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针刺治疗慢性头晕的疗效与安全性:一项随机对照试验的研究方案

Efficacy and safety of acupuncture for chronic dizziness: study protocol for a randomized controlled trial.

作者信息

Xue Zhe, Liu Cun-Zhi, Shi Guang-Xia, Liu Yan, Li Zhao-Xin, Zhang Zhen-Hua, Wang Lin-Peng

机构信息

Acupuncture and Moxibustion Department, Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University, 23 Meishuguanhou Street, Dongcheng District, Beijing 100010, China.

出版信息

Trials. 2013 Dec 13;14:429. doi: 10.1186/1745-6215-14-429.

Abstract

BACKGROUND

Dizziness is one of the most challenging symptoms in medicine. No medication for dizziness in current use has well-established curative or prophylactic value or is suitable for long-term palliative use. Unconventional remedies, such as acupuncture, should be considered and scientifically evaluated. However, there has been relatively little evidence in randomized controlled clinical trials on acupuncture to treat chronic dizziness. The aim of our study is to evaluate the efficacy and safety of acupuncture in patients with dizziness.

METHODS/DESIGN: This trial is a randomized, single-blind, controlled study. A total of 80 participants will be randomly assigned to two treatment groups receiving acupuncture and sham acupuncture treatment, respectively, for 4 weeks. The primary outcome measures are the Dizziness Handicap Inventory (DHI) and the Vertigo Symptom Scale (VSS). Treatment will be conducted over a period of 4 weeks, at a frequency of two sessions per week. The assessment is at baseline (before treatment initiation), 4 weeks after the first acupuncture session, and 8 weeks after the first acupuncture session.

DISCUSSION

The results from this study will provide clinical evidence on the efficacy and safety of acupuncture in patients with chronic dizziness.

TRIAL REGISTRATION

International Standard Randomized Controlled Trial Number Register: ISRCTN52695239.

摘要

背景

头晕是医学上最具挑战性的症状之一。目前使用的治疗头晕的药物均未具有公认的确切疗效或预防价值,也不适合长期姑息治疗。应考虑并科学评估诸如针灸等非常规疗法。然而,在随机对照临床试验中,关于针灸治疗慢性头晕的证据相对较少。我们研究的目的是评估针灸治疗头晕患者的疗效和安全性。

方法/设计:本试验为随机、单盲、对照研究。总共80名参与者将被随机分配到两个治疗组,分别接受针灸和假针灸治疗,为期4周。主要结局指标是头晕残障量表(DHI)和眩晕症状量表(VSS)。治疗将持续4周,每周进行两次。评估时间为基线(治疗开始前)、首次针灸治疗后4周和首次针灸治疗后8周。

讨论

本研究结果将为针灸治疗慢性头晕患者的疗效和安全性提供临床证据。

试验注册

国际标准随机对照试验编号注册库:ISRCTN52695239。

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