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

NCT ID: NCT02255071

Last Updated: 2015-06-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2015-12-31

Brief Summary

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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

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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.

Conditions

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Gastroesophageal Reflux Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Acupressure

Patients will band a acupressure wristband over Neiguan (P6 point) and acupressure for seven days.

Group Type EXPERIMENTAL

Acupressure wristband

Intervention Type DEVICE

A acupressure wristband over Neiguan (P6 point) and acupressure for seven days.

Sham-Acupressure

Patients will band a sham wristband over wrist but no acupressure for seven days.

Group Type SHAM_COMPARATOR

Sham wristband

Intervention Type DEVICE

A wristband over wrist but no acupressure for seven days.

Interventions

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Acupressure wristband

A acupressure wristband over Neiguan (P6 point) and acupressure for seven days.

Intervention Type DEVICE

Sham wristband

A wristband over wrist but no acupressure for seven days.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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China Medical University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Wei-Ti Hsu, MD

Role: PRINCIPAL_INVESTIGATOR

China Medical University Hospital

Locations

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China Medical University Hospital

Taichung, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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CMUH103-REC2-058

Identifier Type: -

Identifier Source: org_study_id

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