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

Not Applicable

• Conditions: Gastroesophageal Reflux Disease
• Interventions: Device: Acupressure wristband; Device: Sham wristband

• Registration Number: NCT02255071
• Lead Sponsor: China Medical University Hospital

Brief Summary

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.

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 Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-09-30
• Study First Submitted QC: 2014-10-01
• Study First Posted: 2014-10-02
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-08
• Last Update Posted: 2015-06-10
• Primary Completion: 2015-08
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 64

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acupressure	Acupressure wristband	Patients will band a acupressure wristband over Neiguan (P6 point) and acupressure for seven days.
Sham-Acupressure	Sham wristband	Patients will band a sham wristband over wrist but no acupressure for seven days.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

China Medical University Hospital; 🇨🇳 Taichung, Taiwan