Clinical Course of Functional Dyspepsia and Factors Predicting Outcome in Patients Receiving Medication-based Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 4
- 主要终点
- 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
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age ≥18 years old
- •Patients who met Rome IV criteria
- •Normal upper endoscopy and abdominal ultrasonography within one year
排除标准
- •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
结局指标
主要结局
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
时间窗: 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.
次要结局
- 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)
研究者
Yanglin Pan
professor
Air Force Military Medical University, China