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[关于针灸临床试验中安慰针刺对照设置的思考]

[Thinking on controlled setting of plarebo acupuncture in clinical trial of acupuncture and moxibustion].

作者信息

Mao Wen-Chao, Liu Bao-Yan, He Li-Yun, Liu Zhi-Shun

机构信息

Institute of Basic Research of Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China; 2. China Academy of Chinese Medical.

出版信息

Zhongguo Zhen Jiu. 2013 Apr;33(4):367-71.

PMID:23819251
Abstract

Differences and relations between effects of acupuncture therapy and sham acupuncture are systematically analyzed in this article through the influential factors of acupuncture effect. And it is held that sham acupuncture effect is not exactly equal to placebo effect. The effects of both acupuncture and sham acupuncture are composed by specific effects and non-specific effects, and the differences of non-specific effects between acupunc ture and sham acupuncture can be minimized furthest with blinding and randomized method. Therefore, the difference of acupuncture and sham acupuncture treatment rests with the degree of differences of the specific effects. Only when both of the specific effect of acupuncture and the effect of acupuncture are minimized, can it be applied as the ideal placebo control. Consequently when placebo acupunture are setted up, factors such as the body condition, site of stimulation and stimulation parameters which can influence the specific effect of acupuncture should be taken into consideration to produce the relatively minimum specific effect.

摘要

本文通过针刺效应的影响因素,系统分析了针刺疗法与假针刺效应之间的差异及关系。并认为假针刺效应并不完全等同于安慰剂效应。针刺和假针刺的效应均由特异性效应和非特异性效应组成,采用盲法和随机化方法可最大程度地减少针刺与假针刺非特异性效应之间的差异。因此,针刺与假针刺治疗的差异在于特异性效应的差异程度。只有当针刺的特异性效应和针刺效应都最小化时,才能将其用作理想的安慰剂对照。因此,在设置安慰剂针刺时,应考虑身体状况、刺激部位和刺激参数等可能影响针刺特异性效应的因素,以产生相对最小的特异性效应。

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[Thinking on controlled setting of plarebo acupuncture in clinical trial of acupuncture and moxibustion].[关于针灸临床试验中安慰针刺对照设置的思考]
Zhongguo Zhen Jiu. 2013 Apr;33(4):367-71.
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Acupuncture, psyche and the placebo response.针刺、心理和安慰剂反应。
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Strategies to maintain the credibility of sham acupuncture used as a control treatment in clinical trials.在临床试验中维持用作对照治疗的假针灸可信度的策略。
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[Placebo effect of acupuncture: a critique and reflection on methodology of clinical research].[针灸的安慰剂效应:对临床研究方法的批判与反思]
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Pain Res Manag. 2021 Nov 19;2021:5329881. doi: 10.1155/2021/5329881. eCollection 2021.
2
Target dIsease-Guided placEbo-contRolled (TIGER) design: a novel method for clinical trials of acupuncture.疾病靶点导向的安慰剂对照(TIGER)设计:一种针灸临床试验的新方法。
Trials. 2013 Oct 29;14:359. doi: 10.1186/1745-6215-14-359.