Milk thistle and indinavir: a randomized controlled pharmacokinetics study and meta-analysis.
OBJECTIVES: To determine whether ingestion of milk thistle affects the pharmacokinetics of indinavir. METHODS: We 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 in...
| Main Authors: | , , , , , , , , , , , |
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| Format: | Journal article |
| Language: | English |
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2005
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| _version_ | 1797106226460360704 |
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| author | Mills, E Wilson, K Clarke, M Foster, B Walker, S Rachlis, B DeGroot, N Montori, V Gold, W Phillips, E Myers, S Gallicano, K |
| author_facet | Mills, E Wilson, K Clarke, M Foster, B Walker, S Rachlis, B DeGroot, N Montori, V Gold, W Phillips, E Myers, S Gallicano, K |
| author_sort | Mills, E |
| collection | OXFORD |
| description | OBJECTIVES: To determine whether ingestion of milk thistle affects the pharmacokinetics of indinavir. METHODS: We 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). RESULTS: All 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). CONCLUSIONS: Indinavir levels were not reduced significantly in the presence of milk thistle. |
| first_indexed | 2024-03-07T06:58:41Z |
| format | Journal article |
| id | oxford-uuid:ff024396-418b-4cf3-9c9e-1e6ff8ee112e |
| institution | University of Oxford |
| language | English |
| last_indexed | 2024-03-07T06:58:41Z |
| publishDate | 2005 |
| record_format | dspace |
| spelling | oxford-uuid:ff024396-418b-4cf3-9c9e-1e6ff8ee112e2022-03-27T13:41:09ZMilk thistle and indinavir: a randomized controlled pharmacokinetics study and meta-analysis.Journal articlehttp://purl.org/coar/resource_type/c_dcae04bcuuid:ff024396-418b-4cf3-9c9e-1e6ff8ee112eEnglishSymplectic Elements at Oxford2005Mills, EWilson, KClarke, MFoster, BWalker, SRachlis, BDeGroot, NMontori, VGold, WPhillips, EMyers, SGallicano, K OBJECTIVES: To determine whether ingestion of milk thistle affects the pharmacokinetics of indinavir. METHODS: We 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). RESULTS: All 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). CONCLUSIONS: Indinavir levels were not reduced significantly in the presence of milk thistle. |
| spellingShingle | Mills, E Wilson, K Clarke, M Foster, B Walker, S Rachlis, B DeGroot, N Montori, V Gold, W Phillips, E Myers, S Gallicano, K Milk thistle and indinavir: a randomized controlled pharmacokinetics study and meta-analysis. |
| title | Milk thistle and indinavir: a randomized controlled pharmacokinetics study and meta-analysis. |
| title_full | Milk thistle and indinavir: a randomized controlled pharmacokinetics study and meta-analysis. |
| title_fullStr | Milk thistle and indinavir: a randomized controlled pharmacokinetics study and meta-analysis. |
| title_full_unstemmed | Milk thistle and indinavir: a randomized controlled pharmacokinetics study and meta-analysis. |
| title_short | Milk thistle and indinavir: a randomized controlled pharmacokinetics study and meta-analysis. |
| title_sort | milk thistle and indinavir a randomized controlled pharmacokinetics study and meta analysis |
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