Workshop on Managing FibrositidFibromyalgia Chairman: Sharon Clark, R.N.

Ms. Sharon Clark: It is apparent from this meeting that there is an emerging consensus regarding the essential features in making a diagnosis of fibrositis. To the practic- ing physician faced with a musculoskeletal pain syndrome that has been diagnosed as fibrositis, the major problem is what to do about it. That is the subject of this workshop and I would like to divide it into three parts: (1) What are the outcome criteria that should be used to measure ef- fectiveness of treatment? (2) What is currently being used as therapy (both pharmacologic and non-pharmacologic modes)? and (3) What other disciplines are currently being used (physical therapy, psychiatric intervention, among others). One of the most difficult areas in manag- ing fibrositis is selecting criteria to be used for evaluating the efficacy of any treatment. Since fibrositis is a chronic problem, we need to look for indicators of improvement rather than cure. Having such criteria may also help pa- tients to be realistic in their expectations of treatment. Are pain, sleep, fatigue, and tender points the parameters that need to be evaluated? Are there others equally as appli- cable to a large percentage of patients with fibrositis? What are the most efficient tools for measuring these pa- rameters? And what factors in the history are of use in gauging the effectiveness of therapy? Dr. Alfonse T. Masi: I believe that fibromyalgia com- plaints are symptomatic behavior in a very broad sense, whether it be sleep behavior, exercise behavior, sexual behavior, diet behavior, or whatever other behavior might possibly be affected. In order to understand what stress factors are operating in a particular patient’s life, one needs to gain some understanding of the patient’s major life experiences. If patient X, who has anxiety and perhaps depression, stress, and tension, is to be reassured and believe that the physician truly understands the problem, then she or he has to feel that what is important has been communicated. In other words, in a history one needs to ascertain the relevant social-environmental interrelation- ships in order to try to determine which are the most im- portant in terms of contributing to the current disorder. It is important to realize that the way one patient processes a certain type of experience can be very different from an- other patient’s processing. For instance, in many cases, in a young man with fibromyalgia, a physical overuse prob- lem may be the major contributor to his musculoskeletal pain syndrome, whereas in a young mother with fibro- myalgia, the major contributors may be emotional stresses and interrupted sleep. Each patient should be viewed as an individual who is interacting in a complex life situation. We should attempt to carefully dissect out and

understand the important contributing stress factors. This basic personal information, which is very time consuming to accrue, is the very bedrock upon which our manage- ment approaches and decisions will be based. Ms. Clark: I would certainly agree with those generaliza- tions. Would you be more specific as to the precise pa- rameters that you find of use in assessing outcome in fi- brositis. Dr. Masi: The quality of sleep is a major determinant in most patients. Maybe this should be discussed initially. Ms. Clark: In one of our recent studies an analogue score was used to try to measure the quality of sleep. The score ranged from “feeling awake and being refreshed” to “feeling unrefreshed and very fatigued.” Is this a reason- able analogue score or are the questions by their nature going to influence the patient’s response? Dr. Frederick Wolfe: I think tfiat it is a very misleading kind of scale. If patients are very fatigued, they are going to respond with a score towards 10. I suspect those are not the best words to use. Maybe Dr. Moldofsky could comment on this. Dr. Harvey Moldofsky: I have not used a scale like this but I would agree with Dr. Wolfe that perhaps the patient is being influenced when such words are used to describe a sleep disturbance. I would suggest that you might con- sider sleep quality. To keep it simple, one scale could be used with the words “refreshed” or “unrefreshed.” Then there probably should be a separate scale for fatigue. These patients become fatigued easily during the day so a separate scale for the duration of fatigue and the duration of morning stiffness may be appropriate. It seems to me that there is a circadian rhythm with regard to many of these symptoms. In my experience, patients usually wake up feeling fatigued with aches and pains. But their condi- tion tends to improve during the latter part of the morning and into the early afternoon and then their symptoms re- turn towards the latter part of the day. How do you ad- dress such variations? Dr. Hugh Smythe: These are important questions which I tend to “back into.” Often I have seen these patients for years, very often for other conditions. They may come in with the worst flare of their “rheumatoid arthritis” that they have ever had. I examine them and don’t find such a flare. Upon questioning, they relate a story of a terrible event occurring in their life situation, which has resulted in a dis- turbance of sleep and other symptoms. It is critical to pick up this new event in the patient’s life. In my experience, an abrupt onset of a recent fibrositic flare, related to a major life stress, has a very good prognosis. In many cases, the

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patient can solve the problem or can successfully adapt to it. Ms. Clark: I would like to discuss the descriptions of pain and fatigue. For instance, is the McGill Pain Questionnaire or the Fatigue Checklist of use in quantitating fibrositis? Dr. Donald L. Goldenberg: One thing that I think we have to be very careful about in assessing the effects of therapy is not to confuse diagnostic criteria with efficacy assessment. I do not think that we need a long question- naire to assess efficacy. We need very brief, carefully composed questions; in fact, the sort of questionnaire used in the Oregon studies is exactly what we have used in our studies. This kind of condition seems to lend itself to the sort of health care status quality evaluation that is now becoming sophisticated. Certainly these sorts of question- naires can be validated in this kind of condition, although as yet this has not been done. We have validated such questionnaires in our studies but they need to be validated in a greater number of subjects, including control subjects. Most investigators are using measurements of fatigue, sleep, global assessment, physician assessment, and tender point scores in their studies. Multivariate analysis can be done, while observing items such as treatment modality, and some meaningful conclusions can be reached. I do not think that it is necessary to confuse the situation by doing complicated physiologic measure- ments, which would include sleep studies, when evaluat- ing fibrositic symptoms or treatment. This is just not practi- cal. The relatively brief kind of evaluation using the ana- logue scores that have already been mentioned and tender point scores are very appropriate for the evaluation of treatment efficacy in fibrositis. Dr. Moldofsky: I would like to say a few words about the McGill Pain Questionnaire that has been used in some of these studies. We have tried it but we have had to aban- don it largely because of the words used. Most of the pa- tients that we see simply do not understand these words. A fair degree of sophistication is required to understand words such as ‘Iancinating,” “searing,” or “flickering.” These kinds of words are only applicable to someone who has had at least a high school or possibly a college educa- tion! We employ a simpler technique, a scale ranging from zero to 10, and just ask patients to indicate where they rank on this scale as regards their pain, with zero being no pain and 10 being the most severe pain. We have a similar analogue score for evaluating mood. Ms. Clark: Analogue scales do appear to have a role in the outgoing evaluation of the effects of therapy. What about the types of therapy that are being used? Did you have something to say about antidepressants, Dr. Gol- denberg? Dr. Goldenberg: We have an article in press describing a randomized, controlled, blinded trial of amitriptyline 25 mg at night (versus naproxen 500 mg twice daily ver- sus placebo). In all of the parameters that we evaluated,

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amitriptyline seemed to be an effective agent. As has been the anecdotal impression of most physicians treating patients with fibrositis, the nonsteroidal drugs, in this case naproxen, did not seem to add very much. In most re- spects, the results of our study are very similar to those presented by Dr. Gatter for the combined Philadelphia/ Oregon study on cyclobenzaprine. There was a similar study done on the use of amitriptyline by the group in London, Ontario. They found essentially similar results to ours but did not find an improvement in the tender point score. Dr. Daniel Hamaty: I have observed that the essentials of treatment are the correction of sleep disturbance and heated-water aerobics. Dr. Shson: I disagree with Dr. Hamaty. In approaching any patient with a nonarticular rheumatic disorder, I think there are six features that are of importance in manage- ment: (1) excluding other diagnoses; (2) providing infor- mation to the patient; (3) recognizing any aggravating fac- tors and trying to modify the patient’s behavior appropri- ately; (4) projecting an outcome to the patient; (5) alleviat- ing pain and sleep disturbance; and (6) providing an exer- cise program to preserve the integrity of the musculoskel- eta1 system. I have recently published a joint protection guide for nonarticular rheumatism with the assistance of Ruth Ann Watkins. This can be administered to a patient in order to change both behavior and regional body me- chanic faults in their activities. I think it is important that all six factors that I have mentioned be addressed on the initial visit. Dr. Thomas Romano: Many of my patients with fibrosi- tis are adverse to taking medications. I have been using tryptophan to try to help improve sleep and I explain to these patients that it is a food substance as opposed to a pharmaceutical substance. Many of my patients also ob- ject to the use of even small amounts of antidepressants. If I do prescribe a tricyclic antidepressant, I explain that although it was initially used for the treatment of depres- sion, in this case it is being used for a different reason. Dr. Moldofsky: When we initially studied tryptophan, there was a theoretic basis for its usefulness. In our study, however, we found that tryptophan only facilitated sleep. It didn’t have any effect on fibrositic symptoms. We have recently done a brief blinded pilot study using 5-hydroxy- tryptophan and carbidopa. 5-Hydroxy-tryptophan, of course, is a precursor of serotonin that seems to be an important neurotransmitter in the modulation of pain and also stage four sleep. The rationale for the use of car- bidopa was to block the peripheral metabolism of 5- hydroxy-tryptophan. Unfortunately, the code was usually discerned by the patient. After getting the combination drug, the patient would awake after a couple of hours with nausea. The study was terminated and we couldn’t draw any further conclusions about the efficacy of the combina- tion.

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Dr. Wolfe: I want to ask Dr. Goldenberg a question. Dr. Bennett says it is difficult to treat fibrositis successfully. I wonder what you think the prognosis of your patients is and whether you have any long-term data on that? Dr. Goldenberg: Dr. David Felson and I have done a three-year longitudinal study in patients who have re- ceived amitriptyline and a nonsteroidal anti-inflammatory drug. Although I don’t have the specific figures, approxi- mately 85 percent of the patients have chosen to continue amitryptyline and a much smaller percentage have cho- sen the nonsteroidal anti-inflammatory drug. It is interest- ing that although those patients receiving amitriptyline are generally feeling better and wish to continue with this medication, they still state they have a significant amount of pain. I am rather bemused by the reports of the difficul- ties physicians are having in treating patients with fibrosi- tis and particularly by the general belief that medications in and of themselves are not of great help. Dr. David Bloom: I would like to hear whether there is a critical dose of tricyclic antidepressants that should be used? Dr. Goldenberg: In our studies, we used 25 mg at night time. The highest dose we have ever administered is 40 mg and in some patients with significant daytime drow- ziness the dose has been reduced to 10 mg at night. In general, at higher doses of amitriptyline, physicians may well be treating an element of depression as well as a sleep disturbance. Patients who require larger doses are the type of patients I would want to treat in conjunction with a psychiatrist. Ms. Clark: I would like to make one comment on relaxa- tion therapy. I did a study in which the Jacobson relaxation technique was used in subjects who had fibrositis. In this technique, the patient first tenses the muscle before learn- ing to relax it. I had to abandon this method because these patients could not tolerate the muscle tension they had to exert prior to relaxing the muscles. Dr. Gordon Senter: Like most of the participants in this symposium, I have used every mode of therapy I have ever heard about,. read about, and some I did not read about with very little success. Early on, I referred patients to psychiatrists because I felt that there were psychologic factors that were playing a role in their disease. These patients were promptly referred back to me as being “nor- mal” and told that they needed a “good medical doctor.” After several years of frustration, I talked to a psycholo- gist/psychotherapist and we began a program of group psychotherapy. We have now been utilizing this technique for more than three years and have treated some 80 pa- tients with fibrositis. I should add that most patients are extremely resistent to this method of treatment. We found that if they were in this form of treatment (meeting once a week) for more than eight weeks, about 55 percent of pa- tients showed moderate or marked improvement and sev- eral were completely asymptomatic. I should add that this

was not begun as a formal study, so it is really anecdotal information. In my experience, however, anything that does seem to be effective in fibrositis should be seriously considered for more formal evaluation. I would also like to point out that our understanding of psychic factors as evi- denced by this meeting seems to have been somewhat biased and perjorative. I think we are talking about psy- chologic factors that are common to all of us, particularly about coping mechanisms that are not sufficient for a pa- tient’s particular stresses. It is important to realize that, in general, these patients did not have significant psychiatric problems and they should not be labeled as “defective” or “deficient” just because we recommend psychotherapy for them. Dr. Robert Gatter: Our physical therapist often alerts us to the patient with fibrositis who cannot learn how to relax muscles. Very often this is the key reason why we refer the patient to our psychologist, who then starts dealing in behavior modification, stress management, and the areas that Dr. Senter mentioned. Emphasizing these issues is the way we get patients to accept psychologic interven- tion. Dr. Sheon: I have had 20 years’ experience using ami- triptyline beginning with the management of migraine and then later for the management of neurosurgical patients with pain problems. I have found that ‘as little as 25 mg every other day may suffice. It seems to be cumulative over a period of time. I would also like to point out that meprobamate is often of some use in this group of pa- tients. There are certainly patients who cannot tolerate amitriptyline because of the side effects. Sometimes these patients show a response to cyclobenzaprine or meprobamate. Ms. Clark: What about the use of exercise therapy? Dr. Sheon: Most of these people cannot start an aerobic exercise program because it intensifies their musculoskel- etal pain. I begin them first on a flexibility program with posture correction and then suggest aerobics later. Aero- bics are utilized by either the pool program or land exer- cises. I have had particularly poor results using the exer- cise program adopted by the cardiologists. DF. Wolfe: I would like to ask Dr. f-ladler whether he uses physical modalities in patients that he sees with “no name” disease. Dr. Nortin Hadler: Anecdotal observations have little to offer if we are to shed some light on the topic at hand. There is some information that pertains to patients with acute and sub-acute back problems. It would seem that some of the mobility exercises are actually harmful. Prob- ably the best information we have is on isometrics. While these exercises appear to at least not be harmful, whether they are beneficial has not yet been proved. Ms. Lois Statham: I wanted to respond to some of Dr. Sheon’s comments. In our practice we have also found there is some improvement with relaxation training. I have

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not found that patients cannot tolerate the tension part of Jacobson’s exercise regimen. Many of my patients with fibrositis have specific regional problems. For instance, they have tension in the neck and often in the low back. So this is one area where we use contraction-relaxation techniques. Another point that has not been mentioned is the use of “neutral warmth.” This technique, which is often a valuable one, refers to wrapping painful areas with wool or warm material to hold in the patient’s own body heat rather than adding heat. For instance, wool scarves around the neck, sweaters, or long sleeves can provide relief and may at times prevent excessive pain. Dr. David Simons: It seems as if there must be a sub- group of patients with fibrositis/fibromyalgia in whom there is an overlap between a myofascial pain syndrome and fibrositis. In this subgroup, injection (0.5 percent procaine) or use of a spray-and-stretch technique should provide significant benefit. I think it is important that we don’t over-

look the indications for specific treatment to inactivate trig- ger points in patients who are diagnosed as having fi- brositis and also have pain referred from myofascial trig- ger points. Ms. Clark: In summarizing the comments that have been presented, there seems to be general agreement that assessment parameters include quality of sleep and pain measured by a simple analogue scale. All patients, of course, need to be approached as individuals whose life situations should be carefully evaluated as possible con- tributing factors to the symptoms of fibrositis. Pharmaco- logic treatment appears best aimed at restoring the sleep cycle rather than reducing pain/inflammation through the use of analgesics or anti-inflammatory drugs. Relaxation, exercise, behavior modification, and group sessions all appear to be potentially important therapeutic modalities in the management of fibrositis but definitive objective studies have yet to be done.

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