The Efficacy of Neiguan (P6 Point) Acupressure in Patients With Gastroesophageal Reflux Disease (GERD)

In recent years, there is an increasing trend in the number of patients with Gastroesophageal reflux disease (GERD). The poor response to medicine was noticed in patients with non-erosive reflux disease. According to the theory of traditional Chinese medicine, acupuncture Neiguan (P6 point) could improve the uncomfortable symptoms of the chest and upper abdomen. Therefore, the aim of this study is to investigate the clinical efficacy of Neiguan (P6 point) acupressure in patients with GERD.

Study Overview

• Status: Unknown
• Conditions: Gastroesophageal Reflux Disease
• Intervention / Treatment: Device: Acupressure wristband; Device: Sham wristband

Detailed Description

In recent years, there is an increasing trend in the number of patients with GERD. GERD mainly related to the reflux of stomach content induced by the dysfunction of lower esophageal sphincter. The common symptoms of GERD are heartburn, acid regurgitation, and chest pain. The methods to treat GERD are changes of lifestyle, pharmacotherapy, antireflux surgery and endoscopy. However, the poor response to medicine was still noticed in patients with non-erosive reflux disease. And long-term use of medicine will result in many side effects including infectious, abdominal pain, diarrhea and osteoporosis. According to the theory of traditional Chinese medicine, acupuncture Neiguan (P6 point) could improve the uncomfortable symptoms of the chest and upper abdomen. Therefore, the aim of this study is to investigate the clinical efficacy of Neiguan (P6 point) acupressure in patients with GERD. 64 patients with GERD were randomly divided into two groups：the acupressure and control. In the acupressure group, in addition to receiving standard treatment, patients will band a hand ring over Neiguan (P6 point) and acupressure for seven days. In the control group, in addition to receiving standard treatment, patients will band a hand ring but no acupressure for seven days. Data was collected by self-recorded symptoms before and after the intervention, according to the Reflux disease questionnaire(RDQ) and the World Health Organization Quality of Life Questionnaire Taiwan condensed version. Data was analyzed by Student's t-tests, Paired Student's t-test, Chi-square, and Fisher exact tests for quantitative and qualitative variables. We anticipate the treatment of Neiguan (P6 point) acupressure will reduce the symptoms of gastroesophageal reflux and improve the quality of life.

• Study Type: Interventional
• Enrollment (Anticipated): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taichung, Taiwan, 404
    • China Medical University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Male or female
2. Age of 20-60 years
3. Suffered from heartburn with or without acid regurgitation

Exclusion Criteria:

1. Suffered from peptic ulcer, gallstones, cancer, and Barrett's esophagus
2. previously underwent the esophagus, stomach or duodenum surgery
3. Lactating women or pregnant women
4. patients with severe cardiovascular disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Acupressure; Patients will band a acupressure wristband over Neiguan (P6 point) and acupressure for seven days.	Device: Acupressure wristband; A acupressure wristband over Neiguan (P6 point) and acupressure for seven days.
Sham Comparator: Sham-Acupressure; Patients will band a sham wristband over wrist but no acupressure for seven days.	Device: Sham wristband; A wristband over wrist but no acupressure for seven days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reflux disease questionnaire(RDQ)	RDQ to assess the severity of GERD for each patient over the past 7 days before study and after banding a wristband for 7days.	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
World Health Organization Quality of Life Questionnaire Taiwan condensed version(WHOQOL-REF)	WHOQOL-REF(Taiwan version) to assess the Quality of Life for each patient before study and after banding a wristband for 7days.	7 days

Collaborators and Investigators

• Sponsor: China Medical University Hospital
• Investigators: Principal Investigator: Wei-Ti Hsu, MD, China Medical University Hospital

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Anticipated): August 1, 2015
• Study Completion (Anticipated): December 1, 2015

Study Registration Dates

• First Submitted: September 30, 2014
• First Submitted That Met QC Criteria: October 1, 2014
• First Posted (Estimate): October 2, 2014

Study Record Updates

• Last Update Posted (Estimate): June 10, 2015
• Last Update Submitted That Met QC Criteria: June 8, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: GERD; Neiguan; Acupressure; P6
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Gastroenteritis; Intestinal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Esophagitis; Peptic Ulcer; Duodenal Diseases; Gastroesophageal Reflux; Esophagitis, Peptic
• Other Study ID Numbers: CMUH103-REC2-058

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No