ME/CFS Primer/Education Bulletins Fall 2006
 

Fall 2006

November 1, 2006
 
 
Fall 2006 
Co-Editors
David S. Bell, M.D. & Rosamund Vallings, MNZM, M.B., B.S.
Managing Editor
Greg Fillmore
Editorial Advisory Board
Leonard A. Jason, Ph.D. • Fred Friedberg, Ph.D. • David S. Bell, M.D.
Rosamund Vallings, MNZM, M.B., B.S. • Gudrun Lange, Ph.D

 

 

SPECIAL EDITION
This special issue of the IACFS Newsletter is being sent to a wide distribution in addition to its regular readership of IACFS members. We invite everyone to discover all that IACFS has to offer.

Table of Contents
Letter from the President
Why the Name of An Illness is of Importance
CFS and the Exercise Conundrum
Updates: Membership Drive, CFS Publishing, and the Future of IACFS
Board Nominations
Call for Nominations for the Governor Rudy Perpich Memorial Lectureship Award and for the Junior Investigator Award
Chronic Fatigue Syndrome Treatment: A Double Blind Trial of Duloxetine By Clinical Trials and University of Cincinnati



Letter from the President

Time is flying. It is already October, and in less than 100 days the membership of the IACFS will be coming to sunny South Florida for the 8th International IACFS Conference on Chronic Fatigue Syndrome, Fibromyalgia and other Related Illnesses. The agenda has been fairly well hammered out, abstracts reviewed, and the letters are going out to let the participants prepare talks and posters; there are a record number of submissions! The hotel rooms are filling up fast with conference participants from all over the globe. We are on our way to one of the best conferences in our history. Get a move on it. Register, and lock in a hotel room. I can assure you, you will not find a nicer facility at the conference rates during the height of the South Florida winter season.

The conference affords us the opportunity to exchange information, hear the latest advances in our scientific understanding of CFS and related illness, develop collaborative relationships, review a tough case with colleagues, and hobnob with old and new friends. But most importantly, it is a place to recharge and develop fresh enthusiasm for a challenging area of research and clinical care.

The conference is also our venue to set the agenda of our organization, the IACFS. The board needs to hear from its membership as we are asked to address critical areas that impact the lives of our patients. The membership meeting gives you an additional place to voice your opinions, and we have a number of issues facing our organization:

1) There will be a motion to combine the CFS and ME names into ME/CFS, as a reflection of our international organization and the language of the illness internationally, and to move away from CFS as a long term goal. I would hope this will provoke a thoughtful discussion and that the science of the meeting will contribute to that discussion.

2) As an international association we have the opportunity to work globally with health policy leaders on behalf of our patients and research field. The advocacy workshop that will kick off the meeting hopes to bring together people from health policy teams, funding agencies, patient advocacy organizations, and our own organization to brainstorm and prioritize needs, and develop collaborative strategies to work internationally towards improving health care and access to health care for our patients.

3) There is a subcommittee working to establish an IACFS affiliated journal, either by establishing a journal or adopting an existing journal as the official publication of our organization. Discussions on e-journals and various publishing houses have been ongoing over the past year, and Gudrun Lange is investigating all of the options. She will bring a progress report to the membership at the meeting.

4) The IACFS will consider sponsoring or co-sponsoring workshops to develop standards of care guidelines that would be useful internationally as policy makers develop policies that reflect advances in diagnosis and management of ME/CFS.

So I am asking the membership to come to the meeting, learn something new, voice your opinions, and help us set the priorities of our organization. Join us!

—Sincerely,
Nancy G. Klimas, M.D.

Members: If you would like to give the board some feedback prior to our next board meeting, please write us c/o IACFS: Admin@iacfs.net



SAVE THE DATE! – January 10 - 14, 2007. 8th International IACFS Conference at the Bahia Mar Beach Resort in Ft. Lauderdale, Florida. Visit www.iacfs.net for updates.

Why the Name of An Illness is of Importance
Leonard A. Jason
DePaul University

Judith Richman
University of Illinois at Chicago

Nicole Porter
DePaul University

Mary Benton
Wichita State University

Despite it’s chronicity and severity, CFS remains highly controversial (Richman, & Jason, 2001). A particularly high percentage of patients with this illness have experienced disrespect and poor treatment by the health care system. Below, we review an issue involving the name given to this illness, which may have contributed to the diagnostic skepticism and stigma that those with this illness encounter.

The name selected to characterize an illness, such as CFS, can influence how patients are perceived and ultimately treated by medical personnel, family members and work associates. The term chronic fatigue syndrome was coined by scientists in 1988 (Holmes et al., 1988). The syndrome had previously been referred to by various names, including Myalgic Encephalomyelitis. In 1955, there was an outbreak of Myalgic Encephalomyelitis at the Royal Free Hospital in Great Britain, which was described by Ramsay, the medical consultant in charge (Hyde, Goldstein, & Levine, 1992). Later, Ramsay (1981) published a definition of this disease under the name Myalgic Encephalomyelitis. The most prominent of these criteria included: (1) fatigue after minimal exertion (not daily fatigue) and delay of recovery of muscle power after exertion ends, (2) one or more symptoms that indicate circulatory impairment, (3) one or more symptoms that indicate central nervous system involvement (cerebral problems), and (4) and fluctuating symptoms.

Because fatigue was considered to be one of the primary symptoms of this syndrome, in 1988, a group of researchers, many of whom were at the Centers for Disease Control and Prevention (CDC), coined the name CFS and developed a new case definition (Holmes et al., 1988). Patients believed that the term CFS trivialized the seriousness of this illness, as the illness is typified by many severe symptoms in addition to fatigue, and fatigue is a common symptom experienced by many otherwise healthy individuals in the general population (Taylor, Friedberg, & Jason, 2001). In addition, CFS is frequently confused with chronic fatigue, which is a symptom of many illnesses, including some psychiatric disorders. The negative stigma associated with CFS may be partially due to the trivializing name that has been given to this disorder in 1988. Two studies explored whether alternative names for CFS (e.g., chronic fatigue syndrome, Myalgic Encephalopathy) do influence attributions by medical trainees (Jason, Taylor, Plioplys et al., 2002), and college undergraduates (Jason, Taylor, Stepanek, & Plioplys, 2001) regarding this syndrome. Participants were randomly assigned to two groups, with the difference between groups involving the type of diagnostic label given for a case description of a patient with prototypic symptoms of chronic fatigue syndrome. Results showed that participants’ attributions about CFS varied on the basis of the different diagnostic labels used to characterize it. The Myalgic Encephalopathy label was associated with the poorest prognosis, and this term was more likely to be associated with a physiological rather than a psychological cause to the illness. Many patient groups believe that changing the name from Myalgic Encephalomyelitis to CFS was thus a major contributing factor to the stigmatization of this illness.

References

Holmes, G.P., Kaplan, J.E., Gantz, N.M., Komaroff, A.L., Schonberger, L.B., Strauss, S.S., Jones, J.F., Dubois, R.E., Cunningham-Rudles, C., Pahwa, S., Tosato, G., Zegans, L.S., Purtilo, D.T., Brown, W., Schooley, R.T., & Brus, I. (1988a). Chronic Fatigue Syndrome: A working case definition. Annals of Internal Medicine, 108,387-389.

Hyde, B.M., Goldstein, J.A., & Levine, P. (1992). The clinical and scientific basis of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome. Nightingale Research Foundation. Ottawa, Ontario, Canada.

Jason, L.A., Taylor, R.R., Plioplys, S., Stepanek, Z., & Shlaes, J. (2002). Evaluating attributions for an illness based upon the name: Chronic fatigue syndrome, Myalgic Encephalopathy and Florence Nightingale Disease. American Journal of Community Psychology, 30, 133-148.

Jason, L.A., Taylor, R.R., Stepanek, Z., & Plioplys, S. (2001). Attitudes regarding chronic fatigue syndrome: The importance of a name. Journal of Health Psychology, 6, 61-71.

Ramsay, M.A. (1981). Myalgic Encephalomyelitis: A baffling syndrome with a tragic aftermath. The ME Association.

Richman, J.A. & Jason, L.A. (2001). Gender biases underlying the social construction of illness states: The case of chronic fatigue syndrome. Current Sociology 49, 15-29.

Taylor, R.R., Friedberg, F., & Jason, L.A. (2001). A clinician's guide to controversial illnesses: Chronic fatigue syndrome, Fibromyalgia, and Multiple Chemical Sensitivities. Sarasota, Fl.: Professional Resource Press.



8th INTERNATIONAL IACFS CONFERENCE, January 10-14, 2007, co-sponsored by P.A.N.D.O.R.A. 23 Category 1 Credits. Two day patient meeting followed by a three day scientific medical conference. Bahia Mar Beach Resort, Ft. Lauderdale, Florida. Details at www.iacfs.net.

CFS and the Exercise Conundrum
Lucinda Bateman, M.D.

 

The key is patience--not doing too much at once and learning not to exceed the threshold that results in “payback” symptoms…Today, 9 years after onset of CFS, I’m still encumbered by my illnesses and still disabled, but muscle pain and weakness are no longer the whole of my story. I can now lift more than folded towels and a dinner setting. I HAVE BICEPS. It has taken over 3 years to achieve “bragging rights” about new found muscular strength, although I am cognizant of the many gradient benefits all along the way, while doing my exercises... At first I did not believe that the little I could do would accomplish any improvement... Specialized exercises, done in gradients (with sufficient rest), taking a day off in between sessions, are the secrets to my success. I have lost 15 unwanted pounds. I look better and I feel better in some ways. Besides adding stamina and strength, exercise has reduced my pain. I no longer need daily pain meds. Gardening is a new hobby, made possible by new found strength and the correct balance of activity and rest. I do use my cane, a gel cushion and proper tools to make it easier.
These words were written by Linda Milne, a 64-year-old patient with disabling CFS whose life changed after she learned how to become more physically conditioned in spite of her illness.

One thing patients and medical providers agree on is that CFS is characterized by post exertional malaise, a term that often understates a “payback” that varies from escalation of widespread pain, to exhaustion requiring a recovery day in bed, to serious relapse of the entire CFS symptom complex:the cognitive dysfunction, flu-like achiness, fatigue, low grade fevers, lymph node tenderness and disturbed sleep patterns of weeks or months duration. Post-exertional malaise has always been considered a defining feature of CFS, although we are still uncertain why it occurs (Fukuda). A recent genomics paper clearly demonstrated a difference, using gene array technology, between CFS patients and controls before and after exercise (Whistler). VanNess, et al recently produced an abstract demonstrating inability of CFS patients to replicate VO2 (measured oxygen consumption) in the second of two graded cardiopulmonary exercise tests separated by only 24 hours of rest, although effort was identical as measured by RQ (VanNess). This finding may be unique to CFS. The CFS patients had almost a 20% drop in VO2 on Day 2 compared to normal, deconditioned controls who achieved the same VO2 on Day 1 and Day 2 of exercise testing. In another study, the same research team objectively demonstrated a decline in cognitive function in 20 CFS patients 30 minutes and 24 hours after a graded cardiopulmonary exercise test compared to pre-exercise levels, with no such observed change in the 20 age matched deconditioned controls (VanNess, unpublished manuscript).

A related concept is the idea that a “threshold” exists at which something pathologic happens in the body because of exercise or activity, and that exceeding the threshold causes post exertional malaise. Knowing exactly what happens at the threshold, where the threshold is, and how we can raise the threshold are questions that have proven difficult to answer, at least in some patients.

This is a not a foreign concept in medicine. A diabetic can develop life-threatening hypoglycemia from exercise. Exercise converts asymptomatic coronary artery disease to ischemia, infarction and fatal arrhythmia. Certain asthmatics develop severe bronchospasm from exercise. In each of these disorders, while potentially deadly, exercise is also an important therapeutic intervention. In each case, exercise is safe if the underlying condition is well defined and under good control, a safe level and type of exercise are prescribed, and the patient is meticulously educated regarding how to exercise and how to recognize signs that exercise should be limited. No doctor would tell these patients that they should “just exercise and they’d feel a lot better.” Our ability to safely prescribe exercise for these disorders is different than CFS because we have a much better understanding of pathophysiology, we can measure the disease severity objectively, and we have effective treatments. In the absence of adequate information about CFS, we should prescribe exercise with the same cautious and attentive approach we might use if we had inadequate clinical information and treatments for our asthmatic, diabetic or cardiac patient. We can still utilize exercise therapeutically if we respect what we do not know, and utilize what we do know from research, clinical experience and the observations of our patients.

It is common knowledge that both muscular and cardiovascular deconditioning occur from inactivity, even in healthy individuals. Pushing beyond one’s current threshold or level of conditioning, by suddenly increasing either the intensity or duration of exercise, may result in fatigue, pain, stiffness and inflammation, even serious difficult-to-reverse conditions such as chronic inflammation (i.e. tennis elbow, plantar fasciitis) or stress fractures. Usually the threshold of deconditioning can be gently raised by gradual increases in the exercise stressor. Young bodies that heal more quickly have a greater capacity to recover from physical stressors or rapid escalation of exercise intensity. Advancing age and co-morbid medical conditions make it more difficult to push exercise efforts too intensely or too long without consequence, hence the “weekend warrior” who ends up limping around in widespread pain or in the Emergency Room from injury.

Patients with CFS who are unable to remain active become deconditioned, but their ability to tolerate exercise stress and raise the threshold may be impaired compared to normal individuals. Indeed, recent studies published by the CDC Computational Challenge teams suggest that CFS patients may have more difficulty than others recovering from common physical stressors, as measured by increased allostatic load (Maloney). It is possible that some stressors leave a mark or permanent injury in patients with CFS, as if their normal stress response and recovery mechanisms are dysregulated or chronically depleted.

In addition to physical deconditioning, there are many partially understood aspects of CFS, well established in the literature, that might contribute to an exercise threshold, the exceeding of which could result in pathologic injury. This might include defects of oxidative metabolism, dysregulation of the autonomic nervous system and HPA-axis (CRH, cortisol and aldosterone), presence of chronic or latent reactivating infection, dysregulated immune or inflammatory systems (cytokine production, natural killer cell function, complement activation) and other yet- to-be clarified processes. It is not difficult to imagine an exercise or activity threshold in someone with CFS after which the body experiences physiologic injury that contributes to post-exertional malaise. It is not necessary to understand this before we respect it.

Clinicians resonate with recent CDC publications supporting the idea that the CFS Case definition defines a heterogeneous group of patients (Vollmer-Conna, Aslakson). Cardiopulmonary test results of more than 200 CFS patients engaged in the Phase III Clinical trial of Ampligen show a stratification of exercise capacity (as measured by VO2, systolic blood pressure and pulse) ranging from mild to severe impairment according to AMA impairment guidelines (VanNess). This exercise tolerance heterogeneity may be the most important reason why, in spite of agreement about post-exertional malaise, there remains a wide array of opinion in published articles about the benefits of exercise in CFS.

Factors that might contribute to heterogeneity and create a number of apparently conflicting clinical or research observations about the benefits of exercise in patients with CFS include the inherent selection bias of small studies, a variety causes of CFS, severity of illness, different stages in the natural history of CFS, age, comorbid medical conditions, weight gain, an inevitable degree of deconditioning, pre-illness state of conditioning, or prior experiences with exercise.

There is no doubt that my hundreds of patients who meet the CFS case definition exhibit a wide spectrum of exercise tolerance. On one end of the spectrum (perhaps a fibromyalgia patient with metabolic syndrome who meets the CFS Case Definition), the response to graded exercise is satisfying and clinically helpful. These patients can gradually increase their strength and aerobic capacity with proper conditioning, resulting in weight loss, better energy, improved pain and fatigue. Some even recover a higher level of function, although the fibromyalgia symptoms usually remain to some degree. On the opposite end of the exercise tolerance spectrum are certain CFS patients who invariably experience a severe relapse of symptoms after attempting to increase their physical activity, either immediately or within a few weeks. It seems that even the more healthy patients of this subset must reduce other activities in order to substitute and sustain a low level exercise regimen.

The point is that we don’t need to understand all aspects of CFS or even be able to objectively subset our patients to begin sensibly utilizing physical conditioning to improve their health. From the clinical standpoint, our patient population will always be heterogeneous. There will always be a spectrum of contributing factors, including primary etiology, stage, co-morbid conditions (including obesity and deconditioning), severity of pain and secondary relapse symptoms, age, plus a variety of personal skills, resources, motivation and discipline. It is possible to adapt exercise advice compassionately and intelligently to the individual situation.

The following are some ideas about how to help your CFS patients discover how they can best improve their physical conditioning, given their particular level or type of illness.

Don’t call it “exercise.”
We all, patients and providers, have inflated perceptions about what the word exercise means. Instead of asking about exercise, try: “What are you able to do ...to keep your muscles from becoming weak? ...to keep your body moving? ...to stay strong and flexible?...to work on physical conditioning?”

Discuss physical conditioning activities in every visit.
Just as I review medications, current symptoms and level of function, I include a question about efforts to become better physically conditioned. Everything counts: walking up and down stairs in the home, sitting on the grass or a gel pillow and pulling a few weeds, walking the dog. Point out and commend what is being done, and think of ways to gradually push toward, but not over, the threshold and discover its nature. Confirm with patients the activities they have discovered helpful (ie, stretching helps reduce pain and stiffness; being stronger makes getting around easier).

Separate physical conditioning into approachable components.
1. Stretching. Stretching is well tolerated and complimented by relaxation and breathing exercises. Start with seated or supine stretching activities, and sustain a regimen for several weeks before moving to standing activities or strength conditioning. Specific instructions are helpful and usually necessary.

2. Strength training. Progress gradually from stretching to strengthening activities. Use very low weights, light stretch bands or no equipment at all, just body weight. Strength training should initially be limited to 30-60 seconds with rest periods between, and a maximum of 3-5 intervals per session. Do not increase weight/resistance much or do prolonged repetitions. Specific instructions are imperative.

3. Cardiovascular conditioning. Aerobic upright activity is usually the least well tolerated, especially if prolonged or intense, so if done, it must be done with care. It should be brief and low intensity, such as walking to the corner and back rather than attempting to go all the way around the block. Start with only a slight increment more than current daily activities demand.

Start with small efforts, increase slowly, and find a sustainable but flexible regimen.
Physical conditioning efforts should approximate an intensity and duration that will cause no post-exertional malaise symptoms the day following the activity. “No pain, no pain,” is advised by Namita Gandhi, an exercise physiologist in Oregon with both personal and professional expertise in fibromyalgia movement therapy. All fatigue, pain or cognitive symptoms should be back to baseline after a good night of sleep. The regimen should not be increased until it can clearly be sustained for weeks without consequence. Then it may be increased a small increment in duration or intensity, and observed for tolerance another 1-2 weeks, etc. There is nothing wrong with finding a tolerable, variable or constant level to maintain without graded increase, as that is the inevitable end.

Allow recovery time.
Rest between short intervals of exercise. Take at least one rest day between conditioning days. Allow more time when stressed or in a flare of symptoms. Give whatever physiologic injury may be present plenty of time to resolve before attempting further exercise.

Be cautious about upright/standing, intense or prolonged activities.
1. Upright/standing: Since people with CFS may have autonomic dysfunction, it makes sense (and works) to engage primarily in activities that minimize orthostatic intolerance (OI). OI is a general term that encompasses a variety of manifestations, including Neurally Mediated Hypotension (NMH) and Postural Orthostatic Tachycardia Syndrome (POTS).

Try to do most physical conditioning activities lying down, seated or in water. If sensitive to orthostatic stress, choose Yoga, Pilates, recumbent cycling or pool therapies rather than standing for Tai Chi, walking on a treadmill, or attempting to play soccer. Water offers a number of theoretical advantages in the setting of OI. Swimming in a horizontal position negates OI. Standing or walking in deeper water creates a hydrostatic pressure gradient, un-weights the joints and spine, and provides uniform light resistance to all movement. Cooler water may contribute positively to peripheral vasoconstriction, thus minimizing OI. Warmer water is more soothing for arthralgia, myalgia and stiffness.

Avoid becoming overheated and volume depleted. Hot tubs, hot showers, sitting too long in a hot car cause vasodilation and can result in marked OI symptoms, manifest silently as a drop in blood pressure or dramatically as a pounding or racing pulse. Frank syncope (fainting) can occur, but getting overheated usually just lowers the threshold, prevents further activity, and can result in severe post-exertional malaise (exhaustion, headaches, cognitive decline, achiness and disturbed sleep).

Volume loading can be strategically timed to improve exercise tolerance in the face of OI. It is effective to “chug or guzzle” oral fluids in anticipation of upright activity. A 500-600 cc (medium size bottled water) bolus begins to raise blood pressure in 15 minutes, peaks in 30 minutes, and the effect is gone in 60 minutes (Shannon).

The peripheral alpha agonist, midodrine (a 10 mg dosage in most people), can compliment fluid loading. Its acts fairly quickly and the effect abruptly wanes within 4 hours due to its short half life. For severe POTS, beta blockade may also be helpful.

2. Intense: Exercising too vigorously is the most common mistake made by those who fail a trial of physical conditioning. Rapidly or dramatically exceeding the threshold results in more illness symptoms, overall a very negative experience. Assume severe underlying deconditioning and co-morbid pathology are present. I tell my patients who hire a personal trainer to begin with a program designed for “an 80 year old with a heart condition.”

Staci Stevens, MS, an experienced CFS exercise physiologist in California, instructs her patients to wear a heart rate monitor with an alarm to notify them when the heart rate has climbed to a predetermined level. She measures a CFS patient’s anaerobic threshold objectively during graded cardiopulmonary testing, notes their heart rate at the anaerobic threshold, and then uses that heart rate value to estimate the anaerobic threshold during physical activity. It is typically somewhere between 90-110. (Linda’s was 80!) Staci counsels patients not to exceed that heart rate during physical activity. When the alarm goes off, the patient stops the activity and sits down to rest. Whether avoiding a defect in oxidative metabolism, an escalation of orthostatic hypotension, or some other mechanism, this may be one tangible way of staying below the threshold of relapse and avoiding post-exertional malaise.

3. Prolonged: Even light exercise can exceed the threshold if pursued too long. Set time limits and gradually increase them if sustainable without relapse. Respect the threshold. If increases in duration of exercise are not well tolerated, continue only shorter, less intense, sustainable regimens. Limit the time of any sustained action initially to 30-60 seconds and the whole activity to 5 minutes. Chuck Lapp, MD, in North Carolina, has shown that five minutes three times during the day are better tolerated than a 15 min block of activity, yet the results in conditioning are equivalent. It is actually better than equal, because exceeding the threshold will inevitably cause a discouraging setback and an understandable desire to abandon all efforts to continue.

Be consistent.
Find a range of well tolerated physical conditioning activities and doggedly stick with it, even if it seems ridiculously insignificant. Learn to pace, assess, and re-adjust the type, intensity and duration of activity day by day to stay under the relapse threshold and avoid post-exertional malaise. Observe any pattern of activity at least a week before increasing the duration or intensity. Be careful about advancing any aspect of physical conditioning unless gradual increases are well tolerated. Recognize and respect the reality that CFS patients may have a point at which, physiologically, they will become more ill from physical activity and experience a substantial set back, even if the mechanisms are not entirely clear.


REFERENCES

Aslakson E, Collmer-Conna U, White PD. The validity of an empirical delineation of heterogeneity in chronic eunexplained fatigue. Pharmacogenomics (2006) 7(3), 365-373.

Fukuda, K. et al. The Chronic Fatigue Syndrome: a comprehensive approach to its definition and study. Annals Int Med, 1994, 121:953-959.

Jammes Y, Steinberg JG, Mambrini O, Bregeon F, Delliaux S. Chronic Fatigue Syndrome: assessment of increased oxidative stress and altered muscle excitability in response to incremental exercise. Jour. Int. Med. 257:299-310 (2005)

Jones JF, Nicholson A, Nisenbaum R, Papanicolaou DA, Solomon L, Boneva R, Heim C, Reeves WC. Orthostatic instability in a population-based study of chronic fatigue syndrome American Journal of Medicine 118:1415.e19-1415.e28, 2005.

Maloney EM, Gurbanxai BM, Jones JF, de Sousa Coelho L, Pennachin C, Goertzel BN. Chronic Fatigue Syndrome and high allostatis load. Pharmacogenomics (2006) 7(3);467-473.

Shannon JR; Diedrich A; Biaggioni I; Tank J; Robertson RM; Robertson D; Jordan J. Water drinking as a treatment for orthostatic syndromes Am J Med. 2002; 112(5):355-60 (ISSN: 0002-9343)

Snell CR, VanNess JM, Stevens SR, Bateman L. Intravenous saline administration improves physical functioning in a patient with Chronic Fatigue Syndrome. Med. Sci. Sports. Exerc. 38(5), 2006

Snell CR, VanNess JM, Strayer DR, Stevens SR. Exercise capacity and immune function in male and female patients with Chronic Fatigue Syndrome (CFS). In Vivo. 19:387-390 (2005).

Stevens SR. Using Exercise Testing to Document Functional Disability in CFS. Jour. of CFS. Vol 1, No.3/4, 127-129 (1995). (Haworth Press)

VanNess JM, Snell CR, Stevens SR, Bateman L, Keller BA. Using serial cardiopulmonary exercise tests to support a diagnosis of Chronic Fatigue Syndrome. Med. Sci. Sports. Exerc. 38(5), 2006.

VanNess JM; Snell CR, Strayer DR, Dempsey L, Stevens SR. Subclassifying Chronic Fatigue Syndrome through exercise testing. Med. Sci. Sports. Exerc. 35(6): 908-913, 2003.

Vernon SD, Reeves WC. The challenge of integrating disparate high-content data: epidemiological, clinical and laboratory data collected during an in-hospital study of chronic fatigue syndrome. Pharmacogenomics (2006) 7(3) 345-354.

Vollmer-Conna U, Aslakson E, White PD. An empirical delineation of the herogeneity of chronic unexplained fatigue in women. Pharmacogenomics (2006) 7(3), 355- 364.

Whistler T, Jones JF, Unger ER, Vernon SD. Exercise responsive genes measured in peripheral blood of women with chronic fatigue syndrome and matched control subjects. BMC Physiology 2005;5(1):5


OTHER USEFUL RESOURCES:

Managing Activity and Exercise. (http://www.cdc.gov/cfs/cfstreatment.htm) (CFS > Consumers>Treatment Options)

The “Skinny” on Exercise and CFS. The CFS Research Review. Summer 2006. Vol 7, Issue 1, 8-10. A publication of the CFIDS Association of America.



ANNOUNCEMENT – The 8th International IACFS Conference will be held January 10 – 14, 2007 in Ft. Lauderdale, Florida. Take advantage of early rates. Register NOW at www.iacfs.net.

Updates: Membership Drive, CFS Publishing, and the Future of IACFS
Fred Friedberg, Ph.D.

With the help of our able management team of Rick and Greg, about 1,000 membership invitation letters have been sent out to peer review authors, and more recently clinicians, in the field of CFS. Unfortunately, the response has been modest with only a few new members added to our roster. We did enroll one lifetime member, a notable event.

One reason for this less-than-hoped-for result may be the relatively flat level of CFS scientific publishing over the past decade. By comparison, fibromyalgia and (non-CFS) fatigue publishing has increased substantially over the same period. (These conclusions are based on a study just completed in my lab.)

This level of publishing may well be related to the low levels of NIH funding for CFS research (ranked 201 out of 210 illness conditions and research areas). Of equal concern, the financial base of our organization is declining. This raises important and potentially critical discussion points about the future of the IACFS that need to be addressed at the Florida conference.

These are the core issues in my view: (1) What can be done to increase membership? (2) How can the financial resources of the organization be strengthened? (3) How can we act as effective advocates for increased federal funding of CFS research?

I think the IACFS Board and the membership in general must collectively generate new ideas in order to sustain our organization in the face of the above threats to our survival. I believe we have the expertise and resources within our membership to accomplish this goal.



Board Nominations
If anyone wants to nominate someone to the IACFS Board, please e-mail me at Ljason@depaul.edu.

Leonard A. Jason, Ph.D.
Director, Center for Community Research
DePaul University




Call for Nominations
for the Governor Rudy Perpich Memorial Lectureship Award
and for the Junior Investigator Award

 

The IACFS Board is seeking nominations for awards, to be presented at the 8th International Conference in January 2007. Please carefully consider nominees for these four awards:

The Rudy Perpich Memorial Lectureship

The Governor Rudy Perpich Memorial Lectureship Award is named after the late Minnesota Governor who provided tremendous enthusiasm, encouragement, and support to the AACFS at its inception, and was instrumental in promoting CFS to governmental and political figures. Nominees should be well known in the CFS/FM field and must have made considerable contributions in research. Previous awardees include Alexis Shelekov, MD (1996), Assistant Secretary of HHS, Dr. Phillip Lee (1998), Anthony Komaroff, MD (2001), Daniel Peterson, MD (2003), and Dedra Buchwald, MD (2004). Awardees are expected to attend the IACFS Banquet and make a brief presentation. Awardees also receive a plaque, travel and accommodations for the meeting, and $300 for expenses.

Junior Investigator

An MD or PhD who has more recently become involved in CFS/FM research is eligible for the Junior Investigator Award. This award was established to encourage new CFS/FM researchers by recognizing their interest, talent, and work. Previous awardees are Pascale DeBecker, PhD (1998), Richard Herrell, Phd (2001), Dane Cook, PhD (2003), and Susan Torres-Harding, PhD (2004). Awardees receive $1000 toward expenses at the meeting.

Special Service

Each year since 2001, the IACFS has recognized extraordinary individuals outside the field of research who have contributed substantially to those with Chronic Fatigue Syndrome or Fibromyalgia. This category may include advocates, leaders, practitioners, supporters, or any person who has lent special effort or talent to the field. Past awardees are:

Christine Hunter (Australia’s Allison Hunter Foundation and MEYA/ ME Young Adults, 2004)
Judy Basso (Minnesota CFS & FM Association, 2004)
Orvalene Prewitt (Founder & President of the National CFS & FM Association, 2003)
Kim Kenney McCleary (Executive Director, CFIDS Association of America, 2001)

Gantz Memorial Outstanding Clinician

This year the IACFS will inaugurate the memorial Nelson Gantz Outstanding Clinician Award. Gantz was a lighthearted and unforgettable character, and a passionate clinician. Colleagues remarked that he had “an uncanny ability to find his way to the correct diagnosis.” He was one of the first clinicians to study the 1983 Lake Tahoe outbreak of CFS, contributed to the international case definition of CFS, and was an empathetic caregiver to many PWCs. Gantz was Chief of Infectious Diseases at Pinnacle Health Center in Harrisburg, Pennsylvania, for many years, but became chief of infectious diseases at Boulder Community Hospital in 2003. He was author or co-author of 77 medical journal articles and contributed to 81 medical texts, but Nelson probably will be best remembered for his signature bow tie, his perpetual grin, and his infectious sense of humor. Nelson Gantz died on June 20, 2006 after a long bout with colon cancer. The Outstanding Clinician Award is dedicated to Gantz, and awarded to a physician who emulates Gantz’s clinical acumen, his passion for medicine, and his empathy for persons with CFS/FM.

Current members of the IACFS Board of Directors are not eligible for awards.

You may email your nominations to Dr. Chuck Lapp care of cwlapp@cs.com, or mail them to:

Charles W. Lapp, M.D.
Hunter-Hopkins Center
10344 Park Road, Suite 300
Charlotte, NC 28210



Chronic Fatigue Syndrome Treatment: A Double Blind Trial of Duloxetine By Clinical Trials and University of Cincinnati

This study is currently recruiting patients.
Verified by University of Cincinnati September 2006

Sponsors and Collaborators: University of Cincinnati
Eli Lilly and Company
Information provided by: University of Cincinnati
ClinicalTrials.gov Identifier: NCT00375973

Purpose

The purpose of this study is to determine the safety and efficacy of duloxetine compared with placebo for reducing fatigue in patients diagnosed with Chronic Fatigue Syndrome (CFS).

Condition: Chronic Fatigue Syndrome (CFS)
Intervention: Drug: Duloxetine
Phase: Phase II
Phase III
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title: A Randomized, Placebo-Controlled, Double-Blind Trial of Duloxetine in the Treatment of Patients With Chronic Fatigue Syndrome.

Further study details as provided by University of Cincinnati:
Primary Outcomes: Multidimensional Fatigue Inventory (MFI)
Secondary Outcomes: Efficacy:; Brief Pain Inventory (BPI); Hospital Anxiety and Depression Scale (HADS); Clinical Global Impression of Severity (CGI-S); Patient Global Impression of Improvement (PGI-I); Safety:; Discontinuation rates; treatment-emergent adverse events; vital signs; laboratory analyses

Expected Total Enrollment: 60

Study start: September 2006; Expected completion: September 2009

Chronic fatigue syndrome (CFS) is characterized by severe disabling fatigue of at least six months duration that cannot be fully explained by an identifiable medical condition . Pain symptoms are also a part of the diagnostic criteria for CFS, and include muscle pain, multi-joint pain, and headaches. The prevalence of CFS ranges from 0.007 to 2.8 % in the general adult population and 0.006 to 3.0% in primary care practice (2). Although most who receive a CFS diagnosis are 30-40 years of age, Caucasian, and female, CFS affects both women and men, adults and children, and all racial and socioeconomic classes.

Patients with CFS have 2-4 times the rate of depression and anxiety compared with the general population. CFS is also commonly comorbid with fibromyalgia, a disorder characterized by chronic widespread pain, tenderness, fatigue, sleep and mood disturbances. In some samples, 70% of patients with fibromyalgia also meet criteria for CFS. CFS and fibromyalgia are characterized by greater similarities than differences and may share pathophysiologic features. Like fibromyalgia, CFS is associated with chronic pain, sleep and mood disturbances. Because fibromyalgia responds to treatment with antidepressants, particularly the dual serotonin and norepinephrine reuptake inhibitors, including duloxetine, antidepressant trials in CFS are clearly needed.

Eligibility

Ages Eligible for Study: 18 Years-65 Years, Genders Eligible for Study: Both

Criteria

Inclusion Criteria:
1. Female and male outpatients between 18-65 years of age.
2. Meet criteria for revised CDC definition of CFS (at least 6 months of persistent fatigue that substantially reduces the person’s level of activity; 4 or more of the following symptoms that must occur with fatigue in a 6-month period: impaired memory or concentration, sore throat, tender glands, aching or stiff muscles, multijoint pain, new headaches, unrefreshing sleep, and post-exertional fatigue. Medical conditions that may explain the fatigue and psychiatric disorders, including eating disorders, psychotic disorders, bipolar disorder, melancholic depression, and substance abuse within 2 years of the onset of fatigue, are excluded).
3. Provision of written informed consent for participation in the trial.
4. Educational level and degree of understanding such that the patient can communicate intelligibly with the investigator and study staff.
5. Judged to be reliable and agree to keep all appointments for clinic visits, tests, and procedures required by the protocol.

Exclusion Criteria:
1. Current melancholic major depressive disorder, or a previous diagnosis of psychosis, eating disorder, or bipolar disorder.
2. History of substance abuse or dependence within the past year, excluding nicotine and caffeine.
3. A positive urine drug screen for any substance of abuse (may be retested if positive test was for a prescribed medication that was not washed out).
4. Women who are pregnant or breast feeding; women must test negative for pregnancy at Visit 1.
5. Women of childbearing potential who are not using a medically accepted means of contraceptive when engaging in sexual intercourse.
6. Patients who, in the opinion of the investigator, are treatment-refractory or whose response is likely to be compromised by existing or future disability compensation issues.
7. Serious unstable medical illness, including cardiovascular, hepatic, renal, respiratory, or hematologic illness, or other unstable medical or psychiatric conditions that in the opinion of the investigator would compromise participation or would likely lead to hospitalization during the duration of the study. Abnormal TSH concentrations (unless treatment for hypothyroidism has been stable for at least the past 3 months and the patient is clinically euthyroid).
8. Patients who have uncontrolled narrow-angle glaucoma.
9. Patients who have acute liver injury (such as hepatitis) or severe cirrhosis (Child-Pugh Class C).
10. Patients who are judged prior to randomization to be at suicidal risk by the clinical investigator.
11. Treatment with antidepressant medication within 14 days prior to randomization with the exception of fluoxetine, which cannot be used within 30 days prior to randomization. Potential need to use a MAOI during the study or within 2 weeks of discontinuation of study treatment.
12. Patients who have previously taken duloxetine
13. Patients who are taking any excluded medications that cannot be discontinued at Visit 1.
14. Treatment within the last 30 days with a drug that has not received regulatory approval at the time of study entry.
15. Known hypersensitivity to duloxetine or any of the inactive ingredients.

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier NCT00375973
Jennifer M Hoff, MSW, LSW 513-475-8114 jennifer.hoff@uc.edu
Susie G Sheridan, B.S. 513-475-8115 dana.sheridan@uc.edu

Ohio Psychiatric Professional Services Inc., Women's Health Research Program, Cincinnati, Ohio, 45219, United States; Recruiting
Jennifer M Hoff, MSW, LSW 513-475-8114 jennifer.hoff@uc.edu
Susie G. Sheridan, B.S. 513-475-8115 dana.sheridan@uc.edu
Lesley M. Arnold, MD, Principal Investigator

Study chairs or principal investigators

Lesley M Arnold, MD, Principal Investigator, University of Cincinnati
Women's Health Research Program



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