Efficacy of Grintuss® pediatric syrup in treating cough in children: a randomized, multicenter, double blind, placebo-controlled clinical trial

Abstract

BackgroundCough is an extremely common problem in pediatrics, mostly triggered and perpetuated by inflammatory processes or mechanical irritation leading to viscous mucous production and increased sensitivity of the cough receptors. Protecting the mucosa might be very useful in limiting the contact with micro-organisms and irritants thus decreasing the inflammation and mucus production. Natural molecular complexes can act as a mechanical barrier limiting cough stimuli with a non pharmacological approach but with an indirect anti-inflammatory action.ObjectiveAim of the study was to assess the efficacy of a medical device containing natural functional components in the treatment of cough persisting more than 7 days.MethodsIn this randomized, parallel groups, double-blind vs. placebo study, children with cough persisting more than 7 days were enrolled. The clinical efficacy of the study product was assessed evaluating changes in day- and night-time cough scores after 4 and 8 days (t4 and t8) of product administration.ResultsIn the inter-group analysis, in the study product group compared with the placebo group, a significant difference (t4 study treatment vs. t4 placebo, p = 0.03) was observed at t4 in night-time cough score.Considering the intra-group analysis, only the study product group registered a significant improvement from t0 to t4 in both day-time (t0 vs. t4, p = 0.04) and night-time (t0 vs. t4, p = 0.003) cough scores.A significant difference, considering the study product, was also found in the following intra-group analyses: day-time scores at t4 vs. t8 (p =0.01) and at t0 vs. t8 (p = 0.001); night-time scores at t4 vs. t8 (p = 0.05), and at t0 vs. t8 (p = 0.005). Considering a subgroup of patients with higher cough (≥3) scores, 92.9% of them in the study product group improved at t0 vs. t4 day-time.ConclusionsGrintuss® pediatric syrup showed to possess an interesting profile of efficacy and safety in the treatment of cough persisting more than 7 days.

Natural remedies for acute post-viral cough in children

“…In the first study, a specific combination of polysaccharides, resins, saponins, flavonoids, and honey was superior to placebo in treating nocturnal post-viral cough persisting for more than seven days. 54 This study was confirmed by another randomized, single-blinded, multicenter study. 55 This second trial included 150 children with acute cough because of URTI; patients were treated with the polysaccharide-resin-saponins-honey-based medical device, or carbocysteine, for four consecutive days.…”

A Review and Evaluation of the Data Supporting Internal Use of Helichrysum italicum

“…In the trial by Canciani et al [ 61 ], Grintuss ® syrup was compared to a placebo syrup in young children suffering from persisting cough. Both syrups were taken in four doses per day for eight days.…”

Acute cough in children and adolescents: A systematic review and a practical algorithm by the Italian Society of Pediatric Allergy and Immunology

“…Moreover, honey, when administered in addition to specific substances, such as resins, polysaccharides, saponins, flavonoids, and sugars, appeared superior also to the placebo in the treatment of cough persisting more than 7 days. 34 Specifically, 102 children aged 3-6 years, randomly assigned to the treatment group and placebo group, experienced a significant improvement both in day-time and nighttime cough scores and, interestingly, severe adverse events or other safety reasons were not recorded in the treatment group. 34 In light of these findings, the authors hypothesized that honey, although not showing specific pharmacological properties, can act effectively as a mechanical barrier limiting the injury caused by external micro-organisms and irritants on the upper respiratory tract mucosa, inhibit the stimulation of nerve endings, and exert an indirect anti-inflammatory action, resulting in the recovery of the damaged tissue.…”

“…34 Specifically, 102 children aged 3-6 years, randomly assigned to the treatment group and placebo group, experienced a significant improvement both in day-time and nighttime cough scores and, interestingly, severe adverse events or other safety reasons were not recorded in the treatment group. 34 In light of these findings, the authors hypothesized that honey, although not showing specific pharmacological properties, can act effectively as a mechanical barrier limiting the injury caused by external micro-organisms and irritants on the upper respiratory tract mucosa, inhibit the stimulation of nerve endings, and exert an indirect anti-inflammatory action, resulting in the recovery of the damaged tissue. Probably, these effects may be potentiated by the components present in the product, including Grindelia, Plantago, and Helichrysum, which exert antiinflammatory and cytoprotective adjunctive effects.…”