Evidence map›Paper›PMID 21646440›Full record

Trial reportJournal of clinical pharmacology2012

Influence of Panax ginseng on cytochrome P450 (CYP)3A and P-glycoprotein (P-gp) activity in healthy participants.

Christine Y Malati, Sarah M Robertson, Jennifer D Hunt, Cheryl Chairez, Raul M Alfaro, Joseph A Kovacs, Scott R Penzak

Registry-linked trialAbstract readClinical Trial
In one paragraph

Trial report in Journal of clinical pharmacology, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06137833 (Clinical Study on Wide Spectrum Micronutrients Supplementation in Patients With Cancer Related Fatigue During Neoadjuvant and Adjuvant Chemotherapy), which is not on this map. Cited by 55 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
55citing papers in PubMed, 3 pooled it
2.4field-weighted citation impact, top 11% 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.

NCT06137833 narecruitingnot on this mapstarted 2023, after this paper: background citation

Clinical Study on Wide Spectrum Micronutrients Supplementation in Patients With Cancer Related Fatigue During Neoadjuvant and Adjuvant Chemotherapy

TypeinterventionalSponsorPharmanutra S.p.a.Ran2023 to 2025Enrolled92ConditionsFatigue, Breast CancerArmsAPPOPRTAL®, Placebo
3 · Its place in the literature

Who cites it

55 citing papers in PubMed, 3 syntheses or guidelines pooled it, 123 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Review
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  7. Article
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  9. A Review of the Mechanisms and Risks ofDiseases (Basel, Switzerland) · 2025
    Review
  10. Review
  11. Review
  12. Review
  13. Article
  14. Article
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  19. Review
  20. Enzyme Activity of Natural Products on Cytochrome P450.Molecules (Basel, Switzerland) · 2022
    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

7 authors at 3 institutions in 1 country.

Christine Y MalatiClinical Pharmacokinetics Research Laboratory, Pharmacy Department, Clinical Research Center, National Institutes of Health, Bethesda, Maryland 20892, USA.
Sarah M Robertson
Jennifer D Hunt
Cheryl Chairez
Raul M Alfaro
Joseph A Kovacs
Scott R Penzak
National Institutes of Health Clinical Center · USNational Institutes of Health · USUnited States Food and Drug Administration · US

Funding

The Influence of Herbal Supplements on Lopinavir/Ritonavir PharmacokineticsZIACL005098 · CLC · CLINICAL CENTER · PI PENZAK, SCOTT · 2009 to 2012
$0k
Intramural NIH HHS ZIA CL005098
6 · The paper itself

Abstract

A number of herbal preparations have been shown to interact with prescription medications secondary to modulation of cytochrome P450 (CYP) and/or P-glycoprotein (P-gp). The purpose of this study was to determine the influence of Panax ginseng on CYP3A and P-gp function using the probe substrates midazolam and fexofenadine, respectively. Twelve healthy participants (8 men) completed this open-label, single-sequence pharmacokinetic study. Healthy volunteers received single oral doses of midazolam 8 mg and fexofenadine 120 mg, before and after 28 days of P ginseng 500 mg twice daily. Midazolam and fexofenadine pharmacokinetic parameter values were calculated and compared before and after P ginseng administration. Geometric mean ratios (postginseng/preginseng) for midazolam area under the concentration-time curve from zero to infinity (AUC(0-∞)), half-life (t(1/2)), and maximum concentration (C(max)) were significantly reduced at 0.66 (0.55-0.78), 0.71 (0.53-0.90), and 0.74 (0.56-0.93), respectively. Conversely, fexofenadine pharmacokinetics were unaltered by P ginseng administration. Based on these results, P ginseng appeared to induce CYP3A activity in the liver and possibly the gastrointestinal tract. Patients taking P ginseng in combination with CYP3A substrates with narrow therapeutic ranges should be monitored closely for adequate therapeutic response to the substrate medication.

Indexed as

Herb-Drug InteractionsAdultATP Binding Cassette Transporter, Subfamily BATP Binding Cassette Transporter, Subfamily B, Member 1Cross-Over StudiesCytochrome P-450 CYP3ACytochrome P-450 CYP3A InhibitorsDrug MonitoringDrugs, Chinese HerbalFemaleHalf-LifeHumansIntestinal AbsorptionMaleMetabolic Clearance RateMidazolamABCB1 protein, humanATP Binding Cassette Transporter, Subfamily BATP Binding Cassette Transporter, Subfamily B, Member 1CYP3A protein, humanCytochrome P-450 CYP3ACytochrome P-450 CYP3A InhibitorsDrugs, Chinese HerbalfexofenadineMidazolamTerfenadine

Identifiers

PMID21646440
PMCPMC3523324
OpenAlexW2100539109

What OpenQuestion holds

Textmetadata
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Read underepoch 390

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.