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 and Standard Care
Electroacupuncture (EA) group plus standard care group: Patients randomized to EA group will receive 20 sessions of electroacupuncture over 10 weeks (2 sessions / week) in the Integrative Medical Clinic (IMC) of the Institute of Integrative Medicine (IIM), Chinese University of Hong Kong. Each patient will receive electroacupuncture on 8 acupoints (bilateral): (ST34, ST36, ST40, ST42, CV12, PC6, BL20 and BL21 points). Chinese medicine practitioners (CMP) delivering the acupuncture will insert sterile, single-use filiform acupuncture needles, with a length of 25-40 mm and a diameter of 0.20 mm, with the aid of a guide tube at each of the points, after first disinfecting the skin. The depth of puncture will be made in accordance with the standards of Chinese medicine practice, to a depth, depending on the patients’ body size. The insertion will be followed by a manual bidirectional rotation of the needle sheath in order to produce the sensation known as De qi. After De qi, auxiliary needles will be applied 20mm lateral to each point. Then, using an electroacupuncture device, each pairs of acupuncture and auxiliary needles will be subjected to a 30 minutes 2Hz continuous wave electro-stimulation. The intensity will be adjusted to produce a muscle twitch that is acceptable to the patient, within the range of 0.5-1.5 mA. For EA procedures as well as the trial as a whole, implementation processes will be standardized, documented and reported according to the STRICTA requirement. CMP registered with the Chinese Medicine Council of Hong Kong will carry out the acupuncture treatment. For all patients, a standard care of 10 weeks of gastrocaine tablets (up to 4 tablets a day) will be provided as a rescue medication.
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
Standard care only group: For patients randomized to the standard care only group, a standard care of 10 weeks of gastrocaine tablets (up to 4 tablets a day) will be provided as a rescue medication.
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
Patients aged 18-70 fulfilling the following criteria will be considered as eligible for this study: 1. Completed test and treat procedure for H. pylori. 2. Completed a 8 week course of prokinetics and PPI. 3. No evidence of structural disease as confirmed by EGD. 4. On top of satisfying criteria 1-3, the patient fulfills the Rome III diagnostic criteria for PDS after a 2 week wash out of prokinetics and PPI. 5. After the 2 week wash out period, severity of symptoms will graded by the patient using a 2 weeks daily on a four-point Likert scale. The patient must have moderate to severe symptoms for at least 4 days to qualify for inclusion. 6. Being able to read and speak Chinese (Cantonese). 7. Signed Informed consent and are willing to attend follow up and / or acupuncture sessions.
Patients who fulfil 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, predominant heartburn or acid regurgitation, gastroesophageal reflux disease (GERD), and peptic ulcer; 2. Current regular use 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, or having underlying major physical illness such as diabetes, malignancy and infections. 5. For patients who fulfill the Rome III diagnostic criteria for both FD and irritable bowel syndrome (IBS), exclusion would be applied if they consider abdominal / bowel symptoms, instead of dyspepsia, as their major complaint.
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
Single-blind
Investigator/research team
Parallel
3
To investigate the effectiveness, safety and cost effectiveness of an integrative approach of using EA plus standard care in managing refractory FD.
2015-12-10
132
Recruiting
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 by weekly interviews at baseline and over the entire trial period.
Assessment of individual symptoms as secondary endpoint
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.
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.
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.
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
Frequency of Individual Adverse Events
Adverse events (AE) will be monitoredon a weekly basis.
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
The EQ-5D scores will be obtained at baseline and at weekly interval in both groups over 12 weeks.
2018-11-17
ChiCTR-IPC-15007109
2015-09-18
|
|
|
|
|
|
|---|---|---|---|---|
| No documents yet. | ||||