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# S-Adenosyl-L-Methionine for Treatment of Depression, Osteoarthritis, and Liver Disease

*Evidence Reports/Technology Assessments, No. 64*

Investigators: Mary Hardy, MD, Principal Investigator, Ian Coulter, PhD, Sally C Morton, PhD, Joya Favreau, MD, Swamy Venuturupalli, MD, Francesco Chiappelli, PhD, Frederico Rossi, MD, Greg Orshansky, MD, Lara K Jungvig, BA, Elizabeth A Roth, MA, Marika J Suttorp, MS, and Paul Shekelle, MD, PhD.

Agency for Healthcare Research and Quality (US)2002 Oct
Report No.: 02-E0341-58763-122-9

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## Structured Abstract

#### Objectives:

We conducted a comprehensive literature review and synthesis of evidence on the use of S-adenosyl-L-methionine (SAMe) for the treatment of depression, osteoarthritis, and liver disease.

#### Search Strategy:

We searched 25 databases using the MesH term SAMe and its many pharmacological synonyms. Additional articles were identified from bibliographies and by experts.

#### Selection Criteria:

The synthesis of SAMe focused on clinical trials of human subjects. Approximately 25 percent of the selected reports were in non-english languages, mainly Italian.

#### Data Collection and Analysis:

Selected titles, abstracts, and articles were reviewed. Patient demographics, disease state, intervention, study design, and outcomes were collected. Meta-analyses were performed where appropriate.

#### Main Results:

Compared to placebo, treatment with SAMe was associated with an improvement of approximately 6 points in the score of the Hamilton Rating Scale for Depression. (This degree of improvement is clinically significant and is equivalent to a partial response to treatment.)

Compared to treatment with conventional therapy, SAMe was not associated with a statistically significant difference in outcomes.

Compared to placebo for osteoarthritis, one large randomized clinical trial showed a small to moderate effect in favor of SAMe.

Compared to nonsteroidal anti-inflammatory agents, treatment with SAMe was not associated with a statistically significant difference in outcomes.

Compared to placebo, treatment with SAMe for cholestasis of pregnancy was associated with a large effect in decreasing pruritus and in decreasing bilirubin levels.

In two clinical trials for cholestasis of pregnancy, conventional therapy (ursodeoxycholic acid) was favored over SAMe for the treatment of pruritus.

Compared to placebo for intrahepatic cholestasis, treatment with SAMe for pruritus was associated with a risk ratio of 0.45, meaning that patients treated with SAMe were twice as likely as placebo-treated patients to have a reduction in pruritus (95% CI [0.37, 0.58]).

Too few studies compared SAMe to active therapy for intrahepatic cholestasis to conduct a pooled analysis.

Twenty remaining studies were too heterogeneous with respect to diagnosis (a wide variety of liver conditions) and outcomes to permit pooled analysis.

#### Conclusions:

These data indicate that SAMe is more effective than placebo for relief of symptoms of depression, pain of osteoarthritis, and pruritus in cholestasis of pregnancy, and in intrahepatic cholestasis. SAMe is more effective than placebo in reducing bilirubin for cholestasis of pregnancy and serum bilirubin for intrahepatic cholestasis. Treatment with SAMe was equivalent to standard therapy for depression and osteoarthritis but not for liver disease.

These results justify additional randomized controlled trials to evaluate the efficacy and tolerability of SAMe for treatment of depression, osteoarthritis, and cholestasis (related to pregnancy and associated with other liver diseases).

## Contents

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                        - Preface
                        - Summary
                        - 1. Introduction                           - Purpose
                          - Scope Of Work
                          - S-Adenosyl-L-Methionine
                          - Depression
                          - Osteoarthritis
                          - Liver Disease
                          - Summary
                        - 2. Methodology                           - Scope Of Work
                          - Objectives
                          - Literature Search Design
                          - Evaluation Of Evidence
                          - Selection Of Studies For Meta-Analysis
                        - 3. Results                           - Description Of Evidence
                          - Analysis Of Depression Studies
                          - Analysis Of The Osteoarthritis Studies
                          - Analysis Of The Liver Disease Studies
                          - Side Effects
                          - Comparison With Results Of Other Systematic Reviews
                          - Limitations Of The Review
                        - 4. Conclusions                           - Availability Of Study Reports
                          - Study Design
                          - The Use Of SAMe For The Treatment Of Depression
                          - The Use Of SAMe For The Treatment Of Osteoarthritis
                          - The Use Of SAMe For The Treatment Of Cholestasis
                          - Future Research
                        - Evidence Tables
                        - Appendixes                           - Appendix A Search Methods
                          - Appendix B
                          - Appendix C Article Screening Form
                          - Appendix D
                          - Appendix E The Jadad Score
                          - Appendix F Side Effects
                          - Appendix G Support Table
                          - Appendix H Abbreviations for Outcomes in the Evidence Tables
                          - Appendix I Authors' Response to Reviewer Comments
                          - Appendix J Acknowledgments
                        - References
                        - Bibliography

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Prepared for: Agency for Healthcare Research and                            Quality, U.S. Department of Health and Human Services.1             Contract No. 290-97-0001. Prepared by: Southern California Evidence-Based Practice Center.

#### Suggested citation:

Hardy M, Coulter I, Morton SC, et al. S-Adenosyl-L-Methionine for Treatment of Depression, Osteoarthritis, and Liver Disease. Evidence Report/Technology Assessment Number 64. (Prepared by Southern California Evidence-based Practice Center under Contract No. 290-97-0001.) AHRQ Publication No. 02-E034 Rockville, MD: Agency for Healthcare Research and Quality. October 2002.

This report may be used, in whole or in part, as the basis for development of clinical practice guidelines and other quality enhancement tools, or as a basis for reimbursement and coverage policies. Endorsement by the Agency for Healthcare Research and Quality (AHRQ) or the U.S. Department of Health and Human Services (DHHS) of such derivative products may not be stated or implied.

AHRQ is the lead Federal agency charged with supporting research designed to improve the quality of health care, reduce its cost, address patient safety and medical errors, and broaden access to essential services. AHRQ sponsors and conducts research that provides evidence-based information on health care outcomes; quality; and cost, use, and access. The information helps heath care decisionmakers—patients and clinicians, health system leaders, and policymakers—make more informed decisions and improve the quality of health care services.

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, device, test,            treatment, or other clinical service.

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

Copyright Notice

Bookshelf ID: NBK36942

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                    - Cite this Page Hardy M, Coulter I, Morton SC, et al. S-Adenosyl-L-Methionine for Treatment of Depression, Osteoarthritis, and Liver Disease. Rockville (MD): Agency for Healthcare Research and Quality (US); 2002 Oct. (Evidence Reports/Technology Assessments, No. 64.)

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                    - [Evaluation of the obstetrical risk in pregnant women with intrahepatic cholestasis treated with S-adenosyl-L-methionine]. [Recenti Prog Med. 1988] [Evaluation of the obstetrical risk in pregnant women with intrahepatic cholestasis treated with S-adenosyl-L-methionine].*Lafuenti G, Plotti G, Nicolanti G, Gaglione R, Tibollo FG, Mancuso S.**Recenti Prog Med. 1988 Oct; 79(10):420-3.*
                    - S-adenosyl-L-methionine in the treatment of patients with intrahepatic cholestasis of pregnancy: a randomized, double-blind, placebo-controlled study with negative results. [Hepatology. 1991] S-adenosyl-L-methionine in the treatment of patients with intrahepatic cholestasis of pregnancy: a randomized, double-blind, placebo-controlled study with negative results.*Ribalta J, Reyes H, Gonzalez MC, Iglesias J, Arrese M, Poniachik J, Molina C, Segovia N.**Hepatology. 1991 Jun; 13(6):1084-9.*
                    - Randomized prospective comparative study of ursodeoxycholic acid and S-adenosyl-L-methionine in the treatment of intrahepatic cholestasis of pregnancy. [J Perinat Med. 2006] Randomized prospective comparative study of ursodeoxycholic acid and S-adenosyl-L-methionine in the treatment of intrahepatic cholestasis of pregnancy.*Binder T, Salaj P, Zima T, Vítek L.**J Perinat Med. 2006; 34(5):383-91.*
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                    - Review S-Adenosyl-L-methionine (SAMe): from the bench to the bedside--molecular basis of a pleiotrophic molecule. [Am J Clin Nutr. 2002] Review S-Adenosyl-L-methionine (SAMe): from the bench to the bedside--molecular basis of a pleiotrophic molecule.*Bottiglieri T.**Am J Clin Nutr. 2002 Nov; 76(5):1151S-7S.*
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