Efficacy and safety of mild-warm moxibustion in treating diarrhea-predominant irritable bowel syndrome (spleen deficiency and dampness excess syndrome): a study protocol for a randomized controlled trial

Background: Irritable bowel syndrome (IBS) is a disorder of bowel function, and diarrhea-predominant irritable bowel syndrome (IBS-D) is the most common. The current treatment for IBS-D is focused on improving patients’ gastrointestinal-related symptoms, but there are limitations such as unstable effects and adverse drug reactions. Acupuncture and moxibustion exerts advantages in treating IBS-D. They include several forms, of which moxibustion is one of the most commonly used. And moxibustion is a common way used in treating IBS-D, but there is a lack of relevant evidence-based medical research data. This protocol aims to compare the efficacy of moxibustion (mild-warm moxibustion) in treating IBS-D (spleen deficiency and dampness excess syndrome) with the first-line treatment. Methods: In this prospective, parallel, randomized controlled trial (RCT) protocol, patients will be randomly allocated for 4-week treatment or control therapies and then 4-week follow-up in both groups. We will use Irritable Bowel Syndrome-Symptom Severity Scale (IBS-SSS) score, Irritable Bowel Syndrome-Quality of Life (IBS-QOL) score, serum brain-gut peptide levels, and traditional Chinese medicine (TCM) syndrome scale score to produce more evidence on IBS-D treatment with moxibustion. Finally, we will use SPSS 22.0 software to statistically analyze the data. Discussion: Mild-warm moxibustion is a complementary alternative therapy that fits with the pathogenesis of IBS-D. We hope to see more clinical evidence for mild-warm moxibustion against IBS-D that this RCT supported.