Zhi Zhu
Kanggan granules may provide potential clinical benefits for children with HFMD as an adjunctive therapy. However, the certainty of evidence remains limited due to methodological weaknesses, substantial heterogeneity, possible publication bias, and insufficient safety reporting. Further high-quality, multicenter, double-blind RCTs with standardized outcomes and comprehensive safety monitoring are required.
BACKGROUND: Hand, foot, and mouth disease (HFMD) is a common infectious disease in children caused by enteroviruses, and effective specific antiviral therapies remain limited. Kanggan granules, a traditional Chinese medicine formulation, have been widely used as an adjunctive treatment for HFMD. This study aimed to systematically evaluate the clinical efficacy and safety of Kanggan granules in children with HFMD.
METHODS: A systematic literature search was conducted in PubMed, Embase, Cochrane Library, CNKI, Wanfang Data, and VIP databases from inception to June 30, 2024. Randomized controlled trials (RCTs) comparing Kanggan granules with or without conventional treatment vs. conventional treatment alone were included. Two reviewers independently performed study selection, data extraction, and risk-of-bias assessment using the Cochrane RoB 2 tool. Meta-analyses were conducted using random-effects or fixed-effects models according to heterogeneity. The certainty of evidence was evaluated using the GRADE framework.
RESULTS: Thirteen RCTs involving 1,320 children with HFMD were included. Compared with conventional treatment alone, Kanggan granules significantly increased the total effectiveness rate (OR = 4.60, 95% CI: 2.86-7.43, p < 0.001). Kanggan granules-based treatment was also associated with shorter herpes regression time (MD = -1.41 days, 95% CI: -1.81 to -1.00), oral ulcer healing time (MD = -1.08 days, 95% CI: -1.42 to -0.74), fever duration (MD = -1.32 days, 95% CI: -1.58 to -1.05), and hospitalization duration (MD = -1.90 days, 95% CI: -2.62 to -1.19). However, substantial heterogeneity was observed for several continuous outcomes. Safety data were insufficient, with only one study reporting adverse events.
CONCLUSIONS: Kanggan granules may provide potential clinical benefits for children with HFMD as an adjunctive therapy. However, the certainty of evidence remains limited due to methodological weaknesses, substantial heterogeneity, possible publication bias, and insufficient safety reporting. Further high-quality, multicenter, double-blind RCTs with standardized outcomes and comprehensive safety monitoring are required.