Abstract
BackgroundIrritable bowel syndrome (IBS) is a chronic gastrointestinal disorder characterized by abdominal pain and change of bowel habit without organic disease. A global perspective given by the World Gastroenterology Organization (WGO) points out that IBS can impact the quality of an individual’s daily life, cause socioeconomic problems and potentially impair the patient-physician relationship. It remains a problem to treat IBS due to the complicated pathophysiology. Acupuncture is an alternative therapy recommended for IBS. The aim of this study is to investigate the efficacy and safety of acupuncture therapy for patients with IBS. We also want to explore the correlation between IBS-gene subtypes and acupuncture effect.Methods/designA multicenter randomized controlled trial will be performed in seven hospitals. Six hundred participants will be stratified into two strata (IBS-C or IBS-D). Then, patients within each stratum will be divided into an experimental group and a control group randomly. The experimental group is treated with acupuncture while the control group is treated with Western medicine. All the patients will receive a 6-week treatment and a 3-month follow-up. The primary outcome is the IBS-Symptom Severity Score (IBS-SSS), the secondary outcome is the score of the IBS-Quality of Life (IBS-QoL).The correlation between IBS-gene subtypes and acupuncture effect will be detected based on polymerase chain reaction-restriction fragment length polymorphism (PCR-RFLP). Outcome measures (including primary and secondary outcome measures) are collected at baseline,1 week, 2 weeks, 4 weeks, and 6 weeks of the intervention, and 12 weeks after the intervention.DiscussionThis is a multicenter randomized controlled trial for IBS in China. It may clarify the efficacy of acupuncture as an alternative therapy for IBS. This is the first time ever that the potential mechanism of IBS based on genomics has been investigated.Trial registrationChinese Clinical Trials Register, ID: ChiCTR-IOR-15006259. First registered on 14 April 2015.
Highlights
Irritable bowel syndrome (IBS) is a chronic gastrointestinal disorder characterized by abdominal pain and change of bowel habit without organic disease
This is a multicenter randomized controlled trial for IBS in China. It may clarify the efficacy of acupuncture as an alternative therapy for IBS
This is the first time ever that the potential mechanism of IBS based on genomics has been investigated
Summary
Irritable bowel syndrome (IBS) is a chronic gastrointestinal disorder characterized by abdominal pain and change of bowel habit without organic disease. The aim of this study is to investigate the efficacy and safety of acupuncture therapy for patients with IBS. Abnormalities in the brain-gut interaction and gastrointestinal mobility, and visceral hypersensitivity are the main pathophysiological basis of IBS, but their underlying. Polymorphisms in the serotonin reuptake transporter (SERT) gene have been widely implicated in the disturbances of gastrointestinal functions in IBS. The SERT gene is responsible for controlling the synaptic concentration of serotonin, or 5-hydroxytryptamine (5-HT), which is an important neurotransmitter and paracrine signaling molecule involved in the brain-gut axis and regulation of gastrointestinal mobility and sensation. Recent studies have identified several polymorphisms in the serotonin-related genes associated with IBS, including the 5-HT-transporter-gene-linked polymorphic region (5-HTTLPR), variable number of tandem repeats STin, and the single-nucleotide polymorphism (SNP) rs25531 [9–12]
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