RealWorld Evidence (RWE) in der Phytotherapie.

Background: Real world evidence (RWE) is becoming increasingly important in the evaluation of medical interventions and complements findings fromcontrolled clinical trials. At the same time, the RWE approach faces considerable methodological and ethical challenges. Herbal medicinal products have their place in therapy by health professionals and in self-medication for minor complaints, as well as symptoms that have a lasting impact on quality of life. However, the currently required key studies for drug approval do not adequately reflect the consequences of a medical prescription and/or self-medication. Therefore, the usability of RWE for research in the field of phytopharmaceuticals as well as methodological basics for the establishment of a phytoregistry was discussed in a workshop. Methods: The workshop consisted of two parts: impulse presentations on the topics of RWE and phytotherapy and the development of the basis of a position paper using the methodology of the nominal group technique. Results: The impulse presentations included interdisciplinary arguments fromthe fields of research and practice of phytotherapy, register creation, health services research, artificial intelligence and telemedicine. In the nominal group process, the chances and risks of phytotherapy, as well as content-related, methodological and practical aspects of a phytoregistry were discussed (focus, added value and methodological standards of the registry, financing, expected criticism, methods of analysis and significance in comparison to other medical fields). Conclusions: Registries are an increasingly accepted way to generate evidence in addition to clinical trials. The establishment of a registry for phytopharmaceuticals with clearly defined methodological criteria and the recording of patient-centered endpoints offers the opportunity to expand the scientific basis of the use and clinical benefit of phytopharmaceuticals. [ABSTRACT FROM AUTHOR]