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

*Evidence Reports/Technology Assessments, No. 21*

Valerie Lawrence, MD, MSc, Principal Investigator, Bradly Jacobs, MD, MPH, Cathi Dennehy, PharmD, Jodi Sapp, RN, Gilbert Ramirez, DrPH, Christine Aguilar, MD, MPH, Kelly Montgomery, MPH, Laura Morbidoni, MD, Jennifer Moore Arterburn, MTSC, Elaine Chiquette, PharmD, Martha Harris, MLS, MA, David Mullins, Andrew Vickers, MD, and Kenneth Flora, MD, FACG.

Agency for Healthcare Research and Quality (US)2000 Oct

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## Structured Abstract

#### Objectives:

This evidence report summarizes studies of efficacy and                adverse effects of milk thistle in humans with alcohol, viral, or toxin-related                liver disease.

#### Search Strategy:

English and non-English citations were identified                through December 1999 from 11 electronic databases, references of pertinent articles                and reviews, manufacturers, and technical experts.

#### Selection Criteria:

Selection criteria regarding efficacy were                placebo-controlled trials of milk thistle. For adverse effects, all studies in                humans were used.

#### Data Collection and Analysis:

Abstractors independently abstracted data                from published reports. Relationships between clinical outcomes and methodologic                characteristics were examined in evidence tables and graphic summaries. Exploratory                meta-analyses were used to examine possible patterns of effects.

#### Main Results:

Sixteen prospective placebo-controlled trials were identified.

Interpreting the evidence was difficult because of inadequate reporting                            and study design regarding severity of liver disease, subject                            characteristics, and potential confounders. Outcome measures, dose,                            duration, and followup widely varied among studies.

Four of six studies of chronic alcoholic liver disease reported                            significant improvement in at least one parameter of liver function or                            histology with milk thistle.

In three of six studies that reported multiple outcome measures, at least                            one outcome measure improved significantly with milk thistle compared                            with placebo, but there were no differences between milk thistle and                            placebo for one or more of the other outcome measures in each study.

Three studies evaluated the effects of milk thistle on viral hepatitis.                            The acute hepatitis study showed no improvement in liver function.                            Improvement in aspartate aminotransferase and bilirubin was significant                            in the study of acute hepatitis. Two studies of chronic viral hepatitis                            showed improvement in aminotransferases with milk thistle in one and a                            trend toward histologic improvement in the other.

There were two studies of patients with alcoholic or nonalcoholic                            cirrhosis. In one study, milk thistle showed a positive effect, but no                            data were given. In the other, milk thistle showed a trend toward                            improved survival and significantly improved survival for subgroups with                            alcoholic cirrhosis or Child's Group A severity.

Two trials specifically studied alcoholic cirrhosis. One showed no                            improvement in liver function, hepatomegaly, jaundice, ascites, or                            survival but did show nonsignificant trends favoring milk thistle in the                            incidence of encephalopathy, gastrointestinal bleeding, and death in                            subjects with hepatitis C. The other reported significant improvements                            in aminotransferases with milk thistle.

Three trials evaluated thistle as therapy or prophylaxis in the setting                            of hepatotoxic drugs; results were mixed.

Meta-analyses generally showed small effect sizes, some statistically                            significant and some not, favoring milk thistle.

Available evidence does not define milk thistle's effectiveness across                            preparations or doses.

Little evidence is available regarding causality, but evidence suggests                            milk thistle is associated with few, generally minor, adverse                            effects.

#### Conclusions:

Milk thistle's efficacy is not established. Published                evidence is clouded by poor design and reporting. Possible benefit has been shown                most frequently, but inconsistently, for aminotransferases, but laboratory tests are                the most common outcome measure studied. Survival and other clinical outcomes have                been studied less, with mixed results. Future research should include definition of                multifactorial mechanisms of action, well-designed clinical trials, and                clarification of adverse effects.

## Contents

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                        - Preface
                        - Summary
                        - 1. Introduction                           - Scope and Objectives
                          - Effects of Milk Thistle on Hepatic Disease
                          - Clinical Adverse Effects of Milk Thistle
                          - Background
                          - Chemistry and Pharmacokinetics of Milk Thistle
                          - Mechanisms of Milk Thistle
                          - Current Preparations of Milk Thistle
                          - Challenges in Interpreting the Evidence
                        - 2. Methodology                           - Expert Input
                          - Questions Addressed in Evidence Report
                          - Literature Search and Selection Methods
                          - Data Abstraction Process
                        - 3. Results                           - Overview of the Evidence
                          - Milk Thistle Preparations and Doses
                          - Milk Thistle and Liver Disease
                          - Effectiveness of Different Preparations of Milk Thistle
                          - Exploratory Meta-Analyses Results
                          - Adverse Effects of Milk Thistle
                        - 4. Conclusions
                        - 5. Future Research                           - Adverse Effects
                          - Beneficial Effects Regarding Liver Diseases
                          - Specific Areas of Research
                        - Summary Tables
                        - Evidence Tables
                        - Appendixes                           - Appendix A. Milk Thistle Search Strategies
                          - Appendix B. Graphic Summaries
                          - Appendix C. Contributors
                          - Appendix D. Acronyms
                        - References
                        - Bibliography

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Program Director: Cynthia Mulrow, MD, MSc.

Prepared for: Agency for Healthcare Research and Quality, U.S. Department                of Health and Human Services.1                 Contract No. 290-97-0012.                Prepared by: San Antonio                    Evidence-based Practice Center based at The University of Texas Health Science                    Center, at San Antonio and The Veterans Evidence-based Research, Dissemination,                    and Implementation Center, a Veterans Affairs Health Services Research and                    Development Center of Excellence.

#### Suggested citation:

Lawrence V, Jacobs B, Dennehy C, et al. Milk                    thistle: effects on liver disease and cirrhosis and clinical adverse effects.                    Evidence Report/Technology Assessment No. 21 (Contract 290-97-0012 to the San                    Antonio Evidence-based Practice Center, based at the University of Texas Health                    Science Center at San Antonio, and The Veterans Evidence-based Research,                    Dissemination, and Implementation Center, a Veterans Affairs Services Research                    and Development Center of Excellence). AHRQ Publication No. 01-E025. Rockville,                    MD: Agency for Healthcare Research and Quality. October 2000.

The authors of this report are responsible for its content. Statements in the report                should not be construed as endorsement by the Agency for Healthcare Research and                Quality or the U.S. Department of Health and Human Services of a particular drug,                test, treatment, or other clinical service.

                        - 1
                        - 
2101 East Jefferson Street, Rockville, MD 20852. www​.ahrq.gov

Copyright Notice

Bookshelf ID: NBK33277

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                    - Cite this Page Lawrence V, Jacobs B, Dennehy C, et al. Milk Thistle: Effects on Liver Disease and Cirrhosis and Clinical Adverse Effects. Rockville (MD): Agency for Healthcare Research and Quality (US); 2000 Oct. (Evidence Reports/Technology Assessments, No. 21.)

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