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The study was designed to investigate the effect of central neuromodulators on refractory functional dyspepsia
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2-week group | Experimental | Patients were treated with antidepressants for 10-14 days combined with first-class medication(anti-acid drugs, prokinetics), followed by on demand. |
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| 4-week group | Experimental | Patients were treated with antidepressants for 4 weeks combined with first-class medication(anti-acid drugs, prokinetics). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Deanxit | Drug | Central neuromodulators was applied in refractory FD patients for different time |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shengliang Chen, PhD | Contact | 13916084817 | chensl@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shengliang Chen | Recruiting | Shanghai | 200001 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24955450 | Result | Yu YY, Fang DC, Fan LL, Chang H, Wu ZL, Cao Y, Lan CH. Efficacy and safety of esomeprazole with flupentixol/melitracen in treating gastroesophageal reflux disease patients with emotional disorders. J Gastroenterol Hepatol. 2014 Jun;29(6):1200-6. doi: 10.1111/jgh.12552. | |
| 25879863 | Result | Wang L, Zhong Z, Hu J, Rong X, Liu J, Xiao S, Liu Z. Sertraline plus deanxit to treat patients with depression and anxiety in chronic somatic diseases: a randomized controlled trial. BMC Psychiatry. 2015 Apr 14;15:84. doi: 10.1186/s12888-015-0449-2. |
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| ID | Term |
|---|---|
| D004415 | Dyspepsia |
| D005767 | Gastrointestinal Diseases |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C000851 | flupentixol, melitracen drug combination |
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| 31593119 | Result | Luo L, Du L, Shen J, Cen M, Dai N. Benefit of small dose antidepressants for functional dyspepsia: Experience from a tertiary center in eastern China. Medicine (Baltimore). 2019 Oct;98(41):e17501. doi: 10.1097/MD.0000000000017501. |
| 25721705 | Result | Fava GA, Gatti A, Belaise C, Guidi J, Offidani E. Withdrawal Symptoms after Selective Serotonin Reuptake Inhibitor Discontinuation: A Systematic Review. Psychother Psychosom. 2015;84(2):72-81. doi: 10.1159/000370338. Epub 2015 Feb 21. |
| 31774947 | Result | Fava GA, Cosci F. Understanding and Managing Withdrawal Syndromes After Discontinuation of Antidepressant Drugs. J Clin Psychiatry. 2019 Nov 26;80(6):19com12794. doi: 10.4088/JCP.19com12794. |
| 36569610 | Derived | Wang QQ, Cheng L, Wu BY, Xu P, Qiu HY, Wang B, Yan XJ, Chen SL. Short-course antidepressant therapy reduces discontinuation syndrome while maintaining treatment efficacy in patients with refractory functional dyspepsia: A randomized controlled trial. Front Psychiatry. 2022 Dec 8;13:1063722. doi: 10.3389/fpsyt.2022.1063722. eCollection 2022. |