TY - JOUR
T1 - Electro-acupuncture for irritable bowel syndrome patients
T2 - study protocol for a single-blinded randomized sham-controlled clinical trial
AU - Zhong, Linda L. D.
AU - Lam, Tsz Fung
AU - Yang, Wei
AU - Zheng, Ya
AU - Lyu, Zipan
AU - Bian, Zhaoxiang
N1 - Funding Information:
This research was financially supported by the donation from K.Y. and Betty Ho. The sponsors have no role in designing and analyzing the study.
Publisher Copyright:
© The Author(s). 2021
PY - 2021/12
Y1 - 2021/12
N2 - Background: Irritable bowel syndrome (IBS) is one of the most common functional gastrointestinal disorders in clinical practice. IBS diagnosis is based on symptoms defined by abdominal pain or discomfort associated with defecation or changes in bowel habits. Gut-brain interaction caused by stress or depressive emotion is one of the essential pathologies. Acupuncture has been used for the treatment of internal medicine, including digestive disorders and depressive disorders in Chinese medicine. This study aims to determine whether electro-acupuncture could have significant benefits than sham acupuncture for IBS. Methods/design: This is a single-blinded randomized sham-controlled clinical trial with two arms. A total of 120 IBS patients will be recruited. 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-week run-in-period, 6-week treatment period, and 6-week follow-up period. Five visits in total were scheduled for each subject in week 0, week 2, week 5, week 8, and week 14. The outcomes would be measured with (1) IBS-SSS, (2) Hamilton Depression Rating Scale (HAMD-17), (3) Clinical Global Impression-Severity (CGI-S), (4) Self-Rating Depression Scale (SDS), and (5) IBS Quality of Life (IBS-QoL). Discussion: The study will compare electro-acupuncture with sham acupuncture to explore the feasibility of electro-acupuncture in improving IBS symptoms. Trial registration: ClinicalTrials.govNCT04387383. Registered on 13 May 2020
AB - Background: Irritable bowel syndrome (IBS) is one of the most common functional gastrointestinal disorders in clinical practice. IBS diagnosis is based on symptoms defined by abdominal pain or discomfort associated with defecation or changes in bowel habits. Gut-brain interaction caused by stress or depressive emotion is one of the essential pathologies. Acupuncture has been used for the treatment of internal medicine, including digestive disorders and depressive disorders in Chinese medicine. This study aims to determine whether electro-acupuncture could have significant benefits than sham acupuncture for IBS. Methods/design: This is a single-blinded randomized sham-controlled clinical trial with two arms. A total of 120 IBS patients will be recruited. 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-week run-in-period, 6-week treatment period, and 6-week follow-up period. Five visits in total were scheduled for each subject in week 0, week 2, week 5, week 8, and week 14. The outcomes would be measured with (1) IBS-SSS, (2) Hamilton Depression Rating Scale (HAMD-17), (3) Clinical Global Impression-Severity (CGI-S), (4) Self-Rating Depression Scale (SDS), and (5) IBS Quality of Life (IBS-QoL). Discussion: The study will compare electro-acupuncture with sham acupuncture to explore the feasibility of electro-acupuncture in improving IBS symptoms. Trial registration: ClinicalTrials.govNCT04387383. Registered on 13 May 2020
KW - Electro-acupuncture
KW - IBS
KW - Irritable bowel syndrome
UR - http://www.scopus.com/inward/record.url?scp=85115066102&partnerID=8YFLogxK
U2 - 10.1186/s13063-021-05563-4
DO - 10.1186/s13063-021-05563-4
M3 - Journal article
C2 - 34526079
AN - SCOPUS:85115066102
SN - 1745-6215
VL - 22
JO - Trials
JF - Trials
IS - 1
M1 - 619
ER -