Functional Abdominal Bloating/Distension
Conditions
Keywords
Functional Bloating/Distension, Transcutaneous electrical acupoint stimulation
Brief summary
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
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.
Interventions
give diffrent parameter TEA treatment for 4 weeks.
Sponsors
Second Affiliated Hospital of Xi'an Jiaotong University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Clinical diagnosis of Functional bloating/distension with Rome IV; 2. Aged 18-65 years old；
Exclusion criteria
1. Have taken drugs that may affect gastrointestinal motility in the past week; 2. Have taken antibiotics and probiotics in the past month; 3. The history of gastrointestinal surgery; 4. Helicobacter pylori is not cleared； 5. Pregnant and breastfeeding women; 6. Skin allergies.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Orocecal ransit time | after 1-month TEA treatment | the lactulose hydrogen breath test was used to evaluate the intestinal transit time and observe the presence or absence of excessive small intestinal bacteria |
| Heart rate variability（HRV） | after 1-month TEA treatment | Assessment of autonomic function with heart rate variability |
| Flora structure | after 1-month TEA treatment | an Illumina MiSeq Platform was used to sequence 16S ribosomal RNA (rRNA) gene of the total bacteria in fecal samples. |
| Rectal sensitivity | after 1-month TEA treatment | Rectal threshold for gas and defecation |
| Plasma gastrointestinal peptide level | after 1-month TEA treatment | CCK、SP、NPY、CGRP、Motilin |
| Symptom improvement rate | after 1 month TEA treatment | the symptom severity score with VAS and abdominal girth measurements |
| The percentage of the normal gastric slow waves in electrogastrograph | after 1 month TEA treatment | The percentage of the normal gastric slow waves in fasting 、fed states and the post-preprandial EGG power ratio |
Countries
China
Contacts
Primary ContactFei Dai
Backup ContactYindi Chen
Outcome results
None listed