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# Defining and Managing Chronic Fatigue Syndrome

*Evidence Reports/Technology Assessments, No. 42*

Cynthia D Mulrow, MD, MSc, Program Director and Gilbert Ramirez, DrPH, Project Director. Investigators: John E Cornell, PhD and Karen Allsup, BS.

Agency for Healthcare Research and Quality (US)2001 Oct

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## Structured Abstract

#### Objectives:

 Objectives of this evidence report are to summarize research evidence regarding                    the case definitions, prevalence, natural history and therapy of chronic fatigue                    syndrome (CFS).

#### Search Strategy:

 English and non-English citations were identified through July 2000 from four                    electronic bibliographic databases (MEDLINE, The Cochrane Library, PsycINFO,                    EMBASE), CFS Internet sites, the Journal of Chronic Fatigue Syndrome, references                    of pertinent articles, textbooks, and experts. The electronic search was updated                    through October 2000 using PubMed; experts identified relevant citations up to                    January 2001.

#### Selection Criteria:

 Published and unpublished studies that were conducted after 1980 and that                    involved adults with CFS were reviewed.

#### Data Collection and Analysis:

 Two reviewers (physician, psychometrician, research methodologist, and/or nurse)                    independently abstracted data from the selected studies. Data were synthesized                    descriptively, emphasizing the quality and methodologic design of studies.                    Meta-analyses were not done because of marked heterogeneity of study                    designs.

#### Main Results:

 There are four well-recognized case definitions of CFS, and the Centers for                    Disease Control and Prevention (CDC) is spearheading the development of a fifth.                    Definitions, developed primarily by expert knowledge and consensus, have evolved                    over time. A few comparative research studies support the concept of a                    condition, characterized by prolonged fatigue and impaired ability to function,                    which is captured by the case definitions. The superiority of one case                    definition over another is not well established. The validity of any definition                    is difficult to establish because there are no clear biologic markers for CFS,                    and no effective treatments specific only to CFS have been identified.

Findings from surveys show that the prevalence of CFS in community populations is                    probably less than 1% and in primary care populations less than 3%. The                    reliability of these estimates is limited, because surveys used different case                    definitions and varied assessment and reporting methods, and sometimes had poor                    response rates.

Precise estimates of recovery, improvement, and/or relapse from CFS are not                    possible because there are few natural history studies and those that are                    available have involved selected referral populations or have used varying case                    definitions and followup methods.

Thirty-eight controlled trials evaluating multiple treatment interventions show                    the following mixed results:

**Immunologic Therapy:**                 Evidence from 11 trials is scant and insufficient to conclude whether                    immunological therapies, such as immunoglobulin, Ampligen, Acyclovir,                    interferon, and transfer factor, are effective or ineffective.

**Corticosteroids:**                 Evidence from four trials suggests that there are no consistent benefits from                    mineralocorticoids (fludrocortisone), but that there are some improvements in                    fatigue and functional status with glucocorticoids (hydrocortisone). However,                    glucocorticoid therapy may severely suppress adrenal function.

**Antidepressants:**                Evidence from five trials show that there is no consistent pattern of benefit                    from antidepressant therapy, though some participants in these trials                    experienced improved vigor and less anxiety.

**Behavioral Therapies:**                Evidence from nine trials generally show that behavioral interventions that                    emphasize increased activity levels result in improvements in fatigue, overall                    well-being, quality of life and functional status.

**Other:**                 Evidence from trials is scant and insufficient to conclude whether complementary                    therapies, such as homeopathy, massage therapy and osteopathy are effective or                    ineffective. Evidence from trials is scant and insufficient to conclude whether                    multiple other therapies, such as nicotinamide adenine dinucleotide (NADH),                    galanthamine, growth hormone, essential fatty acids, and liver extract                    therapies, are effective or ineffective. Findings from one small trial suggest                    that magnesium therapy may improve energy, overall well-being, pain and distress                    in patients with CFS and magnesium deficiency.

#### Conclusions:

 Existing case definitions for CFS appear to characterize a group of people with                    prolonged fatigue and impaired ability to function. The validity and superiority                    of any particular case definition are not well established. Surveys suggest that                    the prevalence of CFS in community populations is less than 1%. Precise                    estimates of rates of recovery, improvement and/or relapse from CFS are not                    available. Although several therapies have been studied, potential benefits as                    well as harms of most therapies are not well established. Behavioral                    interventions that emphasize increasing activity levels may improve quality of                    life and function in some people with CFS.

## Contents

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                        - Preface
                        - Summary
                        - 1. Introduction                           - Report's Purpose and Scope
                          - Defining Chronic Fatigue and Chronic Fatigue Syndrome
                          - Burden of Disease
                          - History and Terms Used to Describe Chronic Fatigue Syndromes
                        - 2. Methodology                           - Expert Input
                          - Questions Addressed in Evidence Report
                          - Literature Search and Selection Methods
                          - Data Abstraction Process
                          - Data Synthesis Process
                        - 3. Results                           - Question 1. What are the Existing Case Definitions for Chronic Fatigue Syndrome?
                          - Question 2. Which Case Definitions, if any, Have Been Substantiated or Validated with Reliably Discriminating Constellations of Symptoms?
                          - Question 3. What are the Prevalence and Natural History of Chronic Fatigue Syndrome?
                          - Question 4. Do Controlled Studies Show that Particular Therapies Improve Clinical Symptoms of CFS, When Compared to Placebo, No Therapy, or Each Other?>
                        - 4. Conclusions                           - Immunologic Therapy
                          - Corticosteroids
                          - Antidepressants
                          - Behavioral interventions
                          - Other pharmacological agents or supplements
                          - Complementary therapies
                        - 5. Future Research
                        - Appendixes                           - Appendix A: Contributors
                          - Appendix B: Glossary of included terms
                        - 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: 290-97-0012.                Prepared by: San Antonio                    Evidence-based Practice Center at The University of Texas Health Science Center                    at Antonio.

#### Suggested citation:

Mulrow CD, Ramirez G, Cornell JE, et al. Defining                    and Managing Chronic Fatigue Syndrome. Evidence Report/Technology Assessment No.                    42 (Prepared by San Antonio Evidence-based Practice Center at The University of                    Texas Health Science Center at San Antonio under Contract No. 290-97-0012). AHRQ                    Publication No. 02-E001. Rockville (MD): Agency for Healthcare Research and                    Quality; October 2001.

On December 6, 1999, under Public Law 106-129, the Agency for Health Care Policy and                Research (AHCPR) was reauthorized and renamed the Agency for Healthcare Research and                Quality (AHRQ). The law authorizes AHRQ to continue its research on the cost,                quality, and outcomes of health care and expands its role to improve patient safety                and address medical errors.

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 a basis for                reimbursement and coverage policies. AHRQ or U.S. Department of Health and Human                Services endorsement 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 health 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.

Partial support for this review was provided by the Veterans Evidence-based Research,                Dissemination, and Implementation Center, a Veterans Affairs Health Services                Research and Development Center of Excellence (VA HFP 98-002). The views expressed                in this article are those of the authors and do not necessarily represent the views                of the Department of Veterans Affairs.

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

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Bookshelf ID: NBK33797

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