Transcutaneous Auricular Vagus Nerve Stimulation in the Treatment of Functional Dyspepsia : A Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Functional Dyspepsia
- Sponsor
- Beijing Tongren Hospital
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Mean change from Baseline in the FD Symptoms Index at 16 Weeks
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age \>=18 and Age \<=
- •Clinical diagnosis of functional dyspepsia.
Exclusion Criteria
- •History of depression, tumors, thyroid disease, diabetes, cardiac diseases.
- •History of gastrointestinal surgery.
- •Pregnant or lactating women.
Outcomes
Primary Outcomes
Mean change from Baseline in the FD Symptoms Index at 16 Weeks
Time Frame: Day 0, 4-weeks, postintervention at Week 4, postintervention at Week 12
FD Symptoms Index to measure the subjective symptoms of dyspepsia.
Mean change from Baseline in the FDQOL at 16 Weeks
Time Frame: Day 0, 4-weeks, postintervention at Week 4, postintervention at Week 12
FDQOL to measure the subjective quality of life.
Secondary Outcomes
- Mean change from Baseline in the SDS at 16 Weeks(Day 0, 4-weeks, postintervention at Week 4, postintervention at Week 12)
- Mean change from Baseline in the HAMD at 16 Weeks(Day 0, 4-weeks, postintervention at Week 4, postintervention at Week 12)
- Mean change from Baseline in the HAMA at 16 Weeks(Day 0, 4-weeks, postintervention at Week 4, postintervention at Week 12)