Abstract
OBJECTIVE: The aim of this study was to evaluate the adjunctive therapeutic efficacy and safety of a concentrated compound phytodietary supplement in the management of prolonged diarrhea in infants, using data derived from real-world clinical settings. METHODS: This retrospective, observational study analyzed real-world clinical data from three tertiary hospitals. Medical records of infants aged 6-12 months diagnosed with prolonged diarrhea (duration >14 days) between January 2020 and August 2021 were reviewed. Infants who received standard therapy alone were assigned to the control group, while those who received standard therapy in combination with the phytodietary supplement comprised the intervention group. Therapeutic response was assessed after 7 days of treatment and categorized as cure, improvement, or ineffective. RESULTS: A total of 505 infants met the inclusion criteria, with 242 infants in the intervention group and 263 in the control group. Baseline characteristics, including sex distribution, median age, and nutritional status, did not differ significantly between groups. At day 7, the intervention group demonstrated cure, improvement, and ineffective rates of 52.9%, 40.9%, and 6.2%, respectively, yielding an overall efficacy rate of 93.8%. In contrast, the control group exhibited rates of 10.3%, 63.9%, and 25.8%, respectively, with a total efficacy rate of 74.2% (χ (2) = 33.621, p < 0.01). The median diarrhea duration was 4 days in the intervention group vs. 6 days in the control group. Among 133 infants in the intervention group who underwent extended follow-up, the baseline prevalence of malnutrition was 40.6%. After 28 days, the number of complementary food categories increased by more than four, the prevalence of malnutrition declined to 31.6%, and the median Z-score for anthropometric indicators increased by 0.2 relative to baseline (p < 0.001, Cohen's d = 0.66). CONCLUSION: This real-world analysis suggests that the adjunctive use of a concentrated phytodietary supplement in infants with prolonged diarrhea may enhance therapeutic outcomes, including a significant reduction in diarrhea duration and improved nutritional status. Continued use following resolution of diarrhea may support the introduction of complementary foods and contribute to improved growth trajectories. These findings support the potential clinical utility of phytodietary supplementation as an adjunct to standard care in the pediatric population.