Sun Ruirui, Hong Xiaojuan, Guo Jing, Yin Shuai, Feng Peiming, Lan Lei, Lei Du, Liu Xiaoyan, Suo Xueling, Yin Tao, Zhang Tingting, Huang Liuyang, Gao Feifei, Gong Qiyong, Liang Fanrong, Zeng Fang
Acupuncture and Tuina School/The 3rd Teaching Hospital, Chengdu University of Traditional Chinese Medicine, 37# Shierqiao Road, Chengdu, 610075, Sichuan, China.
First Affiliated Hospital of Henan University of Traditional Chinese Medicine, Zhengzhou, Henan Province, China.
Trials. 2018 Jul 13;19(1):373. doi: 10.1186/s13063-018-2742-0.
The mechanism of the long-lasting effect and the relationship between the long-lasting effect and the deqi sensation, which is the key of achieving the acupuncture effect, has not been well investigated. This trial focuses on investigating the possible central mechanism of the long-lasting effect influenced by the deqi sensation.
A randomized controlled functional brain imaging trial is currently being conducted in Sichuan, China. In total 105 functional dyspepsia (FD) patients will be allocated into three groups: an acupuncture with deqi group, an acupuncture without deqi group, and a wait-list group. This trial will include a 2-week baseline period, a 4-week treatment period, and a 4-week follow-up period. During the 4-week treatment, patients in two acupuncture groups will receive 20 sessions of acupuncture treatment with or without deqi. The Nepean Dyspepsia Index (NDI) and the short form Leeds Dyspepsia Questionnaire (SF-LDQ) will be used to evaluate the clinical efficacy of acupuncture treatment at baseline, the end of treatment, and the end of the follow-up. Functional magnetic resonance imaging (fMRI) scans will be performed to detect cerebral functional changes in 25 patients in each group at three time points mentioned above. The clinical data and fMRI data will be analyzed, respectively. Correlation analysis will be conducted to investigate the relationship between cerebral functional changes and symptom improvement.
The results of this trial will allow us to compare the changes of acupuncture therapeutic effect at three time points (the baseline vs. the end of treatment vs. the end of follow-up), and investigate the potential central mechanism of the long-lasting effect influenced by acupuncture with deqi. This trial aims to re-identify the long-lasting effect of acupuncture and investigate its central mechanism, and to further explore the central influence of deqi sensation on the long-lasting effect.
Chinese Clinical Trial Registry, IDF: ChiCTR-IOR-15006523 . Registered on 5 June 2015.
针刺持久效应的机制以及持久效应与得气感（实现针刺效应的关键）之间的关系尚未得到充分研究。本试验聚焦于探究得气感影响持久效应的可能中枢机制。
目前正在中国四川进行一项随机对照功能性脑成像试验。总共105名功能性消化不良（FD）患者将被分为三组：得气针刺组、未得气针刺组和等待列表组。本试验将包括一个为期2周的基线期、一个为期4周的治疗期和一个为期4周的随访期。在4周的治疗期间，两个针刺组的患者将接受20次有或无得气的针刺治疗。将使用内皮恩消化不良指数（NDI）和利兹消化不良简表问卷（SF-LDQ）在基线、治疗结束时和随访结束时评估针刺治疗的临床疗效。将在上述三个时间点对每组中的25名患者进行功能性磁共振成像（fMRI）扫描，以检测脑功能变化。将分别分析临床数据和fMRI数据。将进行相关性分析，以研究脑功能变化与症状改善之间的关系。
本试验的结果将使我们能够比较三个时间点（基线期与治疗结束时与随访结束时）针刺治疗效果的变化，并探究得气针刺影响持久效应的潜在中枢机制。本试验旨在重新确定针刺的持久效应并研究其中枢机制，并进一步探索得气感对持久效应的中枢影响。
中国临床试验注册中心，标识符：ChiCTR-IOR-15006523。于2015年6月5日注册。
