Hello, i'm doctor Russell. >> Okay, whenever you're ready go ahead. >> Okay. Hello, i'm doctor Russell. I'm speaking to you from, the University of Minnesota, in a, recording studio here. And it's nice to be back with you again. For this last segment of, section three of our fibromyalgia study. We're going to be talking about the non-pharmacologic treatments of fibromyalgia, and some of these understandably are lifestyle changes. And so, we have, we have listed them as all lifestyle changes, even though some of them would be administered by a skilled therapist or physician. The first slide again i,s a colorful flower. That I painted back in the fifth of October in 2002. And, hope you enjoy that color. So were going to be talking about management of Fibromyalgia with life style changes. And we're in the section three, chapter three, that we're calling What can be done for them? And by them, we're talking about people who have Fibromyalgia Syndrome. You can see that, in previous sessions, quest, chapter one was, what is Fibromyalgia? Chapter two, what is wrong with people who have fFbromyalgia, and here chapter three, we're talking about what can be done for it. We've already talked about pharmical therapy, and how complicated or easy this can be. For the clinician, if a few principles are understood, and now we'll talk about non-pharmacologic therapy and lifestyle education. It's important to understand that Fibromyalgia Symptom complex is a complex of core domains. By core domains, we're referring to another way of saying this would be core symptoms, or primary important symptoms. These core domain symptoms were selected specifically because it was believed they should be evaluated in every research study done to iden, determine whether a new therapeutic intervention or agent is effective in Fibromyalgia. So, we thought it would be valuable, and by we I'm referring to Serge Perrot and myself. Dr. Perrot is, in Paris. An academic, rheumatologist, and caring for, people, a number of people with Fibromyalgia. So we thought it would be interesting to conduct a meta-analysis. Sort of a way of getting an average or assessing the outcome of many research papers, studying the same general topic. And so, here we're going to, we're proposing to look at, the benefit associated with medications and with non-pharmacologic or lifestyle changes in people with Fibromyalgia. And see if we use the core manifestations, or core domains as outcome measures. Would this help teach us something specifically new about Fibromyalgia? And so, in this research study, which was accomplished over the past, approximately two, to three years. We included patients who had, I mean, we included research, reports, research, study reports, that were found in electronic databases such as PubMed, Embase, and the Cochrane library. The key words in looking for these articles was that we put in Fibromyalgia, human, randomized clinical trial, and adult. So we're not likely to get, studies about children with Fibromyalgia. We're not likely to get animal studies, and we're seeking good careful randomized control trials that have included in them a definable placebo or sham intervention. Which allows us to know what would happen if the, placebo were present. And then we used only articles that we could find in electric format in full text from, providers and i-in the English language. We required that the patients in the research study be diagnosed as having Fibromyalgia. Using the 1990 American College of Rheumatology Research Classification criteria that were designed for research studies such as this. And the unique fix, feature of this study, which separates it from other studies that have done meta analysis of treatment with medications of Fibromyalgia. Is that we require that at least two of the core domains be measured, and data reported in the studies, so that we would have a chance of looking to see how those domains would fair with different kinds of treatments. The first data table that I'm going to show you looks very complicated, but we're going to be able to, size it down easily and quickly for you so that you can understand what the major findings are. And this paper did come out. Actually I got my copy of this paper for the first time last night, around one or two o'clock in the morning. I was able to download it from the internet. So it is now available. And one could, obtain the paper and see all of the details of the study. But what we have in this medication treatment analysis report is, treatment drugs. Amitriptyline, Citalopram, an SSRI. Duloxetine, that we've talked about quite a bit here today. Fluoxetine, duloxetine is an SNRI. Fluoxetine is an SSRI growth hormone is a hormone from the hypothalamic-pituitary-axis. The, the drug Milnacipran, we've talked about, Pregabalin. And one we haven't discussed much is sodium oxybate, which was extensively studied over the past few years and, found to be quite effective in many respects, but not approved by the FDA for safety reasons. So let's look at amitriptyline. We see if we look down at the bottom, the scale is that the effect sizes, which are the reported numbers here, meaning how much better the active treatment was than the placebo for a given domain, like pain, or sleep disturbance, or fatigue. Or affective symptoms such as depression or anxiety. Or functional, physical function defect. Or thinking, concentrating, cognitive impairment. So, if the effect size were 0.2 or above, in that region, it would be considered a small effect. If it were 0.5 or higher, it would be considered in the medium range. And 0.80 or higher would be considered, considered a large effect. So you can see here with amitriptyline, in studies that were all done many many years ago, probably 15 to 20 years ago, that pain was in the higher range. Sleep dysfunction or disturbance was benefited in the medium range. The same with fatigue. Affective symptoms weren't helped very much, and that's curious, because amitriptyline is considered to be a, antidepressant drug. But the dosage of amitriptyline used in these studies was quite small, between 10 and 25 milligrams. And so it wasn't very, antidepressant at that, dosage. And small effect from functional physical function defect and cognitive impairment was not measured or evaluated, or if it was the data was not sufficient to evaluate it in this format. So we have to look at this and see if we believe that's really representative of that medication. Citalopram, an SSRI, you can see had quite low effects. This one, a small effect in sleep disturbance. But other effects were generally not very high and the affective benefit in people with fibromyalgia, surprisingly was not very good, which is its primary objective in treatment of such of a person. Unless the physician is is not understanding the approach. We would not usually use citalopram for treatment of pain, or sleep disturbance or fatigue in people with fibromyalgia. Duloxetine comes next, and you'll notice that duloxetine has small range effect in many of the outcome measures. These were the result of many, many studies, large numbers of studies of large numbers of patients. And so these numbers are really very accurate numbers. Whereas the studies done with amitriptyline tended to be smaller numbers but several studies were done. Growth hormone had a very large effect. Both on pain and on functional, physical function. But sleep disturbance and fatigue, and affective symptoms and cognitive were not measured. Milnacipran was slightly less in terms of nearly every category, than duloxetine. Pregabalin was in the medium range for sleep disturbance. But, only in the high, higher portion or middle of the small range for pain and other areas aside from function, which is close to 0.2 small effect, were not measured. Not measured were fatigue and affective symptoms, and cognitive impairment, at least not in a way that could be used for this study. Sodium oxybate measured three of those effects, and all of them were between small and close to the medium size effect. But not measured were affective symptoms, functional deficit and cognitive impairment. So, now we're interested in seeing what's going to happen if we look at non-medicinal treatments. So, here we have non-medicinal treatments and they in, that were, for which there were articles published using these treatments that met the criteria of the research study. They included acupuncture, balneotherapy, which would be sort of like going to a spa and laying in water, or a, at the ocean, or in, in a a building. Cognitive behavioral therapy, for which there is much discussion and many people believe that this is an effective therapy for people with fibromyalgia. Exercise therapy, education we go down here to massage and pool water therapy. So let's look at these to see how they compare to the medicinal therapies. Here you can see balneotherapy measured was pain, and affective symptoms, and functional deficit. And you can see that all of these measures are in the very large or medium range. So even though some things weren't measured, we wonder if they might be helped if they were measured and included in such a study. Cognitive behavioral therapy shows medium outcomes for, or even high outcomes. High count for fatigue and medium range outcomes for fatigue, for. For functional deficit and for pain. And even a reasonable response for sleep disturbance. But exercise is just about as good as that and there are exercise studies which show medium benefit in nearly all of the six outcome measures, or outcome domains that we're interested in. Education looks fairly good as a benefit to people with fibromyalgia. And I would point you to pool water aerobic therapy, which is maybe somewhat similar in some respects, certainly water at least is involved, to the balneotherapy. And you can see that there is data for each of the out, six outcome measures we are interested in for fibromyalgia, and the outcomes are fairly large in value. And so, this allows us to say that the outcomes associated with use of non-medicinal treatments can be as high or higher than the outcomes in medication trials. But we need to be careful when we interpret such to, when we make such an interpretation. Because, the non-medicinal treatment studies were done on a much different basis than the medication studies. They tended to be smaller in number, in the number of subjects recruited. They tended to involve more outcome measures than the medication studies did. And they dec, tended to have a larger loss to follow-up of patients during the study. So a smaller number of patients finishing the study. And the less rigid control over these studies then was control over the medication studies makes one wonder if we really can compare them directly. Or if these studies are, inappropriately high in their effect sizes because the standards of the study may not have been as rigid as the standards in the, medicinal studies that were controlled by their need to present them to the Food and Drug Administration. So, Dr. Perrot and I said as one of our analyses of this study is our hope that this analysis may encourage research into the combination of pharmacologic and non-pharmacologic therapies. And let's make emphasis on combination, that is studies done with both pharmacologic and non-pharmacologic therapies in the same study in well-designed clinical trials. We think that might lead to improved benefit for patients. Now, there are some lifestyle changes that we think we should incorporate into care even while we're waiting for such complicated studies. One of those is an exercise program. I recommend an exercise program to every patient that I see with fibromyalgia, and I recommend that the exercise be done in water. I have a specific handout for that, and we will see it as we move on through this lecture, and we may take time to go over the details of this exercise program. It's quite simple but it's very effective, and patients seem to gain a lot of energy in their step. And it helps with the weight loss program, which is the second in the list here. And there is a handout available for that one as well. Sleep hygiene principals have to do with how one prepares for bed and how one maintains their ability to stay asleep during the night. There are several things that can be done. They certainly are related to lifestyle changes and for example we suggest that patients discontinue use of tobacco which has number of adverse effects over a period of time. And, that no alcohol be taken in just before bedtime. Some people think they should drink a nightcap before they go to bed, or a glass of wine. But, the outcome is that they wake up two, a couple of hours later. Because of the alcohol that they've injected. We suggest discontinuing all stimulants. Whether they be drugs or whether they be caffeinated beverages. It has come to seem true in this country and perhaps many other countries of the world that caffeinated beverages like coffee and tea or Coca-Cola have moved up to the status of a food group. People think that it's inappropriate to take away from them these caffeinated beverages, but we all should realize that those beverages are being ingested partly as comfort foods. And partly, because they contain the caffeine which helps people zip themselves up and be al, alert and energetic. But they, caffeine binds to a receptor in the brain, and stays there a long time. And probably is responsible for making it more difficult for people with fibromyalgia to stay asleep. So I think we should do everything we can to help patients stay asleep during the night and enjoy a, a feeling of refreshed restoration in the morning. Now, vitamin D deficiency is very common in the Untied States and many countries of the world. People with darker skin or who cover their faces and heads to avoid sun exposure are at substantial risk for developing vitamin D deficiency. Vitamin D deficiency can cause a form of bone disease which is very painful, particularly in the spine. And so people who have back pain I think should or, or pain anywhere, if they have the sense that they might not be getting adequate sun exposure where we activate the vitamin D in our, in our bloodstream. We should have the vitamin D level checked, and if it's below 20, certainly, we would recommend treatment with vitamin D in a capsule form. We suggest that people taper off their opioid medication. This needs to be done with the advice and monitoring of a healthcare provider. It shouldn't be done by oneself, because it can be quite threatening, but I think the opioids don't do anything beneficial for fibromyalgia, and we should avoid their use. This is the exercise program. And basically, each step tells exactly what needs to be done, but I can say in review overview that one should locate a pool some place in the near vicinity of their home. The pool should not be a hot tub because they need to be able to stand up and do the walking in place exercise that we're going to recommend. And the cooler water while it feels cold when they get in, they adapt to it very quickly, and it takes away the heat of their body generated by exercise. Then I have them plan to walk in place for 20 minutes on alternate days for three days a week. If they get into the water at approximately breast level, they, it's not necessary to swim, and there is really no risk of drowning under these circumstances because the upper part of the chest and head are above the water. And we recommend that, that you would i, imagine a small circle enclosure around your feet and that you stay in that circle. So to stay in this circle it would be necessary to move your arms around the body to sort of sweep your hands back and forth to help you stay in the circle. And if you do that three times a week, you're going to notice, I'm sure a feeling of more energy and enthusiasm for life. And you will strengthen your muscles of the abdomen, of the abdomen. You will help to control back pain by giving better support to the spine itself, and it will help with the Weight Loss Program which is the next category. In the Weight Loss Program, we suggest that you weigh yourself on one weekend, and write down that weight. Then you make a decision about what food you're willing to give up for an entire month, something that you eat regularly. For example, some people have said I'm going to quit drinking a soda every afternoon. Well that's a good one, because there's a lot of sugar in the soda, and certainly it also most soda's have caffeine in them. So, that would be a way to get rid of empty calories. And then not, and then write down what you're going to give up, and then don't weight yourself again until four weeks later. Four weeks later, we expect that you would have lost one pound for each week. If you haven't lost four pounds, then you have stay off whatever you gave up, and give up something else for the next period of four weeks. Then you keep doing that, and if you do that regularly through a period of 12 months or 52 weeks, you will have lost about 50 pounds of weight. And that would make a substantial difference in the body habitus of many people. Finally, I recommend sleep hygiene principles, they are listed here and I'll not go through them in detail, but I will say that people should use the bed only for sleeping and for marital intimacy. And that it should not be used for working, for you working on the computer, watching movies on TV, or reading a book. When a person goes to bed they should turn out the light, get comfortable, and assume that they're going to sleep through the night. If a person does wake up during the night, then I say they should change their sleeping location each time they wake up. So they may end up back in the bed but for a while, they might go to a recliner chair or to the davenport or something. And during that time, they're likely to go to sleep more quickly than they would have had they remained in the bed. We recommend a soft red night light, so that one doesn't stub toes on the furniture and the purpose of that is that melatonin has been shown to be produced during the night. And if a person uses a soft red light as a night light, that doesn't stop melatonin production, as occurs with white light or yellow light or blue light. So a soft red night light will help the person not bump into furniture on the way to the bathroom, and still doesn't interfere with their being able to return to sleep. Sleep should start at a given time every night, and end every night, every morning at approximately the same time, giving the person 79 hours of sleep each night. So, in conclusion, we've talked about non-medicinal interventions that can be as effective as medicine interventions. Lifestyle changes such as exercise, weight loss, and better sleep can be combined with medication treatment in hopes of greater benefit. And with that we turn again to our happy dog that I painted in New Orleans on the 26 of October, 2002. He's saying with this happy face we're making progress with fibromyalgia, keep up the good work. Thank you.
