Effect of Transcutaneous Electroacupuncture on Functional Abdominal Bloating/Distension

Study Overview
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Brief Summary
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Functional abdominal bloating/distension (FAB/D) is a common functional bowel disorder that lacks effective treatment options. Transcutaneous electroacupuncture (TEA) as a new therapeutic method has great effect on functional gastrointestinal diseases such as functional dyspepsia and functional constipation. Research on TEA for FAB/D has not yet been explored.

Detailed Description
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Functional abdominal bloating/distension (FAB/D) is a common functional bowel disorder that lacks effective treatment options. Rome IV was introduced in 2016. Studies have shown that bloating may affect about 30% general population and 96% of patients with functional gastrointestinal disorders (FGID).Transcutaneous electroacupuncture (TEA) as a new therapeutic method has great effect on functional gastrointestinal diseases such as functional dyspepsia and functional constipation. Research on TEA for FAB/D has not yet been explored. Thirty patients who fulfilled the Rome IV diagnostic criteria of FAB/D in the department of the second affiliated hospital of Xi'an jiaotong University.Inclusion criteria included: Symptoms of recurrent abdominal fullness, pressure, or a sensation of trapped gas (bloating), and/or measurable (objective) increase in abdominal girth (distention) more than 6 month；the main symptoms appeared in the past 3 months；Not taking related drugs; aged 18-65 years old；From January 2020 to December 2021; Sign informed consent. All patients were randomly assigned to 3 groups and received TEA at Zusanli (ST36) and Neiguan (PC6) with 3 diffrent parameter for 4weeks. The symptom severity score, abdominal girth, electrogastrogram (ECG) and orocecal transit time (OCTT) ,heart rate variability (HRV) ,rectal sensitivity and intestinal flora were recorded at baseline and after 2-week treatment, respectively. The symptom severity score was repeated at baseline and after 4-week treatment. Through the comparison of the index before and after TEA treatment to identify optimal stimulation parameters and explore its possible mechanism. The study was proved by the medical ethics committee of the Second Affiliated Hospital of Xi'an jiaotong University.

Official Title
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Effect of Transcutaneous Electroacupuncture on Patients With Functional Abdominal Bloating/Distension

Conditions
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Functional Abdominal Bloating/Distension

Intervention / Treatment
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* Device: Transcutaneous Electroacupuncture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of Functional bloating/distension with Rome IV; Aged 18-65 years old； Exclusion Criteria: Have taken drugs that may affect gastrointestinal motility in the past week; Have taken antibiotics and probiotics in the past month; The history of gastrointestinal surgery; Helicobacter pylori is not cleared； Pregnant and breastfeeding women; Skin allergies.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: One parameter TEA group for 4 weeks<br>Choose two acupoints,give 25Hz electrical stimulation for 4 weeks. | Device: Transcutaneous Electroacupuncture<br>* give diffrent parameter TEA treatment for 4 weeks.<br>|
| Experimental: Another parameter TEA group for 4 weeks<br>Choose two acupoints,give 100 Hz electrical stimulation for 4weeks. | Device: Transcutaneous Electroacupuncture<br>* give diffrent parameter TEA treatment for 4 weeks.<br>|
| Experimental: Sham-TEA group for 2 weeks, and the random TEA for the next 2 weeks.<br>Choose two non-acupoints，give 25Hz and 100Hz electroacupuncture stimulation respectively for the first 2 weeks. Then give supplement TEA treatment as described above for the next 2 weeks. | Device: Transcutaneous Electroacupuncture<br>* give diffrent parameter TEA treatment for 4 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom improvement rate | the symptom severity score with VAS and abdominal girth measurements | after 1 month TEA treatment | 
| The percentage of the normal gastric slow waves in electrogastrograph | The percentage of the normal gastric slow waves in fasting 、fed states and the post-preprandial EGG power ratio | after 1 month TEA treatment | 
| Orocecal ransit time | the lactulose hydrogen breath test was used to evaluate the intestinal transit time and observe the presence or absence of excessive small intestinal bacteria | after 1-month TEA treatment | 
| Heart rate variability（HRV） | Assessment of autonomic function with heart rate variability | after 1-month TEA treatment | 
| Flora structure | an Illumina MiSeq Platform was used to sequence 16S ribosomal RNA (rRNA) gene of the total bacteria in fecal samples. | after 1-month TEA treatment | 
| Rectal sensitivity | Rectal threshold for gas and defecation | after 1-month TEA treatment | 
| Plasma gastrointestinal peptide level | CCK、SP、NPY、CGRP、Motilin | after 1-month TEA treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Functional Bloating/Distension, Transcutaneous electrical acupoint stimulation