Abstract
BackgroundAcute cough in children often causes discomfort to children and parents, reducing their quality of life. Despite the extensive utilization of over-the-counter remedies for cough, the efficacy of most of these treatments in children has not been confirmed.MethodsWe conducted a randomized, double blind, placebo-controlled clinical trial of 106 children with acute cough to evaluate the efficacy and safety of KalobaTUSS®, a paediatric cough syrup based on acacia honey and on Malva sylvestris extract, Inula helenium extract, Plantago major extract, and Helichrysum stoechas extract by using a validated 6 points Likert scale.ResultsChildren were orally treated with KalobaTUSS® or placebo for 8 days. Children receiving KalobaTUSS® showed an early and significant reduction in night-time and day-time cough scores measured using a specific scale and a shorter duration of cough than children treated with the placebo.ConclusionsKalobaTUSS® is well tolerated and produces positive effects by reducing the severity and shortening the duration of cough in children.Trial registrationClinicaltrials.gov no. NCT04073251. Retrospectively registered.
Highlights
Acute cough in children often causes discomfort to children and parents, reducing their quality of life
Children belonging to the active group received the KalobaTUSS® syrup and the second group received a placebo as the syrup formulation
Data are expressed as means ± standard deviation
Summary
Acute cough in children often causes discomfort to children and parents, reducing their quality of life. Cough is classified as acute or chronic. Acute cough is a very common symptom resolving in the short term, while chronic cough lasts for more than 3 weeks [1]. Acute cough in children is a common reason why parents seek medical treatment and it is a real challenge for paediatricians. Acute cough is self-restrained, but its perseverance can be exasperating and can worsen the quality of life and common social participation [3]. The effect of cough experienced by children on the family’s life may create increasing discomfort. Children with acute cough may experience a transient disability, prompting parents to miss work and children to miss school, increasing the global community cost [4].
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