Planta Med 2019; 85(18): 1543
DOI: 10.1055/s-0039-3400072
Main Congress Poster
Poster Session 2
© Georg Thieme Verlag KG Stuttgart · New York

Phytotherapy in children: data from the PhytoVIS study, a NIS in 20,870 users of herbal medicinal products

E Raskopf
1   Institut für Medizinische Statistik und Bioinformatik, Universitätsklinikum Köln,, Kerpener Str. 62, 50937 Cologne, Germany
2   ClinNovis GmbH,, Genter Str. 7, 50672 Cologne, Germany
,
J Möller
3   Bayer Consumer Health, Research & Development, Phytomedicines Supply and Development Center, Steigerwald Arzneimittelwerk GmbH,, Havelstr. 5, 64295 Darmstadt, Germany
,
O Greinert
1   Institut für Medizinische Statistik und Bioinformatik, Universitätsklinikum Köln,, Kerpener Str. 62, 50937 Cologne, Germany
,
G Zadoyan
1   Institut für Medizinische Statistik und Bioinformatik, Universitätsklinikum Köln,, Kerpener Str. 62, 50937 Cologne, Germany
,
S Schleicher
1   Institut für Medizinische Statistik und Bioinformatik, Universitätsklinikum Köln,, Kerpener Str. 62, 50937 Cologne, Germany
,
K Sha-Hosseini
1   Institut für Medizinische Statistik und Bioinformatik, Universitätsklinikum Köln,, Kerpener Str. 62, 50937 Cologne, Germany
,
T Wegener
4   Kooperation Phytopharmaka GbR,, Plittersdorfer Str. 218, 53173 Bonn, Germany
5   Consulting HMP,, Brückstr. 11, 69469 Weinheim, Germany
,
O Kelber
3   Bayer Consumer Health, Research & Development, Phytomedicines Supply and Development Center, Steigerwald Arzneimittelwerk GmbH,, Havelstr. 5, 64295 Darmstadt, Germany
4   Kooperation Phytopharmaka GbR,, Plittersdorfer Str. 218, 53173 Bonn, Germany
,
K Kraft
4   Kooperation Phytopharmaka GbR,, Plittersdorfer Str. 218, 53173 Bonn, Germany
6   Lehrstuhl für Naturheilkunde, Universitätsmedizin Rostock,, Ernst-Heydemann Str. 6, 18057 Rostock, Germany
,
K Nieber
4   Kooperation Phytopharmaka GbR,, Plittersdorfer Str. 218, 53173 Bonn, Germany
7   Institute of Pharmacy, University of Leipzig,, Brüderstr. 34, 04103 Leipzig, Germany
,
R Mösges
1   Institut für Medizinische Statistik und Bioinformatik, Universitätsklinikum Köln,, Kerpener Str. 62, 50937 Cologne, Germany
2   ClinNovis GmbH,, Genter Str. 7, 50672 Cologne, Germany
› Author Affiliations
Further Information

Publication History

Publication Date:
20 December 2019 (online)

 

Herbal medicinal products are frequently used in the paediatric population. Since the number of clinical studies is limited, pharmaco-epidemiological research can be an important source of information. To gain insight into the use of herbal medicinal products, data from the PhytoVIS study, the world’s largest pharmaco-epidemiological study on the use of herbal medicinal products [1], were evaluated focusing on the paediatric population.

The PhytoVIS data set has been captured in doctor´s offices and pharmacies in compliance to the ENCePP Code of Conduct [2].

2063 data sets from paediatric patients were evaluated, thereof 254 from patients below 2 years, 473 from patients age 2-5, 551 from age 6-11 and 785 from age 12-17. The majority of patients (67.7%) was treated because of common cold and fever, other were gastrointestinal disorders, injuries and pain among others. Co-medication was documented in 24,9% of patients. The efficacy of the therapy was rated very good in 48,4%, good to moderate in 36.8%, missing in 4.0%. 93.7% experienced no adverse events at all, only 0.8% felt a marked impairment due to side effects. Neither the efficacy nor the tolerability seemed to differ within age groups.

The results shed light to a field of pharmacotherapy and give a picture of the use of herbal medicines in an unselected cohort of paediatric patients. They clearly show the safety and therapeutic usefulness in children. They offer good background information for therapeutic decisions based on overall tolerability and perceived effect.

 

  • References

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  • 2 European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP), 2018 EMA/929209/2011.
    PubMedGoogle Scholar