Prospective

Fanny FANG

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

2632-3476

fannyfang@cuhk.edu.hk

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

Hong Kong SAR

Arthur Dun Ping,MAK

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

26076035/ 74723529/ 93013429

arthurdpmak@cuhk.edu.hk

Department of Psychiatry,The Chinese University of Hong Kong

Hong Kong SAR

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

Yes

2014-12-02

Joint CUHK-NTEC Clinical Research Ethics Committee

CREC 2014.559

Other

Traditional Chinese Medicine,Electroacupuncture

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.

acupuncture session

10 weekly acupuncture sessions

10 weeks

1 session per week for 10 weeks

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.

sham acupuncture session

same as active treatment but sham (blunt) needles used

as in active treatment

as in active treatment

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

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.

18

999

Both Male and Female

Randomized

block randomisation

Placebo

Single-blind

Trial subjects

Parallel

3

No