Clinical Efficacy and Safety of Liquid Pelargonium sidoides Preparation (EPs 7630) in Children with Acute Non-Streptococcal Tonsillopharyngitis

Journal of Comprehensive Pediatrics

ARTICLE

V. Berezhnoi, Viatcheslav¹  Heger, Marianne¹  Lehmacher, Walter²  Seifert, Georg³ 

[1] Shupyk National Medical Academy of Postgraduate Education;Institut fuer Medizinische Statistik;Otto-Heubner-Center for Pediatric and Adolescent Medicine (OHC), Department of Pediatric Hematology and Oncology

关键词: Placebo;    EPs 7630;    Pelargonium sidoides;    Tonsillopharyngitis;   

DOI  :  10.17795/compreped-42158

来源: Kowsarmedical

【 摘 要 】

Background: Acute tonsillopharyngitis is amongst the most common reasons for children, adolescents and young adults to consult with a physician. Despite extensive prescription, antibiotic therapy is indicated in less than one-fifth of these cases. New treatment strategies for patients with non-group-A-streptococcal acute tonsillopharyngitis are therefore required. Objectives: EPs 7630 is an extract from the roots of Pelargonium sidoides DC . After positive clinical study results in children with acute bronchitis, the present study was conducted to demonstrate the efficacy of EPs 7630 in the treatment of acute tonsillopharyngitis in children. Methods: In this double-blind placebo-controlled clinical trial with a group sequential design, the efficacy and tolerability of EPs 7630 were investigated in 6- to 10-year-old patients with acute tonsillopharyngitis, who showed no evidence of group A β-hemolytic streptococcus. Treatment duration was 6 days. Primary efficacy variable was change in the sum score of the tonsillitis severity score (TSS) on day 4 compared to baseline. Results: Overall, data on the change of the TSS measured for the EPs 7630 and placebo group were available for 60 and 64 children, respectively. After 4 days of treatment, the TSS had decreased from 9.6 ± 1.2 to 2.8 ± 2.6 points in the active medication group and from 9.5 ± 1.3 to 6.1 ± 4.1 points in the placebo group (P < 0.001), indicating superiority of EPs 7630 over placebo. Conclusions: EPs 7630 was found to be efficacious in the treatment of acute tonsillopharyngitis in children and was very well tolerated.

【 授权许可】

Unknown