Phytotherapeutics in children: Clinical trials vs. Real World Data-which is the better approach?

Introduction: The number of phytotherapeutics available for the use in children has been decreasing in recent decades, particularly in EU member states, as many products previously used without concerns have no longer been approved for the pediatric age group due to “lack of scientific data.”

Aim: To address this, the review of clinical trials vs. the generation of Real-World Data should be explored.

Methods: Firstly, a systematic review of clinical trials worldwide was conducted according to the PRISMA statement [1], [2]. Secondly, the PhytoVIS data base, a pharmacoepidemiological data base documenting the use of phytomedicines in 20,870 patients in Germany according to EnCePP [3], was evaluated [4].

Results: The review included 133 clinical trials, of which 43 were double-blind, most with small group sizes and using partly poorly defined products. From the PhytoVIS data base 2063 data sets from children of all age groups in a wide range of indications were evaluated. Neither tolerability nor the perceived therapeutic benefit were age dependent, and data also showed no influence of the use within age limits compared with the small number of cases below the approved age limits, physicians and pharmacists being the main source of recommendation.

Conclusions: While available clinical trials on phytotherapeutics mostly have limited added value for the documentation of a safe use in children, Real World Data can provide information on a wide range of herbal medicinal products. Accordingly, the large-scale generation of Real-World Data should be encouraged, and regulatory acceptance activated.

Publikationsverlauf

Artikel online veröffentlicht:
12. Dezember 2022

• References

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• 3 European Network of Centers for Pharmacoepidemiology and Pharmacovigilance (ENCePP), 2018, EMA/929209/2011.
• 4 Nieber K, Raskopf E, Möller J. et al. Pharmaco-epidemiological Research on Herbal Medicinal Products in the Paediatric Population: Data From the PhytoVIS Study. European Journal of Pediatrics 2020; 179: 507-512