Acupuncture for Irritable Bowel Syndrome Patients: A Single-blinded Randomized Sham-controlled Clinical Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Irritable Bowel Syndrome
- Sponsor
- Hong Kong Baptist University
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Change on IBS Quality of Life (IBS-QoL)
- Last Updated
- 4 years ago
Overview
Brief Summary
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
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.
Investigators
Zhong Lidan
Assistant Professor
Hong Kong Baptist University
Eligibility Criteria
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
Outcomes
Primary Outcomes
Change on IBS Quality of Life (IBS-QoL)
Time Frame: 0,8,14 weeks
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.
Change on Self-Rating Depression Scale (SDS)
Time Frame: 0,8,14 weeks
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.
Change on IBS-symptom severity scale
Time Frame: 0,8,14 weeks
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.
Change on Hamilton Depression Rating Scale (HAMD-17)
Time Frame: 0,8,14 weeks
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.
Change on Clinical Global Impression-severity (CGI-S)
Time Frame: 0,8,14 weeks
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.