ArticleCPT: pharmacometrics & systems pharmacology2015
Quantitative prediction and clinical evaluation of an unexplored herb-drug interaction mechanism in healthy volunteers.
Article in CPT: pharmacometrics & systems pharmacology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
22 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Utility of physiologically based pharmacokinetic (PBPK) modeling in oncology drug development and its accuracy: a systematic review.European journal of clinical pharmacology · 2018Pooled it
- Fraxetin Inhibits UGT1A1 and UGT1A9 Activities In Vitro: Inhibition Kinetics, Molecular Dynamics Simulation, and Prediction of Herb-Drug Interaction Risk.Pharmaceuticals (Basel, Switzerland) · 2026Article
- Herb-drug interactions in oncology: pharmacodynamic/pharmacokinetic mechanisms and risk prediction.Chinese medicine · 2025Review
- A new paradigm for drug discovery in the treatment of complex diseases: drug discovery and optimization.Chinese medicine · 2025Review
- Artificial Intelligence Models and Tools for the Assessment of Drug-Herb Interactions.Pharmaceuticals (Basel, Switzerland) · 2025Review
- Efflux and uptake transport and gut microbial reactivation of raloxifene glucuronides.Basic & clinical pharmacology & toxicology · 2025Article
- Advancements in Virtual Bioequivalence: A Systematic Review of Computational Methods and Regulatory Perspectives in the Pharmaceutical Industry.Pharmaceutics · 2024Review
- Co-consuming green tea with raloxifene decreases raloxifene systemic exposure in healthy adult participants.Clinical and translational science · 2023Article
- Review
- Utilization of Physiologically Based Pharmacokinetic Modeling in Pharmacokinetic Study of Natural Medicine: An Overview.Molecules (Basel, Switzerland) · 2022Review
- Examination of the Impact of CYP3A4/5 on Drug-Drug Interaction between Schizandrol A/Schizandrol B and Tacrolimus (FK-506): A Physiologically Based Pharmacokinetic Modeling Approach.International journal of molecular sciences · 2022Article
- Modeling Pharmacokinetic Natural Product-Drug Interactions for Decision-Making: A NaPDI Center Recommended Approach.Pharmacological reviews · 2021Review
- Potential for pharmacokinetic interactions between Schisandra sphenanthera and bosutinib, but not imatinib: in vitro metabolism study combined with a physiologically-based pharmacokinetic modelling approach.British journal of clinical pharmacology · 2020Article
- "Natural" is not synonymous with "Safe": Toxicity of natural products alone and in combination with pharmaceutical agents.Regulatory toxicology and pharmacology : RTP · 2020Review
- Current trends in drug metabolism and pharmacokinetics.Acta pharmaceutica Sinica. B · 2019Review
- Herb-drug interactions: a novel algorithm-assisted information system for pharmacokinetic drug interactions with herbal supplements in cancer treatment.European journal of clinical pharmacology · 2019Article
- Selection and characterization of botanical natural products for research studies: a NaPDI center recommended approach.Natural product reports · 2019Review
- Mechanistic Assessment of Extrahepatic Contributions to Glucuronidation of Integrase Strand Transfer Inhibitors.Drug metabolism and disposition: the biological fate of chemicals · 2019Article
- Hepatoprotective effect of gastrodin against alcohol-induced liver injury in mice.Journal of physiology and biochemistry · 2019Article
- Identification of Intestinal UDP-Glucuronosyltransferase Inhibitors in Green Tea (Drug metabolism and disposition: the biological fate of chemicals · 2018Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors.
Funding
Abstract
Quantitative prediction of herb-drug interaction risk remains challenging. A quantitative framework to assess a potential interaction was used to evaluate a mechanism not previously tested in humans. The semipurified milk thistle product, silibinin, was selected as an exemplar herbal product inhibitor of raloxifene intestinal glucuronidation. Physiologically based pharmacokinetic (PBPK) model simulations of the silibinin-raloxifene interaction predicted up to 30% increases in raloxifene area under the curve (AUC0-inf) and maximal concentration (Cmax). Model-informed clinical evaluation of the silibinin-raloxifene interaction indicated minimal clinical interaction liability, with observed geometric mean raloxifene AUC0-inf and Cmax ratios lying within the predefined no effect range (0.75-1.33). Further refinement of PBPK modeling and simulation approaches will enhance confidence in predictions and facilitate generalizability to additional herb-drug combinations. This quantitative framework can be used to develop guidances to evaluate potential herb-drug interactions prospectively, providing evidenced-based information about the risk or safety of these interactions.
Identifiers
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.