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

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ClinicalTrials.gov Identifier: NCT02255071
Recruitment Status : Unknown
Verified June 2015 by China Medical University Hospital.
Recruitment status was:  Active, not recruiting
First Posted : October 2, 2014
Last Update Posted : June 10, 2015
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Gastroesophageal Reflux Disease Device: Acupressure wristband Device: Sham wristband Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: The Efficacy of Neiguan (P6 Point) Acupressure in Patients With Gastroesophageal Reflux Disease (GERD)
Study Start Date : June 2014
Estimated Primary Completion Date : August 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD

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.




Primary Outcome Measures :
  1. Reflux disease questionnaire(RDQ) [ Time Frame: 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 :
  1. World Health Organization Quality of Life Questionnaire Taiwan condensed version(WHOQOL-REF) [ Time Frame: 7 days ]
    WHOQOL-REF(Taiwan version) to assess the Quality of Life for each patient before study and after banding a wristband for 7days.



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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02255071


Locations
Taiwan
China Medical University Hospital
Taichung, Taiwan, 404
Sponsors and Collaborators
China Medical University Hospital
Investigators
Principal Investigator: Wei-Ti Hsu, MD China Medical University Hospital

Responsible Party: China Medical University Hospital
ClinicalTrials.gov Identifier: NCT02255071     History of Changes
Other Study ID Numbers: CMUH103-REC2-058
First Posted: October 2, 2014    Key Record Dates
Last Update Posted: June 10, 2015
Last Verified: June 2015

Keywords provided by China Medical University Hospital:
GERD
Neiguan
Acupressure
P6

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases