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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
90
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.
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.
Beijing Tongren Hospital
Beijing, China
Mean change from Baseline in the FD Symptoms Index at 16 Weeks
FD Symptoms Index to measure the subjective symptoms of dyspepsia.
Time frame: 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.
Time frame: Day 0, 4-weeks, postintervention at Week 4, postintervention at Week 12
Mean change from Baseline in the HAMA at 16 Weeks
HAMA to measure the subjective anxiety symptoms
Time frame: Day 0, 4-weeks, postintervention at Week 4, postintervention at Week 12
Mean change from Baseline in the HAMD at 16 Weeks
HAMD to measure the subjective depression symptoms
Time frame: 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
Time frame: Day 0, 4-weeks, postintervention at Week 4, postintervention at Week 12
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