Effectiveness and safety of appetite-stimulating syrup in the management of pediatric patients with loss of appetite due to acute or chronic illness: results of a prospective, single-arm, multi-center and open-label study

Background: We evaluated the effectiveness and safety of appetite-stimulating syrup (AST) for managing loss of appetite (LOA) due to acute or chronic illness in Indian children and adolescents. Methods: This was a prospective, multicenter, single-arm, open-label, observational study. Pediatric patients aged ≥6 to ≤15 years, with LOA due to acute or chronic illness were prescribed AST containing multivitamins (vitamins B12, B3, and B6), lysine, and zinc at a dose of 5 ml BID along with standard-of-care for 14 days. Results: In all, 380 patients with a mean (SD) age of 10.0 (2.4) years were enrolled. Mean (SD) duration of LOA symptoms was 1.7 (1.2) months. Overall, 79.6% of patients reported improved appetite on day 14. Correspondingly, 25.7% and 79.6% patients reported statistically significant improvement in food consumption on days 7 and 14, respectively. The mean (SD) no. of meals per day improved significantly (p<0.001) to 2.9 (0.7) on day 7 and to 3.6 (0.8) on day 14, compared to 2.5 (0.5) meals per day at baseline. Investigators ranked the effectiveness of AST from very good to excellent in 73.2% and good in 26.5% of patients. No severe treatment-emergent adverse events were reported. Conclusions: Two weeks of treatment with AST showed clinically relevant improvements in appetite and increased food consumption in children and adolescents with LOA due to acute or chronic illness. The syrup was ranked good to excellent for efficacy by investigators. These findings suggest that AST containing multivitamins, lysine, and zinc is effective for treating LOA in children and adolescents without any significant safety concerns.