Xiyanping injection as adjunctive therapy for viral diarrhea in children under 5 years of age: a systematic review and meta-analysis of randomized controlled trials

Diarrhea is a common and consequential gastrointestinal disorder in children aged <5 years and remains a major global public health concern. Viral pathogens account for most cases of pediatric diarrhea; however, no specific antiviral treatment is available. Xiyanping injection, a traditional Chinese medicine with antiviral and anti-inflammatory properties, has been increasingly adopted in clinical practice. This study aimed to systematically evaluate the efficacy and safety of Xiyanping injection as an adjunct to conventional treatment for viral diarrhea in children aged <5 years.

A comprehensive search of PubMed, the Cochrane Library, Web of Science, China National Knowledge Infrastructure, Wanfang, Chinese Scientific Journals Database, and SinoMed was conducted from database inception to October 1, 2025 (updated to July 15, 2026), to identify randomized controlled trials (RCTs). Methodological quality was assessed using the Cochrane Risk of Bias tool. Meta-analyses were conducted using R software, and certainty of evidence was evaluated using the Grading of Recommendations Assessment, Development and Evaluation approach.

Twenty-seven RCTs involving 3721 children were included. Compared with control interventions, adjunctive Xiyanping injection significantly improved the 3-day cure rate (relative risk [RR] = 1.52, 95% confidence interval [CI]: 1.32, 1.75) and 3-day efficacy rate (RR = 1.16, 95% CI: 1.13, 1.19). It also shortened diarrhea duration (mean difference [MD] = −1.54 days, 95% CI: −1.87, −1.20) and hospital stay (MD = −1.60 days, 95% CI: −2.35, −0.844), although substantial heterogeneity was observed. No statistically significant difference in adverse reactions was found between the groups. Sensitivity analyses supported the robustness of the results, with evidence certainty ranging from low to very low.

Xiyanping injection may improve short-term clinical outcomes in children with viral diarrhea. However, overall certainty of evidence is limited, and the available safety evidence remains insufficient. Further high-quality RCTs are needed to confirm its efficacy and safety.

This study was registered with the International Prospective Register of Systematic Reviews (https://www.crd.york.ac.uk/prospero/, CRD420251238691).