Trial reportEuropean journal of clinical pharmacology2005
Milk thistle and indinavir: a randomized controlled pharmacokinetics study and meta-analysis.
Trial report in European journal of clinical pharmacology, 2005. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers.
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
17 citing papers in PubMed, 76 citations in OpenAlex.
- The effects of milk thistle (Silybum marianum) on human cytochrome P450 activity.Drug metabolism and disposition: the biological fate of chemicals · 2014Trial
- Effect of milk thistle on the pharmacokinetics of darunavir-ritonavir in HIV-infected patients.Antimicrobial agents and chemotherapy · 2012Trial
- Effect of silymarin on the pharmacokinetics of losartan and its active metabolite E-3174 in healthy Chinese volunteers.European journal of clinical pharmacology · 2009Trial
- Assessing the clinical significance of botanical supplementation on human cytochrome P450 3A activity: comparison of a milk thistle and black cohosh product to rifampin and clarithromycin.Journal of clinical pharmacology · 2006Trial
- Effect of milk thistle (Silybum marianum) and black cohosh (Cimicifuga racemosa) supplementation on digoxin pharmacokinetics in humans.Drug metabolism and disposition: the biological fate of chemicals · 2006Trial
- Milk Thistle (Current medicinal chemistry · 2025Review
- Silymarin and Cancer: A Dual Strategy in Both in Chemoprevention and Chemosensitivity.Molecules (Basel, Switzerland) · 2020Review
- Metabolism, Transport and Drug-Drug Interactions of Silymarin.Molecules (Basel, Switzerland) · 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
- A regulatory science viewpoint on botanical-drug interactions.Journal of food and drug analysis · 2018Review
- Therapeutic Risk and Benefits of Concomitantly Using Herbal Medicines and Conventional Medicines: From the Perspectives of Evidence Based on Randomized Controlled Trials and Clinical Risk Management.Evidence-based complementary and alternative medicine : eCAM · 2017Review
- Herb-drug interactions: challenges and opportunities for improved predictions.Drug metabolism and disposition: the biological fate of chemicals · 2014Article
- Drug interactions with herbal medicines.Clinical pharmacokinetics · 2012Review
- Silybin and the liver: from basic research to clinical practice.World journal of gastroenterology · 2011Review
- Clinical assessment of CYP2D6-mediated herb-drug interactions in humans: effects of milk thistle, black cohosh, goldenseal, kava kava, St. John's wort, and Echinacea.Molecular nutrition & food research · 2008Article
- Potential of pharmacokinetic profiling for detecting herbal interactions with drugs.Clinical pharmacokinetics · 2008Review
- Therapeutic challenges in hepatitis C-infected injection drug using patients.Harm reduction journal · 2006Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors at 9 institutions in 5 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesTo determine whether ingestion of milk thistle affects the pharmacokinetics of indinavir.
methodsWe conducted a three-period, randomized controlled trial with 16 healthy participants. We randomized participants to milk thistle or control. All participants received initial dosing of indinavir, and baseline indinavir levels were obtained (AUC(0-8)) (phase I). The active group were then given 450 mg milk-thistle extract capsules to be taken t.i.d. from day 2 to day 30. The control group received no plant extract. On day 29 and day 30, indinavir dosing and sampling was repeated in both groups as before (phase II). After a wash-out period of 7 days, indinavir dosing and sampling were repeated as before (phase III).
resultsAll participants completed the trial, but two were excluded from analysis due to protocol violation. There were no significant between-group differences. Active group mean AUC(0-8) indinavir decreased by 4.4% (90% CI, -27.5% to -26%, P=0.78) from phase I to phase II in the active group, and by 17.3% (90% CI, -37.3% to +9%, P=0.25) in phase III. Control group mean AUC(0-8) decreased by 21.5% (90% CI, -43% to +8%, P=0.2) from phase I to phase II and by 38.5% (90% CI, -55.3% to -15.3%, P=0.01) of baseline at phase III. To place our findings in context, milk thistle-indinavir trials were identified through systematic searches of the literature. A meta-analysis of three milk thistle-indinavir trials revealed a non-significant pooled mean difference of 1% in AUC(0-8) (95% CI, -53% to 55%, P=0.97).
conclusionsIndinavir levels were not reduced significantly in the presence of milk thistle.
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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.