacy and long-term effects of acupuncture in patients with early ISSNHL.
METHODS/DESIGN: In this randomized controlled clinical trial, we will enroll 124 participants with ISSNHL diagnosed 2 to 4 weeks prior to enrollment, who have shown little hearing improvement after routine Western medical treatment (i.e., corticosteroids). 62 of these participants will have flat audiogram and the other 62 will have a high-frequency drop audiogram; they will all take Methycobal while half of the flat type and half of the high-frequency drop type will also receive acupuncture treatments for 4 weeks in a four-group design. The primary outcome measure will be the effective rate of hearing improvement (defined as the proportion of patients with at least 15-dB improvement in the hearing loss frequency band). The secondary outcome will measure the improvements in Pure Tone Average, Word Recognition Score, and Tinnitus Handicap Inventory. The assessments of the participants will be made at baseline, after treatment (week 4), and at follow-up (week 28).
This study aims to explore the efficacy and long-term effects of acupuncture in patients with ISSNHL. This study will be a randomized controlled trial with strict methodology and few design deficits. If our study yields positive results, acupuncture could be recommended as a salvage therapy for patients with ISSNHL.
Chinese Clinical Trial Registry, ChiCTR-ICR-15006787 . Registered on 12 July 2015.
特发性突发性感音神经性听力损失（ISSNHL）是一种常见的耳聋形式。自公元前200年起，针灸在中国就被用作ISSNHL的挽救性治疗方法。然而，针灸的疗效尚未在严格对照试验中得到证实。我们设计了一项随机对照临床试验，以评估针灸对早期ISSNHL患者的疗效和长期影响。
方法/设计：在这项随机对照临床试验中，我们将招募124名在入组前2至4周被诊断为ISSNHL的参与者，这些参与者在接受常规西医治疗（即皮质类固醇）后听力改善甚微。其中62名参与者听力图呈平坦型，另外62名呈高频下降型听力图；他们都将服用甲钴胺，同时在四组设计中，平坦型的一半和高频下降型的一半还将接受为期4周的针灸治疗。主要结局指标将是听力改善有效率（定义为听力损失频段至少改善15分贝的患者比例）。次要结局指标将测量纯音平均听阈、言语识别得分和耳鸣障碍量表的改善情况。将在基线、治疗后（第4周）和随访（第28周）对参与者进行评估。
本研究旨在探讨针灸对ISSNHL患者的疗效和长期影响。本研究将是一项方法严格且设计缺陷较少的随机对照试验。如果我们的研究产生阳性结果，针灸可被推荐作为ISSNHL患者的挽救性治疗方法。
中国临床试验注册中心，ChiCTR-ICR-15006787。于2015年7月12日注册。
