Efficacy of BianShi Moxibustion for bowel preparation: study protocol for a randomized controlled trial

Background Adequate bowel preparation is one of the most important prerequisite during the colonoscopy. It is conductive to detect the polypus, adenoma and early colorectal carcinoma and decrease the rate of overuse of medical resource. BianShi Moxibustion(BSM) is one of the most important Traditional Chinese Medicine(TCM) treatment options, which is called TCM proper technology. BSM is applied to prevent and cure digestive system disorder widely, including functional constipation(FC), irritable bowel syndrome(IBS), functional dyspepsia(FD) etc. we speculate that BSM can improve the bowel preparation quality through ameliorating the function of digestive tract, especially in high risk of inadequate bowel preparation patients, including elderly individual, diabetes mellitus, neurodegenerative changes etc. Hence, the objective of this research is to evaluate the efficacy of BSM on the quality of bowel preparation before colonoscopy. Method This is a randomized triple-blinded, single-center, prospective study. We will recruit 72 inpatients who are scheduled to undergo colonoscopy for screening and diagnostic or therapeutical purposes for the first time will be randomized to assign into treatment group or control group at a ratio of 1:1. The intervention plan in the treatment group consists of 3L polyethylene glycol(PEG) solution plus BSM(Treatment period is 3 days, Qd). In the control group, the plan is 3L PEG plus sham BSM. Boston Bowel Preparation Scale(BBPS) will be used to evaluate the efficacy of the bowel preparation and regarded as the primary outcome measure. The secondary outcomes including caecal intubation rate, the willingness to repeat colonoscopy, the tolerance of bowel preparation regimens, the rate of adverse events. Discussion The aim of this clinical trial is to confirm the influence of BSM on the quality of bowel preparation. The hypothesis of this study is that the BSM has a positive role on the quality of bowel preparation. The routine bowel preparation regime combines with TCM proper technology will enhance bowel preparation quality and ameliorate the subjective feeling of participants. In addition, it will provide the reliable evidence of bowel preparation prior to colonoscopy from the point of view of integrative medicine. Trial registration This protocol and trial was registered in the Chinese Clinical Trial Registry(ChiCTR2300077168). ### Competing Interest Statement The authors have declared no competing interest. ### Clinical Trial ChiCTR2300077168 ### Funding Statement This study did not receive any funding ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: Ethics committee of ShenZhen hospital of BeiJing university of Chinese medicine(Long Gang) gave ethical approval for this work I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes All data produced in the present study are available upon reasonable request to the authors