针刺治疗耳鸣时得气的有效性：一项随机对照试验的研究方案
Effectiveness of De Qi during acupuncture for the treatment of tinnitus: study protocol for a randomized controlled trial.
作者信息
Xie Hui, Li Xinrong, Lai Jiaqin, Zhou Yanan, Wang Caiying, Liang Jiao
机构信息
Department of Otorhinolaryngology, Head and Neck Surgery of the Teaching Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan Province 610072, PR China.
出版信息
Trials. 2014 Oct 15;15:397. doi: 10.1186/1745-6215-15-397.
BACKGROUND
Acupuncture has been used in China to treat tinnitus for a long time. There is debate as to whether or not De Qi is a key factor in achieving the efficacy of acupuncture. However, there is no sufficient evidence obtained from randomized controlled trials to confirm the role of De Qi in the treatment of acupuncture for tinnitus. This study aims to identify the effect of De Qi for patients who receive acupuncture to alleviate tinnitus by a prospective, double-blind, randomized, sham-controlled trial.
METHODS AND DESIGN
This study compares two acupuncture groups (with or without manipulation) in 292 patients with a history of subjective tinnitus. The trial will be conducted in the Teaching Hospital of Chengdu University of Traditional Chinese Medicine. In the study, the patients will be randomly assigned into two groups according to a computer-generated randomization list and assessed prior to treatment. Then, they will receive 5 daily sessions of 30 minutes each time for 4 consecutive weeks and undergo a 12-week follow-up phase. The administration of acupuncture follows the guidelines for clinical research on acupuncture (WHO Regional Publication, Western Pacific Series Number 15, 1995), and is performed double-blind by physicians well-trained in acupuncture. The measures of outcome include the subjective symptoms scores and quantitative sensations of De Qi evaluated by Visual Analog Scales (VAS) and the Chinese version of the 'modified' Massachusetts General Hospital Acupuncture Sensation Scale (C-MMASS). Furthermore, adverse events are recorded and analyzed. If any subjects are withdrawn from the trial, intention-to-treat analysis (ITT) and per-protocol (PP) analysis will be performed.
DISCUSSION
The key features of this trial include the randomization procedures, large sample and the standardized protocol to evaluate De Qi qualitatively and quantitatively in the treatment of acupuncture for tinnitus. The trial will be the first study with a high evidence level in China to assess the efficacy of De Qi in the treatment of tinnitus in a randomized, double-blind, sham-controlled manner.
TRIAL REGISTRATION
Chinese Clinical Trial Registry: ChiCTR-TRC-14004720 (6 May 2014).
背景
在中国，针灸治疗耳鸣已有很长时间。关于得气是否是实现针灸疗效的关键因素存在争议。然而，尚无足够的随机对照试验证据来证实得气在针灸治疗耳鸣中的作用。本研究旨在通过一项前瞻性、双盲、随机、假针刺对照试验，确定得气对接受针灸治疗以缓解耳鸣患者的效果。
方法与设计
本研究比较了292例有主观性耳鸣病史患者的两个针灸组（有手法操作或无手法操作）。试验将在成都中医药大学附属医院进行。在研究中，患者将根据计算机生成的随机列表随机分为两组，并在治疗前进行评估。然后，他们将连续4周每天接受5次每次30分钟的治疗，并进行为期12周的随访阶段。针灸治疗遵循针灸临床研究指南（世界卫生组织西太平洋地区出版物，第15号，1995年），由训练有素的针灸医生进行双盲操作。结局指标包括通过视觉模拟量表（VAS）和中文版“改良”麻省总医院针刺感觉量表（C-MMASS）评估的主观症状评分和得气的量化感觉。此外，记录并分析不良事件。如果有任何受试者退出试验，将进行意向性分析（ITT）和符合方案分析（PP）。
讨论
本试验的关键特征包括随机化程序、大样本以及在针灸治疗耳鸣中对得气进行定性和定量评估的标准化方案。该试验将是中国首个以随机、双盲、假针刺对照方式评估得气治疗耳鸣疗效的具有高证据水平的研究。
试验注册
中国临床试验注册中心：ChiCTR-TRC-14004720（2014年5月6日）。
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