Zeitschrift für Phytotherapie 2019; 40(S 01): S16
DOI: 10.1055/s-0039-1697279
Vorträge
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

J Möller
1   Bayer Consumer Health, Research & Development, Phytomedicines Supply and Development Center, Steigerwald Arzneimittelwerk GmbH, Darmstadt, Germany
,
E Raskopf
2   Institut für Medizinische Statistik und Bioinformatik, Universitätsklinikum Köln, Germany
3   ClinNovis GmbH, Cologne, Germany
,
O Greinert
2   Institut für Medizinische Statistik und Bioinformatik, Universitätsklinikum Köln, Germany
,
G Zadoyan
2   Institut für Medizinische Statistik und Bioinformatik, Universitätsklinikum Köln, Germany
,
S Schleicher
2   Institut für Medizinische Statistik und Bioinformatik, Universitätsklinikum Köln, Germany
,
K Sha-Hosseini
2   Institut für Medizinische Statistik und Bioinformatik, Universitätsklinikum Köln, Germany
,
T Wegener
4   Kooperation Phytopharmaka GbR, Bonn, Germany
5   Consulting HMP, Weinheim, Germany
,
O Kelber
3   ClinNovis GmbH, Cologne, Germany
4   Kooperation Phytopharmaka GbR, Bonn, Germany
,
J Singh
2   Institut für Medizinische Statistik und Bioinformatik, Universitätsklinikum Köln, Germany
3   ClinNovis GmbH, Cologne, Germany
,
K Kraft
4   Kooperation Phytopharmaka GbR, Bonn, Germany
6   Lehrstuhl für Naturheilkunde, Universitätsmedizin Rostock, Germany
,
K Nieber
4   Kooperation Phytopharmaka GbR, Bonn, Germany
7   Institute of Pharmacy, University of Leipzig, Germany
,
R Mösges
2   Institut für Medizinische Statistik und Bioinformatik, Universitätsklinikum Köln, Germany
3   ClinNovis GmbH, Cologne, Germany
› Author Affiliations
Further Information

Publication History

Publication Date:
09 September 2019 (online)

 

Herbal medicinal products are frequently used also 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 in this age group, data from the PhytoVIS study, presumably 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 practices and pharmacies in compliance to the ENCePP Code of Conduct [2]. It was screened for data on indications, treatments, perceived effect and tolerability in the paediatric population.

Overall, 2063 data sets from paediatric patients were evaluated, thereof 254 from patients below 2 years, 473 from patients age 2 – 5 years, 551 from age 6 – 11 years and 785 from age 12 – 17 years. The majority of patients (67.7%) was treated because of common cold and fever, other reasons for herbal therapy were gastrointestinal disorders, injuries and pain among others. A co-medication was documented in 24,9% of patients. The efficacy of the therapy was rated very good in 48,4% of patients, good to moderate in 36.8%, missing in 4.0%. Out of all patients 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 depending on the age group evaluated.

These results shed light to a field of pharmacotherapy for which data were rare 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 of phytopharmacotherapy in children. By this, they also provide good background information for therapeutic decisions based on the overall tolerability and perceived effect.

Acknowledgment:

The study is supported by Kooperation Phytopharmaka GbR, Bonn, Germany.

References:

[1] Raskopf E et al. Z Phytother 2017, 38(Suppl. 01): S40–S41

[2] European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP), 2018. EMA/929209/2011