EPs 7630 is effective and safe in children under 6 years with acute respiratory tract infections: clinical studies revisited

Abstract

Objective: Pelargonium sidoides preparation EPs 7630 has been proven safe and effective in acute respiratory tract infections (aRTIs), but data for young children have not been presented separately. This study reviewed clinical studies and presents an overview of known and newly analyzed data from children <6 years.

Methods: MEDLINE and EMBASE were searched for interventional and non-interventional studies which investigated the effects of EPs 7630 in aRTIs and included children <6 years of age. Sub-group analyses for this age range were performed for symptom scales, global efficacy or effectiveness assessments, and safety outcomes.

Results: Seven studies with 1067 children <6 years exposed to EPs 7630 were identified. Efficacy of EPs 7630 was significantly superior to placebo in reducing symptom intensity and time until complete recovery in two randomized, double-blind trials in patients with acute bronchitis (AB). Similar symptom time courses were observed in two non-comparative observational studies in AB. One non-comparative, open-label study was identified in acute tonsillopharyngitis (ATP), and one in acute rhinosinusitis (ARS). In both indications, nearly all children showed complete recovery or major symptom improvements during the treatment period, with changes that were similar to those observed in controlled trials investigating older patient populations. The results were supported by an additional observational study including children with various diagnoses of aRTIs. EPs 7630 was safe and well-tolerated.

Conclusions: EPs 7630 is efficacious in children <6 years suffering from AB. The analyses also support the effectiveness of the product in ATP and in ARS. No safety concerns were identified.

Keywords:

• Pelargonium sidoides
• EPs 7630
• acute respiratory tract infections
• children
• review
• clinical trials
• efficacy
• safety

Note

Transparency

Declaration of funding

This work, including provision of all trial data used in this article, was supported by Dr. Willmar Schwabe GmbH & Co. KG, Karlsruhe, Germany.

Declaration of financial/other interests

WK, GS, and WL received honoraria from Dr. Willmar Schwabe GmbH & Co. KG, Karlsruhe, Germany for scientific services. PF and AZ are employees of Dr. Willmar Schwabe GmbH & Co. KG, Karlsruhe, Germany. CMRO peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Acknowledgments

Medical writing services were provided by Dr. Andreas Völp, Psy Consult Scientific Services, Frankfurt, Germany.

Notes

1 EPs^® 7630 is the active ingredient of the product Umckaloabo^® (ISO Arzneimittel, Ettlingen, Germany).