Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00441

2 Trial Registration Date

2014-12-30

i Registration Status

Prospective

3 Secondary IDs

CREC Ref.No.:2014.559

4 Source(s) of Funding

Health and Medical Research Fund

5 Primary Sponsor

Department of Psychiatry,The Chinese University of Hong Kong

6 Secondary Sponsor

Department of Medicine and Therapeutics,The Chinese University of Hong Kong;
Hong Kong Institute of Integrative Medicine,The Chinese University of Hong Kong

Function

Please specify

7 Responsible Contact Person (public contact person for patients interested in participating)

i Name

Fanny FANG

ii Address

Centre for Digestive Health, 4M, 4/F,Day Treatment Block, Prince of Wales Hospital, Shatin, Hong Kong

iii Phone

2632-3476

iv Email

fannyfang@cuhk.edu.hk

v Affiliation

Department of Medicine and Therapeutics,The Chinese University of Hong Kong

vi Country

8 Research Contact Person (person to contact for scientific inquiries)

i Name

Arthur Dun Ping,MAK

ii Address

Department of Psychiatry, The Chinese University of Hong Kong, Tai Po Hospital, Tai Po,Hong Kong

iii Phone

26076035/ 74723529/ 93013429

iv Email

arthurdpmak@cuhk.edu.hk

v Affiliation

Department of Psychiatry,The Chinese University of Hong Kong

vi Country

9 Official Scientific Title of the Study

A Pragmatic Randomised Controlled Trial Comparing an Integrated Electroacupuncture Protocol vs Sham-control in Chinese Adults with Generalized Anxiety Disorder and Diarrhea-predominant Irritable Bowel Syndrome

10 Public Title

A Pragmatic Randomised Controlled Trial Comparing an Integrated Electroacupuncture Protocol vs Sham-control in Chinese Adults with Generalized Anxiety Disorder and Diarrhea-predominant Irritable Bowel Syndrome

i Public Title in Chinese 研究名稱

電針灸對同時患有經常焦慮症和肚瀉型腸易激綜合症的療效研究

11 Short Title (Optional)

EA IBS GAD study

12 Countries of Recruitment

Hong Kong SAR, China

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2014-12-02

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

comorbid generalized anxiety disorder and diarrhea-predominant irritable bowel syndrome

15 Intervention

i Types of intervention

Other

Please specify

Traditional Chinese Medicine,Electroacupuncture

ii Description/ name of Intervention/article

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 on acupoints pairs (bilateral PC6 and HT7; bilateral ST36 and ST37; bilateral SP6 and LR3; left GV20 and Yintang). 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 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. 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 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 all patients, routine care will be provided. This usually consists of 2 to 3-monthly consultations with doctors who may provide symptom-based medical management for bowel symptoms except anti-diarrhoeal drugs, as well as sedatives (such as benzodiazepines and benzodiazepine analogues) for complaints of insomnia and anxiety. Medication use will be recorded by pill count at the final follow up, and number of attendances documented.Doctors attending to these patients are blinded to treatment assignment.

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

10 weeks: 1 session per week for 10 weeks

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

Shame control+routine care:For patients randomized to the control group, ten sessions of sham EA on top of routine care same as the treatment group described above will be given on the same acupoints. The non-penetrating sham acupuncture will be used in this study. Blunted telescopic placebo needles hidden inside foam cubes will be placed on the same acupoints as the EA group, touching the skin but without penetration deep into the acupoints. The needles are connected with electrical wire but no electrical stimulation will be applied during the sessions.

ii Dosage form of the comparative treatments

iii Dosage of the comparative treatments

iv Duration of the comparative treatments

v Frequency of the comparative treatments

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

i) Rome III criteria for irritable bowel syndrome- diarrheal subtype:
a. 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.
b. Normal colonic evaluation (colonoscopy or barium enema) within the past 5 years.
ii) DSM-5 Criteria for Generalized Anxiety Disorder with GAD7 score 10 or above
iii) Age >18
iv) Provision of written consent

ii Exclusion Criteria

i) Functional dyspepsia (Rome III definition) and/or Gastro-esophageal reflux disease (Montreal definition) as dominant syndrome
ii) Previous gastrointestinal surgery (except appendicectomy and cholecystectomy)
iii) 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
iv) Pregnancy, lactation or not under proper contraception.
v) Concomitant use of anti-diarrheal drugs.
vi) History of drug abuse or regular alcohol use in recent 6 months
vii) Active suicidal thoughts or history of violence or suicide attempts.
viii) Currently suffering from depression of at least moderate severity (PHQ-9 15 or above)
ix) 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.
x) History of psychotropic drug use or treatment in recent month
xi) Currently receiving psychological treatment.

iii Age Minimum

18

iv Age Maximum

999

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Placebo

iii Degree of masking

Single-blind

If Single-blind, who will be masked?

iv Group Assignment

Parallel

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2015-01-15

21 Target Sample Size

74

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

Clinically significant response defined as 50% reduction in GAD-7 scores at 10 weeks

24 Secondary Outcome

(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

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2017-01-03

27 Primary Registry and Trial Identifying Number

28 Date of Registration in Primary Registry

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

N/A

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Trial History Detail on 2014-12-30