Acupuncture as a treatment for functional dyspepsia: design and methods of a randomized controlled trial.
BACKGROUND
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.


METHODS
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.


CONCLUSIONS
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.


BACKGROUND
Clinical Trials.gov Identifier: NCT00599677.
Zheng
Hui
H
Chengdu University of Traditional Chinese Medicine, Sichuan, PR China. zhhui126@yahoo.com.cn
Tian
Xiao-ping
XP
Li
Ying
Y
Liang
Fan-rong
FR
Yu
Shu-guang
SG
Liu
Xu-guang
XG
Tang
Yong
Y
Yang
Xu-guang
XG
Yan
Jie
J
Sun
Guo-jie
GJ
Chang
Xiao-rong
XR
Zhang
Hong-xing
HX
Ma
Ting-ting
TT
Yu
Shu-yuan
SY
D015670:Acupuncture Therapy; D004415:Dyspepsia / Q000628:therapy*; D006801:Humans; D012107:Research Design
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