Mechanisms of Electroacupuncture for Functional Dyspepsia Based on "Enterotypes" and Metabolomics
Functional Dyspepsia
About this trial
This is an interventional treatment trial for Functional Dyspepsia focused on measuring Functional Dyspepsia, Electroacupuncture, Intestinal flora
Eligibility Criteria
FD diagnostic criteria: Functional dyspepsia diagnostic criteria: According to the Rome IV diagnostic criteria for functional dyspepsia (2016). Symptoms:①Early satiety; ②Postprandial fullness and bloating; ③Epigastric pain;④ Epigastric burning. One or more of these four symptoms must be met, and there must be no evidence of structural diseases (including gastroscopy, etc.) that can explain these symptoms. In addition, the detailed diagnostic criteria for postprandial distress syndrome (PDS) or epigastric pain syndrome (EPS) must also be met. The diagnosis of EPS meets the following criteria. Meeting at least one of the following criteria for at least one day per week. ① Postprandial fullness and bloating (of such a degree as to affect daily living); ② Early satiety (of such a degree as to result in inability to finish a normal meal). Routine examinations (including gastroscopy) did not reveal any systematic, organic, or metabolic diseases that could explain the above symptoms; Symptoms must have appeared for at least six months prior to diagnosis, and met the above criteria for the past three months. The diagnostic criteria for EPS include meeting at least one of the following criteria for at least one day per week: Epigastric pain (of such a degree as to affect daily living); Epigastric burning (of such a degree as to affect daily living); Routine examinations (including gastroscopy) did not reveal any systematic, organic, or metabolic diseases that could explain the above symptoms; Symptoms must have appeared for at least six months prior to diagnosis, and met the above criteria for the past three months. Inclusion criteria Meeting the Western medicine diagnostic criteria for FD; Aged 18-65 years (inclusive of 18 and 65 years old); Not having taken any gastrointestinal prokinetic drugs for at least 15 days before treatment, and not having participated in any other clinical studies; Voluntary signing of an informed consent form for this study. Note: Only patients who meet all four of the above criteria can be included in this study. Exclusion criteria Pregnant or lactating women; Patients with severe organic digestive system diseases indicated by endoscopic examination, such as severe dysplasia or mucosal erosion, or pathological indication of malignancy; Patients with endocrine, cardiovascular, cerebrovascular, hematopoietic system, or neurological diseases such as diabetes, severe coronary heart disease, hypoglycemia, or hemiplegia; Patients with mental illness,infectious diseases, progressive malignant tumors,or life- threatening diseases; Patients who are afraid of acupuncture, have allergies or are allergic to medical supplies. Note: Patients who meet any of the above criteria will be excluded. Removal criteria Cases that are mistakenly included due to concealment of illness information or failure to meet inclusion criteria should be excluded; Participants with poor compliance or those who withdraw from the study on their own during the treatment period, or those who use treatment methods prohibited by this protocol during the study phase; Participants who experience severe adverse events or complications and are unable to continue the treatment, and the trial is terminated; Participants who do not follow the prescribed treatment or whose data is incomplete, affecting efficacy and safety evaluation. Dropout criteria Participants who have been included but are unable to participate in the trial on time, or who do not follow the trial requirements, or who drop out during treatment. The handing of exclusion and dropout When a participant drops out, the researcher should contact them as much as possible through house visits, scheduled phone calls, letters, etc., to inquire about the reasons for dropout. record the date of the last treatment, and complete the evaluation items that can be completed. All cases of exclusion and dropout will be subjected to intention-to-treat analysis after the end of the trial. Research Termination Criteria If the condition worsens during the experiment or other serious illness occurs, it is determined that participation needs to be terminated or other treatments are necessary. If a serious adverse event occurs during the experiment that prevents further participation. The investigator should record the reason and time for withdrawing from the study. Those who have completed more than half of the treatment should be included in the efficacy statistics.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
No Intervention
Experimental
Sham Comparator
Experimental
Sham Comparator
Healthy control group
PDS electroacupuncture group
PDS sham electroacupuncture group
EPS electroacupuncture group
EPS sham electroacupuncture group
26 healthy volunteers without any intervention, detecting gastrointestinal hormone levels and intestinal microbiota and their metabolites.
Each with 26 patients who were treated with electro-acupuncture.
Each with 26 patients. Shallow acupuncture needles are used and then disconnected from the electrode.
Each with 26 patients who were treated with electro-acupuncture.
Each with 26 patients. Shallow acupuncture needles are used and then disconnected from the electrode.