This study is a randomized, patient and assessor-blinded, and sham-controlled trial. Sixty Gastroesophageal Reflux Disease (GERD) participants who have GERD symptoms and experienced standard treatment formerly will be recruited from August 2015 at Kyung Hee University Korean Medicine hospital. Participants will be allocated into Electroacpuncture(EA) (n = 30) and sham EA group (n = 30) and allocation will be concealed from participants and blinding will also be performed. The EA group will be treated by penetrating acupuncture using Park device with electric stimulation on 18 fixed points and 2 optional points chosen by Pattern Identification for GERD. The sham EA group will be taken non-penetrating acupuncture using Park device without electrical stimulation on 18 non-specific points which are 2 cm apart from acupoint only. The treatment will be lasting for 6 weeks (with two weekly sessions) and the evaluation of outcome will be carried out at baseline, 3 weeks and 6 weeks. The primary outcome is the proportion of responders with adequate symptom relief and the secondary outcomes include Nepean dyspepsia index (NDI), Korean Gastrointestinal Symptom Rating Scale, European Quality of Life-5 Dimension, level of gastrin and motilin hormone, the inflammatory cytokines, Perceived Stress Scale, Qi-stagnation questionnaire, Patient Global Impression of Change, and Spleen Qi Deficiency Questionnaire.

Treatment

▶ Electroacupunture group(Treatment group)
(1) Using a Park sham device with real needle and electrical stimulation
(2) Acupoints (18-20 points)
- Comnom points: ST36, a point 0.5 cun below ST36, PC6, LI4, LR3, SP4, SP9, GB34 (bilateral), CV10, and CV13 (unilateral).
Among these points, the electrical stimulation will be put on ST36, a point 0.5 cun below ST36, PC6, LI4 (bilateral), CV10, and CV13 (unilateral) only.
- Optional points will be selected according to the participant’s pattern identification: 
1) ‘Liver qi invading the stomach’ type: SP11, LR2 (Rt. side); 2) ‘Spleen-stomach weakness’ type: CV12(one point), ST41 (Rt. side); 3) ‘Spleen-stomach dampness-heat’ type: LR13, SP3 (Rt. side); 4) ‘Stomach yin deficiency’ type: CV12 (one point), ST44 (Rt. side)
(3) Duration of treatment sessions: 20 minutes
(4) Frequency of treatment sessions: 2/6 Hz
(5) Number of treatment sessions: Twice weekly for 6 weeks, 20 minutes for each session.

▶Sham electroacupuncture group: non-penetrating, non-acupoint, sham electroacupuncture
(1) Using a Park sham device with sham needle without electrical stimulation
(2) Acupoints (18 points)
Participants in sham electroacupunture group group will be taken eighteen fixed acupoints. Each acupoint is 2 cm apart from the acupoints of electroacupunture group to the medial side. The acupoints according to individual pattern identification will not be included. At the electroacupunture points, the same accessories of the electroacupunture equipment will be applied without electric current, but there will be a “timer” sound and a blinking light.
(3) Duration of treatment sessions: 20 minutes
(4) Number of treatment sessions: Twice weekly for 6 weeks, 20 minutes for each session.

Arm Label

Target Number of Participant

Arm Type

Arm Description

▶ Electroacupunture group (Treatment group)
(1) Using a Park sham device with real needle with electrical stimulation
(2) Acupoints (18-20 points)
- Comnom points: ST36, a point 0.5 cun below ST36, PC6, LI4, LR3, SP4, SP9, GB34 (bilateral), CV10, and CV13 (unilateral).
Among these points, the electrical stimulation will be put on ST36, a point 0.5 cun below ST36, PC6, LI4 (bilateral), CV10, and CV13 (unilateral) only.
- Optional points will be selected according to the participant’s pattern identification: 
1) ‘Liver qi invading the stomach’ type: SP11, LR2 (Rt. side); 2) ‘Spleen-stomach weakness’ type: CV12(one point), ST41 (Rt. side); 3) ‘Spleen-stomach dampness-heat’ type: LR13, SP3 (Rt. side); 4) ‘Stomach yin deficiency’ type: CV12 (one point), ST44 (Rt. side)
(3) Duration of treatment sessions: 20 minutes
(4) Frequency of treatment sessions: 2/6 Hz
(5) Number of treatment sessions: Twice weekly for 6 weeks, 20 minutes for each session.

Arm Label

Target Number of Participant

Arm Type

Arm Description

▶Sham electroacupuncture group: non-penetrating, non-acupoint, sham electroacupuncture
(1) Using a Park sham device with sham needle without electrical stimulation
(2) Acupoints (18 points)
Participants in sham electroacupunture group will be taken eighteen fixed acupoints. Each acupoint is 2 cm apart from the acupoints of electroacupunture group to the medial side. The acupoints according to individual pattern identification will not be included. At the electroacupunture points, the same accessories of the electroacupunture equipment will be applied without electric current, but there will be a “timer” sound and a blinking light.
(3) Duration of treatment sessions: 20 minutes
(4) Number of treatment sessions: Twice weekly for 6 weeks, 20 minutes for each session.

Gender

Age

Description

(1) are aged between 19 and 75 years
(2) are diagnosed with GERD (including both erosive reflux disease and non-erosive reflux disease) within a year 
(3) have one or more of following symptoms for a month recently
: heartburn, regurgitation, dyspepsia, epigastric pain, belching, nausea, globus (feeling of a lump in the esophagus), dysphagia, cough, hoarseness 
(4) have symptoms stated above either with frequency for ≥4 days of mild symptom or ≥ 2 days of moderate to severe symptom during last 7 days (mild: symptoms were easily tolerated, the discomfort was only minimal and did not affect normal activities; moderate: symptoms were sufficient to affect normal activities; severe: symptoms markedly affected normal activities) [25]
(5) have symptoms stated above despite the experience of standard treatment (pharmacological treatment or lifestyle modification) for GERD during 4 weeks within last one year.
(6) agree with participation in this study and sign a written informed consent voluntarily

(1) have structural disease, confirmed by esophagogastroduodenoscopy, related current symptoms (ex. gastrointestinal cancer, eosinophilic esophagitis, candida esophagitis, etc.).
(2) have alarm symptoms (severe dysphagia, hematemesis, weight loss, and hematochezia)
(3) have past history of gastrointestinal cancer within 5 years
(4) have received chemotherapy due to cancer within a month
(5) are diagnosed with ischemic heart disease (ex. angina pectoris, myocardial infarction)
(6) have artificial cardiac pacemaker in the chest
(7) experienced hypersensitivity reaction after acupuncture treatment or are not feasible person to take the acupuncture treatment 
(8) are taking part in the other clinical trial which might affect the result of this trial or taking Korean medical treatment related GERD; minimum wash-out period of two weeks is required before participating in the trial
(9) Individuals who have difficulties in attending the trial (e.g serious mental illness, dementia, drug addiction, severe disorder in vision or hearing, illiteracy, and time constraint etc.)
(10) are pregnant or breastfeeding

proportion of responders (PR) 

before and after treatment (at baseline and 6 weeks)

Nepean Dyspepsia Index - Korean version (NDI-K)

before and after treatment (at baseline and 6 weeks)

gastrointestinal hormone(Gastrin, Motilin)

before and after treatment (at baseline and 6 weeks)

Inflammatory mediator cytokine (IL-1, IL-6, IL-8, IL-4, and IL-10 )

before and after treatment (at baseline and 6 weeks)

EuroQol-5 Dimension (EQ-5D)

before and after treatment (at baseline and 6 weeks)

Korean Gastrointestinal Symptom rating scale (KGSRS) 

before and after treatment (at baseline and 6 weeks)

11 point Numerical Rating Scale (NRS)

before and after treatment (at baseline and 6 weeks)

Perceived Stress Scale (PSS)

before and after treatment (at baseline and 6 weeks)

Blinding Index & Credibility assessment 

after treatment (at 6 weeks)

Pattern Identification for Gastroesophageal Reflux Disease (PIGERD)

before and after treatment (at baseline and 6 weeks)

The Acupuncture Beliefs Scale

at baseline

Patient Global Impression of Change (PGIC)

at 3 and 6 weeks

Qi-stagnation questionnaire

before and after treatment (at baseline and 6 weeks)

Spleen Qi Deficiency Questionnaire

before and after treatment (at baseline and 6 weeks)

Evaluation of rescue medicine

after treatment (at 6 weeks)

adverse events

at every visit