Efficacy and Safety of Oral Herbal Medicine Combined with Diosmectite for Pediatric Rotavirus Gastroenteritis: A Systematic Review and Meta-Analysis

Background/Objectives: Rotavirus is a leading cause of severe acute gastroenteritis in children and is commonly associated with prolonged diarrhea and dehydration. Herbal medicine (HM) is frequently used in combination with diosmectite in clinical practice, but the effectiveness of this combined approach has not been systematically evaluated. This study aimed to assess the efficacy and safety of HM combined with diosmectite in pediatric rotavirus gastroenteritis. Methods: We searched 12 databases from inception to 10 December 2025. Randomized controlled trials comparing HM plus diosmectite with diosmectite alone in children with rotavirus gastroenteritis were included. Study selection, data extraction, and risk-of-bias assessment were independently performed by two researchers. Meta-analyses were conducted using RevMan 5.4, and the certainty of evidence was evaluated with GRADEpro. Results: A total of 26 RCTs involving 2876 children were included. Compared with diosmectite alone, HM combined with diosmectite significantly reduced the duration of diarrhea (SMD −1.31; 95% CI −1.63 to −0.99), improved the total effective rate (RR 1.25; 95% CI 1.19 to 1.31), decreased the incidence of adverse events (RR 0.24; 95% CI 0.06 to 0.92), and a shorter length of hospital stay (MD −1.53; 95% CI −1.73 to −1.33). The certainty of evidence ranged from moderate to very low. Conclusions: HM combined with diosmectite may offer a potential adjunctive therapy for pediatric rotavirus gastroenteritis. However, more robust and high-quality evidence is required to further substantiate its efficacy and safety.