Electroacupuncture, Functional Dyspepsia
Conditions
Keywords
functional dyspepsia, electroacupuncture, Local Acupoints, Distal Acupoints
Brief summary
Functional dyspepsia (FD) is a common disorder that causes stomach discomfort, such as fullness or pain after eating, without any visible structural disease. Acupuncture is often used to manage these symptoms. This study aims to evaluate the safety and effectiveness of electroacupuncture-a form of acupuncture that uses gentle electrical stimulation-for treating functional dyspepsia. Specifically, the trial will compare the benefits of applying electroacupuncture to points on the abdomen (local points) versus points on the arms and legs (distal points), alongside a control group receiving a sham (inactive) treatment. The goal is to determine the most effective acupuncture strategy for improving patients' digestive symptoms and overall quality of life.
Detailed description
Functional dyspepsia (FD) significantly impairs patients' quality of life and is often accompanied by psychological distress. While traditional acupuncture is widely used in the treatment of FD, electroacupuncture has been suggested to enhance therapeutic effects by providing continuous, standardized electrical stimulation to specific acupoints. However, the comparative effectiveness of targeting local abdominal acupoints versus distal limb acupoints remains unclear. This multicenter randomized controlled trial is designed to investigate the physiological and clinical effects of electroacupuncture on FD. Following informed consent, participants are randomly assigned in a 1:1:1 ratio to one of three parallel arms: Local Electroacupuncture Group: Electrical stimulation applied to selected abdominal acupoints. Distal Electroacupuncture Group: Electrical stimulation applied to selected limb acupoints. Control Group: Acupuncture with a sham electroacupuncture device that delivers no electrical current. The intervention phase consists of treatments administered twice weekly for 3 weeks (totaling 6 sessions). All procedures are standardized and performed by licensed acupuncturists with a minimum of three years of clinical experience. Active groups utilize a standard electroacupuncture device to deliver the current, while the sham group is designed to maintain blinding without providing active electrical stimulation. Following the intervention phase, participants enter a 12-week follow-up period to assess the sustainability of the therapeutic effects. By comparing local and distal stimulation strategies, this research intends to elucidate the optimal clinical application of electroacupuncture and provide evidence-based guidance for the management of functional dyspepsia.
Interventions
OTHERElectroacupuncture (Local Acupoints)
Participants assigned to this intervention will receive electroacupuncture at local abdominal acupoints, including bilateral Shangwan (CV13), Zhongwan (CV12), Xiawan (CV10), Liangmen (ST21), and Tianshu (ST25). Sterile disposable acupuncture needles (0.30 × 40 mm) will be inserted vertically by licensed acupuncturists with at least three years of clinical experience to a depth of approximately 20-30 mm to elicit the Deqi sensation (such as soreness, numbness, distension, or heaviness). Two pairs of acupoints (Shangwan-Zhongwan and left Liangmen-right Liangmen) will be connected to an SDZ-V electroacupuncture device. Electrical stimulation will be applied at a frequency of 5 Hz, with current intensity adjusted to the participant's tolerance. Each treatment session will last 30 minutes and will be administered twice weekly for 3 weeks (6 sessions in total).
OTHERElectroacupuncture (Distal Acupoints)
Participants in this group will receive electroacupuncture at distal limb acupoints, including bilateral Zusanli (ST36), Shangjuxu (ST37), Xiajuxu (ST39), and Yinlingquan (SP9). Sterile disposable acupuncture needles (0.30 × 40 mm) will be inserted by trained acupuncturists to achieve the Deqi sensation. Electrical stimulation will be applied by connecting bilateral Zusanli (ST36) and Xiajuxu (ST39) to an SDZ-V electroacupuncture device. The stimulation frequency will be set at 5 Hz, and the current intensity will be adjusted according to the participant's tolerance. Each session will last 30 minutes, administered twice weekly for 3 weeks (6 sessions in total).
OTHERSham Electroacupuncture (Control)
Participants in the control group will receive acupuncture at the same acupoints as the electroacupuncture groups using identical needling procedures to achieve the Deqi sensation. However, the needles will be connected to a specially designed sham electroacupuncture device that appears identical to the active SDZ-V electroacupuncture device but does not deliver electrical stimulation. Each treatment session will last 30 minutes and will be administered twice weekly for 3 weeks (6 sessions in total).
Sponsors
The Third Affiliated hospital of Zhejiang Chinese Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Participants who meet the Rome IV diagnostic criteria for functional dyspepsia (FD). * Age 18 to 80 years, male or female. * Chinese patients with a normal upper gastrointestinal endoscopy within the past 1 year, or judged by a gastroenterologist with more than 3 years of clinical experience to have no structural disease that explains the symptoms. * Willing and able to provide written informed consent and comply with study procedures.
Exclusion criteria
* Functional dyspepsia symptoms caused by severe or malignant diseases (e.g., liver cirrhosis, heart failure, or gastrointestinal tumors). * Helicobacter pylori infection, defined as a positive urea breath test or positive Hp test on endoscopy. * History of gastrointestinal surgery (except minimally invasive procedures such as laparoscopy). * Presence of a permanent or temporary cardiac pacemaker or use of external/temporary pacing support. * Use of medications that may affect dyspepsia symptoms within 2 weeks prior to enrollment, including antisecretory drugs, antacids, prokinetic agents, digestive enzymes, nonsteroidal anti-inflammatory drugs, antidepressants, or traditional Chinese medicine for FD. * Conditions that may make participation difficult, such as severe mental or physical illness, dementia, or illiteracy. * Severe coagulation disorders. * Acupuncture treatment for gastrointestinal diseases within the past 1 month. * Participation in another clinical trial within the past 2 months. * Drug abuse or alcohol abuse. * Pregnant or breastfeeding women.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Treatment Effect (OTE) Response Rate at Week 3 | Week 3 | The overall treatment effect will be assessed using a 7-point Likert scale evaluating the change in gastrointestinal symptoms compared with baseline. Participants who report "improved" or "extremely improved" will be considered responders. The response rate will be calculated as the proportion of participants achieving improvement at the end of the 3-week treatment period. |
| Main Symptom Elimination Rate at Week 3 | Week 3 | The elimination rate of the main symptoms will be defined as the proportion of participants whose primary symptoms score is 0 (no symptoms) at week 3. In the postprandial distress syndrome (PDS) subtype, the main symptoms include postprandial fullness and/or early satiety. In the epigastric pain syndrome (EPS) subtype, the main symptoms include epigastric pain and/or burning. For participants with combined PDS and EPS, the main symptoms include both symptom categories. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Global Overall Symptom (GOS) Score | Baseline (Week 0), Week 3, Week 7, Week 11, and Week 15 | The Global Overall Symptom (GOS) scale will be used to assess the severity of eight dyspeptic symptoms, including epigastric pain, epigastric burning, regurgitation, postprandial fullness, nausea/vomiting, belching, early satiety, and heartburn. Each symptom is rated on a 7-point Likert scale ranging from 1 (no problem) to 7 (very severe problem). Changes in GOS scores will be evaluated over time to assess symptom improvement. |
| Nepean Dyspepsia Index (NDI) Score | Baseline (Week 0), Week 3, Week 7, Week 11, and Week 15 | Health-related quality of life in patients with functional dyspepsia will be evaluated using the Nepean Dyspepsia Index (NDI). The NDI quality-of-life total score ranges from a minimum of 0 to a maximum of 100, where higher scores indicate a better health-related quality of life (less impairment from dyspepsia). The scale measures the impact of dyspepsia on multiple aspects of daily life, including tension, interference with daily activities, eating/drinking, knowledge/control, and work/study. Changes in NDI scores will be assessed during treatment and follow-up. |
| Hospital Anxiety and Depression Scale (HADS) Score | Baseline (Week 0), Week 3, Week 7, Week 11, and Week 15 | The Hospital Anxiety and Depression Scale (HADS) will be used to assess levels of anxiety and depression in participants. The HADS consists of two subscales: Anxiety (HADS-A) and Depression (HADS-D). Each subscale score ranges from a minimum of 0 to a maximum of 21. If combined into a total score, the minimum is 0 and the maximum is 42. For both the subscales and the total score, higher scores indicate higher levels of anxiety and depression (a worse outcome). Changes in HADS scores will be evaluated to explore the psychological effects of the intervention. |
| Expectation of Electroacupuncture Treatment | Baseline (Week 0) | Before treatment, participants will be asked to evaluate their expectations regarding the effectiveness of electroacupuncture using a 5-point scale (strongly agree, agree, neutral, disagree, strongly disagree) in response to the statement that electroacupuncture will significantly improve their symptoms. |
| Blinding Assessment | Baseline (after Session 1) and Week 3 (after Session 6) | Participants will be asked to guess whether they received electroacupuncture or sham electroacupuncture after the first treatment session and after the sixth treatment session in order to assess the effectiveness of blinding. |
| Treatment Adherence | Week 0, Week 3, and Week 15 | Treatment adherence will be evaluated by recording whether participants complete the scheduled treatment sessions and outcome assessments. Reasons for withdrawal, exclusion, or loss to follow-up will also be documented. |
| Safety Outcomes (Adverse Events) | From baseline to Week 15 | All adverse events occurring during the study period will be recorded and evaluated to assess the safety of electroacupuncture treatment. |
Countries
China
Contacts
CONTACTYI Liang, Doctor
Outcome results
None listed