Irritable Bowel Syndrome Clinical Trial
Official title:
Effectiveness of Counseling for Functional Gastrointestinal Disorder Patients: A Double-blind Randomized Controlled Trial
Background:
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.
Indication:
Patients who have symptoms suggestive of FGID including non-erosive gastroesophageal reflux
disease (NERD), functional dyspepsia (FD) or irritable bowel syndrome (IBS).
Aim:
To validate the effectiveness of counseling in patients suffering from FGID.
Method:
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.
Randomization:
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:
First Visit
- 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 Visit
- 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.
Randomization:
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.
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