Assessing Organoleptic Properties Simulation of a Placebo of Raw Food Material to a Chinese Medicine Oral Liquid FYTF-919.

BACKGROUND: Research on blinding and physical consistency between placebo and Chinese medicine is in early stages. We complement novel methodologies for assessing blinding and physical consistency meanwhile investigate different roles of the two evaluations, taking Chinese botanical drug FYTF-919 with matched placebo as an example. METHODS: Subjective evaluation through a clinical trial and objective evaluation by intelligent sensory analysis technology were used in this study. Eligible individuals were recruited and randomly provided FYTF-919 or placebo. Participants were instructed to determine nature of the substance (FYTF-919 or placebo) and compare odor and taste of the given substance with true FYTF-919. Objective evaluation on odor and taste properties was conducted by E-nose and E-tongue. RESULTS: Forty-seven participants completed this trial. More than half participants identified placebo as FYTF-919; comparable proportions of participants in each group identified testing drug as FYTF-919. There's no significant difference in taste score between two groups. Higher odor score for FYTF-919 was associated with medical experience. Consistent with the clinical trial findings, intelligent machines-based sensory evaluation revealed that the two drugs could be confused in taste, whereas their odors were distinguishable. CONCLUSIONS: The placebo was effectively blinded to the traditional Chinese medicine in this study. However, the similarity between the drug and the placebo has not been fully confirmed, as their odor might be detected by the E-nose and medical staff. Therefore, medicine dispensing by dedicated personnel and preventing medical staff from having access to the investigational drugs are necessary for successful blinding throughout the clinical trial. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT05483595.