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Patients with dyspeptic symptoms vary from 10% to 20% globally. Up to 70% of patients with dyspepsia who undergo endoscopy have unremarkable examination and are diagnosed with functional dyspepsia (FD). Given the lack of information related to its pathophysiology, the treatment is largely empirical and of limited efficacy. Previous small study showed therapeutic potential of transcutaneous auricular vagal nerve stimulation (taVNS) for FD. This study aims to investigate whether taVNS can improve the dyspeptic symptoms of patients with FD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group 1 | Experimental | Based on the infection of Hp or not, patients will receive quadruple therapy (amoxicillin, clarithromycin, pantoprazole, and bismuth) or PPI (pantoprazole) plus taVNS (produced by by Xi'an Bashui Health Technology Co., Ltd) at left tragus. Patients were given taVNS thirty minutes twice a day in the morning and the night for four weeks (duty circle: 30s "on" periods and 30s "off" periods; frequency: 10 Hz; current intensity: minimal pain threshold; pulse width: 500 μs). |
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| Treatment group 2 | Experimental | Based on the infection of Hp or not, patients will receive quadruple therapy (amoxicillin, clarithromycin, pantoprazole, and bismuth) or PPI (pantoprazole) plus taVNS (produced by by Xi'an Bashui Health Technology Co., Ltd) at left tragus. Patients were given taVNS thirty minutes twice a day in the morning and the night for four weeks (duty circle: 30s "on" periods and 30s "off" periods; frequency: 25 Hz; current intensity: minimal pain threshold; pulse width: 500 μs). |
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| Control group | Active Comparator | Based on the infection of Hp or not, patients will receive quadruple therapy (amoxicillin, clarithromycin, pantoprazole, and bismuth) or PPI (pantoprazole) plus taVNS (produced by by Xi'an Bashui Health Technology Co., Ltd) at left earlobe. Patients were given taVNS thirty minutes twice a day in the morning and the night for four weeks (duty circle: 30s "on" periods and 30s "off" periods; frequency: 10 Hz; current intensity: minimal pain threshold; pulse width: 500 μs). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| taVNS 10 | Device | Patients were given taVNS (by Xi'an Bashui Health Technology Co., Ltd) thirty minutes twice a day in the morning and the night for four weeks (duty circle: 30s "on" periods and 30s "off" periods; frequency: 10 Hz; current intensity: minimal pain threshold; pulse width: 500 μs) |
| Measure | Description | Time Frame |
|---|---|---|
| Responder rate | The proportion of patients whose Functional Dyspepsia Symptom Diary Total Symptom Scores were reduced ≥5 after four weeks treatment when compared with baseline. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Functional Dyspepsia Symptom Diary (FDSD) | The FDSD consists of 5 cardinal items (burning in the stomach, stomach pain, bloating, postprandial fullness, and early satiety) and 3 supplementary items (nausea, burping/belching rating, and burping/belching bother). Each item can be scored from 0 (no) to 10 (worst). Total Symptom Score includes the 5 cardinal items and ranges from 0 to 50. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Short Form of Nepean Dyspepsia Index (SF-NDI) | The SF-NDI consists of 10 questions regarding the effects of dyspepsia symptoms ("stomach problems") on different aspects of life (tension, interference with daily activities, eating/drinking, knowledge/control, and work/study). Each response can be from 1 (not at all affected) to 5 (extremely affected), or 0 (N/A), for a total summed score out of 50. | 4 weeks |
Inclusion Criteria:
Exclusion Criteria:
Injury or inflammation on the ear
Asthma or COPD not under control
History of cardiac pacemaker planting or other medical digital devices
History of VNS treatment
Patients with local or systemic diseases which may cause dyspeptic symptoms:
Known active peptic ulcer, cholecystitis, gallstone, gastrointestinal obstruction, gastroparesis, and etc.; Known acute or chronic injury of liver or kidney; Obvious hematological abnormality, or endocrine and metabolic diseases; Known malignancy; Obvious cardiovascular or cerebrovascular diseases (such as coronary heart disease, arrhythmia, cerebral infarction and etc.; Other conditions which may be associated with dyspeptic symptoms (such as NSAIDs associated dyspepsia)
Patients with serious mental disorders or tendency to suicide
Pregnancy or lactic women
Inability to give informed consent
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yanglin Pan, M.D. | Contact | 13991811225 | yanglinpan@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lanzhou University Second Hospital | Recruiting | Lanzhou | Gansu | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37787432 | Derived | Shi X, Zhao L, Luo H, Deng H, Wang X, Ren G, Zhang L, Tao Q, Liang S, Liu N, Huang X, Zhang X, Yang X, Sun J, Qin W, Kang X, Han Y, Pan Y, Fan D. Transcutaneous Auricular Vagal Nerve Stimulation Is Effective for the Treatment of Functional Dyspepsia: A Multicenter, Randomized Controlled Study. Am J Gastroenterol. 2024 Mar 1;119(3):521-531. doi: 10.14309/ajg.0000000000002548. Epub 2023 Oct 3. |
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Other researchers can contact PI to get IPD.
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| taVNS 25 | Device | Patients were given taVNS (by Xi'an Bashui Health Technology Co., Ltd) thirty minutes twice a day in the morning and the night for four weeks (duty circle: 30s "on" periods and 30s "off" periods; frequency: 25 Hz; current intensity: minimal pain threshold; pulse width: 500 μs) |
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| Control | Device | Patients were given taVNS (by Xi'an Bashui Health Technology Co., Ltd) thirty minutes twice a day in the morning and the night for four weeks (duty circle: 30s "on" periods and 30s "off" periods; frequency: 10 Hz; current intensity: minimal pain threshold; pulse width: 500 μs) |
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| Gastrointestinal Symptom Rating Scale (GSRS) | The GSRS contains 15 items. All individual items are scored on a 7-point Likert scale (1 = not at all to 7 = extremely) and are subsequently clustered into five domains (abdominal pain, reflux, indigestion, diarrhea, and constipation); higher scores indicate more severe symptoms. | 4 weeks |
| Adequate relief rate | The proportion of patients who acquire overall symptom relief when compared with baseline | 4 weeks |
| Elimination rate of cardinal symptom | The proportion of patients whose cardinal symptom is completely eliminated when compared with baseline. | 4 weeks |
| Hamilton Anxiety and Depression Scale | Anxiety and depression of patients are assessed by using Hamilton Anxiety and Depression Scale. Hamilton Anxiety Scale consists of 14 items. Each item is scored on a scale from 0 (absent) to 4 (most severe) with a total score range of 0-56. Hamilton Depression Scale consists of 17 items. Individual items scored on 3 point (0 to 2) or 5 point scale (0 to 4); 0=absent, 4=most severe. Total score: 0 to 52. | 4 weeks |
| Adverse event | 4 weeks |
| Xijing Hospital of Digestive Diseases | Recruiting | Xi'an | Shaanxi | 710032 | China |
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| The Second Affiliated Hospital of Xi'an Jiaotong University | Recruiting | Xi'an | Shaanxi | China |
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