Short-term and Low-dose Application of Neuromodulators Increases Treatment Efficacy and Minimizes Antidepressant Discontinuation Syndrome in Refractory Functional Dyspepsia
Overview
- Phase
- Not Applicable
- Intervention
- Deanxit
- Conditions
- Dyspepsia
- Sponsor
- RenJi Hospital
- Enrollment
- 220
- Locations
- 1
- Primary Endpoint
- Changes from baseline Leeds Dyspepsia Questionnaire (LDQ) scores at 2 weeks and 4 weeks were obtained to assess the dyspepsia outcomes.
- Last Updated
- 4 years ago
Overview
Brief Summary
The study was designed to investigate the effect of central neuromodulators on refractory functional dyspepsia
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.
Investigators
Shengliang Chen
professor, chief physician
RenJi Hospital
Eligibility Criteria
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.
Arms & Interventions
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.
Intervention: Deanxit
4-week group
Patients were treated with antidepressants for 4 weeks combined with first-class medication(anti-acid drugs, prokinetics).
Intervention: Deanxit
Outcomes
Primary Outcomes
Changes from baseline Leeds Dyspepsia Questionnaire (LDQ) scores at 2 weeks and 4 weeks were obtained to assess the dyspepsia outcomes.
Time Frame: 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.
Time Frame: 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.
Time Frame: 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 Outcomes
- Antidepressants discontinuation syndrome was recorded.(1 week)