Track topics on Twitter Track topics that are important to you
Functional gastrointestinal disorder (FGID) is the most common gastrointestinal disease in daily clinical practice. The disease is symptomatic but has no identifiable cause by standard diagnostic tests such as endoscopy. It is characterized by its frequent relapses and thus the disease causes a significant level of stress and anxiety to patients. Due to the complexity and chronicity of the disease, it is believed that appropriate counseling on the nature and management of the disease is necessary to decrease patient's anxiety level and improve quality of life.
Patients who have symptoms suggestive of FGID including non-erosive gastroesophageal reflux disease (NERD), functional dyspepsia (FD) or irritable bowel syndrome (IBS).
To validate the effectiveness of counseling in patients suffering from FGID.
Patients recruited to the study will follow the usual management of patients attending the Gastroenterology specialty clinic in Prince of Wales Hospital. Standard blood tests and endoscopy will be performed. Standard medication will be given to the patients for 8 weeks after endoscopy and the patients will come back to the specialty clinic for a final visit.
The patient will be given an "on-demand follow up within 1 year" option at final visit. The patient will decide if he/she wants to come back to our specialty clinic to follow up his/her problem within one year.
Follow-up after Final Visit Follow-up questionnaires will be mailed to patients 6 months, 1 and 2 years after Final visit.
All the patients will be randomized into two groups in First Visit: 1) Control group, and 2) Counseling group. Both groups of patients will follow the above protocol, except that 2 extra counseling sessions will be arranged for the Counseling group immediately after visiting the physician.
Patients recruited to the study will follow the usual management of patients attending the Gastroenterology specialty clinic in Prince of Wales Hospital, along with the following protocol:
- Patient signs written consent
- Attending physician manages patient as usual
- Blood tests will be arranged for patient:
- FD & NERD patients: CBC w/ differential count, LFT, TFT, random glucose
- IBS patients: CBC w/ differential count, LFT, TFT, ESR, C-reactive protein
- Patient completes questionnaires
- Endoscopy examinations
- FD & NERD patients: oesophagogastroduodenoscopy (OGD) with rapid urea test (RUT) and biopsy of antrum sample for histology to check h. pylori status
- IBS patients: colonoscopy
- If no organic causes are found to explain for FGI symptoms, the following standard medication will be prescribed for 8 weeks:
FD: Pantoprazole 40mg daily; GERD: Pantoprazole 40mg daily; IBS: Mebeverine 135mg tid PRN before meal, Loperamide 4mg tid PRN (for diarrhea), Metamucil 2 teaspoon bid (for constipation).
Final Visit (8 weeks after endoscopy visit)
- Attending physician manages patient as usual
- Printout of investigation (endoscopy, blood tests) reports given to patient
- Patient completes questionnaires
The patient will be given an "on-demand follow up within 1 year" option at this visit. The patient will decide if he/she wants to come back to our specialty clinic to follow up his/her problem within one year. If the patient does not come back during this period, his/her case will be closed and a new referral will be required if he/she wants to be taken care by the specialty again.
Follow-up after Final Visit:
Follow-up questionnaires will be mailed to patients 6 months, 1 and 2 years after Final visit.
All the patients will be randomized into two groups in First Visit: 1) Control group, and 2) Counseling group. Both groups of patients will follow the above protocol, except that 2 extra counseling sessions will be arranged for the Counseling group immediately after visiting the physician:
Counseling at first visit:
- Contents include: prevalence of FGID in Hong Kong, chronicity nature of the disease, negative endoscopy result to be expected, time to answer patient's questions
Counseling at final visit:
- Contents include: prevalence of FGID in Hong Kong (reinforcement), chronicity nature of the disease (reinforcement), explanation of the endoscopy result, management of disease via lifestyle modification, use of medication, need for further or repeated investigation, time to answer patient's questions.
A research personnel who has been working with patients with FGID for at least one year will be responsible for the counseling service.
The random allocation sequence will be obtained from a computer-generated list of random numbers in blocks of 10 supplied by a trial statistician. Concealed allocation is achieved by an independent research staff who assigns intervention group according to consecutive numbers in sealed envelopes. The patients will be invited to participate in the study to assess 1 of 2 potentially helpful interventions. They will be explained that the relative effectiveness of both interventions are unproven and may or may not be beneficial.
In this study, the patients, attending physicians and endoscopes will all be blinded to the randomized arm that the patients are assigned to. The nature of the two arms will also be blinded to them. This arrangement is essential in clinical trials comparing different services or managing strategies and is clearly specified in the Patient Information Sheet.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Health Services Research
Non-erosive Gastroesophageal Reflux Disease
Prince of Wales Hospital
Active, not recruiting
Chinese University of Hong Kong
Published on BioPortfolio: 2014-08-27T03:16:41-0400
The aim of the study is to evaluate the effect of pantoprazole on fast symptom reduction in patients with NERD (non-erosive reflux disease) or eGERD (erosive gastroesophageal reflux diseas...
The purpose of this study is to evaluate the efficacy and safety of oral TAK-438 10 mg once-daily in the treatment of non-erosive gastroesophageal reflux disease
To investigate the efficacy and safety of a 4-week treatment of 5 mg/day or 10 mg/day of E3810 in patients with non-erosive gastroesophageal reflux disease in a multicenter, randomized, do...
Gastroesophageal reflux disease (GERD) considered to be associated with mucosal damages in the esophagus and heartburn, which may sometimes interfere with daily activities due likely to re...
The aim of the study is to evaluate the effect of pantoprazole on fast symptom reduction in hospitalized patients with NERD (non-erosive reflux disease) or GERD (gastroesophageal reflux di...
Nocturnal gastroesophageal reflux has been associated with poor sleep quality. Normal physiologic adaptations of the aerodigestive system to sleep prolong and intensify nocturnal reflux events. This o...
In most cases gastroesophageal reflux disease proceeds without macroscopic erosions in the esophagus. We aimed to clarify if abnormalities detectable in magnifying endoscopy may offer additional diagn...
Esomeprazole is commonly administered with food; however, clinical data to support this practice are lacking. We aimed to determine the effect of postprandial ingestion of esomeprazole on reflux sympt...
Clinical Validity and Reliability of the Malay Language Translations of Gastroesophageal Reflux Disease Questionnaire and Quality of Life in Reflux and Dyspepsia Questionnaire in a Primary Care Setting.
Gastroesophageal Reflux Disease Questionnaire (GERDQ) and Quality of Life in Reflux and Dyspepsia Questionnaire (QOLRAD) are reliable tools for evaluation of GERD.
Combined 24-h intraesophageal pH-multichannel intraluminal impedance (24MII-pH) used for assessing gastroesophageal reflux disease by measuring baseline impedance (BI) requires a 24-h measuring period...
Retrograde bile flow. Reflux of bile can be from the duodenum to the stomach (DUODENOGASTRIC REFLUX); to the esophagus (GASTROESOPHAGEAL REFLUX); or to the PANCREAS.
Back flow of gastric contents to the LARYNGOPHARYNX where it comes in contact with tissues of the upper aerodigestive tract. Laryngopharyngeal reflux is an extraesophageal manifestation of GASTROESOPHAGEAL REFLUX.
The R-isomer of lansoprazole that is used to treat severe GASTROESOPHAGEAL REFLUX DISEASE.
Chronic ESOPHAGITIS characterized by esophageal mucosal EOSINOPHILIA. It is diagnosed when an increase in EOSINOPHILS are present over the entire esophagus. The reflux symptoms fail to respond to PROTON PUMP INHIBITORS treatment, unlike in GASTROESOPHAGEAL REFLUX DISEASE. The symptoms are associated with IgE-mediated hypersensitivity to food or inhalant allergens.
A substituted benzamide used for its prokinetic properties. It is used in the management of gastroesophageal reflux disease, functional dyspepsia, and other disorders associated with impaired gastrointestinal motility. (Martindale The Extra Pharmacopoeia, 31st ed)
Stress is caused by your perception of situations around you and then the reaction of your body to them. The automatic stress response to unexpected events is known as 'fight or flight'. Discovered by Walter Cannon in 1932, it is the release of h...
Anxiety is caused by stress. It is a natural reaction, and is beneficial in helping us deal with tense situations and pressure. It is deterimental when is becomes an excessive, irrational dread of everyday situations. The most common types of anxiety di...