Electro-acupuncture for Irritable Bowel Syndrome Patients: Study Protocol for A Single-blinded Randomized Sham-controlled Clinical Trial

Background:  Irritable bowel syndrome (IBS) is one of the most commonly 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 habit, and no absence of organic diseases. Acupuncture has been used for the treatment of internal medicine including digestive disorders and depressive disorder 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. 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-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. 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); 5) IBS Quality of Life (IBS-QoL). Discussion： The study will compare electro-acupuncture with sham acupuncture to explore the feasibility for electro-acupuncture in improving IBS symptoms.   Trial registration: ClinicalTrials.gov Identifier: NCT04387383