Acupuncture for Irritable Bowel Syndrome Patients

Study Overview
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Brief Summary
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In this study, a 14-week, single blinded, randomized controlled clinical trial will be conducted to determine whether acupuncture could have significant benefits than sham acupuncture for IBS.

Detailed Description
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This is a single blinded randomized sham controlled clinical trial with two arms. 120 IBS patients will be recruited. The study will cooperate with Hong Kong Baptist University, and University of Toronto. After a 2-week run-in period, eligible subjects will be randomly assigned to one of two arms, acupuncture (AC) arm and sham acupuncture (SAC) arm. Each eligible subject will go through a 2-wk run-in-period, 6-wk treatment period and follow by a 6-wk of follow-up period. Five visits in total were scheduled for each subject in week 0, week 2, week 5, week 8 and week 14.

Official Title
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Acupuncture for Irritable Bowel Syndrome Patients: A Single-blinded Randomized Sham-controlled Clinical Trial

Conditions
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Irritable Bowel Syndrome

Intervention / Treatment
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* Device: Acupuncture
* Device: Sham-acupuncture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Fulfillment of the Rome IV criteria for IBS IBS Symptom Severity Scale (IBS-SSS) > 75 points (a range of 0-500 points of VAS on five questions) at baseline and during the 2-week run-in period Written informed consent. Exclusion Criteria: Pregnancy or breast-feeding Medical history of inflammatory bowel diseases, carbohydrate malabsorption, hormonal disorder, known allergies to food additives, and/or any other serious diseases Unstable medical conditions Unstable mental condition or with history of mental illness Patients who have received acupuncture treatment in last three months, or took concomitant medication with affect gastrointestinal motility or visceral sensation, such as antidiarrheal agent, antidepressant, narcotic analgesic, and anticholinergic Alcoholism or drug abuse in past 1 year Having needle phobia

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: single-blinded, randomized, sham-controlled clinical trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acupuncture group<br>Electro-acupuncture will be conducted for 2 sessions per week over 6 consecutive weeks. Disposable acupuncture needles (0.30 mm in diameter and 25-40 mm in length) are inserted at a depth of 10-30 mm obliquely into scalp acupuncture points (Baihui, Toulinqi) or straightly into body acupuncture points (Taichong, Zhangmen, Sanyinjiao, Zhongwan, Guanyuan, Tianshu, Zusanli). Electroacupuncture will be applied to the abdominal points at fast and dispersed waves through electric needle stimulator (ES-160 6-Channel Programmable Electro-acupuncture) for 30 min. The intensity is adjusted to a level at which patients feel comfortable. | Device: Acupuncture<br>* Disposable acupuncture needles (0.30 mm in diameter and 25-40 mm in length) are inserted at a depth of 10-30 mm obliquely into scalp acupuncture points (Baihui, Toulinqi) or straightly into body acupuncture points (Taichong, Zhangmen, Sanyinjiao, Zhongwan, Guanyuan, Tianshu, Zusanli). Electroacupuncture will be applied to the abdominal points at fast and dispersed waves through electric needle stimulator (ES-160 6-Channel Programmable Electro-acupuncture) for 30 min. The intensity is adjusted to a level at which patients feel comfortable.<br>|
| Placebo Comparator: sham-acupuncture group<br>Sham-acupuncture will be conducted for 2 sessions per week over 6 consecutive weeks. Disposable acupuncture needles (0.30 mm in diameter and 25-40 mm in length) are inserted at the same way as in the acupuncture group but on sham-acupuncture points (Sham-Baihui, Sham-Toulinqi, Sham-Taichong, Sham-Zhangmen, Sham-Sanyinjiao, Sham-Zhongwan, Sham-Guanyuan, Sham-Tianshu, Sham-Zusanli). The sham points are non-acupuncture points nor located on meridians | Device: Sham-acupuncture<br>* Disposable acupuncture needles (0.30 mm in diameter and 25-40 mm in length) are inserted at the same way as in the acupuncture group but on sham-acupuncture points (Sham-Baihui, Sham-Toulinqi, Sham-Taichong, Sham-Zhangmen, Sham-Sanyinjiao, Sham-Zhongwan, Sham-Guanyuan, Sham-Tianshu, Sham-Zusanli). The sham points are non-acupuncture points nor located on meridians<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change on IBS-symptom severity scale | Value from 0-500. The higher the score, the more severe the symptoms. When there is lowering of the sore between baseline and treatments, it indicates clinical improvement. | 0,8,14 weeks | 
| Change on Hamilton Depression Rating Scale (HAMD-17) | Value from 0-57. Scoring 8-16: mild depression, 17-23: moderate depression, over 24: severe depression. When there is lowering of the sore between baseline and treatments, it indicates improvement on depressive symptoms. | 0,8,14 weeks | 
| Change on Clinical Global Impression-severity (CGI-S) | Rating from 1-7, the higher rate indicates more severe of the mental problem. The subject is rated by researcher from his clinical experience. When there is lowering of the rating between baseline and treatments, it indicates improvement. | 0,8,14 weeks | 
| Change on Self-Rating Depression Scale (SDS) | Value from 20-80. Scoring 50-69: depression, over 70: severe depression. When there is lowering of the sore between baseline and treatments, it indicates improvement. | 0,8,14 weeks | 
| Change on IBS Quality of Life (IBS-QoL) | Value from 35-170. The higher the score, the lower the quality of life. When there is lowering of the sore between baseline and treatments, it indicates improvement. | 0,8,14 weeks |