Chinese Medicine Services, Pok Oi Hospital, Hong Kong SAR, China.
School of Chinese Medicine, Faculty of Medicine, The Chinese University of Hong Kong, Shatin, NT, Hong Kong SAR, China.
Medicine (Baltimore). 2023 Jul 21;102(29):e34315. doi: 10.1097/MD.0000000000034315.
Tinnitus is a common auditory condition that can lead to serious problems. Clinically, acupuncture and moxibustion have been commonly applied to treat tinnitus in China, with potential therapeutic effects but with limitations in study methodology and high-quality evidence. Therefore, we designed a randomized controlled trial to evaluate the efficacy and safety of either electroacupuncture alone or combined with warm needling for reducing tinnitus loudness and improving quality of life.
This study is a prospective, multicenter, assessor-blind, 3-arm, parallel-group, randomized, waitlist-controlled trial. In total, 90 patients will be randomly assigned to the electroacupuncture, electroacupuncture and warm needing, or waitlist control group in a 1:1:1 ratio. Patients in the 2 treatment groups will be treated twice a week for a total of 5 weeks. Patients in the control group will not receive treatment during the study period and will be informed that they can receive it for free after a 10-week waiting period. The duration of intervention for this study will be 5 weeks, followed by another 5 weeks for the posttreatment assessment. The primary outcome is the change in the visual analog scale score for tinnitus loudness from baseline until the end of treatment. The secondary outcome is the tinnitus discomfort assessment measured using the Tinnitus Handicap Inventory. Outcome parameters will be assessed at baseline and at weeks 5 and 10. Any adverse events will be observed and recorded for safety assessment. Linear mixed models for repeated measures will be applied in the analysis.
Acupuncture and moxibustion could be potentially effective treatment alternatives for tinnitus. The study results will provide evidence to determine the efficacy and safety of electroacupuncture with or without warm needling for tinnitus.
耳鸣是一种常见的听觉病症，可导致严重问题。临床上，针刺和艾灸在中国常用于治疗耳鸣，具有潜在的治疗效果，但研究方法和高质量证据存在局限性。因此，我们设计了一项随机对照试验，以评估单独电针或电针结合温针灸治疗降低耳鸣响度和改善生活质量的疗效和安全性。
这是一项前瞻性、多中心、评估者盲、3 臂、平行组、随机、等待对照试验。总共将有 90 名患者按照 1:1:1 的比例随机分配到电针组、电针和温针组或等待对照组。治疗组的患者每周接受两次治疗，共 5 周。对照组患者在研究期间不接受治疗，并告知他们在 10 周的等待期后可以免费接受治疗。本研究的干预时间为 5 周，随后进行 5 周的治疗后评估。主要结局是从基线到治疗结束时耳鸣响度的视觉模拟量表评分变化。次要结局是使用耳鸣残疾评估量表测量的耳鸣不适评估。在基线和第 5 周和第 10 周评估结局参数。将观察并记录任何不良事件以进行安全性评估。将应用重复测量线性混合模型进行分析。
针刺和艾灸可能是耳鸣的潜在有效治疗选择。研究结果将为确定电针加或不加温针灸治疗耳鸣的疗效和安全性提供证据。
