title: In vivo effect of I'm-Yunity on hepatic cytochrome P450 3A4.
abstract: The inhibition or induction of hepatic cytochrome P450 3A4 (CYP3A4) enzyme associated with herbal medicines such as I'm-Yunity (Coriolus versicolor) can result in clinically significant herb-drug interactions. The active ingredient of I'm-Yunity is believed to be polysaccharopeptide polymer (PSP). Drug interactions between I'm-Yunity and other medications or supplements are yet to be investigated. The objective of this single-treatment, one-period, three-phase, open-labeled study was to evaluate the ability of I'm-Yunity to inhibit or induce CYP3A4 in 12 healthy adult volunteers (8 women and 4 men) aged between 23 and 54 years through the use of a CYP3A4-specific assay, the erythromycin breath test (EBT). EBT measurements are reported as percentage of 14C-Erythromycin metabolized/hr. Participants were given a 14-day supply of I'm-Yunity and instructed to take 1200 mg, three times daily with meals. Comparisons of all subjects' mean CYP3A4 activities were performed with the EBT before and after taking I'm- Yunity. Results revealed a mean EBT change (SD) from baseline of 0.08% (0.56%) 14C-Erythromycin metabolized/hr, which was not significant (p = 0.63). Therefore, 14 days of exposure to I'm-Yunity was not associated with clinically significant CYP3A4 inhibition or induction, suggesting that short-term administration of I'm-Yunity with medications primarily metabolized by CYP3A4 is safe and not expected to be associated with significant herb-drug interactions. However, it is still unknown whether interactions exist between I'm-Yunity and other medications metabolized by other CYP450 isozymes or enzyme/transporter systems.
authors.affiliation: Dept of Clinical Pharmacy, University of California, San Francisco, CA 94143, USA. ps01459@itsa.ucsf.edu
authors.forename: Jean Paul A
authors.initials: JP
authors.lastname: Nicandro
authors.forename: Candy
authors.initials: C
authors.lastname: Tsourounis
authors.forename: Lynda
authors.initials: L
authors.lastname: Frassetto
authors.forename: B Joseph
authors.initials: BJ
authors.lastname: Guglielmo
mesh_terms: D000328:Adult; D001692:Biological Transport; D001944:Breath Tests; D051544:Cytochrome P-450 CYP3A; D003577:Cytochrome P-450 Enzyme System / Q000187:drug effects* / Q000378:metabolism; D004305:Dose-Response Relationship, Drug; D004365:Drugs, Chinese Herbal / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D004917:Erythromycin; D005260:Female; D041743:Herb-Drug Interactions; D006801:Humans; D008297:Male; D008875:Middle Aged; D010936:Plant Extracts / Q000494:pharmacology
chemical_list: D004365:Drugs, Chinese Herbal; C515565:I'm-Yunity; D010936:Plant Extracts; D004917:Erythromycin; D003577:Cytochrome P-450 Enzyme System; D051544:Cytochrome P-450 CYP3A; C510163:CYP3A4 protein, human