Open, Randomised, Controlled Study to Evaluate the Role of a Dietary Supplement Containing Pelargonium sidoides Extract, Honey, Propolis, and Zinc as Adjuvant Treatment in Children with Acute Tonsillopharyngitis.

BACKGROUND/OBJECTIVES: A common reason for a pediatrician's visit is acute tonsillopharyngitis (ATR), which is usually caused by viruses. A dietary supplement comprising Pelargonium sidoides extract, honey, propolis, and zinc was proposed as an effective adjuvant for the management of respiratory tract infections. The study aimed to determine the efficacy of this dietary supplement in conjunction with standard of care (SoC) compared to SoC alone, in a pediatric population affected by ATR.

METHODS: This open randomized study (registered on ClinicalTrials.gov: NCT04899401) involved three Romanian sites specialized in pediatric care. The primary endpoints were changes in Tonsillitis Severity Score and the number of patients failing to respond (evaluating the use of ibuprofen or high-dose paracetamol as a rescue medication). One hundred and thirty children, distributed into two groups, were enrolled and treated for six days.

RESULTS: The results showed an overall better performance in terms of efficacy of dietary supplement + SoC, compared to SoC alone, with lower total Tonsillitis Severity Score ratings on day 6 (p = 0.002) and lower sub-scores related to erythema and throat pain on day 6. No adverse events were reported. Investigators found compliance to be optimal.

CONCLUSIONS: The administration of the dietary supplement + SoC in pediatric patients with ATR was found to be safe and superior to the administration of SoC alone in terms of efficacy. The results confirmed that the tested dietary supplement is an optimum effective adjuvant in the treatment of respiratory tract infections and is suitable for the daily clinical practice of pediatricians.