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Objective: To observe the effect of the treatment of transcutaneous auricular vagus nerve stimulation (taVNS) for the functional dyspepsia (FD).
Methods: We accrued 94 patients at Beijing TongRen Hospital. All treatments were self-administered by the patients at home after training at the hospital. Patients completed questionnaires at baseline and after 4 weeks, 8 weeks, 12 weeks. The FD Symptoms Index, Functional Dyspepsia Quality of Life Scale (FDDQL), Hamilton Anxiety Scale (HAMA), Hamilton Depression Scale (HAMD), and Self-Depression Rating Scale (SDS) were performed to evaluate the therapeutic effects.
A difference of P < 0.05 was considered statistically significant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| taVNS group | Experimental |
| |
| tnVNS group | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| taVNS | Device | taVNS was applied using a Huatuo stimulator (SDZ-IIB) developed by Suzhou manufacture of Medical Device and Material. Stimulation parameters was 1 mA of electrical current at a frequency of 30 Hz with pulse duration ≤ 1 ms, for 30min, administered twice daily. The two electrodes were placed on the cymba conchae and concha around the left ear. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change from Baseline in the FD Symptoms Index at 16 Weeks | FD Symptoms Index to measure the subjective symptoms of dyspepsia. | Day 0, 4-weeks, postintervention at Week 4, postintervention at Week 12 |
| Mean change from Baseline in the FDQOL at 16 Weeks | FDQOL to measure the subjective quality of life. | Day 0, 4-weeks, postintervention at Week 4, postintervention at Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change from Baseline in the HAMA at 16 Weeks | HAMA to measure the subjective anxiety symptoms | Day 0, 4-weeks, postintervention at Week 4, postintervention at Week 12 |
| Mean change from Baseline in the HAMD at 16 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tongren Hospital | Beijing | China |
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|
| tnVNS | Device | tnVNS was applied using a Huatuo stimulator (SDZ-IIB) developed by Suzhou manufacture of Medical Device and Material. Stimulation parameters was 1 mA of electrical current at a frequency of 30 Hz with pulse duration ≤ 1 ms, for 30min, administered twice daily. The two electrodes were placed on the antihelix around the left ear. |
|
HAMD to measure the subjective depression symptoms
| Day 0, 4-weeks, postintervention at Week 4, postintervention at Week 12 |
| Mean change from Baseline in the SDS at 16 Weeks | SDS to measure the subjective depression symptoms | Day 0, 4-weeks, postintervention at Week 4, postintervention at Week 12 |