Gastroesophageal Reflux Disease
Conditions
Brief summary
Gastroesophageal reflux disease (GERD) is a common chronic digestive system disorder with a high prevalence and a notably increasing trend. It imposes significant costs in terms of treatment expenses and impacts patients' quality of life. Acid suppression remains the primary treatment for GERD. However, numerous clinical studies have shown that 20-30% of patients still exhibit poor response to proton pump inhibitors (PPIs) even after completing a standard course of acid-suppressive therapy. Many studies have demonstrated that the incidence of abnormal psychological conditions, such as anxiety, depression, and obsessive-compulsive disorder, is higher in GERD patients compared to the general population. Current international consensus acknowledges that the application of psychosomatic medicine principles and the use of neuromodulators can effectively alleviate symptoms in patients with gut-brain interaction disorders. Nevertheless, with the growing emphasis on digestive-psychosomatic-holistic medicine in clinical practice and the deepening of research on gut-brain interactions, recent studies in the field of psycho-gastroenterology have challenged the notion that psychological processes are unique to gut-brain interaction disorders. Instead, these processes may play a universal role in symptom generation across the entire spectrum of GERD. Previous experiments have confirmed that Flupentixol-Melitracen (FM) can improve symptoms in GERD patients with a low incidence of adverse reactions. Therefore, we aim to verify the efficacy and safety of neuromodulators in patients with GERD, reduce healthcare costs, and provide new insights for optimizing treatment strategies for GERD patients in the future.
Interventions
Flupentixol-Melitracen and Lansoprazole for the treatment of GERD
DRUGLansoprazole and placebo
Placebo and Lansoprazole for GERD
Sponsors
RenJi Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
\- Adults aged 18-70 years with gastroesophageal reflux disease (GERD) meeting diagnostic criteria.
Exclusion criteria
* Patients with organic gastrointestinal disorders (e.g., celiac disease, inflammatory bowel disease, history of gastrointestinal malignancies); Severe dysfunction of major organs (e.g., class IV cardiac dysfunction, hepatic failure, uremia, respiratory failure) or congenital diseases (e.g., hemophilia, Wilson's disease); Hypersensitivity to study medications; Patients who are pregnant, lactating, or planning pregnancy; Use of monoamine oxidase inhibitors (e.g., linezolid or intravenous methylene blue) within the past 5 weeks; Severe psychological symptoms or cognitive impairment (GAD-7 \>15 or PHQ-9 ≥15); Circulatory failure, central nervous system depression (e.g., acute alcohol, barbiturate, or opioid intoxication), or coma.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| GERD questionnaire (GerdQ) | Until the end of the study, up to 12 weeks | The GerdQ Scale is a validated tool for assessing gastroesophageal reflux disease (GERD). It includes 6 items evaluating symptom frequency (heartburn, regurgitation), extra-esophageal manifestations, and quality of life impact (e.g., sleep disturbance, medication use) over the past week. Scores range 0-18; ≥8 suggests high GERD likelihood, guiding stepwise treatment (lifestyle changes or PPIs). |
Countries
China
Outcome results
None listed