Functional Dyspepsia (FD)
Conditions
Interventions
Two groups:Electroacupuncture (EA) plus on-demand gastrocaine versus Waiting list to EA plus on-demand Gastrocaine
Sponsors
JC School of Public Health and Primary Care, The Chinese University of Hong Kong
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Patients who have completed oesophagogastroduodenoscopy (OGD) with H. pylori negative results, or patients who has tested positive for H. pylori but have completed medication course the for the eradication of H. pylori; 2. Patients with symptoms that fulfill the reference standard for Functional Dyspepsia Postprandial Distress Syndrome, including the presence of either or both of the following symptoms once per week in the past 1 month:postprandial fullness, early satiety. In accordance to the pragmatic approach of this trial, this reference standard is chosen as it reflects presentations of FD patients in real-world clinical settings, increasing the external validity of future results; 3. Voluntary discontinuation of any conventional pharmacological treatments for their functional dyspepsia 2 weeks prior to enrolment, due to perceived ineffectiveness; 4. Hong Kong permanent resident; 5. 18 – 70 years of age.
Exclusion criteria
Exclusion criteria: Patients who fulfill any of the following criteria would be excluded. Criteria will be assessed through patient history, medical record review, or physical examination. 1. Documented diagnosis of esophageal or gastric disease, including esophagitis, gastroesophageal reflux disease (GERD), peptic ulcer, predominant heartburn or acid regurgitation in the past 1 month; 2. Current regular user of non-steroidal anti-inflammatory drugs, anti-depressants or anxiolytic drugs, as defined as daily use in the past 2 months; 3. Patients who had received major abdominal surgery; 4. Patients who are pregnant; 5. Patients who are wearing cardiac pacemaker; 6. Patients who are having underlying major physical illness such as malignancy and infections; 7. Patients are using any dose of PPIs or prokinetics two weeks prior to enrollment; 8. For patients with coexisting IBS as diagnosed by the Manning criteria, exclusion is applied if a patient considers abdominal or bowel symptoms, instead of dyspepsia, as their major complaint. Manning criteria for Irritable Bowel Syndrome (IBS) is positive in this trial when = 4 of the following symptoms are present in the past month: Visible abdominal distension, Pain relieved by a bowel action, More frequent stools with the onset of pain, Looser stools with the onset of pain, Rectal passage of mucus, A sensation of incomplete evacuation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Binary assessment of adequate relief as primary endpoint; | — |
Secondary
| Measure | Time frame |
|---|---|
| Nepean Dyspepsia Index (NDI);Patient Health Questionnaire 9 (PHQ9);Patient Health Questionnaire section for Anxiety (GAD7);Nutrient Drink Test (NDT);Adverse Events Questionnaire;EuroQol (EQ-5D) questionnaire to estimate Quality-adjusted life-years (QALYs) gained;Patient reported change in individual symptoms;Patient reported change in global symptoms;Direct medical cost associated with the management of FD; | — |
Countries
China
Contacts
Public ContactVincent Chi Ho, Chung
JC School of Public Health and Primary Care, The Chinese University of Hong Kong
Outcome results
None listed