Functional dyspepsia (FD) is a common gastrointestinal disease, which is associated with decreased life quality and increased medical cost. Antipsychotic drugs were demonstrated to be effective in relieving symptoms in FD patients, especially for patients with refractory FD. However, the use of those drugs was associated with obvious adverse events. Cognitive behavioral therapy (CBT) has extensive applications and exhibited potential treatment effects in clinical practices, especially for treating anxiety, depression, pain or stress disorders. Several previous RCT studies have confirmed the effects of psychological intervention on improving dyspepsia in FD patients. Our hypothesis was that 8-week smartphone-based CBT would be non-inferior to conventional pharmacotherapy in reducing FD-related symptoms in patients with refactory FD.
Age 18-80
Refractory functional dyspepsia (patients with Rome IV functional dyspepsia remained symptomatic after treatment of 8 weeks of proton pump inhibitor and 4 weeks of prokinetics)
Negative or unrelated-to-FD symptom findings of gastroscopy, upper abdominal ultrasound, Hp test and routine blood tests within the past 1 year.
Severe mental illness (PHQ-9 ≥20 or GAD-7 ≥15) or suicidal ideation;
Known hp infection, active gastrointestinal peptic ulcer, cholecystitis, gallstones, suspected or known bowel obstruction, gastroparesis, major gastrointestinal surgery etc.;
Known or suspected malignant tumor, significant heart/brain/liver/kidney diseases, obvious hematologic abnormalities or endocrine diseases etc., which may be -related to FD symptoms;
Known or suspected drug-related FD (e.g.NSAIDs-related FD);
Parallel
cognitive behavioural therapy mobile application
Procedure/SurgeryThe CBT mobile application enables patients to conduct cognitive therapy independently.
Flupentixol and Melitracen Tablets
Drugpatients take Flupentixol and Melitracen Tablets
1. The primary endpoint was the change in GOSS scores from baseline to week 8 after treatment.
GOSS (7-point Global Overall Symptom Scale) is a scoring system composed of ten primary symptom ratings. The main symptoms include upper abdominal pain, early satiety, postprandial fullness discomfort, bloating, nausea, acid reflux, heartburn, excessive belching, upper abdominal discomfort, and other upper abdominal discomforts. Each item is scored from 1 to 7, with 7 representing the most severe symptom. The total score is the sum of the scores for the ten symptoms.
5-Likert score
The patients were interviewed to answer the question "Compared with the condition before receiving treatment, how about your gut condition now?" The following questions were chosen: (1) extremely worse, (2) slightly worse, (3) same as before, (4) slightly better, (5) much better.
Patient-Reported Outcomes Measurement Information System Global-10 (PROMIS-10)
PROMIS (Patient-Reported Outcomes Measurement Information System) Global-10, also known as the Global Quality of Life Score, is a patient-reported questionnaire consisting of 10 items. The responses are rated on a scale of 1-5 (with an additional 0-10 rating scale for a single item), and the final outputs are two standardized scores: the global physical health score and the global mental health score. Higher scores indicate better quality of life for the patient.
GOSS score
GOSS (7-point Global Overall Symptom Scale) is a scoring system composed of ten primary symptom ratings. The main symptoms include upper abdominal pain, early satiety, postprandial fullness discomfort, bloating, nausea, acid reflux, heartburn, excessive belching, upper abdominal discomfort, and other upper abdominal discomforts. Each item is scored from 1 to 7, with 7 representing the most severe symptom. The total score is the sum of the scores for the ten symptoms.
Short Form of Nepean Dyspepsia Index (SF-NDI)
The SF-NDI consists of 10 questions regarding the effects of dyspepsia symptoms ("stomach problems") on different aspects of life (tension, interference with daily activities, eating/drinking, knowledge/control, and work/study). Each response can be from 1 (not at all affected) to 5 (extremely affected), or 0 (N/A), for a total summed score out of 50.
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Air Force Military Medical University, China
Lead sponsor
Xi'an 986 Hospital
Collaborator
Shaanxi Second People's Hospital
Collaborator
Xi'an People's Hospital (Xi'an Fourth Hospital)
Collaborator
Tang-Du Hospital
Collaborator
Hainan General Hospital (Hainan Affifiliated Hospital ofHainan Medical University)
Collaborator
Mianyang Third Hospital
Collaborator
