Electro-acupuncture for irritable bowel syndrome patients: study protocol for a single-blinded randomized sham-controlled clinical trial

Abstract Background Irritable bowel syndrome (IBS) is one of the most common functional gastrointestinal disorders in clinical practice. IBS diagnosis based on symptoms defined by abdominal pain or discomfort associated with defecation changes habits. Gut-brain interaction caused stress depressive emotion essential pathologies. Acupuncture has been used for treatment internal medicine, including digestive and Chinese medicine. This study aims to determine whether electro-acupuncture could have significant benefits than sham acupuncture IBS. Methods/design a single-blinded randomized sham-controlled trial two arms. A total 120 patients will be recruited. After 2-week run-in period, eligible subjects randomly assigned arms, (AC) arm (SAC) arm. Each subject go through run-in-period, 6-week follow-up period. Five visits were scheduled each week 0, 2, 5, 8, 14. The outcomes would measured (1) IBS-SSS, (2) Hamilton Depression Rating Scale (HAMD-17), (3) Clinical Global Impression-Severity (CGI-S), (4) Self-Rating (SDS), (5) Quality Life (IBS-QoL). Discussion compare explore feasibility improving symptoms. Trial registration ClinicalTrials.gov NCT04387383 . Registered 13 May 2020