Safety of Pelargonium extract EPs 7630 in young children with acute bronchitis
Wolfgang Kamin1,2, Ulrich Behre3, Klaus Helm4
1Children's Hospital, Evangelic Hospital, Hamm, Germany.
Insights
Pelargonium sidoides root extract EPs 7630, in syrup and oral solution forms, demonstrated equal safety and tolerability in children with acute bronchitis. Both formulations effectively improved symptoms and overall health status.
Area of Science:
- Phytomedicine
- Pediatrics
- Respiratory Medicine
Background:
- Pelargonium sidoides DC. root extract EPs 7630 is recognized for its efficacy in treating acute bronchitis (AB) in children.
- Previous studies established the effectiveness and tolerability of EPs 7630.
- This study specifically evaluated a syrup formulation and an oral solution in pre-school children.
Purpose of the Study:
- To investigate the safety and tolerability of two pharmaceutical forms of EPs 7630 (syrup and oral solution).
- To compare the efficacy of the syrup and oral solution in treating acute bronchitis in pre-school children.
Main Methods:
- An open-label, randomized clinical trial involving children aged 1-5 years with acute bronchitis.
- Participants received either EPs 7630 syrup or oral solution for 7 days.
- Safety was assessed via adverse events, vital signs, and lab values. Efficacy was measured using the Bronchitis Severity Scale (BSS-ped), respiratory symptom assessment, general health status (IMOS), and patient satisfaction (IMPSS).
Main Results:
- 591 children were randomized; adverse events were similarly low in both groups, with no safety concerns identified.
- The most common adverse events were infections and gastrointestinal disorders, occurring at comparable rates in both syrup and solution groups.
- Over 90% of children showed symptom improvement (BSS-ped) after one week, with over 80% achieving complete recovery or major improvement. Parent satisfaction was high (86.1%).
Conclusions:
- Both EPs 7630 syrup and oral solution are equally safe and well-tolerated in pre-school children with acute bronchitis.
- The pharmaceutical forms demonstrated similar efficacy in improving health status and alleviating symptoms.
- The findings support the use of both EPs 7630 syrup and oral solution for treating acute bronchitis in young children.
Background:
The efficacy and tolerability of Pelargonium sidoides DC. root extract EPs 7630 in children with acute bronchitis (AB) have been widely demonstrated. We investigated the safety and tolerability of a syrup formulation and an oral solution in pre-school children.
Methods:
In an open-label, randomized clinical trial (EudraCT number 2011-002652-14), children aged 1-5 years suffering from AB received EPs 7630 syrup or solution for 7 days. Safety was assessed by frequency, severity, and nature of adverse events (AE), vital signs, and laboratory values. Outcome measures for evaluating the health status were the intensity of coughing, pulmonary rales, and dyspnea, measured by the short version of the Bronchitis Severity Scale (BSS-ped), further symptoms of the respiratory infection, general health status according to the Integrative Medicine Outcomes Scale (IMOS), and satisfaction with treatment according to the Integrative Medicine Patient Satisfaction Scale (IMPSS).
Results:
591 children were randomized and treated with syrup (n = 403) or solution (n = 188) for 7 days. In both treatment groups, the number of adverse events was similarly low and revealed no safety concerns. The most frequently observed events were infections (syrup: 7.2%; solution: 7.4%) or gastrointestinal disorders (syrup: 2.7%; solution: 3.2%). After one week's treatment, more than 90% of the children experienced an improvement or remission of the symptoms of the BSS-ped. Further respiratory symptoms decreased similarly in both groups. At Day 7, more than 80% of the whole study population had completely recovered or showed a major improvement as assessed by the investigator and the proxy, respectively. Parents were "very satisfied" or "satisfied" with the treatment in 86.1% of patients in the combined syrup and solution group.
Conclusion:
Both pharmaceutical forms, EPs 7630 syrup and oral solution, were shown to be equally safe and well tolerated in pre-school children suffering from AB. Improvement of health status and of complaints were similar in both groups.
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