Evidence map›Paper›PMID 17079360›Full record

Trial reportDrug metabolism and disposition: the biological fate of chemicals2007

Effect of goldenseal (Hydrastis canadensis) and kava kava (Piper methysticum) supplementation on digoxin pharmacokinetics in humans.

Bill J Gurley, Ashley Swain, Gary W Barone, D Keith Williams, Philip Breen, C Ryan Yates, Leslie B Stuart, Martha A Hubbard, Yudong Tong, Sreekhar Cheboyina

Open access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Drug metabolism and disposition: the biological fate of chemicals, 2007. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed, 2 pooled it
12.1field-weighted citation impact, top 2% of its field
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

22 citing papers in PubMed, 2 syntheses or guidelines pooled it, 67 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Article
  5. Article
  6. Article
  7. Review
  8. Review
  9. Review
  10. Review
  11. Review
  12. Article
  13. Article
  14. Drug interactions with herbal medicines.Clinical pharmacokinetics · 2012
    Review
  15. Article
  16. Review
  17. Gene expression profiling in male B6C3F1 mouse livers exposed to kava identifies--changes in drug metabolizing genes and potential mechanisms linked to kava toxicity.Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association · 2010
    Article
  18. Article
  19. Gene expression profiling as an initial approach for mechanistic studies of toxicity and tumorigenicity of herbal plants and herbal dietary supplements.Journal of environmental science and health. Part C, Environmental carcinogenesis & ecotoxicology reviews · 2010
    Review
  20. Analysis of gene expression changes of drug metabolizing enzymes in the livers of F344 rats following oral treatment with kava extract.Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association · 2009
    Article
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

10 authors at 3 institutions in 1 country.

Bill J GurleyDepartment of Pharmaceutical Sciences, University of Arkansas for Medical Sciences, College of Pharmacy, 4301 West Markham Street, Slot 522-3, Little Rock, AR 72205, USA. gurleybillyj@uams.edu
Ashley Swain
Gary W Barone
D Keith Williams
Philip Breen
C Ryan Yates
Leslie B Stuart
Martha A Hubbard
Yudong Tong
Sreekhar Cheboyina
University of Arkansas for Medical Sciences · USUniversity of Mississippi · USUniversity of Tennessee Health Science Center · US

Funding

Verruca Vulgaris--Skin Test &Candida /Mumps AntigenM01RR014288 · NCRR · UNIV OF ARKANSAS FOR MED SCIS · PI PONNAPPAN, USHA · 1999 to 2006
$11.1M
Clinical Assessment of Herb-Drug InteractionsR01GM071322 · NIGMS · UNIVERSITY OF ARKANSAS MED SCIS LTL ROCK · PI GURLE, BILL J · 2003 to 2005
$910k
NCRR NIH HHS M01 RR014288NCRR NIH HHS M01 RR14288NIGMS NIH HHS R01 GM071322NIGMS NIH HHS R01 GM071322-01A2NIGMS NIH HHS R01 GM71322
6 · The paper itself

Abstract

Phytochemical-mediated modulation of P-glycoprotein (P-gp) and other drug transporters may give rise to many herb-drug interactions. Serial plasma concentration-time profiles of the P-gp substrate, digoxin, were used to determine whether supplementation with goldenseal or kava kava modified P-gp activity in vivo. Twenty healthy volunteers were randomly assigned to receive a standardized goldenseal (3210 mg daily) or kava kava (1227 mg daily) supplement for 14 days, followed by a 30-day washout period. Subjects were also randomized to receive rifampin (600 mg daily, 7 days) and clarithromycin (1000 mg daily, 7 days) as positive controls for P-gp induction and inhibition, respectively. Digoxin (Lanoxin, 0.5 mg) was administered p.o. before and at the end of each supplementation and control period. Serial digoxin plasma concentrations were obtained over 24 h and analyzed by chemiluminescent immunoassay. Comparisons of area under the curve (AUC)((0-3)), AUC((0-24)), C(max,) CL/F, and elimination half-life were used to assess the effects of goldenseal, kava kava, rifampin, and clarithromycin on digoxin pharmacokinetics. Rifampin produced significant reductions (p < 0.01) in AUC((0-3)), AUC((0-24)), CL/F, t(1/2), and C(max), whereas clarithromycin increased these parameters significantly (p < 0.01). With the exception of goldenseal's effect on C(max) (14% increase), no statistically significant effects on digoxin pharmacokinetics were observed following supplementation with either goldenseal or kava kava. When compared with rifampin and clarithromycin, supplementation with these specific formulations of goldenseal or kava kava did not appear to affect digoxin pharmacokinetics, suggesting that these supplements are not potent modulators of P-gp in vivo.

Indexed as

Herb-Drug InteractionsHydrastisKavaAdultCardiotonic AgentsClarithromycinCytochrome P-450 CYP2D6 InhibitorsCytochrome P-450 CYP3ACytochrome P-450 Enzyme InhibitorsDigoxinDrug InteractionsFemaleHumansMaleRifampinCardiotonic AgentsClarithromycinCYP3A4 protein, humanCytochrome P-450 CYP2D6 InhibitorsCytochrome P-450 CYP3ACytochrome P-450 Enzyme InhibitorsDigoxinRifampin

Identifiers

PMID17079360
PMCPMC1868501
OpenAlexW2105550727

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.