The Role of Neuromodulators in Refractory Functional Dyspepsia
Study Details
Study Description
Brief Summary
The study was designed to investigate the effect of central neuromodulators on refractory functional dyspepsia
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 2-week group Patients were treated with antidepressants for 10-14 days combined with first-class medication(anti-acid drugs, prokinetics), followed by on demand. |
Drug: Deanxit
Central neuromodulators was applied in refractory FD patients for different time
Other Names:
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| Experimental: 4-week group Patients were treated with antidepressants for 4 weeks combined with first-class medication(anti-acid drugs, prokinetics). |
Drug: Deanxit
Central neuromodulators was applied in refractory FD patients for different time
Other Names:
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Outcome Measures
Primary Outcome Measures
- Changes from baseline Leeds Dyspepsia Questionnaire (LDQ) scores at 2 weeks and 4 weeks were obtained to assess the dyspepsia outcomes. [2 weeks and 4 weeks]
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.
- 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. [2 weeks and 4 weeks]
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.
- 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. [2 weeks and 4 weeks]
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.
Secondary Outcome Measures
- Antidepressants discontinuation syndrome was recorded. [1 week]
Rate of patients with dicscontinuation symdrome including headache, insomia, or flu-like reactions was obtained after antidepressant withdrawal within 1 week.
Eligibility Criteria
Criteria
Inclusion Criteria:
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18-70 years old;
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education level higher than middle school;
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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;
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absence of Helicobacter pylori infection;
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signed written informed consent for participation in the study.
Exclusion Criteria:
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evidence of organic digestive diseases;
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diabetes, cancer and other diseases might affect GI function;
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pregnancy, lactation or breastfeeding;
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a history of allergic reaction to any of the drugs used in the study;
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participation in other clinical trials in the previous 3 months.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Shengliang Chen | Shanghai | China | 200001 |
Sponsors and Collaborators
- RenJi Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RJYYXHNK