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Multiple Sclerosis

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Multiple Sclerosis

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Multiple SclerosisThe Guide to Treatmentand Management

Sixth Edition


http://www.demoshealth.com


Multiple Sclerosis

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Multiple SclerosisThe Guide to Treatmentand ManagementSixth Edition

Chris H. Polman, MD, PhDProfessor of NeurologyFree University Medical CentreAmsterdam, The Netherlands

Alan J. Thompson, MD, FRCP, FRCPIGarfield Weston Professor of Clinical Neurology and NeurorehabilitationInstitute of Neurology, University College LondonClinical Director, National Hospital for Neurology and NeurosurgeryLondon, England

T. Jock Murray, OC, MD, FRCPC, MACP, FRCPProfessor of Medicine (Neurology)Professor of Medical HumanitiesDalhousie UniversityHalifax, Nova Scotia, Canada

Allen C. Bowling, MD, PhDMedical DirectorRocky Mountain Multiple Sclerosis CenterEnglewood, Colorado, USAClinical Associate Professor of NeurologyUniversity of Colorado Health Sciences CenterDenver, Colorado, USA

John H. Noseworthy, MD, FRCPCProfessor and ChairDepartment of NeurologyMayo Clinic College of MedicineRochester, Minnesota, USA




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Demos Medical Publishing, LLC, 386 Park Avenue South, NewYork, New York 10016

Visit our website at www.demosmedpub.com

2006 Multiple Sclerosis International Federation. All rights re-served. This book is protected by copyright. No part of it may bereproduced, stored in a retrieval system, or transmitted in any formor by any means, electronic, mechanical, photocopying, recording,or otherwise, without the prior written permission of the publisher.

Library of Congress Cataloging-in-Publication Data

Multiple sclerosis : the guide to treatment and management / ChrisH. Polman . . . [et al.].—6th ed.

p. cm.Includes bibliographical references and index.ISBN 1-932603-51-4 (alk. paper)

1. Multiple sclerosis. 2. Multiple sclerosis—Treatment.I. Polman, Chris.RC377.5583 2006616.8'3406—dc22

2005018980

Made in the United States of America

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Multiple Sclerosis

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Contents

Foreword xiPreface xiiiThe MSIF International Medical and Scientific

Board (IMSB) Medical Management Committee xv

1. Introduction: The Changing Understanding 1of MS

Better Diagnosis 3Therapy That Is More Focused 4Evidence of Effectiveness in Therapy of MS 5Complementary and Alternative Medicines 7Acquiring Up-to-Date Information on MS 8General Health Measures and Preventative 9

Approaches

2. Treatment for an Acute Exacerbation 11Overview 11Specific Agents 14

Intravenous Methylprednisolone 14Intravenous Dexamethasone 15Intramuscular Adrenocorticotropic Hormone 15Oral Steroids 15Intrathecal Steroids 17Aspirin and Nonsteroidal Antiinflammatory 17

DrugsPlasmapheresis 17Intravenous Immunoglobulin 18

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3. Treatments That Affect the Long-Term Course of 21the Disease (“Disease-Modifying Therapy”)From Better Understanding to Better Treatment 23Drugs Approved for Use in MS 26

Interferon Beta (Avonex®, Betaseron®/ 26Betaferon®, and Rebif®)Interferon Beta-1a 27Interferon Beta-1b 30Side Effects Associated with Interferon 32

Beta TreatmentUnresolved Issues Related to Treatment 33

with Interferon BetaGlatiramer Acetate (Copaxone®) 35Mitoxantrone 37Natalizumab (Tysabri®) 39

Treatments That Are Not Specifically Approved for 41MS But Are Being Used in Certain Partsof the World

Intravenous Immunoglobulin 41Azathioprine 42Cyclophosphamide 43Cyclosporin-A 44Methotrexate 44Cladribine (2-Chlorodeoxyadenosine) 45Sulfasalazine 46Interferon Alpha 47Corticosteroids 47Interferon Gamma 48Plasmapheresis 48Acyclovir (Zovirax®) and Other Antiviral 49

AgentsBone Marrow Transplantation and 49

Hemopoietic Stem Cell TransplantationEmerging Treatments: Alemtuzumab, Statins, 50

Estriol, and OthersAlemtuzumab 50



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Contents vii

Statins 50Estriol 51Other Experimental Treatments 51

4. Symptomatic Treatment, Neurorehabilitation, 59and Service DeliverySymptomatic Treatment of MS 61

Spasticity 61Oral Agents for Spasticity 63

Baclofen 63Tizanidine 63Dantrolene 64Benzodiazepines 64Cannabinoids 64Other Drugs 66

Other Routes of Administration in Spasticity 66Surgery for Spasticity 67

Ataxia and Tremor 68Medical Treatment for Ataxia and Tremor 68Surgical Intervention in Ataxia and Tremor 69

Fatigue 70Medication for Fatigue 71

Bladder Dysfunction 75Bowel Dysfunction 78Sexual Dysfunction 79

Management of Sexual Dysfunction 79in Women

Management of Sexual Dysfunction in Men 79Oral Treatments for Sexual Dysfunction 80Other Approaches to the Treatment of Sexual 81

DysfunctionPain 82Other Paroxysmal Symptoms 83Cognitive Symptoms 84Psychiatric and Psychological Dysfunction 85Other Symptoms 86



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Visual Dysfunction 86Vertigo 86Swallowing, Speech, and Respiratory 87

DysfunctionTemperature Sensitivity 87

Neurorehabilitation 88Measuring Outcome 89

Diagnostic Phase 90Minimal Disability 91Moderate Disability 93Do Benefits of Rehabilitation Carry Over 99

in Medium Term?Severe Disability 101

Evaluating Service Delivery: Developing 101Models of Care in MS

5. Unconventional Therapies and MS 117Definition of Unconventional Medicine 117Popularity of Unconventional Medicine 119Evidence for the Safety and Effectiveness 119

of TherapiesUsing Unconventional Medicine 121Unconventional Therapies Relevant to MS 123

Acupuncture and Traditional Chinese Medicine 123Bee Venom Therapy 126Cannabis (Marijuana) 127Chiropractic Medicine 129Cooling Therapy 131Dental Amalgam Removal 132Dietary Supplements 133

Antioxidants 134Cranberry and Other Supplements Used 135

for Urinary Tract InfectionsEchinacea and Other “Immune-Stimulating” 137

SupplementsGinkgo Biloba 138Kava Kava 139



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Contents ix

Padma 28 140Psyllium 141St. John’s Wort 142Valerian 143Vitamin B12 (cobalamin, cyanocobalamin) 144Vitamin D and Calcium 145Zinc 147

Diets 148The Swank Diet 148Supplementation with Omega-6 Fatty Acids 150Supplementation with Omega-3 Fatty Acids 152

Feldenkrais 154Guided Imagery and Relaxation 155Hyperbaric Oxygen 156Magnetic Field Therapy (Electromagnetic 157

Therapy)Massage 159Neural Therapy 160Reflexology 162Tai Chi 163Yoga 164

Index 181



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Foreword

Information about multiple sclerosis (MS) has never been morewidely available. The Internet has enabled people affected byMS and health professionals in every part of the world to sharetheir knowledge about effective treatments and has created areal opportunity for truly international cooperation in finding acure and ending the devastating effects of this disease.

However, this rich source of facts, advice, and support istempered by misinformation and opinion that has also been dis-seminated. Therefore it becomes increasingly important to de-liver up-to-date and accurate information in order to distinguishvalid treatments from those that are ineffective or evendangerous.

The Multiple Sclerosis International Federation (MSIF)prides itself on providing quality information on all aspects ofMS, and is particularly pleased to sponsor this sixth edition ofMultiple Sclerosis: The Guide to Treatment and Management.It is the result of meticulous work by the International Medicaland Scientific Board of the MSIF to establish authoritative guid-ance on a wide range of therapies currently being used in themanagement of MS. The book has been completely revised toreflect the latest available information about this disease.

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xii Foreword

People with MS, their friends and caregivers, and healthcare professionals, will find great value in the Guide, and theMSIF thanks everyone who has contributed so generously oftheir time to produce this edition.

Christine PurdyChief Executive

Multiple Sclerosis International FederationJune 2005



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Preface

Since publication of the fifth edition of Multiple Sclerosis: TheGuide to Treatment and Management in 2001, the ability tobetter understand relevant disease mechanisms as well as tomodify the course of the disease has had a profound impact onthe outlook of people with multiple sclerosis (MS). There aremore grounds for hope now than four years ago, although wemust also recognize that in our attempts to advance the art ofmedicine unexpected complications can occur.

Improvements have also been achieved in symptomaticmanagement and neurologic rehabilitation. New drugs have beendeveloped, and more effective ways of administering older drugsdevised. Controlled trials of certain aspects of neurorehabilita-tion have shown that there are many effective approaches tomanagement of MS.

This book provides a comprehensive, readily accessibleguide to the wide diversity of therapeutic options now availableto treat MS. As with previous editions, all therapies in currentuse are discussed in detail and a statement given for each thatreflects consensus opinion about each therapy’s usefulnessand effectiveness.

In deciding whether to adopt a particular form of treatment(whether it be medical, surgical, rehabilitative, or “alternative”),it is necessary to weigh the evidence about its effectiveness andthe risk and nature of side effects for the individual patient. Wehave done that in this book to the best of our ability, trying toprovide a general recommendation. Wherever possible we have

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xiv Preface

based our recommendations on scientific, peer-reviewed pub-lications.

Readers of the previous editions will notice that we haveadded a guide to further reading for additional details aboutparticular treatments and how their effectiveness and side effectshave been assessed. Summaries or abstracts of the journal articlescited in this book may be found through “Medline” searches,available through the website of the National Library of Medicine(www.hlm.nih.gov); entire articles may be obtained from medi-cal libraries.

As today the Internet is the first place to which many peopleturn for information the contents of this book are available onthe Multiple Sclerosis International Federation (MSIF) Web site,“The World of MS” (www.msif.org). The online version allowsfor rapid updating of material between print editions, and weurge readers to use this resource to access newly availableinformation.

All material included in this volume was reviewed by mem-bers of the International Medical & Scientific Board (IMSB) ofMSIF, all of whom are neurologists in active practice who treatpatients with MS on a daily basis; the authors thank them fortheir many suggestions and comments. Their opinions are basednot only on published data but also on their daily experiencesand information from trusted colleagues. We give special thanksto the Multiple Sclerosis International Federation, the officialsponsor of this volume, for facilitating publication of thissixth edition.



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The MSIF International Medical andScientific Board (IMSB)Medical Management Committee

Dr. Fernando Caceres Dr. Elizabeth McDonaldClınica de Neuroimmunologıa Multiple Sclerosis SocietyDivisıon Neurologıa Victoria, AustraliaHospital Ramos Mejıa

Dr. Xavier MontalbanBuenos Aires, ArgentinaNeurology Department

Professor Michel Clanet H.G.U. Vall D’HebronHopital Purpan Barcelona, SpainToulouse, France

Dr. John NoseworthyProfessor Hans-Peter Hartung Department of NeurologyDepartment of Neurology Mayo Clinic College ofKarl-Franzens-Universitat Medicine

Graz Rochester, MinnesotaGraz, Austria

Dr. Chris H. PolmanProfessor Jurg Kesselring Department of NeurologyDepartment of Neurology Free University MedicalRehabilitation Center CentreValens, Switzerland Amsterdam, The Netherlands

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xvi IMSB Medical Management Committee

Dr. Carlo Pozzilli Dr. Randall T. SchapiroDepartment of Neurological Department of Neurology

Sciences University of MinnesotaUniversity of Rome Minneapolis, MinnesotaRome, Italy

Professor Alan J. ThompsonDr. Juhani Ruutiainen Institute of NeurologyMasku Neurological University College

Rehabilitation Centre London, EnglandMasku, Finland



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Chapter 1

Introduction: The ChangingUnderstanding of MS

There is a good reason why this book is being continuouslyrevised: The research and information on how best to treat andmanage persons with multiple sclerosis (MS) is rapidly changingand advancing.

Jean Martin Charcot described the clinical and pathologicalfeatures of MS in 1868, and for the next century there was anunderstanding of the nature of the disease according to the clini-cal and laboratory methods of the day. It was believed to be adisease primarily affecting young adults that began with an attackof neurological symptoms. A number of attacks might occur,and these were noted to be related to scattered inflammatorylesions (plaques) in the white matter of the central nervous sys-tem (CNS). The inflammatory lesions were characterized by abreakdown of the myelin that surrounds the central axon of thenerves, but with relative preservation of the axons. After a longperiod when there were frequent attacks and remissions of symp-toms, there was often a stage of slow progression of neurologicaldeficit. This picture seemed to fit what physicians were seeingin most patients. However, in the last few years there has beena rapid expansion of the research effort to better understand thedisease and its underlying mechanisms. This new informationhas provided a different understanding of the disease.

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2 Multiple Sclerosis: The Guide to Treatment and Management

We now see that MS does not start with the first attack,because there is information that there has been disease activitylong before this, probably many years before. Although it mostlyaffects young adults, it can also occur in children or much olderadults. Patches of inflammation and demyelination certainly arepresent in the white matter of the CNS, and can be seen onmagnetic resonance imaging (MRI), but there is increasing evi-dence that the changes in the disease are much more widespreadthan the scattered lesions would suggest, including in areas pre-viously thought to be normal. The information from serial MRIstudies also shows that there is a process of ongoing activity,even when the person does not notice any new symptoms. Forover a century the focus has been on the breakdown of the myelinsheath that surrounds the central axon of the nerve, but currentinterest centers on the axon and on the demonstration that thereis subtle but important and widespread axonal change. This wide-spread axonal damage may be more important in causing theprogression seen later in the disease. Although always regardedas a white matter disease, there is now evidence that changesmay occur in the grey matter as well. From this brief outline itis clear that understanding of the underlying processes in MSis rapidly changing, and these clarified concepts are crucial inthe development of new therapies and treatment approaches forpersons with MS.

There is also substantial new information about the geneticaspect of the disease, as well as the potential “triggers” thatmight precipitate the appearance of the disease in someone whois predisposed to the disorder. The complex immunologicalchanges that affect the myelin and axons are becoming betterunderstood, allowing the development of therapies that are fo-cused on specific steps and pathways in the immune system.

It has long been noted that MS has a variable incidence indifferent parts of the world, and epidemiology research revealspossibilities for why some populations are more at risk thanothers. Studies of the natural history of the disease clarify thevarious patterns of MS that can occur. Using this natural history



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Introduction: The Changing Understanding of MS 3

information, investigators will be able to better measure whethernew therapies will alter the eventual outcome of the disease.

Almost all of the major advances in medicine have occurredin a steady, stepwise fashion, with new information and advancesfrom basic research giving insights leading to the next stage.Subsequent research has led to other stages prior to the eventual“discovery.” Although patients and physicians are naturallywaiting impatiently for major advances, the pace of change andadvance is proceeding at an unparalleled rate, and the view ismore hopeful than ever.

BETTER DIAGNOSIS

Diagnosis of MS has always been a clinical decision, but manytests and criteria have assisted the clinician in arriving at conclu-sions. Tests such as MRI, the examination of the cerebrospinalfluid (CSF), and visual evoked potentials (VEP) are helpful inconfirming the clinical suspicion of MS.

The clinician first conducts a history of the features of thepatient’s story of neurological symptoms, and then a neurologicalexamination to assess how the nervous system has been affected.Defined criteria are used to conclude whether the features fulfillthe clinical diagnosis. Tests then help confirm the suspicion thatthe disease is or is not present. Having defined criteria for theclinical diagnosis and criteria for a positive MRI for MS allowfor more precision in the diagnosis and lessen the likelihood ofa premature diagnosis in questionable cases wherein the MS-like symptoms may be due to some other condition. Just as withother aspects of the disease, we learn more as the criteria areadjusted and improved. The McDonald Criteria are currentlybeing used to incorporate the clinical understanding. Helpfultests such as MRI, CSF examination, and visual evoked poten-tials are also used.

Although the MRI is a relatively new test in the last fewdecades, it is of great diagnostic assistance to the clinician. Itis valuable in revealing much about the activity of the disease,



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helpful in assessing potentially effective drugs, and useful aspart of the evaluation of the impact of new therapies.

As we become aware of the variety of presentations andcourses of MS, we are able to diagnose cases that would havebeen undiagnosed in the past, or would have gone on for manyyears without a diagnosis.

THERAPY THAT IS MORE FOCUSED

The current approaches to therapy are becoming much morefocused on the specific mechanisms thought to be important inthe disease, as research teaches more about the complex phenom-ena involved in the disease.

It was noted by the earliest observers of MS that inflamma-tory lesions caused local patches of demyelination. When corti-costeroids were discovered, their remarkable antiinflammatoryactivity was used in MS for acute attacks of the disease. It is nowclear that steroids in high doses, usually given intravenously, canreduce inflammation and shorten the attack of symptoms, butthey probably do not have more than a short-term benefit. Earlyobservers realized that something more than a drug to reduceinflammation was necessary. When it became clear that an immu-nological reaction was how the demyelination occurred, generalagents that could stimulate or suppress the immune system weretried, but they also had little effect and had many side effects.Over the years the complexity of the immune reaction was betterunderstood, and now agents that target various steps are beingdeveloped and tested. This explains why so much basic researchneeds to be done before an effective drug is available. It ispossible, but less likely, that very effective therapy will becomeavailable before we understand the disease better through basicresearch into the amazing ways the nervous system reacts, re-sponds, heals, and fails under the influences of disease. Thereis an increasing sense of hope in patients, their physicians, andresearchers, because of the research effort and the number of



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studies, and because the community of investigators has neverbeen so great and it increases each year.

Since the 1970s, neurologists have been able to modify theacute attacks of the disease, but they have also searched foragents that would modify the eventual outcome of MS. In thelast two decades a number of agents have been tested, and forthe first time show evidence that they can modify the numberand severity of the attacks of MS and reduce the activity seenon MRI. We would expect this modification of the inflammatoryactivity of the disease to reduce the rate of eventual progressionof the disease, but better long-term studies will be necessary toconvincingly demonstrate this most important outcome effect.

An exciting development has been the observation that thereare at least four patterns of reaction involved in the areas ofmyelin and axon damage. This may lead to different focusedtherapeutic interventions, depending on the pattern of neurologi-cal damage, but will involve finding practical ways to identifythe patterns in a patient, especially early in the disease.

The challenges are great, but there is hope that in the overone hundred clinical trials, the over thirty different agents beingstudied, and the fourteen combination studies being conductedthat substantial benefits will continue to come to the many whocurrently suffer from MS.

EVIDENCE OF EFFECTIVENESS IN THERAPY OF MS

For centuries, therapies have been applied by trial and error,and varied according to the theory of disease at the time. Themain measure of effectiveness has been the experience of thepractitioner. But theories can be incorrect and experience faulty.The fact that something has been used for many years, even forcenturies, is not assurance that it is helpful. The best exampleis bleeding, which was a mainstay of therapy for most of theserious diseases for thousands of years, even though we nowknow it was probably more harmful than helpful.



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Confidence that something is helpful in the treatment ofMS requires evidence, and there are different levels of evidence.A neighbor’s claim that a particular medicine helped her ora story of someone who responded dramatically to a therapy(anecdotal evidence) constitutes weak evidence. More peopleclaiming the same thing adds weight, but is still not solid evi-dence, since almost any approach – useful or useless – hasenthusiastic believers.

Stronger evidence would be provided by a carefully fol-lowed group of patients in an open trial – but since both thepatient and physician are aware of the nature of the therapy, theresults can be affected by bias and by the placebo effect. Inaddition, in an open trial patients may drop out if they do notdo well or feel worse, so the therapist accumulates all the goodresponders and has the impression that most of the treated pa-tients do well.

Defining how patients will be treated and assessed over afuture period – a prospective trial – is stronger evidence than astudy that looks back in time to see how people fared from atreatment – a retrospective trial.

Monumental advances have been made in the last half cen-tury in the development of a scientific approach to measurementof effectiveness versus risk for a therapy. The most obvious isthe development of the double-blind, placebo-controlled, ran-domized, clinical trial (RCT). The randomized clinical trial canbe used to study new drugs, but also surgical procedures andother methods of care.

Trials can be made stronger by using a placebo controlgroup to compare with the group on the proposed therapy. Thetwo groups are matched for as many factors as possible (similarage, sex, duration, type, and severity of disease, and any otherfactors that seem important), and by keeping the therapist andthe patient blinded as to whether they are receiving the treatmentor the placebo. Only an overseeing safety committee is able toaccess information as to what patients are taking in the trial.

Many alleged treatments can be put forward as beneficialfor patients with MS, but it is humbling to realize that what



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seems like a good idea may not be helpful, and may even beharmful. Some approaches may seem to be helpful because wewant them to be, and we take any sign of improvement to be dueto the treatment. We are realizing that no matter how objective wemay try to be, our biases and our hopes influence what we thinkwe are seeing. Clinical trials are designed to reduce bias as muchas possible.

When using a therapy, the benefit seen may be due to theplacebo effect, which is a real effect that has been shown to besignificant in therapies used for MS. The interesting and complexnature of the placebo effect is now better understood, and thedesign of clinical trials allows for assessment of a study drugin comparison to the effect one might see with a placebo.

Clinical trials also use statistical methods to indicate howmany patients need to be studied in equal groups and for howlong, in order to demonstrate a significant effect if there is one.The process of randomization of patients assures that the groupsto be compared, one on the study drug and the other on a similarappearing placebo, are similar on defined characteristics.

In recent years, a technique called meta-analysis has addedeven stronger evidence about therapies. Meta-analysis takes allof the well designed trials that meet defined criteria and analysestheir results in order to reach a conclusion about the safety andeffectiveness of a treatment.

COMPLEMENTARY AND ALTERNATIVE MEDICINES

This volume has a large section dealing with complementaryand alternative medicines (CAM) because they are widely usedby people with any serious or chronic disease. Many studieshave shown that three out of four MS patients use one or morealternative medicines and often seek help from alternative thera-pists, often while also using the conventional therapies pre-scribed by their physicians.

Dr. Marcia Angell and Dr. Jerome Kassirer, former editorsof the New England Journal of Medicine, wrote that there cannot



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be two forms of medicine – conventional and alternative. “Thereis only medicine that has been adequately tested and medicinethat has not, medicine that works and medicine that may or maynot work.” They argued that alternative medicines have beengiven a free ride, and when something is tested rigorously andshown to be safe and effective it does not matter whether it isalternative or conventional. Belief in alternative approaches maybe strong, even when there are no studies to show effect orsafety. They add, “But assertions, speculation, and testimonialsdo not substitute for evidence.” The authors conclude, “Alterna-tive treatments should be subjected to scientific testing no lessrigorous that that required for conventional treatments.”

ACQUIRING UP-TO-DATE INFORMATION ON MS

It is exciting to live in the “Information Age,” but the methodsavailable also bring confusion and even mis-information. Thisedition incorporates the new information, especially as it relatesto the treatment and management of MS attacks, symptoms, andthe underlying disease. As more people obtain information on theInternet, this book, which is sponsored by the MS InternationalFederation, will also be available online (www.msif.org). Thiswill also make it possible for the authors to rapidly update thetext as important new information appears.

Other valuable sources of balanced, reliable, current infor-mation on MS include the national MS societies, which provideboth printed information and Web sites.

Information on studies of conventional and alternative ap-proaches to therapies are collected and evaluated by the CochraneControlled Trials Register, which lists thousands of randomizedcontrolled trials and has conducted hundreds of meta-analyseson these trials. This information can be accessed through theCochrane Library Web site (http://hiru.mcmaster.ca/COCHRANE.default.htm).



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GENERAL HEALTH MEASURESAND PREVENTATIVE APPROACHES

Although this book assesses various treatments that have beenused in MS, it is important to recognize that drugs and proceduresare only one aspect of the effective treatment and managementof a person with MS. There are many ways that a person withMS can stay as healthy as possible, and cope and manage themany challenges that the disease brings, including:

1. Become informed about the disease, because throughinformation you can best deal with questions, chal-lenges, and issues as they arise.

2. Foster your support group of family, friends, andcommunity.

3. Develop a good relationship with your physician andother health professionals.

4. Maintain normal activities and responsibilities as muchas your symptoms and disease allow. Adopt a “rehabili-tation approach” that emphasizes maintenance of activ-ities despite the presence of symptoms and limitations.Good coping skills can be used to manage deficits andapply solutions to challenges.

5. Exercise.

6. Maintain a healthy diet.

7. Control weight.

8. Maintain a positive attitude that is wellness-orientedrather than disease-oriented.

9. Remember to pay attention to the basic health measuresthat are for everyone. Blood pressure measurement,breast examination, Pap tests, prostate examination,blood sugar level, cholesterol and lipids, and other



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preventative approaches are equally important for aperson who has MS.

10. MS affects the body, but the person living with MShas personal and spiritual resources that will allowthem to remain strong and have a good quality of life.


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