title: Electroacupuncture to treat gastroesophageal reflux disease: study protocol for a randomized controlled trial.
abstract: BACKGROUND
  Gastroesophageal reflux disease lowers the quality of life and increases medical costs. Electroacupuncture has been used to ease symptoms and improve gastrointestinal motility in patients with gastroesophageal reflux disease. The main purposes of this study are to evaluate the efficacy and safety of this procedure.
  
  
  METHODS
  This is a protocol for a randomized, patient-blinded, assessor-blinded, sham-controlled trial. Sixty participants with symptoms of gastroesophageal reflux disease, who have previously undergone standard treatment, will be recruited from August 2015 at Kyung Hee University Korean Medicine Hospital. The participants will be allocated to either the electroacupuncture (n = 30) or the sham electroacupuncture group (n = 30); the allocation will be concealed from both the participants and the assessors. The EA group will undergo penetrating acupuncture at 18 fixed points and two optional points chosen using the pattern identification for gastroesophageal reflux disease. Electrical stimulation will be applied at some of the acupoints. The sham electroacupuncture group will undergo nonpenetrating acupuncture without electrical stimulation at 18 nonspecific points, each of which will be only 2 cm away from the true acupoints used in the electroacupuncture group. In both groups, the procedure will be performed using the Park device. The treatment will last for 6 weeks (with two sessions each week), and the outcome will be evaluated at baseline, 3 weeks, and 6 weeks. The primary outcome will be the proportion of responders with adequate symptom relief, whereas the secondary outcomes will comprise the results of the Nepean dyspepsia index; the Korean gastrointestinal symptom rating scale; the EQ-5D™; levels of gastrin, motilin, and inflammatory cytokines; the perceived stress scale; the qi-stagnation questionnaire; the patient global impression of change; and the spleen qi deficiency questionnaire.
  
  
  CONCLUSIONS
  The results of this trial will provide information about the efficacy and safety of electroacupuncture in the treatment of gastroesophageal reflux disease symptoms, as well as evidence regarding the use of electroacupuncture to treat gastroesophageal reflux disease in real clinical practice.
  
  
  BACKGROUND
  Clinical Research Information Service Identifier, KCT0001653 . Registered on 12 October 2015.
authors.affiliation: Korean Medicine Clinical Trial Center, Kyung Hee University Korean Medicine Hospital, 23 Kyungheedae-ro, Dongdaemun-gu, Seoul, 02447, Republic of Korea.|Department of Gastroenterology, College of Korean Medicine, Kyung Hee University, 26 Kyungheedae-ro, Dongdaemun-gu, Seoul, 02447, Republic of Korea.
authors.forename: Gajin
authors.initials: G
authors.lastname: Han
authors.affiliation: Department of Clinical Korean Medicine, Graduate School, Kyung Hee University, 26 Kyungheedae-ro, Dongdaemun-gu, Seoul, 02447, Republic of Korea.
authors.forename: Jungtae
authors.initials: J
authors.lastname: Leem
authors.affiliation: Department of Clinical Korean Medicine, Graduate School, Kyung Hee University, 26 Kyungheedae-ro, Dongdaemun-gu, Seoul, 02447, Republic of Korea.
authors.forename: Hojung
authors.initials: H
authors.lastname: Lee
authors.affiliation: Korean Medicine Clinical Trial Center, Kyung Hee University Korean Medicine Hospital, 23 Kyungheedae-ro, Dongdaemun-gu, Seoul, 02447, Republic of Korea. ssljh@khu.ac.kr.|Department of Sasang Constitutional Medicine, College of Korean Medicine, Kyung Hee University, 26 Kyungheedae-ro, Dongdaemun-gu, Seoul, 02447, Republic of Korea. ssljh@khu.ac.kr.
authors.forename: Junhee
authors.initials: J
authors.lastname: Lee
mesh_terms: D015669:Acupuncture Points; D000328:Adult; D000368:Aged; D015415:Biomarkers / Q000097:blood; D002985:Clinical Protocols; D016207:Cytokines / Q000097:blood; D004311:Double-Blind Method; D015671:Electroacupuncture / Q000009:adverse effects; D005260:Female; D005755:Gastrins / Q000097:blood; D005764:Gastroesophageal Reflux / Q000097:blood / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D006801:Humans; D018836:Inflammation Mediators / Q000097:blood; D008297:Male; D008875:Middle Aged; D009037:Motilin / Q000097:blood; D017060:Patient Satisfaction; D019413:Qi; D020127:Recovery of Function; D056910:Republic of Korea; D012107:Research Design; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D015415:Biomarkers; D016207:Cytokines; D005755:Gastrins; D018836:Inflammation Mediators; D009037:Motilin
keywords: Electroacupuncture; Gastroesophageal reflux disease; Park device; Pattern identification; Proportion of responders