Functional gastrointestinal diseases in children: Pharmacoepidemiological data on STW 5 from the PhytoVIS data base

Introduction Data from pharmacoepidemiological research can provide insight where clinical trials are difficult to conduct, as e. g., in children. [1].

This also applies to STW 5, a herbal medicinal product used for the treatment of functional GI diseases. It is approved for use in children, and there is a large body of data on overall 44 488 children from non-interventional studies available [2]. To broaden this evidence, data from the German PhytoVIS study, with 20,870 patients presumably the world’s largest pharmacoepidemiological study on the use of herbal medicinal products [3], were evaluated.

Method A screening on paediatric patients using STW 5 was conducted.

Results Overall, 77 datasets from the paediatric population were evaluated (60% female, 40% male). Dyspepsia-associated symptoms (FD) were the largest group (90%) while IBS could be assigned to 4% and FD-/IBS associated to 6% of the patients. In most cases, the onset of the therapeutic effect was within 60 minutes. In 60% of the patients, the treatment was rated as very, in 30% as moderately and in 10% as minimally effective. 7% of patients experienced slight adverse effects with no significant impairment and 93% experienced no adverse effects at all.

Conclusion The results confirm the therapeutic usefulness and safety of STW 5 in children [2]. In general, the data from the PhytoVIS study turned out to be a valuable basis for studying the pharmacoepidemiology of children in Germany.

Publikationsverlauf

Artikel online veröffentlicht:
13. Dezember 2021

• References

• 1 Marquard P. et al. Wien Med Wochenschr 2015;165:236-42
• 2 Möller J. ZPT 2019; 40 (S 01): S15
• 3 Raskopf et al. ZPT 2017, 38 (S 01): S1-S44; [4] Nieber K et al., Eur J Pediatr. 2020 179:507-512