Gegen huangqin huanglian decoction for children rotavirus enteritis: A protocol for systematic review and meta-analysis.

BACKGROUND: Rotavirus infection is the main cause of severe dehydration enteritis in children under 5 years old. It gives rise to malnutrition and even death in children even though there were rotavirus vaccines. However, there is no effective anti-virus drugs for rotavirus, supporting treatments are used in the clinics. Traditional Chinese medicine (TCM) has been treating diarrhea for many years. Gegen Huangqin Huanglian Decoction (GHHD)is a classic prescription for diarrhea in TCM. With the development of clinical trials and basic studies, GHHD has been proved that a good curative effect on diarrhea. Therefore, a systematic review is necessary to improve available evidence for GHHD in therapy of children under 5 years old with rotavirus enteritis. METHODS: Different studies from various databases will be involved in this study. Only randomized controlled trials of rotavirus enteritis patients diagnosed with Guidelines for the Treatment of Acute Gastroenteritis in Outpatient Pediatrics, which released by the Washington International Children's Medical Center, Zhu Futang's Practical Pediatrics (7 th Edition), and the 2016 clinical practice guidelines for children with acute infectious diarrhea in China. We will search the literature in the databases from China Conference Paper Database, manual searching. Electronic database includes PubMed, Embase, Cochrane Library, Web of Science, CNKI (China National Knowledge Internet), WanFang, VIP (Chongqing VIP), and CBM (China Biomedical Literature CDROM Database). The primary outcomes include the total effective rate, the time of stopping diarrhea, the level of IL-6 serum concentration, fecal microflora ratio, the conversion of fecal rotavirus antigen. The secondary outcomes include clinical efficacy and the quantitative integral of TCM symptom, recovery time of stool character, treatment period. Besides, incidence of adverse events (such as irritation and toxicity) and costs will be also considered. 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 high-quality evidence based on the data of the currently published GHHD for the treatment of children rotavirus enteritis, in terms of the total effective rate, the time of stopping diarrhea, the level of IL-6 serum concentration, fecal microflora ratio, stool rotavirus antigen, clinical efficacy and the quantitative integral of TCM symptom, recovery time of stool character, treatment period, and safety. CONCLUSION: This systematic review aims to evaluated the benefits and harms of GHHD for the treatment of children rotavirus enteritis reported in randomized controlled trials, and provide more options for clinicians and patients to treat children rotavirus enteritis. REGISTRATION NUMBER: INPLASY2020100023.