Acupuncture for Irritable Bowel Syndrome Patients

Irritable Bowel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04387383
• Other study ID #: HKBU AcupIBS
• Status: Recruiting
• Phase: N/A
• Start date: May 18, 2020
• Est. completion date: December 2021

Study information

• Verified date: July 2021
• Source: Hong Kong Baptist University
• Contact: Linda Zhong, MD., Ph.D
• Phone: 852-34116523
• Email: ldzhong0305[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Syndrome

Intervention

Device:
• Acupuncture
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
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

Locations

Country	Name	City	State
Hong Kong	Linda Zhong	Kowloon Tong	Kowloon

Sponsors (1)

Lead Sponsor	Collaborator
Hong Kong Baptist University

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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