Moxibustion intervention for patients with irritable bowel syndrome: A study protocol for a randomised controlled trial

Introduction: This study is designed to evaluate the efficacy and safety of treating irritable bowel syndrome patients with a proper dose of moxibustion. Methods and analysis: This study will be a 4-week-long, randomised controlled pilot clinical trial. Twentyfour patients will be recruited and randomly allocated to 1 of 2 groups: a 3 moxibustion treatment intervention group and a 1 moxibustion treatment control group. Both groups will receive two moxibustion sessions a week for 4 weeks (8 sessions in total). The primary outcome will be measured using the Bowel Symptom Severity Scale. The inclusion criteria are as follows. The patients will be between 18 and 30 years old and of either gender. The patients will have experienced repeated abdominal pain or discomfort (i.e., an uncomfortable sensation not described as pain) at least 3 times per month in association with two or more of the following over the previous 3 months: (a) improvement with defecation; (b) onset associated with a change in the frequency of defecation; (c) onset associated with a change in the form (appearance) of stool. All included patients will have provided written consent to the clinical ethics committee and have agreed with both the clinical trial plan and follow-up observations. Ethics and dissemination: This research protocol has been reviewed and approved by the institutional review board of the trial centre (Semyung Korean Medicine Hospital, IRB No. 2016-06-01). The results will be published in a journal and will be disseminated both electronically and in print. (C) 2016 Elsevier GmbH. All rights reserved.