Electroacupuncture to treat gastroesophageal reflux disease: study protocol for a randomized controlled trialReportar como inadecuado




Electroacupuncture to treat gastroesophageal reflux disease: study protocol for a randomized controlled trial - Descarga este documento en PDF. Documentación en PDF para descargar gratis. Disponible también para leer online.

Trials

, 17:246

First Online: 17 May 2016Received: 23 November 2015Accepted: 28 April 2016DOI: 10.1186-s13063-016-1371-8

Cite this article as: Han, G., Leem, J., Lee, H. et al. Trials 2016 17: 246. doi:10.1186-s13063-016-1371-8

Abstract

BackgroundGastroesophageal 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-designThis 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.

DiscussionThe 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.

Trial registrationClinical Research Information Service Identifier, KCT0001653. Registered on 12 October 2015.

KeywordsGastroesophageal reflux disease Electroacupuncture Park device Proportion of responders Pattern identification AbbreviationsGERDgastroesophageal reflux disease

PPIproton pump inhibitor

EAelectroacupuncture

ESPesophageal sphincter pressure

TLESRstransient lower esophageal sphincter relaxations

RCTsrandomized controlled trials

KMDKorean Medicine Doctor

SOPstandard operating procedure

STRICTAStandards for Reporting Interventions in Clinical Trials of Acupuncture

ARadequate relief

PRproportion of responders

NDI-KNepean dyspepsia index —Korean version

EQ-5DEuropean Quality of life-5 Dimension

PSSperceived stress scale

ANCOVAanalysis of covariance

AEsadverse events

IRBInstitutional Review Board

FGIDsfunctional gastrointestinal disorders

Electronic supplementary materialThe online version of this article doi:10.1186-s13063-016-1371-8 contains supplementary material, which is available to authorized users.

Download fulltext PDF



Autor: Gajin Han - Jungtae Leem - Hojung Lee - Junhee Lee

Fuente: https://link.springer.com/







Documentos relacionados