Zheng Hui, Tian Xiao-ping, Li Ying, Liang Fan-rong, Yu Shu-guang, Liu Xu-guang, Tang Yong, Yang Xu-guang, Yan Jie, Sun Guo-jie, Chang Xiao-rong, Zhang Hong-xing, Ma Ting-ting, Yu Shu-yuan
Chengdu University of Traditional Chinese Medicine, Sichuan, PR China.
Trials. 2009 Aug 23;10:75. doi: 10.1186/1745-6215-10-75.
Acupuncture is widely used in China to treat functional dyspepsia (FD). However, its effectiveness in the treatment of FD, and whether FD-specific acupoints exist, are controversial. So this study aims to determine if acupuncture is an effective treatment for FD and if acupoint specificity exists according to traditional acupuncture meridians and acupoint theories.
This multicenter randomized controlled trial will include four acupoint treatment groups, one non-acupoint control group and one drug (positive control) group. The four acupoint treatment groups will focus on: (1) specific acupoints of the stomach meridian; (2) non-specific acupoints of the stomach meridian; (3) specific acupoints of alarm and transport points; and (4) acupoints of the gallbladder meridian. These four groups of acupoints are thought to differ in terms of clinical efficacy, according to traditional acupuncture meridians and acupoint theories. A total of 120 FD patients will be included in each group. Each patient will receive 20 sessions of acupuncture treatment over 4 weeks. The trial will be conducted in eight hospitals located in three centers of China. The primary outcomes in this trial will include differences in Nepean Dyspepsia Index scores and differences in the Symptom Index of Dyspepsia before randomization, 2 weeks and 4 weeks after randomization, and 1 month and 3 months after completing treatment.
The important features of this trial include the randomization procedures (controlled by a central randomization system), a standardized protocol of acupuncture manipulation, and the fact that this is the first multicenter randomized trial of FD and acupuncture to be performed in China. The results of this trial will determine whether acupuncture is an effective treatment for FD and whether using different acupoints or different meridians leads to differences in clinical efficacy.
Clinical Trials.gov Identifier: NCT00599677.
在中国，针灸被广泛用于治疗功能性消化不良（FD）。然而，其治疗FD的有效性以及是否存在针对FD的特定穴位存在争议。因此，本研究旨在确定针灸是否为治疗FD的有效方法，以及根据传统针灸经络和穴位理论是否存在穴位特异性。
本多中心随机对照试验将包括四个穴位治疗组、一个非穴位对照组和一个药物（阳性对照）组。四个穴位治疗组将分别针对：（1）胃经特定穴位；（2）胃经非特定穴位；（3）募穴和输穴特定穴位；（4）胆经穴位。根据传统针灸经络和穴位理论，这四组穴位在临床疗效方面被认为存在差异。每组将纳入120例FD患者。每位患者将在4周内接受20次针灸治疗。该试验将在中国三个中心的八家医院进行。本试验的主要结局将包括尼平消化不良指数评分的差异，以及随机分组前、随机分组后2周和4周、完成治疗后1个月和3个月的消化不良症状指数差异。
本试验的重要特点包括随机化程序（由中央随机系统控制）、标准化的针灸操作方案，以及这是中国首次进行的关于FD与针灸的多中心随机试验。本试验的结果将确定针灸是否为治疗FD的有效方法，以及使用不同穴位或不同经络是否会导致临床疗效的差异。
ClinicalTrials.gov标识符：NCT00599677。
