Clinical studies on herbal remedies in children: A systematic literature analysis

Introduction: Due to the increasing use of herbal remedies, knowledge of the nature of the preparations, and potential benefits and risks, as well as drug-herb interactions is necessary. However, referring to child-population controlled clinical studies are still rather rare.

Aim and Methods: The aim of our project was an appraisal of clinical trials performed in children. A systematic literature analysis was 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 designed 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 indication varied widely. The treatment of asthma, infections of the upper respiration tract, Otitis media, diarrhea and disorders of the nervous system were indications for the treatment with herbal remedies. More than 70% of the studies showed a positive therapeutic effect.

Conclusions: In children until now efficacy and safety could be demonstrated only for a few herbal remedies. According to the standards of evidence-based medicine, controlled clinical trials on other empirically well-proven herbal remedies should follow.

Disclosure Statement: No conflict of interest disclosed.

Keywords: Children, clinical trials, literature analysis,