Evidence Report/Technology Assessment Number 21

Milk Thistle: Effects on Liver Disease and Cirrhosis and Clinical Adverse Effects

File Inventory


Prepared by:

San Antonio Evidence-based Practice Center based at the University of Texas Health Science Center at San Antonio
The Veterans Evidence-based Research, Dissemination
Implementation Center, a Veterans Affairs Health Services Research and Development Center of Excellence

Cynthia Mulrow, M.D., M.Sc.
   Program Director
Valerie Lawrence, M.D., M.Sc.
   Principal Investigator
Bradly Jacobs, M.D., M.P.H.
Cathi Dennehy, Pharm.D.
Jodi Sapp, R.N.
Gilbert Ramirez, Dr.P.H.
Christine Aguilar, M.D., M.P.H.
Kelly Montgomery, M.P.H.
Laura Morbidoni, M.D.
Jennifer Moore Arterburn, M.T.S.C.
Elaine Chiquette, Pharm.D.
Martha Harris, M.L.S., M.A.
David Mullins
Andrew Vickers, M.D.
Kenneth Flora, M.D., F.A.C.G.


File Name		Description			Software	Version		File	Size
__________________________________________________________________________________________________________
01front.doc		Microsoft Word® Document	MS Word®	97 SR-1		43KB	8 pages
Contents: Cover Page, Title Page, Preface, Structured Abstract
__________________________________________________________________________________________________________
02cont.doc		Microsoft Word® Document	MS Word®	97 SR-1		102KB	2 pages
Contents: Table of Contents
__________________________________________________________________________________________________________
03summ.doc		Microsoft Word® Document	MS Word®	97 SR-1		106KB	6 pages
Contents: Summary: Overview, Reporting the Evidence, Methodology, Findings, Conclusions, 
Future Research
__________________________________________________________________________________________________________
04intro.doc		Microsoft Word® Document	MS Word®	97 SR-1		153KB	8 pages
Contents: Chapter 1. Introduction: Scope and Objectives, Effects of Milk Thistle on Hepatic 
Disease, Clinical Adverse Effects of Milk Thistle, Background, (Figure 1 in separate file), 
Chemistry and Pharmacokinetics of Milk Thistle, Mechanisms of Milk Thistle, 
Current Preparations of Milk Thistle, Challenges in Interpreting the Evidence
__________________________________________________________________________________________________________
05fig1.doc		Microsoft Word® Document	MS Word®	97 SR-1		138KB	1 page
Contents: Figure 1. Evidence model: Milk thistle and liver disease (Chapter 1)
__________________________________________________________________________________________________________
06method.doc		Microsoft Word® Document	MS Word®	97 SR-1		113KB	8 pages
Contents: Chapter 2. Methodology: Expert Input, Questions Addressed in Evidence Report, 
(Table 1 in separate file), Literature Search and Selection Methods, (Table 2 in separate file), 
(Figure 2 in separate file), Data Abstraction Process
__________________________________________________________________________________________________________
07tab1.doc		Microsoft Word® Document	MS Word®	97 SR-1		94KB	1 page
Contents: Table 1. Key questions and selection criteria for evidence (Chapter 2)
__________________________________________________________________________________________________________
08tab2.doc		Microsoft Word® Document	MS Word®	97 SR-1		99KB	1 page
Contents: Table 2. Electronic sources searched (Chapter 2)
__________________________________________________________________________________________________________
09fig2.doc		Microsoft Word® Document	MS Word®	97 SR-1		120KB	1 page
Contents: Figure 2. Selection process (Chapter 2)
__________________________________________________________________________________________________________
10result.doc		Microsoft Word® Document	MS Word®	97 SR-1		174KB	16 pages
Contents: Chapter 3. Results: Overview of the Evidence; Milk Thistle Preparations and Doses; 
Figure 3. Distribution of durations of therapy for 16 blinded, placebo-controlled studies; 
Figure 4. Distribution of doses for 16 placebo-controlled trials; Milk Thistle and Liver Disease; 
Effectiveness of Different Preparations of Milk Thistle; Exploratory Meta-Analyses Results; 
(Table 3 in separate file); (Table 4 in separate file); (Table 5 in separate file); 
(Table 6 in separate file); Adverse Effects of Milk Thistle
__________________________________________________________________________________________________________
11tab3.doc		Microsoft Word® Document	MS Word®	97 SR-1		111KB	2 pages
Contents: Table 3. Outcome measures and followup times for trials of chronic liver disease, 
chronic liver disease of mixed etiology, and viral liver disease (Chapter 3)
__________________________________________________________________________________________________________
12tab4.doc		Microsoft Word® Document	MS Word®	97 SR-1		106KB	2 pages
Contents: Table 4. Effect sizes and meta-analysis for chronic alcoholic liver disease (6 studies) 
(Chapter 3)
__________________________________________________________________________________________________________
13tab5.doc		Microsoft Word® Document	MS Word®	97 SR-1		98KB	1 page
Contents: Table 5. Effect sizes and meta-analysis for chronic liver disease of mixed etiologies 
(6 studies) (Chapter 3)
__________________________________________________________________________________________________________
14tab6.doc		Microsoft Word® Document	MS Word®	97 SR-1		94KB	1 page
Contents: Table 6. Effect sizes and meta-analysis for viral liver disease, acute and chronic 
(3 studies) (Chapter 3)
__________________________________________________________________________________________________________
15conclu.doc		Microsoft Word® Document	MS Word®	97 SR-1		91KB	2 pages
Contents: Chapter 4. Conclusions
__________________________________________________________________________________________________________
16future.doc		Microsoft Word® Document	MS Word®	97 SR-1		96KB	2 pages
Contents: Chapter 5. Future Research: Adverse Effects, Beneficial Effects Regarding Liver Diseases, 
Specific Areas of Research
__________________________________________________________________________________________________________
17refs.doc		Microsoft Word® Document	MS Word®	97 SR-1		120KB	6 pages
Contents: References
__________________________________________________________________________________________________________
18smtb1.doc		Microsoft Word® Document	MS Word®	97 SR-1		105KB	2 pages
Contents: Summary Table 1. Placebo-controlled studies of milk thistle for chronic alcoholic 
liver disease (n = 6)
__________________________________________________________________________________________________________
19smtb2.doc		Microsoft Word® Document	MS Word®	97 SR-1		106KB	3 pages
Contents: Summary Table 2. Placebo-controlled studies of milk thistle for chronic liver disease, 
mixed etiologies (n = 6)
__________________________________________________________________________________________________________
20smtb3.doc		Microsoft Word® Document	MS Word®	97 SR-1		93KB	1 page
Contents: Summary Table 3. Placebo-controlled studies of milk thistle for acute viral hepatitis
__________________________________________________________________________________________________________
21smtb4.doc		Microsoft Word® Document	MS Word®	97 SR-1		96KB	1 page
Contents: Summary Table 4. Placebo-controlled studies of milk thistle for chronic viral hepatitis
__________________________________________________________________________________________________________
22smtb5.doc		Microsoft Word® Document	MS Word®	97 SR-1		96KB	1 page
Contents: Summary Table 5. Placebo-controlled studies of milk thistle and cirrhosis due to alcohol 
or other etiologies
__________________________________________________________________________________________________________
23smtb6.doc		Microsoft Word® Document	MS Word®	97 SR-1		96KB	1 page
Contents: Summary Table 6. Placebo-controlled studies of milk thistle and alcoholic cirrhosis 
(other etiologies of cirrhosis excluded)
__________________________________________________________________________________________________________
24smtb7.doc		Microsoft Word® Document	MS Word®	97 SR-1		94KB	1 page
Contents: Summary Table 7. Placebo-controlled study of milk thistle and toxin-induced liver disease
__________________________________________________________________________________________________________
25smtb8.doc		Microsoft Word® Document	MS Word®	97 SR-1		95KB	1 page
Contents: Summary Table 8. Prophylactic milk thistle with hepatotoxic drugs
__________________________________________________________________________________________________________
26smtb9.doc		Microsoft Word® Document	MS Word®	97 SR-1		93KB	1 page
Contents: Summary Table 9. Phase II study of SilipideR
__________________________________________________________________________________________________________
27smtb10.doc		Microsoft Word® Document	MS Word®	97 SR-1		111KB	2 pages
Contents: Summary Table 10. Effect sizes and meta-analyses of 16 placebo-controlled trials 
(Evidence Tables 1 and 2)
__________________________________________________________________________________________________________
28smtb11.doc		Microsoft Word® Document	MS Word®	97 SR-1		110KB	2 pages
Contents: Summary Table 11. Effect sizes and meta-analyses of 14 randomized, placebo-controlled 
trials of higher methodological quality (Evidence Table 1)
__________________________________________________________________________________________________________
29smtb12.doc		Microsoft Word® Document	MS Word®	97 SR-1		94KB	1 page
Contents: Summary Table 12. Adverse effects of oral use of milk thistle, silymarin, or SilipideR
__________________________________________________________________________________________________________
30etab1.doc		Microsoft Word® Document	MS Word®	97 SR-1		125KB	9 pages
Contents: Evidence Table 1. Milk thistle for treatment of liver disease: Placebo-controlled, 
randomized, blinded trials
__________________________________________________________________________________________________________
31etab2.doc		Microsoft Word® Document	MS Word®	97 SR-1		95KB	1 page
Contents: Evidence Table 2. Milk thistle for treatment of liver disease:  Placebo-controlled, 
prospective trials with unclear blinding
__________________________________________________________________________________________________________
32etab3.doc		Microsoft Word® Document	MS Word®	97 SR-1		128KB	10 pages
Contents: Evidence Table 3. Milk thistle for treatment of liver disease:  Studies without 
placebo controls
__________________________________________________________________________________________________________
33etab4.doc		Microsoft Word® Document	MS Word®	97 SR-1		94KB	1 page
Contents: Evidence Table 4. Milk thistle for prophylaxis against liver disease: Ineligible 
(normal liver function at study entry) but provocative studies
__________________________________________________________________________________________________________
34etab5.doc		Microsoft Word® Document	MS Word®	97 SR-1		113KB	5 pages
Contents: Evidence Table 5. Milk thistle for treatment of liver disease: Adverse effects
__________________________________________________________________________________________________________
35biblio.doc		Microsoft Word® Document	MS Word®	97 SR-1		159KB	12 pages
Contents: Bibliography
__________________________________________________________________________________________________________
36appa.doc		Microsoft Word® Document	MS Word®	97 SR-1		102KB	2 pages
Contents: Appendix A. Milk Thistle Search Strategies
__________________________________________________________________________________________________________
37appb.doc		Microsoft Word® Document	MS Word®	97 SR-1		1.3MB	26 pages
Contents: Appendix B. Graphic Summaries (Figures 1-1 through 1-45)
__________________________________________________________________________________________________________
38appc.doc		Microsoft Word® Document	MS Word®	97 SR-1		103KB	6 pages
Contents: Appendix C. Contributors
__________________________________________________________________________________________________________
39appd.doc		Microsoft Word® Document	MS Word®	97 SR-1		90KB	1 page
Contents: Appendix D. Acronyms
__________________________________________________________________________________________________________

AHRQ Publication No. 01-E025
Current as of October 2000


Internet Citation:

Milk Thistle: Effects on Liver Disease and Cirrhosis and Clinical Adverse Effects. File Inventory, Evidence Report/Technology Assessment Number 21. AHRQ Publication No. 01-E025, October 2000. Agency for Healthcare Research and Quality, Rockville, MD. http://www.ahrq.gov/clinic/thistlinv.htm


Return to Evidence-based Practice
Clinical Information
AHRQ Home Page
Department of Health and Human Services