The Role of Neuromodulators in Refractory Functional Dyspepsia

Study Overview
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Brief Summary
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The study was designed to investigate the effect of central neuromodulators on refractory functional dyspepsia

Detailed Description
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Functional dyspepsia (FD) is a prevalent disease combined with emotional disorders. Antidepressants are beneficial in the treatment of refractory FD, while for the long-term use of antidepressants, it could lead to withdrawal syndrome or other adverse events. Refractory FD patients were unsatisfied with the regular first-line anti-acid treatment. However, many patients were worried about taking antidiepressants, even though guideline has recommended antidepressant use in FD. In our study, we would use low-dose and short-term antidepressant in refractory FD patients, and investigate whether short-term antidepressants application would improve therapeutic efficacy and minimize antidepressant withdrawal of FD patients.

Official Title
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Short-term and Low-dose Application of Neuromodulators Increases Treatment Efficacy and Minimizes Antidepressant Discontinuation Syndrome in Refractory Functional Dyspepsia

Conditions
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Dyspepsia, Functional Gastrointestinal Disorders, Antidepressant Discontinuation Syndrome, Antidepressant Drug Adverse Reaction

Intervention / Treatment
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* Drug: Deanxit


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-70 years old; education level higher than middle school; met the Rome IV criteria for FD; absence of abnormalities on physical examination, laboratory tests (including a routine blood test, blood glucose, and liver function examination), and abdominal imaging and GI endoscopy within 6 months; absence of Helicobacter pylori infection; signed written informed consent for participation in the study. Exclusion Criteria: evidence of organic digestive diseases; diabetes, cancer and other diseases might affect GI function; pregnancy, lactation or breastfeeding; a history of allergic reaction to any of the drugs used in the study; participation in other clinical trials in the previous 3 months.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 2-week group<br>Patients were treated with antidepressants for 10-14 days combined with first-class medication(anti-acid drugs, prokinetics), followed by on demand. | Drug: Deanxit<br>* Central neuromodulators was applied in refractory FD patients for different time<br>* Other names: Flupentixol and Melitracen;|
| Experimental: 4-week group<br>Patients were treated with antidepressants for 4 weeks combined with first-class medication(anti-acid drugs, prokinetics). | Drug: Deanxit<br>* Central neuromodulators was applied in refractory FD patients for different time<br>* Other names: Flupentixol and Melitracen;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from baseline Leeds Dyspepsia Questionnaire (LDQ) scores at 2 weeks and 4 weeks were obtained to assess the dyspepsia outcomes. | The LDQ scores of 0-4 were classified as very mild dyspepsia, 5-8 as mild dyspepsia, 9-15 as moderate dyspepsia, and >15 as severe or very severe dyspepsia. | 2 weeks and 4 weeks | 
| Changes from baseline Patient Health Questionaire-9 (PHQ-9) scores at 2 weeks and 4 weeks was obtained to assess the depression contition after treatment. | The PHQ-9 scores of 0-4 were classified as none or minimal depression, 5-9 as mild, 10-14 as moderate, 15-19 as moderately severe, and ≥20 as severe depression. | 2 weeks and 4 weeks | 
| Changes from baseline Generalized Anxiety Questonaire-7 (GAD-7) scores at 2 weeks and 4 weeks were obtained to assess the anxiety contition after treatment. | The GAD-7 scores of 0-4 were classified as the absence of anxiety, 5-9 as mild, 10-14 as moderate, and ≥15 as severe. | 2 weeks and 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antidepressants discontinuation syndrome was recorded. | Rate of patients with dicscontinuation symdrome including headache, insomia, or flu-like reactions was obtained after antidepressant withdrawal within 1 week. | 1 week |