[ASPIRE guidelines and their enlightenment on application of sham acupuncture in clinical researches].

Xiao-Yu Liu, Cheng-Yi Sun, Chong-Yang Sun, Chi-Yun Sun, Ze-Yin Xin, Yu-Zhi Hu, Yue Wang, Yi Guo, Bao-Yan Liu, Cun-Zhi Liu, Shi-Yan Yan
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Abstract

Reasonable and standard application of sham acupuncture control is the key to determine the quality of acupuncture clinical trials, and is also a difficult problem faced by acupuncture clinical research. The UK National Institute for Health Research and the Medical Research Council jointly published the Applying Surgical Placebo in Randomised Evaluation (ASPIRE) guidelines on the application of placebo surgical operation in randomized evaluation, which includes 4 parts: rationale and ethics, design, conduct, and interpretation and translation, providing comprehensive guidance for the application of placebo controls in surgical trials. As an operational intervention, acupuncture is similar to surgery, so, ASPIRE guidelines can also provide certain guidance for the application of sham acupuncture. In the present paper, we introduce the ASPIRE guidelines, and put forward its enlightenment and reference to the application of sham acupuncture control in combination with retrospecting the current situations of sham acupuncture research. We hold that future studies should strengthen the consideration of the rationality and ethics of sham acupuncture, standardize the design of sham acupuncture control, and convey the information related to sham acupuncture to patients with appropriate descriptions.

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[ASPIRE指南及其对假针灸临床研究应用的启示]。
合理规范地应用假针对照是决定针灸临床试验质量的关键,也是针灸临床研究面临的难题。英国国家健康研究所和医学研究委员会联合发布了《在随机评价中应用手术安慰剂指南》(ASPIRE),该指南包括4个部分:基本原理和伦理、设计、实施、解释和翻译,为安慰剂对照在外科试验中的应用提供了全面的指导。针灸作为一种操作干预手段,类似于外科手术,因此,ASPIRE指南也可以为假针灸的应用提供一定的指导。本文介绍了ASPIRE指南,并结合对假针研究现状的回顾,提出了其对假针控制应用的启示和借鉴。我们认为,未来的研究应加强对假针灸的合理性和伦理性的考虑,规范假针灸控制的设计,并以适当的描述向患者传达假针灸的相关信息。
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