Effect of Transcutaneous Auricular Vagal Nerve Stimulation on Functional Dyspepsia: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 试验地点
- 3
- 主要终点
- Responder rate
研究概览
简要总结
Patients with dyspeptic symptoms vary from 10% to 20% globally. Up to 70% of patients with dyspepsia who undergo endoscopy have unremarkable examination and are diagnosed with functional dyspepsia (FD). Given the lack of information related to its pathophysiology, the treatment is largely empirical and of limited efficacy. Previous small study showed therapeutic potential of transcutaneous auricular vagal nerve stimulation (taVNS) for FD. This study aims to investigate whether taVNS can improve the dyspeptic symptoms of patients with FD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-65 years old
- •Patients who met the Rome IV diagnostic criteria of FD
- •Moderate to severe FD (functional dyspepsia symptom diary ≥10)
- •Normal upper endoscopy and abdominal ultrasonography within one year.
排除标准
- •Injury or inflammation on the ear
- •Asthma or COPD not under control
- •History of cardiac pacemaker planting or other medical digital devices
- •History of VNS treatment
- •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)
- •Patients with serious mental disorders or tendency to suicide
- •Pregnancy or lactic women
- •Inability to give informed consent
结局指标
主要结局
Responder rate
时间窗: 4 weeks
The proportion of patients whose Functional Dyspepsia Symptom Diary Total Symptom Scores were reduced ≥5 after four weeks treatment when compared with baseline.
次要结局
- Gastrointestinal Symptom Rating Scale (GSRS)(4 weeks)
- Elimination rate of cardinal symptom(4 weeks)
- Functional Dyspepsia Symptom Diary (FDSD)(4 weeks)
- Adequate relief rate(4 weeks)
研究者
Yanglin Pan
Associated professor
Air Force Military Medical University, China