Acupuncture for Irritable Bowel Syndrome Patients

Not Applicable

• Conditions: Irritable Bowel Syndrome
• Interventions: Device: Acupuncture; Device: Sham-acupuncture

• Registration Number: NCT04387383
• Lead Sponsor: Hong Kong Baptist University

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.

Study Timeline

• Study First Submitted: 2020-05-03
• Study First Submitted QC: 2020-05-12
• Study First Posted: 2020-05-13
• Study Start: 2020-05-18
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-17
• Last Update Posted: 2021-07-20
• Primary Completion: 2021-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acupuncture group	Acupuncture	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.
sham-acupuncture group	Sham-acupuncture	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

Primary Outcome Measures

Name	Time	Method
Change on IBS Quality of Life (IBS-QoL)	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)	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	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)	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)	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.

Trial Locations

Locations (1)

Linda Zhong; 🇭🇰 Kowloon Tong, Kowloon, Hong Kong