Functional Dyspepsia
Conditions
Keywords
Functional Dyspepsia
Brief summary
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.
Interventions
DEVICEtaVNS 10
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)
DEVICEtaVNS 25
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)
DEVICEControl
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)
Sponsors
Air Force Military Medical University, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. 18-65 years old 2. Patients who met the Rome IV diagnostic criteria of FD 3. Moderate to severe FD (functional dyspepsia symptom diary ≥10) 4. Normal upper endoscopy and abdominal ultrasonography within one year.
Exclusion criteria
1. Injury or inflammation on the ear 2. Asthma or COPD not under control 3. History of cardiac pacemaker planting or other medical digital devices 4. History of VNS treatment 5. 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) 6. Patients with serious mental disorders or tendency to suicide 7. Pregnancy or lactic women 8. Inability to give informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Responder rate | 4 weeks | The proportion of patients whose Functional Dyspepsia Symptom Diary Total Symptom Scores were reduced ≥5 after four weeks treatment when compared with baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gastrointestinal Symptom Rating Scale (GSRS) | 4 weeks | 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. |
| Functional Dyspepsia Symptom Diary (FDSD) | 4 weeks | 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. |
| Adequate relief rate | 4 weeks | The proportion of patients who acquire overall symptom relief when compared with baseline |
| Elimination rate of cardinal symptom | 4 weeks | The proportion of patients whose cardinal symptom is completely eliminated when compared with baseline. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adverse event | 4 weeks | — |
| Hamilton Anxiety and Depression Scale | 4 weeks | 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. |
| Short Form of Nepean Dyspepsia Index (SF-NDI) | 4 weeks | 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. |
Countries
China
Contacts
Primary ContactYanglin Pan, M.D.
Outcome results
None listed