Pharmaco-epidemiological research on herbal medicinal products in the paediatric population: data from the PhytoVIS study

Kija Shah-Hosseini,Olaf Kelber,Jaswinder Singh,Esther Raskopf,Johanna Möller,Karin Kraft,Karen Nieber,Robert Fürst,Ralph Mösgens

doi:10.1007/s00431-019-03532-3

Abstract

In paediatrics, clinical study data are limited, especially on herbal medicinal products. To address this gap, 2063 datasets from the paediatric population were evaluated in the PhytoVIS data base. By screening for paediatric data, information on indication, gender, treatment, co-medication and tolerability were evaluated. The majority of patients was treated because of common cold, fever, digestive complaints, skin diseases, sleep disturbances and anxiety. The perceived effect of the therapy was rated in 84% of the patients as very good or good without adverse events. The data shed light on a still neglected field of phyto-pharmacotherapy by giving information on the use of herbal medicines in an unselected cohort of paediatric patients. The results confirm the good clinical effects and safety of herbal medicinal products in this patient population and show that they are widely used in Germany.What is Known:• In Germany, about 85% of children receive one or more herbal medicinal products per year.• Despite international initiatives to promote clinical research in paediatrics, there are still many gaps of knowledge in the use of drugs in paediatrics.What is New:• The PhytoVIS project evaluated 2063 data sets from the paediatric population using herbal medicinal products.• The majority of patients was treated because of common cold, fever, digestive complaints, skin diseases, sleep disturbances and anxiety, and 84% of the patients rated the therapy as very good or good without adverse events.

Highlights

More and more parents are considering the use of herbal medicinal products (HMPs) to maintain the health of their children and to treat their diseases [1]
The field of pharmaco-epidemiology has grown substantially in the last 20 years, very few researchers focus on the paediatric patient group and on HMPs, where data on clinical studies are rare [12].The PhytoVIS database was created as a tool by which the experiences of patients who acquired HMPs in pharmacies could be recorded
In the lower age groups (0 to 11 years), more male patients were treated with herbal medicines, whereas among the adolescents (12– 17 years), females clearly outweighed them (Fig. 2)

Summary

Introduction

More and more parents are considering the use of herbal medicinal products (HMPs) to maintain the health of their children and to treat their diseases [1]. Some of the safety information can be provided by randomized controlled trials (RCTs), they are often limited in terms of sample size and in length of follow-up [4,5,6,7] This implicates that safety can best be answered by pharmacoepidemiological studies [8, 9] or by individual case safety reports [10]. This is relevant for children among whom the use of drugs is frequently off-label but recorded in routine care [11]. The data were evaluated with respect to the paediatric population

Methods

Results

Conclusion