Abstract
BackgroundIrritable 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/designThis 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).DiscussionThe study will compare electro-acupuncture with sham acupuncture to explore the feasibility of electro-acupuncture in improving IBS symptoms.Trial registrationClinicalTrials.govNCT04387383. Registered on 13 May 2020
Highlights
Irritable bowel syndrome (IBS) is one of the most common functional gastrointestinal disorders in clinical practice
The study will compare electro-acupuncture with sham acupuncture to explore the feasibility of electro-acupuncture in improving IBS symptoms
In addition to the change of bowel habits, people with IBS frequently suffered from anxiety, and depression or mood change further worsens the IBS
Summary
Irritable bowel syndrome (IBS) is one of the most common functional gastrointestinal disorders in clinical practice. The diagnosis of IBS is based on symptoms defined by abdominal pain or discomfort associated with defecation or changes in bowel habits [1]. People with IBS frequently suffer from anxiety and depression, which can worsen the symptoms. Of those who do seek treatment, research has found that 54 to 94% have a psychiatric disorder such as an anxiety disorder or depression [4,5,6]. Acupuncture can be a more convenient option for patients with IBS as the treatment does not require daily intake of medication nor frequent clinical visits
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