comorbid generalized anxiety disorder and diarrhea-predominant irritable bowel syndrome
Conditions
Interventions
Two groups:Traditional Chinese Medicine,Electroacupuncture versus Shame control+routine care
(to be continued):Electroacupuncture + routine care: Patients randomized to electroacupuncture (EA) group will receive 10 sessions of EA over 10 weeks (1 session / week), each patient will receive EA
bilateral ST36 and ST37
bilateral SP6 and LR3
left GV20 and Yintang).
(Electroacupuncture + routine care: to be continued):A Chinese medicine practitioner (CMP) delivering the EA will insert sterile, single-use filiform EA needles, with a length of 25-40 mm and a diamet
(Electroacupuncture + routine care: to be continued):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.
(Electroacupuncture + routine care: to be continued):Then, using an EA device, each pair of EA and auxiliary needles will be subjected to a 30 minutes 2Hz continuous wave electro-stimulation. The inte
(Electroacupuncture + routine care: to be continued):For all patients, routine care will be provided. This usually consists of 2 to 3-monthly consultations with doctors who may provide symptom-based m
(Electroacupuncture + routine care: to be continued):Medication use will be recorded by pill count at the final follow up, and number of attendances documented.Doctors attending to these patients are
(Shame control+routine
Sponsors
Department of Medicine and Therapeutics,The Chinese University of Hong Kong
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Rome III criteria for irritable bowel syndrome- diarrheal subtype: (1) Current (weekly) symptoms of type and severity: i. Abdominal pain intensity: weekly average of worst daily (in the past 24 hours) abdominal pain score of at least 1 on 0-4 5-point Likert scale, AND ii. Stool consistency: at least one stool with a consistency of Type 6 or Type 7 Bristol Stool Score in at least 25% of the time. (2) Normal colonic evaluation (colonoscopy or barium enema) within the past 5 years. 2. DSM-5 Criteria for Generalized Anxiety Disorder with GAD7 score 10 or above; 3. Age >18; 4. Provision of written consent.
Exclusion criteria
Exclusion criteria: 1. Functional dyspepsia (Rome III definition) and/or Gastro-esophageal reflux disease (Montreal definition) as dominant syndrome; 2. Previous gastrointestinal surgery (except appendicectomy and cholecystectomy); 3. History of organic disease of the gastrointestinal tract, such as colorectal cancer, advanced colonic polyp, celiac disease, inflammatory bowel disease, previous gastrointestinal surgery or systemic diseases that may cause diarrhea; 4. Pregnancy, lactation or not under proper contraception; 5. Concomitant use of anti-diarrheal drugs; 6. History of drug abuse or regular alcohol use in recent 6 months; 7. Active suicidal thoughts or history of violence or suicide attempts; 8. Currently suffering from depression of at least moderate severity (PHQ-9 15 or above); 9. History of severe mental illness, such as psychosis, bipolar disorder, or organic brain syndrome that may limit the response of anxiety and somatic symptoms to electroacupuncture. 10. History of psychotropic drug use or treatment in recent month xi) Currently receiving psychological treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinically significant response defined as 50% reduction in GAD-7 scores at 10 weeks; | — |
Secondary
| Measure | Time frame |
|---|---|
| (1)Clinically significant response in anxiety symptoms at 16 weeks;(2)Bowel symptom at 10 and 16 weeks;(3)Depressive (PHQ9) and Somatic symptoms (PHQ-15) scores at 10 and 16 weeks;(4)EQ-5D health utility score as economic benefit at 10 and 16 weeks;(5)Direct medical costs and indirect medical costs:time period: from week 0 to week 10 and from week 10 to week 16; | — |
Countries
China
Contacts
Public ContactArthur Dun Ping, MAK
Department of Medicine and Therapeutics,The Chinese University of Hong Kong
Outcome results
None listed