Zusanli (ST36) acupoint injection for acute diarrhea in children under 5 years old A protocol of systematic review and meta-analysis of randomized clinical trials

Background: Acute diarrhea is the 2nd highest prevalence disease among children under 5 years of age. It can cause malnutrition and even death in children, especially in developing country. Traditional Chinese medicine therapy has been applied and already in the guidelines for clinical practice of acute infectious diarrhea in children in China, but there is no specific methods or recommendations due to lacking of evidence. Zusanli acupoint injection as a form of acupuncture therapy, which is proved to be effective in randomised controlled trials (RCTs) and very suitable for children, has been used in acute diarrhea in children for a long time; therefore, a systematic review is necessary to provide available evidence for further study. Methods: Different studies from various databases will be involved in this study. Only RCTs of children under 5 years of age diagnosed with acute diarrhea using any recognized diagnostic criteria will be included. We will search manually the literature in the databases from China Conference Paper Database. Electronic database includes PubMed, Embase, Cochrane Library, Web of Science, China National Knowledge Internet, WanFang, Chongqing VIP, and China Biomedical Literature CDROM Database. Primary outcomes: clinical cure rate (clinical cure is defined as the frequency, timing and character of stool back to normal status, as well as disappearance of diarrhea symptoms), diarrhea duration (from admission to the cessation of diarrhea). Secondary outcomes: stool frequency within 24 hours, rate of adverse effect. Data will be extracted by 2 researchers independently; risk of bias of the meta-analysis will be evaluated based on the Cochrane Handbook for Systematic Reviews of Interventions. All data analysis will be conducted by data statistics software Review Manager V.5.3. and Stata V.12.0. Results: This study will synthesize and provide evidence based on the data of the currently published zusanli (ST36) acupoint injection for acute diarrhea in children under 5 years old, especially in terms of clinical efficacy and safety. Conclusion: This systematic review aims to evaluate the benefits and harms of zusanli acupoint injection for acute diarrhea in children under 5 years old reported in RCTs, and provide evidence reference in TCM field for Chinese guidelines on the treatment of acute diarrhea in children. Ethics and dissemination: This study is a systematic review; the outcomes are based on the published evidence, and hence examination and agreement by the ethics committee are not required in this study. We intend to publish the study results in a journal or conference presentations. PROSPERO registration number: PROSPERO 2019 CRD42019135275.