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DOI: 10.1055/s-0039-3400072
Phytotherapy in children: data from the PhytoVIS study, a NIS in 20,870 users of herbal medicinal products
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.
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References
- 1 Raskopf. et al. Z Phytother. 2017 38. (S 01): S1-S44
- 2 European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP), 2018 EMA/929209/2011.