An expert Delphi study to derive minimum reporting set of indices for herbal medicine samples in non-clinical laboratory studies

Abstract

IntroductionThe purpose of this study was to establish minimum reporting sets (MRS) on the quality of herbal medicines used in non-clinical laboratory studies to secure the reliability and reproducibility, provididng basis for follow-up clinical studies and increasing scalability for industrialisation, in the long run. MethodsThe types of herbal medicines used in laboratory studies are classified into crude drugs, herbal extracts, and herbal medicine formulations. A modified Delphi survey was conducted on multi-disciplinary experts of traditional medicine in Korea. In the first round, a written survey was conducted to select candidates for MRS. In the second round, an expert meeting was held to discuss the items for MRS. The final agreement was reached in the third round to propose the determined MRS for non-clinical laboratory studies using herbal medicine. ResultsThe agreed MRS included component observation, identification, and origin (scientific names and their origins) for crude drugs and quantitative test results on key marker compounds for herbal extracts and herbal medicine formulations, respectively. It was also agreed that herbal Good Manufacturing Practice and Good Manufacturing Practice standard test results of herbal medicine samples can replace MRS. ConclusionThis study proposed a MRS items for herbal medicine samples used in non-clinical laboratory studies. Further studies on standards of quality for herbal medicine samples would be required in the future.