Abstract
Acute respiratory infections (ARI) are the main reason for morbidity in childhood. In ca. 90% of cases, they are accompanied by cough. The purpose of this research was to study the effectiveness and safety of the STODAL® drug in the treatment of cough in children. Materials and methods used: a multicenter prospective observational non-randomized clinical study was conducted involving 1000 outpatients with ARI aged 2 to 7 y/o and whose cough duration did not exceed 3 days from the onset of the disease. All of them were prescribed and treated with the complex homeopathic anticough drug on the day of their visit to pediatric practitioner in the outpatient hospital facilities. The patients were divided into two age groups as follows: G1 (n=500) of children aged 2 to 4 y/o and G2 (n=500) of children aged 4 years and 1 day old to 7 y/o. Results: on the 7th day of the therapy, a statistically significant decrease in the severity of daytime cough was noted: in G1 the severity of cough decreased by 1.51 points (from 2.16 to 0.65 points, p<0.001) and by 1.56 points (from 2.24 to 0.68 points, p<0.001) in G2. There was no difference in the reduction in daytime cough severity between the groups (p=0.158). The severity of night cough in G1 decreased by 1.16 points (from 1.64 to 0.48 points, p<0.001) and by 1.25 points (from 1.71 to 0.46 points, p<0.001) in G2. There were no differences in the dynamics of the severity of night cough between the groups as well (p=0.135). The proportion of patients whose cough resolved completely or became clinically insignificant on the 7th day of treatment was 98%, these patients were therefore considered recovered. Cough treatment was rated positively by 95.1% of parents/caretakers. Adverse events (AEs) were reported in 5 patients (0.5% of all cases) and there were no serious AEs among them. Conclusion: the effectiveness and safety of the STODAL® drug in the treatment of cough in ARI in children aged 2 to 7 y/o allows recommending a homeopathic drug with complex anti-inflammatory, antitussive and antimicrobial action for its inclusion in the treatment regimens starting from the first days of the disease.
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