Mechanisms of Electroacupuncture for Functional Dyspepsia Based on "Enterotypes" and Metabolomics
- Conditions
- Functional Dyspepsia
- Interventions
- Other: Sham electro-acupuncture groupOther: Electro-acupuncture
- Registration Number
- NCT05920395
- Lead Sponsor
- Wuhan Central Hospital
- Brief Summary
The goal of this clinical trial is to explore the clinical efficacy and possible mechanisms of electroacupuncture treatment for functional dyspepsia (FD). The main question it aims to answer are:
* Differences in the effects of electroacupuncture and sham electroacupuncture intervention on FD.
* Differences in gastrointestinal hormone levels and gut microbiota and their metabolites between healthy individuals and FD patients.
Participants receive electroacupuncture and sham electroacupuncture interventions respectively. Before and after the intervention, the clinical symptom score, gastrointestinal symptom evaluation scale, gastrointestinal symptom score questionnaire, and functional dyspepsia quality of life scale of the subjects will be observed. The levels of gastrointestinal hormones MTL, Ghrelin, 5-HT, CCK, PYY, and GLP-1 will be measured, as well as the changes in microbial diversity and SCFAs in their metabolites in feces, A follow-up visit will be conducted one month after the intervention for all participants.
- Detailed Description
Functional dyspepsia (FD) is a common and difficult clinical disease, and there is currently no effective treatment plan. Electroacupuncture is commonly used in clinical practice, but there is a lack of high-quality clinical evidence of its effectiveness. This study explores the clinical efficacy and possible mechanisms of electroacupuncture in the treatment of FD.
The study set up a healthy control group and an FD group. The FD group was divided into PDS type and EPS type according to their classification, and received electroacupuncture and sham electroacupuncture intervention, respectively. Before and after intervention, the clinical symptom score, gastrointestinal symptom evaluation scale, gastrointestinal symptom score questionnaire, and functional dyspepsia quality of life scale of the participants were observed. The levels of gastrointestinal hormones MTL, Ghrelin, 5-HT, CCK, PYY, GLP-1 were measured, and changes in fecal microbiota diversity and SCFAs in their metabolites were also detected. A follow-up visit will be conducted one month after the intervention for all participants.
Experiment 1: Observing the differences in various indicators between healthy individuals and FD patients Grouping: ① Healthy control group: 26 healthy volunteers, without any intervention, were tested for gastrointestinal hormone levels, gut microbiota, and their metabolites.② FD group: A total of 104 patients were included, and the levels of gastrointestinal hormones, gut microbiota, and their metabolites were detected after inclusion. The differences in gut type between the two groups of patients were analyzed.
Experiment 2: Observing the Effect of Electroacupuncture on FD Patients Grouping: The 104 FD patients included as required included 52 PDS type and 52 EPS type. Both types of patients were randomly assigned to the electroacupuncture group and the sham electroacupuncture group, with 26 patients in each group. It is divided into PDS electroacupuncture group (Group A), PDS sham electroacupuncture group (Group B), EPS electroacupuncture group (Group C), and EPS sham electroacupuncture group (Group D).
① Electroacupuncture group: including Group A and Group C, with 26 cases each, all receiving electroacupuncture treatment. The patient lies on his back on the treatment bed. After routine disinfection, a 0.30X50mm or 0.30X40mm disposable sterile acupuncture and moxibustion needle is directly punctured into the acupoint. After getting qi, the needling sensation is maintained by the manipulation of leveling, reinforcing and reducing. Point selection: Zhongwan, Zusanli, Neiguan, and Tianshu, connected to the 6805-AII electroacupuncture treatment instrument; Connect one set of electrodes to Zhongwan and Tianshu acupoints, with the positive electrode connected to Zhongwan acupoint and the negative electrode connected to Tianshu acupoint on one side; Using dense wave pulse stimulation with a frequency of 2Hz/100Hz, with a stimulation intensity that the patient can tolerate, 30 minutes each time, treated once every other day for a total of 4 weeks.
② False electroacupuncture: including group B and group D, with 26 cases each, with shallow acupuncture. After disconnecting the end of the electrode and binding it with black tape, the false electrode was connected without being electrified, and the rest were the same as the electroacupuncture group.
The positioning of acupoints shall refer to the positioning standards in the new century national planning textbook for higher Chinese medicine colleges and universities, "Meridian and Acupoint Science," edited by Shen Xueyong. A follow-up visit will be conducted one month after the intervention for all subjects.
During the intervention, all subjects did not take drug treatment. If the corresponding symptoms of the subjects such as abdominal pain, abdominal burning, early satiety and so on were significantly aggravated, the subjects would be given symptomatic treatment of the emergency drug pantoprazole sodium enteric coated tablets when the investigator diagnosed that drug intervention was needed. Participants can also consider choosing to seek treatment at the gastroenterology outpatient department. If needed, they can assist in contacting a specialist to provide corresponding professional diagnosis and treatment advice. Subjects receiving emergency medication or other medications that affect gastrointestinal motility need to terminate the study. If they have completed 1/2 course of treatment, the corresponding outcome indicators should be included in the efficacy statistics.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 130
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PDS sham electroacupuncture group Sham electro-acupuncture group Each with 26 patients. Shallow acupuncture needles are used and then disconnected from the electrode. PDS electroacupuncture group Electro-acupuncture Each with 26 patients who were treated with electro-acupuncture. EPS sham electroacupuncture group Sham electro-acupuncture group Each with 26 patients. Shallow acupuncture needles are used and then disconnected from the electrode. EPS electroacupuncture group Electro-acupuncture Each with 26 patients who were treated with electro-acupuncture.
- Primary Outcome Measures
Name Time Method Overall efficacy evaluation up to 4 weeks Refer to the efficacy criteria in the "Draft of Integrated Traditional Chinese and Western Medicine Diagnosis and Treatment Plan for Functional Dyspepsia", and evaluate the efficacy based on four levels: clinical cure, marked improvement, improvement, and inefficacy. Calculate the efficacy index based on the total symptom score. Efficacy index = {(pre-treatment total symptom score - post-treatment total symptom score) ÷ pre-treatment total symptom score} × 100%.
Clinical Cure: Efficacy Index \> 85%; Marked Improvement: Efficacy Index 5%-85%; Improvement: Efficacy Index 26%-50%; Inefficacy: Efficacy Index \< 26%.Gastric electrogastrography (EGG) testing up to 4 weeks The Hefei Scientific Experimental Instrument Factory's GAP-24A high-resolution gastrointestinal electrogastrography analysis system is used for testing. In the fasted state, the subject lies in a supine position, and electrodes are placed on the upper abdomen at the first lead of the gastric antrum (2-4 cm to the right of the midpoint between the xiphoid process and umbilicus) and the second lead of the gastric body (3-5 cm to the left of the midpoint between the xiphoid process and umbilicus, 1 cm upward). Conductive gel is applied locally to the skin, and a baseline EGG recording is made before conducting gastric EGG evaluation. After recording for 30 minutes, subjects are given a standard meal (50% carbohydrates, 25% protein, 25% fat, total energy intake of 570kcal, and 150mL water), which they eat within 15 minutes, followed by another EGG recording 5 minutes after eating. Recording continues for 30 minutes, with a sampling frequency of 4Hz.
- Secondary Outcome Measures
Name Time Method Functional Dyspepsia Quality of Life questionnaire (FDQOL). up to 8 weeks Evaluate each subject using the FDQOL scale
Gastrointestinal Symptom Score Questionnaire (GIS) up to 8 weeks Evaluate each subject using the GIS scale
Gastrointestinal hormone level testing up to 4 weeks 5mL of venous blood is drawn from the subject in a fasted state. After centrifugation at 3000 rpm for 10 minutes at 4℃, the plasma is separated and stored in a -80℃freezer. ELISA method is used to test the levels of MTL, Ghrelin, 5-HT, CCK, PYY, and GLP-1.
Nepean Dyspepsia Index (NDI) up to 8 weeks Evaluate each subject using the NDI scale
Intestinal microbiota metabolite testing up to 4 weeks Non-targeted metabolomics detection method is used to measure the content of SCFAs before and after intervention in healthy volunteers and each group using chromatography-mass spectrometry technology.
Gastrointestinal Symptom Rating Scale (GSRS) up to 8 weeks Evaluate each subject using the GSRS scale
Intestinal microbiota diversity testing up to 4 weeks Approximately 5g of feces are collected using a sterile fecal collection tube from each subject anytime within three days before and after the start of intervention. The central portion of the feces is collected to avoid contamination with urine or other substances. Diarrhea or loose stools are excluded. The feces samples are stored in a -80℃ freezer for measurement. The QIAamp Fast DNA Stool kit is used for fecal DNA extraction, and 16S rDNA sequencing technology is used to analyze the composition and diversity of the intestinal microbial communities.