Primary care experience on Stimunex® gocce in children with recurrent respiratory infections: a real-world study during the COVID-19 pandemic era.
- 2022-05-01
- Allergologia et immunopathologia 50(3)
- Alessandro Giannattasio
- Elena Poggi
- Gianfranco Trapani
- Cosimo Muia
- Luisella Zanino
- Massimo Landi
- Giorgio Ciprandi
- PubMed: 35527651
- DOI: 10.15586/aei.v50i3.562
Study Design
- Type
- Randomized Controlled Trial (RCT)
- Sample size
- n = 160
- Population
- 298 children with recurrent respiratory infections (RRI)
- Methods
- randomly prescribed the food supplement daily for 4 months (Active group); remaining children treated only with standard therapy (Control group)
- Blinding
- Open-label
- Duration
- 4 months
- Funding
- Unclear
- Large Human Trial
Background
Respiratory infections (RI) significantly burden society, mainly when there are recurrent respiratory infections (RRI). Thus, there is a need to prevent RI in clinical practice. In this regard, the modulation of the immune system and resolution of the inflammatory cascade could represent an ideal way to prevent RI. Stimunex® gocce, a multicomponent food supplement, contains Sambucus nigra extract, β-glucan, Zinc, and Vitamin D3. This study investigated its ability to prevent RRI in children using a real-world setting: the pediatric primary care.Materials and methods
Two hundred and ninety-eight children with RRI were enrolled in the current study. The food supplement was randomly prescribed to 160 children with RRI daily for 4 months (Active group); the remaining 138 children with RRI were treated only with standard therapy for RI (Control group). The number and duration of RI, parental perception of symptom severity and treatment efficacy, use of medications, and school and working absence were evaluated.Results
Children treated with Stimunex® gocce had significantly less RI than the Control group, both concerning upper and lower RI (p˂0.001 and 0.003, respectively) during the follow-up period. Moreover, children in the Active group experienced shorter RI duration during the treatment and follow-up phases (p˂0.001 for both). In addition, parents of treated children perceived less severe symptoms and better treatment efficacy during the first and follow-up phases (p˂0.001 for all). The food supplement was well tolerated and there was no adverse event.Conclusions
The current real-world study demonstrated that Stimunex® gocce supplementation in children with RRI might safely prevent RI episodes and reduce RI duration. These outcomes should be highlighted as obtained during the COVID-19 pandemic era, characterized by a dramatic reduction of RI.Research Insights
parents of treated children perceived less severe symptoms and better treatment efficacy during the first and follow-up phases (p˂0.001 for all)
- Effect
- Beneficial
- Effect size
- Small
children in the Active group experienced shorter RI duration during the treatment and follow-up phases (p˂0.001 for both)
- Effect
- Beneficial
- Effect size
- Small
Children treated with Stimunex® gocce had significantly less RI than the Control group, both concerning upper and lower RI (p˂0.001 and 0.003, respectively)
- Effect
- Beneficial
- Effect size
- Small
parents of treated children perceived less severe symptoms and better treatment efficacy during the first and follow-up phases (p˂0.001 for all)
- Effect
- Beneficial
- Effect size
- Small
Children treated with Stimunex® gocce had significantly less RI than the Control group, both concerning upper and lower RI (p˂0.001 and 0.003, respectively)
- Effect
- Beneficial
- Effect size
- Small
parents of treated children perceived less severe symptoms and better treatment efficacy during the first and follow-up phases (p˂0.001 for all)
- Effect
- Beneficial
- Effect size
- Small
children in the Active group experienced shorter RI duration during the treatment and follow-up phases (p˂0.001 for both)
- Effect
- Beneficial
- Effect size
- Small
Children treated with Stimunex® gocce had significantly less RI than the Control group, both concerning upper and lower RI (p˂0.001 and 0.003, respectively)
- Effect
- Beneficial
- Effect size
- Small
parents of treated children perceived less severe symptoms and better treatment efficacy during the first and follow-up phases (p˂0.001 for all)
- Effect
- Beneficial
- Effect size
- Small
Children treated with Stimunex® gocce had significantly less RI than the Control group, both concerning upper and lower RI (p˂0.001 and 0.003, respectively)
- Effect
- Beneficial
- Effect size
- Small
parents of treated children perceived less severe symptoms and better treatment efficacy during the first and follow-up phases (p˂0.001 for all)
- Effect
- Beneficial
- Effect size
- Small
children in the Active group experienced shorter RI duration during the treatment and follow-up phases (p˂0.001 for both)
- Effect
- Beneficial
- Effect size
- Small
Children treated with Stimunex® gocce had significantly less RI than the Control group, both concerning upper and lower RI (p˂0.001 and 0.003, respectively)
- Effect
- Beneficial
- Effect size
- Small
parents of treated children perceived less severe symptoms and better treatment efficacy during the first and follow-up phases (p˂0.001 for all)
- Effect
- Beneficial
- Effect size
- Small
Children treated with Stimunex® gocce had significantly less RI than the Control group, both concerning upper and lower RI (p˂0.001 and 0.003, respectively)
- Effect
- Beneficial
- Effect size
- Small
Adverse Events Reported
The food supplement was well tolerated and there was no adverse event.
- Finding
- Reported