This randomized, controlled study, evaluated the effects of an oral supplement composed with Sambucus nigra, Zinc, Tyndallized Lactobacillus acidophilus (H122), Arabinogalactans, vitamin D, vitamin E and vitamin C, on inflammation of the upper airway tract and the outcome of otitis media with effusion (OME) in 198 children. Children were supplemented with either 10 ml of oral supplements (OS) with immune-stimulating molecules for three months (20 days consecutively, then 10 days of suspension – the therapeutic scheme was repeated three times), or 10 ml of OS for 90 consecutive days or 15 ml of OS for 45 consecutive days or the standard treatment for rhinitis and OME. Outcome measures included otoscopy, tympanometry, fibroendoscopy, and the pure tone audiometry (PTA) at T0 (before treatment), T1 (45 days after treatment), and T2 (90 days after treatment).

Results showed that all children treated with OS showed a reduction of Upper Airway Infection (UAI) episodes and OME compared to the control group independent of the administration method and posology. The three groups treated with OS showed statistically significant differences between T0 and T2 for otoscopy, tympanometry, fibroendoscopy, and PTA.

In conclusion, OS with immune-stimulating molecules should be considered as a supporting therapy in children affected by recurrent episodes of UAI associated with OME due to their capacity to improve the immune response and reduce the inflammatory phenomena.

Della Volpe A, Ricci G, Ralli M, Gambacorta V, De Lucia A, Minni A, Pirozzi C, Paccone M, Pastore V, Di Stadio A. The effects of oral supplements with Sambucus nigra, Zinc, Tyndallized Lactobacillus acidophilus (HA122), Arabinogalactans, vitamin D, vitamin E and vitamin C in otitis media with effusion in children: a randomized controlled trial. Eur Rev Med Pharmacol Sci. 2019 Jul;23(14):6360-6370.