Clinical Course of Functional Dyspepsia and Factors Predicting Outcome in Patients Receiving Medication-based Treatment
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 300
- Locations
- 4
- Primary Endpoint
- score of 4 (slightly better) or 5 (much better) on a 5-point Likert scale assessing symptom improvement at 6 months after the initial visit
Study Overview
Brief Summary
Functional dyspepsia (FD) is one of most common chronic gastrointestinal disorders. Several types of drugs were demonstrated to be effective in reduction or remission of symptoms and severity of FD, including proton pump inhibitors (PPI), Tricyclic antidepressant and prokinetics. However, the clinical course of FD after taking medication-based treatment was unknown. Furthermore, 20-50% patients remained persistent or worsening of dyspepsia symptoms after treatment. Previous studies have suggested psychological factors (eg. anxiety, sleep disturbance) were related to less improvement of symptoms in natural clinical course. However, there is limited evidence in terms of clinical and psychological factors for less improvement in patients receiving medication treatment for dyspepsia.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •age ≥18 years old
- •Patients who met Rome IV criteria
- •Normal upper endoscopy and abdominal ultrasonography within one year
Exclusion Criteria
- •Patients with local or systemic diseases which may cause dyspeptic symptoms:
- •Known active peptic ulcer, cholecystitis, gallstone, gastrointestinal obstruction, gastroparesis, and etc.; Known acute or chronic injury of liver or kidney; Obvious hematological abnormality, or endocrine and metabolic diseases; Known malignancy; Obvious cardiovascular or cerebrovascular diseases (such as coronary heart disease, arrhythmia, cerebral infarction and etc.; Other conditions which may be associated with dyspeptic symptoms (such as NSAIDs associated dyspepsia)
- •organ failure defined by Marshall standard
- •severe psychiatric illnesses
- •known malignancy
- •pregnancy or lactation
- •unable to provide consent
- •suspected or identified bowel obstruction
Outcomes
Primary Outcomes
score of 4 (slightly better) or 5 (much better) on a 5-point Likert scale assessing symptom improvement at 6 months after the initial visit
Time Frame: 6 months
A 5-point likert scale was used for accessing symptom relief. 1. Worse, 2,slightly worse, 3.same, 4.slightly better, 5.much better. A score of 4 or 5 was classified as relief response.
Secondary Outcomes
- subtypes of functional dyspepsia(6 months)
- Short Form of Nepean Dyspepsia Index (SF-NDI)(1 day)
- Hospital anxiety and depression scale(1 day)
- Quality of Life scores assessed by Patient-reported outcomes measurement information system (PROMIS) Global-10 questionaire.(1 day)
- the change of Global Overall Symptom score (GOSS)(1month, 3 months, 6 months,12 months)
- Adequate relief rate(1month, 3 months, 6 months,12 months)
- the change of Functional dyspepsia symptom diary (FDSD) score(1month, 3 months, 6 months,12 months)
Investigators
Yanglin Pan
professor
Air Force Military Medical University, China