Abstract
BackgroundIrritable bowel syndrome (IBS) is a common gastrointestinal functional disease. Adults with IBS may experience abdominal pain, change of bowel habits, and abnormal stool form without organic disease. IBS can seriously affect their work productivity and quality of life, especially diarrhea-predominant irritable bowel syndrome (IBS-D). The Chinese medicine JCM-16021 has been shown to be potentially effective in improving the symptoms of IBS-D based on a small scale clinical trial. Hence, a large scale clinical study is designed to further evaluate the efficacy and safety of the Chinese medicine JCM-16021 for IBS-D with traditional Chinese medicine (TCM) pattern of Liver Stagnation and Spleen Deficiency (LSSD).MethodsThis study is a multi-center, randomized, double-blind, placebo-controlled clinical trial. 392 eligible participants will be enrolled with 2-week run-in, 8-week treatment and 8-week follow-up. After run-in period, participants will be randomized to receive either the Chinese medicine JCM-16021 or placebo for 8 weeks, and will have post-treatment follow up for another 8 weeks. The primary outcome is the improvement rate on the global assessment of improvement (GAI) at week 10. The secondary outcomes consist of changes of IBS-D symptoms, TCM pattern improvement, IBS-Quality of Life (IBS-QoL), IBS-Symptom Severity Score (IBS-SSS), safety, etc.ResultsA standard protocol has been developed for the study. The protocol will provided a detailed procedure to conduct a clinical trial and verify if the Chinese medicine JCM-16021 would significantly improve the overall symptoms of IBS-D with LSSD pattern of TCM by relieving abdominal pain, reducing stool frequency, improving the stool consistency and improving quality of life. The consolidated evidence from the study can shed light on the treatment of IBS-D with Chinese medicine.ConclusionThe protocol will provide details for investigators about the study following SPIRIT Statement. High-quality evidence on the efficacy and safety of Chinese medicine JCM-16021 for IBS-D will be provided through strict compliance with the protocol.Trial registration: ClinicalTrial.gov identifier: NCT03457324. Registered 8 February 2018, https://clinicaltrials.gov/ct2/show/NCT03457324?term=NCT03457324&draw=2&rank=1
Highlights
Irritable bowel syndrome (IBS) is a common gastrointestinal functional disease
Highquality evidence on the efficacy and safety of Chinese medicine JCM-16021 for irritable bowel syndrome (IBS-D) will be provided through strict compliance with the protocol
Some studies show that IBS-D is the most common subtype in IBS based on Rome IV criteria [8,9,10]
Summary
Irritable bowel syndrome (IBS) is a common gastrointestinal functional disease. Irritable bowel syndrome (IBS) is a common functional gastrointestinal disorder, which is diagnosed on the basis of recurrent abdominal pain related to defecation or in association with a change in stool frequency and form [1]. In Hong Kong, based on Rome II criteria, the prevalence was reported to be 6.6%, of which the proportion of diarrheapredominant irritable bowel syndrome (IBS-D) was 27% [4]. The pathogenesis of IBS is currently unclear as none of its anatomical causes could be found. It is caused by multiple factors, which include psychological factors, changes in gastrointestinal motility, neural and endocrine factors, infection, diet, drugs etc. Some studies show that IBS-D is the most common subtype in IBS based on Rome IV criteria [8,9,10]
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