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Gulf War Veterans
TREATING SYMPTOMS AND SYNDROMES

Committee on Identifying Effective Treatments for Gulf War Veterans' Health Problems
Board on Health Promotion and Disease Prevention
Bernard M. Rosof and Lyla M. Hernandez, Editors
INSTITUTE OF MEDICINE


NATIONAL ACADEMY PRESS
Washington, D.C.




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Page i Gulf War Veterans TREATING SYMPTOMS AND SYNDROMES Committee on Identifying Effective Treatments for Gulf War Veterans' Health Problems Board on Health Promotion and Disease Prevention Bernard M. Rosof and Lyla M. Hernandez, Editors INSTITUTE OF MEDICINE NATIONAL ACADEMY PRESS Washington, D.C.

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Page ii NATIONAL ACADEMY PRESS 2101 Constitution Avenue, N.W. Washington, DC 20418 NOTICE: The project that is the subject of this report was approved by the Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. The members of the committee responsible for the report were chosen for their special competences and with regard for appropriate balance. Support for this project was provided by the Department of Veterans Affairs. The views presented in this report are those of the Institute of Medicine's Committee on Identifying Effective Treatments for Gulf War Veterans' Health and are not necessarily those of the funding agencies. International Standard Book Number 0-309-07587-4 Additional copies of this report are available for sale from the National Academy Press , 2101 Constitution Avenue, N.W. , Box 285, Washington, DC 20055 . Call (800) 624-6242 or (202) 334-3313 (in the Washington metropolitan area), or visit the NAP's home page at www.nap.edu . The full text of this report is available at www.nap.edu . For more information about the Institute of Medicine, visit the IOM home page at: www.iom.edu . Copyright 2001 by the National Academy of Sciences . All rights reserved. Printed in the United States of America The serpent has been a symbol of long life, healing, and knowledge among almost all cultures and religions since the beginning of recorded history. The serpent adopted as a logotype by the Institute of Medicine is a relief carving from ancient Greece, now held by the Staatliche Museen in Berlin.

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Page iii “Knowing is not enough; we must apply. Willing is not enough; we must do.” —Goethe ~ enlarge ~ INSTITUTE OF MEDICINE Shaping the Future for Health

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Page iv THE NATIONAL ACADEMIES National Academy of Sciences National Academy of Engineering Institute of Medicine National Research Council The National Academy of Sciences is a private, nonprofit, self-perpetuating society of distinguished scholars engaged in scientific and engineering research, dedicated to the furtherance of science and technology and to their use for the general welfare. Upon the authority of the charter granted to it by the Congress in 1863, the Academy has a mandate that requires it to advise the federal government on scientific and technical matters. Dr. Bruce M. Alberts is president of the National Academy of Sciences. The National Academy of Engineering was established in 1964, under the charter of the National Academy of Sciences, as a parallel organization of outstanding engineers. It is autonomous in its administration and in the selection of its members, sharing with the National Academy of Sciences the responsibility for advising the federal government. The National Academy of Engineering also sponsors engineering programs aimed at meeting national needs, encourages education and research, and recognizes the superior achievements of engineers. Dr. William A. Wulf is president of the National Academy of Engineering. The Institute of Medicine was established in 1970 by the National Academy of Sciences to secure the services of eminent members of appropriate professions in the examination of policy matters pertaining to the health of the public. The Institute acts under the responsibility given to the National Academy of Sciences by its congressional charter to be an adviser to the federal government and, upon its own initiative, to identify issues of medical care, research, and education. Dr. Kenneth I. Shine is president of the Institute of Medicine. The National Research Council was organized by the National Academy of Sciences in 1916 to associate the broad community of science and technology with the Academy's purposes of furthering knowledge and advising the federal government. Functioning in accordance with general policies determined by the Academy, the Council has become the principal operating agency of both the National Academy of Sciences and the National Academy of Engineering in providing services to the government, the public, and the scientific and engineering communities. The Council is administered jointly by both Academies and the Institute of Medicine. Dr. Bruce M. Alberts and Dr. William A. Wulf are chairman and vice chairman, respectively, of the National Research Council.

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Page v COMMITTEE ON IDENTIFYING EFFECTIVE TREATMENTS FOR GULF WAR VETERANS' HEALTH PROBLEMS Bernard M. Rosof, MD (Chair), Senior Vice President, Clinical Affairs/Quality, North Shore-Long Island Jewish Health System, Great Neck, NY Dan G. Blazer, III, MD, PhD, MPH, JP Gibbons Professor of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC Donald W. Black, MD, Professor of Psychiatry, University of Iowa College of Medicine, Iowa City, IA Dedra Buchwald, MD, Professor, Department of Medicine, University of Washington, Harborview Medical Center, Seattle, WA John J. Halperin, MD, Professor of Neurology, NYU School of Medicine, and Chair, Department of Neurology, North Shore University Hospital, Manhasset, NY Isabel V. Hoverman, MD, Austin Internal Medicine Associates, L.L.P., Austin, TX, and Clinical Assistant Professor of Medicine, University of Texas Medical Branch, Galveston, TX Alvin I. Mushlin, MD, ScM, Professor and Chairman, Department of Public Health, Weill Medical College, Cornell University, New York, NY David R. Nerenz, PhD, Professor, College of Human Medicine, Director, Health Care Studies, Institute for Managed Care, Michigan State University, East Lansing, MI John A. Rich, MD, MPH, Medical Director, Boston Public Health Commission, and Associate Professor, Boston University School of Medicine, Boston, MA Kenneth G. Saag, MD, MSc, Associate Professor, Division of Rheumatology and Clinical Immunology, and Director, Center for Education and Research on Therapeutics of Musculoskeletal Disorders, University of Alabama at Birmingham, Birmingham, AL Staff Lyla M. Hernandez, Study Director Patricia Spaulding, Project Assistant Gabor Erdelyi, Project Assistant Rose Marie Martinez, Director, Division of Health Promotion and Disease Prevention Rita Gaskins, Division Assistant Melissa French, Financial Associate

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Page vi

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Page vii Acknowledgments The committee wishes to express its appreciation to the many individuals who contributed in various ways to the completion of this project. Charles C. Engel, Jr, M.D., and Wayne J. Katon, M.D., wrote a paper providing an exceptional description of current efforts to understand the clinical management of medically unexplained physical symptoms. Chapter 5 contains material abstracted from that paper. Stephen Hunt, M.D., and Ralph Richardson, Ph.D., shared with the committee their experiences in treating Gulf War veterans' health problems; Howard Spiro, M.D., provided insight into the diagnosis and treatment of irritable bowel syndrome; and many Gulf War veterans and other interested individuals addressed the committee during its August 2000 meeting. A summary of the testimony appears in the report as Appendix B. This report has been reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise, in accordance with procedures approved by the National Research Council's Report Review Committee. The purpose of this independent review is to provide candid and critical comments that will assist the institution in making its published report as sound as possible and to ensure that the report meets institutional standards for objectivity, evidence, and responsiveness to the study charge. The review comments and draft manuscript remain confidential to protect the integrity of the deliberative process. We wish to thank the following individuals for their review of this report: Gerard N. Burrow, M.D., Yale University School of Medicine; Nelson Gantz, M.D., Chairman, Department of Medicine, and Chief, Division of Infectious Diseases, Pinnacle Health Hospitals; William Golden, M.D., University of Arkansas for Medical Sciences; John E. Helzer, M.D., Health Behavior

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Page viiiResearch Center of the University of Vermont; Richard T. Johnson, M.D., Professor of Neurology, Microbiology, and Neuroscience, The Johns Hopkins University School of Medicine and Bloomberg School of Public Health; Lauren B. Krupp, M.D., State University of New York at Stony Brook; David Mechanic, Ph.D., Institute for Health, Health Care Policy and Aging Research, Rutgers University; Michael H. Weisman, M.D., Director, Division of Rheumatology, Cedars-Sinai Medical Center, and Professor of Medicine, University of California at Los Angeles; and John D. Wynn, M.D., University of Washington. Although the reviewers listed above have provided many constructive comments and suggestions, they were not asked to endorse the conclusions or recommendations nor did they see the final draft of the report before its release. The review of this report was overseen by Robert B. Wallace, M.D., University of Iowa College of Public Health, appointed by the Institute of Medicine, and Harold C. Sox, M.D., Dartmouth-Hitchcock Medical Center, appointed by the NRC's Report Review Committee, who were responsible for making certain that an independent examination of this report was carried out in accordance with institutional procedures and that all review comments were carefully considered. Responsibility for the final content of this report rests entirely with the authoring committee and the institution.

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Page ix Contents EXECUTIVE SUMMARY 1     Introduction, 1     Identifying Health Problems, 1     Treatment Effectiveness, 3     Condition-Specific Treatments, 6     Conclusion, 7 1     INTRODUCTION 11     Background, 12     Clinical Registries, 13     Summary of Gulf War Reports and Evaluations, 14     Gulf War Veterans' Health: Research Summary, 18     Ongoing Clinical Research, 19     War-Related Illnesses and Postdeployment Health Research, 20 2     IDENTIFYING CONDITIONS FOR STUDY 23 3     DETERMINING TREATMENT EFFECTIVENESS 31     Study Designs and Strength of Inference, 31     Efficacy Versus Effectiveness, 34     Outcomes Research, 35     Meta-Analysis, 36     Levels of Evidence for Efficacy and Effectiveness Research, 37     Specific Levels of Evidence or Weights, 38     Other Considerations, 40     Recommendations, 41

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Page x 4     GENERAL APPROACH TO TREATING PATIENTS 43     Recommendation, 49 5     EFFECTIVE TREATMENTS 51     Chronic Fatigue Syndrome, 52     Depression, 61     Fibromyalgia, 72     Headache, 82     Irritable Bowel Syndrome, 93     Panic Disorder, 99     Posttraumatic Stress Disorder, 107     Medically Unexplained Physical Symptoms, 114 6     CONCLUSION 123 REFERENCES 125 APPENDIXES     A     Coalition Forces and Force Strength 139     B     Workshop Summary 141     C     Unique Considerations in Chronic Fatigue Syndrome 151