Evidence map›Paper›PMID 29735755›Full record

ArticleDrug metabolism and disposition: the biological fate of chemicals2018

Recommended Approaches for Pharmacokinetic Natural Product-Drug Interaction Research: a NaPDI Center Commentary.

Mary F Paine, Danny D Shen, Jeannine S McCune

Registry-linked trialAbstract read
In one paragraph

Article in Drug metabolism and disposition: the biological fate of chemicals, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05157672 (Evaluating the Pharmacokinetics and Drug Interaction Potential of the Botanical Dietary Supplement Cinnamon), which is not on this map. Cited by 22 papers.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from 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.

2 · The registry

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.

NCT05157672 early_phase1completednot on this mapstarted 2021, after this paper: background citation

Evaluating the Pharmacokinetics and Drug Interaction Potential of the Botanical Dietary Supplement Cinnamon

TypeinterventionalSponsorWashington State UniversityRan2021 to 2024Enrolled16ConditionsInteraction Drug FoodArmsCinnamon (2 g), Nicotine gum (2.5 mg), Letrozole (2.5 mg)
3 · Its place in the literature

Who cites it

22 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Review
  4. Article
  5. Article
  6. Article
  7. Natural Products Inhibition of Cytochrome P450 2B6 Activity and Methadone Metabolism.Drug metabolism and disposition: the biological fate of chemicals · 2024
    Article
  8. Article
  9. Article
  10. Review
  11. Review
  12. Review
  13. Review
  14. Review
  15. Article
  16. Sources of Interindividual Variability.Methods in molecular biology (Clifton, N.J.) · 2021
    Article
  17. Article
  18. Article
  19. Article
  20. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

3 authors.

Mary F PaineCenter of Excellence for Natural Product-Drug Interaction (NaPDI) Research, Spokane, Washington (M.F.P., D.D.S., J.S.M.); Department of Pharmaceutical Sciences, College of Pharmacy, Washington State University, Spokane, Washington (M.F.P.); and Department of Pharmaceutics, School of Pharmacy, University of Washington, Seattle, Washington (D.D.S., J.S.M.).
Danny D ShenCenter of Excellence for Natural Product-Drug Interaction (NaPDI) Research, Spokane, Washington (M.F.P., D.D.S., J.S.M.); Department of Pharmaceutical Sciences, College of Pharmacy, Washington State University, Spokane, Washington (M.F.P.); and Department of Pharmaceutics, School of Pharmacy, University of Washington, Seattle, Washington (D.D.S., J.S.M.).
Jeannine S McCuneCenter of Excellence for Natural Product-Drug Interaction (NaPDI) Research, Spokane, Washington (M.F.P., D.D.S., J.S.M.); Department of Pharmaceutical Sciences, College of Pharmacy, Washington State University, Spokane, Washington (M.F.P.); and Department of Pharmaceutics, School of Pharmacy, University of Washington, Seattle, Washington (D.D.S., J.S.M.) jmccune@coh.org.

Funding

Pharmacology CoreU54AT008909 · NCCIH · WASHINGTON STATE UNIVERSITY · PI BOYCE, RICHARD DAVID · 2015 to 2024
$22.4M
NCCIH NIH HHS U54 AT008909
6 · The paper itself

Abstract

Sales of botanical dietary supplements and other purported medicinal natural products (NPs) have escalated over the past ∼25 years, increasing the potential for NPs to precipitate clinically significant pharmacokinetic interactions with U.S. Food and Drug Administration-approved medications [NP-drug interactions (NPDIs)]. However, published NPDI studies to date often lack consistency in design, implementation, and documentation, which present difficulties in assessing the clinical significance of the results. Common hurdles include large variability in the admixture composition of phytoconstituents between and within batches of a given NP, limited knowledge on the pharmacokinetics of precipitant NP constituents, and use of animal and/or in vitro models which, in some cases, are not mechanistically appropriate for extrapolation to humans. The National Center for Complementary and Integrative Health created a Center of Excellence for Natural Product-Drug Interaction Research (NaPDI Center) to address these unmet research needs. The NaPDI Center has two overarching goals: 1) develop Recommended Approaches to guide researchers in the proper conduct of NPDI studies, which will evolve over time concurrent with emerging technologies and new research data, and 2) apply the Recommended Approaches in evaluating four model NPs as precipitants of NPDIs with clinically relevant object drugs. The major objectives of this commentary are to 1) explain the rationale for creating the NaPDI Center; 2) describe the decision trees developed by the NaPDI Center to enhance the planning, rigor, and consistency of NPDI studies; and 3) provide a framework for communicating results to the multidisciplinary scientists interested in the NaPDI Center's interaction projects.

Indexed as

AnimalsBiological ProductsDietary SupplementsDrug InteractionsHumansPharmaceutical PreparationsBiological ProductsPharmaceutical Preparations

Identifiers

PMID29735755
PMCPMC6003437

What OpenQuestion holds

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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.