Overview

This trial is active, not recruiting.

Condition gastroesophageal reflux disease
Treatments acupressure wristband, sham wristband
Sponsor China Medical University Hospital
Start date June 2014
End date August 2015
Trial size 64 participants
Trial identifier NCT02255071, CMUH103-REC2-058

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose supportive care
Arm
(Experimental)
Patients will band a acupressure wristband over Neiguan (P6 point) and acupressure for seven days.
acupressure wristband
A acupressure wristband over Neiguan (P6 point) and acupressure for seven days.
(Sham Comparator)
Patients will band a sham wristband over wrist but no acupressure for seven days.
sham wristband
A wristband over wrist but no acupressure for seven days.

Primary Outcomes

Measure
Reflux disease questionnaire(RDQ)
time frame: 7 days

Secondary Outcomes

Measure
World Health Organization Quality of Life Questionnaire Taiwan condensed version(WHOQOL-REF)
time frame: 7 days

Eligibility Criteria

Male or female participants from 20 years up to 60 years old.

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

Additional Information

Official title The Efficacy of Neiguan (P6 Point) Acupressure in Patients With Gastroesophageal Reflux Disease (GERD)
Principal investigator Wei-Ti Hsu, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2015.
Information provided to ClinicalTrials.gov by China Medical University Hospital.