CUHK_CCRB00478
2015-09-18
Prospective
2014.552-T
Health and Medical Research Fund
JC School of Public Health and Primary Care, The Chinese University of Hong Kong
Integrative Medical Centre (IMC), Faculty of Medicine, The Chinese University of Hong Kong
Not Applicable
Vincent Chi Ho, Chung
4/F, School of Public Health and Primary Care, Prince of Wales Hospital, Shatin, Hong Kong
2252-8453
vchung@cuhk.edu.hk
JC School of Public Health and Primary Care, The Chinese University of Hong Kong
Hong Kong
Dr Vincent Chi Ho Chung
4/F, School of Public Health and Primary Care, Prince of Wales Hospital, Shatin, Hong Kong
2252-8453
vchung@cuhk.edu.hk
JC School of Public Health and Primary Care, The Chinese University of Hong Kong
Hong Kong
Electroacupuncture plus standard care for managing refractory functional dyspepsia: pragmatic randomized trial with economic evaluation
Electroacupuncture plus standard care for managing refractory functional dyspepsia: pragmatic randomized trial with economic evaluation
電針灸聯合標準療法治療難治性功能性消化不良：實況隨機對照試驗及經濟學評價
Hong Kong
Yes
2015-08-24
Joint CUHK-NTEC Clinical Research Ethics Committee
2014.552-T
Functional Dyspepsia (FD)
Other
Electroacupuncture (EA) plus on-demand gastrocaine
20 sessions of EA over 10 weeks plus on-demand gastrocaine
EA/ Tablets
30 minutes EA/ Each tablet [Oxethazaine 5 mg, Al(OH)3 dried gel 126 mg, Mg(OH)2 100 mg]
10 weeks
2 sessions per week/ Up to 4 tablets a day
Waiting list to EA plus on-demand Gastrocaine:
On-demand gastrocaine and being nominated on to a waiting list for EA, which entitles 20 sessions of EA over 10 weeks after 12 weeks of waiting
Tablets
Each tablet [Oxethazaine 5 mg, Al(OH)3 dried gel 126 mg, Mg(OH)2 100 mg]
10 weeks
Up to 4 tablets a day
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
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
18 years old
70 years old
Both Male and Female
Interventional
Randomized
Blocked randomization will be used to allocate patients to the two groups, with random block sizes.
Active
Not Applicable
Parallel
3
To compare the effectiveness and cost effectiveness of electroacupuncture (EA) plus on-demand gastrocaine with waiting list for EA plus on-demand gastrocaine in providing symptom relief and quality of life improvement among FD patients.
2015-12-10
132
Complete
Binary assessment of adequate relief as primary endpoint
The outcome will be assessed by a weekly question of “in the past 7 days, have you had adequate relief of your upper abdominal pain or discomfort? (Yes / No)”.
Data on the primary outcome of adequate relief will be assessed via a weekly standardized phone interview by blinded assessors at baseline and over the entire trial period.
Patient reported change in individual symptoms
Changes in postpradinal fullness, early satiety, epigastric pain, epigastric burning, and postprandial nausea measured on a 5 point Likert scale (absent, very mild or mild, moderate, severe, very severe) can be measured.
Assessment of the outcome will be performed at baseline and 12th week via face to face interview and at weekly interval over 12 weeks via phone interview.
Nepean Dyspepsia Index (NDI)
For symptom checklist, simple addition of the frequency, severity and bothersomeness items to create a total score; Four 0 to 100 point subscales to measure Interference, Knowledge/control, Eating/ drinking and Sleep
Assessment of the outcome will be performed at baseline and 12th week.
Patient Health Questionnaire 9 (PHQ9)
A point range of 0 to 27
Assessment of the outcome will be performed at baseline and 12th week via face to face interview and at bi-weekly interval over 12 weeks via phone interview.
Patient Health Questionnaire section for Anxiety (GAD7)
A point range of 0 to 21
Assessment of the outcome will be performed at baseline and 12th week via face to face interview and at bi-weekly interval over 12 weeks via phone interview.
Nutrient Drink Test (NDT)
Four 0 to 100 point subscales to measure Nausea, Bloating, Pain and Fullness
Assessment of the outcome will be performed at baseline and 12th week.
Adverse Events Questionnaire
Have you experienced any symptoms which you think might be caused by your electroacupuncture treatment/ Gastrocaine? (Yes/No). If yes, please describe. How likely do you think it is the acupuncture procedure/ Gastrocaine that caused these symptoms? (Definitely /Probably /Possibly /Unlikely).
Adverse events (AE) will be monitored at weekly interval over 12 weeks via phone interview.
EuroQol (EQ-5D) questionnaire to estimate Quality-adjusted life-years (QALYs) gained
Five levels of perceived problems in Mobility, Self-care, Usual activities, Pain/ discomfort and Anxiety/ depression; A visual analogue scale with a point range of 0 to 100
Assessment of the outcome will be performed at baseline and 12th week via face to face interview and at weekly interval over 12 weeks via phone interview.
Patient reported change in global symptoms
Using a 7-point Likert scale (symptoms-free, marked improvement, slight improvement, no improvement, slight deterioration, marked deterioration, severe deterioration), patients are asked to assess the change in global symptoms.
Assessment of the outcome will be performed at baseline and 12th week via face to face interview and at weekly interval over 12 weeks via phone interview.
Direct medical cost associated with the management of FD
Hong Kong dollars
Assessment of the outcome will be performed at baseline and 12th week via face to face interview and at weekly interval over 12 weeks via phone interview.
2018-11-17
ChiCTR-IPC-15007109
2015-09-18
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