The Effectiveness of a Dietary Supplement with Honey, Propolis, Pelargonium sidoides Extract, and Zinc in Children Affected by Acute Tonsillopharyngitis: An Open, Randomized, and Controlled Trial

Abstract

Physicians are currently finding products for pediatric respiratory diseases of viral etiology to reduce the inappropriate use of antibiotic therapy. This study evaluated PediaFlù (Pediatrica S.r.l.), a dietary supplement already on the market composed of honey, propolis, Pelargonium sidoides extract, and zinc (DSHPP), in children affected by acute tonsillopharyngitis (ATR). The open-label, randomized, and controlled study compared DSHPP + standard of care (SoC) versus SoC alone for six days. Children between 3 and 10 years with an ATR ≤ 48 h, a negative rapid test for beta-hemolytic Streptococcus, or a culture identification of nasal and/or pharyngeal exudates were included. A tonsillitis severity score (TSS) and the number of treatment failures (using ibuprofen or high-dose paracetamol as rescue medication) were the primary endpoints. DSHPP+ SoC showed better performance than SoC alone for TSS sub-scores: throat pain and erythema on day 6 (p < 0.001 and p < 0.05), swallowing (p < 0.01 on day 4), and TSS total score on days 4 and 6 (p < 0.05 and p < 0.001). Only one patient (SoC group) had treatment failure for ibuprofen administration. No adverse events were reported. DSHPP is an optimal adjuvant in the treatment of URTI and could potentially be useful in the daily clinical practice of paediatricians evaluating the correct antibiotic prescription.

Keywords: Pelargonium sidoides; dietary supplements; honey; nasopharyngitis; pharyngitis; propolis; severity score; tonsillitis; zinc.

Figure 1

Flow diagram of the study. Standard of care (SoC); DSHPP dietary supplement PediaFlù^® based on honey and propolis associated to zinc and Pelargonium sidoides extract.

Figure 2

Change in TSS Throat pain; mean ± SD ratings from start of administration to final visit. On day 6 p < 0.001 (Mann–Whitney U test).

Figure 3

Difficulty in swallowing mean ± SD ratings with independent statistical tests between administration groups, from start of administration to final visit. ** p < 0.01; ns: non-significance.

Figure 4

Erythema mean ± SD ratings from start of administration to final visit with chi-square test. * p < 0.05; ns: non-significance.