Journal Article

Efficacy of compatible acupoints and single acupoint versus sham acupuncture for functional dyspepsia: study protocol for a randomized controlled trial

Huang, Xin, Sun, Ping-Hui, Wang, Fu-Chun, Han, Xi-Ying, Wang, Ying, Ha, Li-Juan, Zhang, Jing-Zhou, Hu, Jing-Lin, Mi, Jia, Guo, Le, Li, Tie

2020

Overview

Background Acupoint selection is a key factor in the treatment of diseases and has not been well studied. The aim of this trial is to explore the differences in efficacy between compatible acupoints and a single acupoint for patients with functional dyspepsia (FD). Methods This randomized controlled trial will be conducted in the First Affiliated Hospital of Changchun University of Chinese Medicine in China. Two hundred and sixteen FD patients will be randomly assigned to the compatible acupoints group, single acupoint group, or sham acupuncture group. This trial will include a 1-week baseline period, a 4-week treatment period, and a 4-week follow-up period. During the 4-week treatment period, patients will receive 20 sessions of acupuncture (weekly cycles of one session per day for 5 consecutive days followed by a 2-day break). The primary outcome will be a change in the Nepean Dyspepsia Life Quality Index from baseline to after the 4-week treatment period. Secondary outcome measures will include the dyspeptic symptom sum score, Overall Treatment Effect questionnaire, and 36-item Short Form survey. Adverse events also will be recorded. Ultraweak photon emission and metabolomics tests will be performed at baseline and at the end of treatment to explore the mechanisms of the differences between compatible acupoints and a single acupoint. Discussion The results of this trial will allow us to compare the difference in efficacy between compatible acupoints and a single acupoint. The findings from this trial will be published in peer-reviewed journals. Trial registration Acupuncture-Moxibustion Clinical Trial Registry, AMCTR-IPC-18000176 , registered on 4 March 2019; Chinese Clinical Trial Registry, ChiCTR1900023983 , registered on 23 June 2019.

• Publisher: BioMed Central,BioMed Central Ltd,Springer Nature B.V,BMC
• Subject: Acupuncture / Acupuncture Points - classification / Acupuncture Therapy - adverse effects / Acupuncture Therapy - methods / Adolescent / Adult / Antacids / Antidepressants / Asian medicine / Biomedicine / Case-Control Studies / China - epidemiology / Clinical trials / Compatible acupoints / Disease / Diseases / Drug therapy / Drugs / Dyspepsia / Dyspepsia - physiopathology / Dyspepsia - psychology / Dyspepsia - therapy / Electroacupuncture / Female / Functional dyspepsia / Health Sciences / Hospitals / Humans / Informed consent / Male / Medical research / Medicine / Medicine & Public Health / Metabolomics - methods / Middle Aged / Patients / Photons / Quality of Life / Randomized controlled trial / Randomized Controlled Trials as Topic / Research Design / Single acupoint / Statistics for Life Sciences / Study Protocol / Surveys and Questionnaires / Therapeutics / Treatment Outcome / Young Adult