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Milk thistle and indinavir: a randomized controlled pharmacokinetics study and meta-analysis
Edward Mills1, Kumanan Wilson, Mike Clarke
1Faculty of Health Sciences, Clinical Epidemiology and Biostatistics, McMaster University, HSC-2C12, 1200 Main Street West, Hamilton, ON, L8N 3Z5, Canada. millsej@mcmaster.ca
European Journal of Clinical Pharmacology
|January 25, 2005
Summary
Milk thistle (Silybum marianum) did not significantly affect indinavir pharmacokinetics in healthy participants. This randomized controlled trial found no significant reduction in indinavir levels when co-administered with milk thistle extract.
Area of Science:
- Pharmacokinetics
- Herbal Medicine Interactions
- Drug Metabolism
Background:
- Milk thistle is a popular herbal supplement.
- Indinavir is an antiretroviral medication used to treat HIV/AIDS.
- Potential interactions between herbal supplements and antiretroviral drugs require investigation.
Purpose of the Study:
- To evaluate the effect of milk thistle (Silybum marianum) ingestion on the pharmacokinetics of indinavir.
- To determine if milk thistle alters indinavir absorption or metabolism.
Main Methods:
- A three-period, randomized controlled trial involving 16 healthy participants.
- Participants received indinavir dosing, with measurements of indinavir levels (AUC(0-8)).
- The intervention group received milk thistle extract, while the control group did not, followed by repeated indinavir dosing and sampling.
Main Results:
- No significant differences in indinavir pharmacokinetics were observed between the milk thistle and control groups.
- Mean indinavir AUC(0-8) showed a non-significant decrease of 4.4% in the active group.
- A meta-analysis of three trials confirmed a non-significant pooled mean difference of 1% in indinavir AUC(0-8).
Conclusions:
- Milk thistle ingestion does not significantly alter indinavir pharmacokinetics.
- Co-administration of milk thistle with indinavir appears safe from a pharmacokinetic interaction perspective.
- Further research may be warranted for specific patient populations.