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| Exploration on optimal design framework for acupuncture explanatory randomized controlled trial based on acupuncture elements |
| Hits 4 Download times 4 Received:August 25, 2024 |
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| DOI
10.11656/j.issn.1672-1519.2024.11.10 |
| Key Words
acupuncture clinical trial;key acupuncture element;interpretive randomized controlled trial;design framework |
| Author Name | Affiliation | E-mail | | NIU Jianfei | Dongzhimen Hospital of Beijing University of Chinese Medicine, Beijing 100700, China | | | WEN Xiaohua | Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China | | | WANG Guanqun | Dongzhimen Hospital of Beijing University of Chinese Medicine, Beijing 100700, China | | | XIE Xiaolong | Dongzhimen Hospital of Beijing University of Chinese Medicine, Beijing 100700, China | | | DU Shuo | Dongzhimen Hospital of Beijing University of Chinese Medicine, Beijing 100700, China | | | PENG Bihui | Dongzhimen Hospital of Beijing University of Chinese Medicine, Beijing 100700, China | | | ZHAO Jiping | Dongzhimen Hospital of Beijing University of Chinese Medicine, Beijing 100700, China | zjp7883@sina.com |
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| Abstract
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| The design of competent acupuncture interventions and placebo acupuncture controls is an urgent need for explanatory randomized controlled trials(ERCT) of investigating acupuncture. Accurate inclusion of acupuncture elements and screening of critical acupuncture elements from them are critical to meet this need in ERCT. To this end,this paper first outlines the names and contents of the four attributes and eleven types of acupuncture elements,discusses the definition of the needling element,and discusses the types of elements which can produce critical acupuncture elements. Afterwards,taking this as a reference,the paper discusses the bias of the current acupuncture ERCT in the inclusion of acupuncture elements and the screening of critical acupuncture elements. Finally,with the "differentiating the location of the disease" as the core,combined with the understanding of the "stimulus quantity","action quantity" and "treatment quantity" in the theory of quantity-effect relationship of acupuncture,a design framework of ERCT containing six segments is proposed,and the core contents of each segment are as following:differentiating the location of the disease,evaluation of quantity-effect relationship of acupuncture,determination of ultimate treatment quantity,determination of the weakest critical acupuncture element,elimination or modification,and pre-test validation,respectively. It is hoped that this paper will throw light on the optimization of ERCT design and the promotion of acupuncture therapy. |
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