gms | German Medical Science

Aim: Due to the increasing use of herbal medicines, knowledge of the nature of the preparations and the potential benefits and risks is necessary. However, controlled clinical studies in children are, despite the long standing use of herbal medicines in this population, still rather rate. The aim of our project was therefore an appraisal of clinical trials preformed in children.

Method: A systematic literature analysis in accordance to the PRISMA statement was therefore performed in the databases Pubmed and Web of Science with relevant mesh terms (MeSH) of the MeSH database.

Results: The assessment of the countries in which the trials were performed has revealed that approximately 63% were conducted in 6 countries with the following order: China 37, Germany 19, USA 12, Russia 12, and UK 4. 133 clinical studies were identified, from these 90 (67.7%) were randomized and 43 (32.2%) additionally double blind. Most children involved in the trials were between 6 to 12 years old followed by preschool children and adolescents. An accumulation of clinical trials referring to the following herbal remedies could be found: Hedera helix 5, Pelargonium sidoides 4, Ginkgo biloba 3, Vaccinium macrocarpon 3, Astragalus membranaceus 3, Allium sativum 3. The indications covered a broad spectrum. The treatment of asthma, infections of the upper respiratory tract, Otitis media, diarrhoe and disorders of the nervous system were indications for the treatment with herbal medicines. More than 70 % of the studies showed a positive therapeutic effect.

Conclusion: In children until now efficacy and safety have been demonstrated for a number of herbal medicines. According to the standards of evidence-based medicine, controlled clinical trials on other herbal medicines which are empirically well-proven in children are desirable.