Acupuncture for Irritable Bowel Syndrome Patients: A Single-blinded Randomized Sham-controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change on IBS Quality of Life (IBS-QoL)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Subjects of both groups will be randomly assigned to receive either electro-acupuncture or control (sham) treatment. For randomization, simple, complete non-sequential random numbers will be generated in advance by a computer program in a block of four, and kept by the principal investigator. After a patient's eligibility is confirmed, a randomization number which corresponds to the group allocation will be provided to the acupuncturist by the PI. This arrangement will ensure that the clinical assessor and participants are blinded to the allocation.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Change on IBS Quality of Life (IBS-QoL)
时间窗: 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)
时间窗: 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
时间窗: 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)
时间窗: 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)
时间窗: 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.
次要结局
未报告次要终点
研究者
Zhong Lidan
Assistant Professor
Hong Kong Baptist University