The Treatment Showdown : CDC Toolkit vs IACFS/ME Primer

Posted by Cort Johnson

The publication of the IACFS/ME Treatment Primer “Chronic Fatigue Syndrome/Myalgic Encephalomyelitis: A Primer for Clinical Practitioners” is a landmark event. In this article we’re going to compare, section by section, the two documents.

The CFIDS Association  has created some good doctor education courses in the past  but only the IACFS/ME – the organization of ME/CFS professionals – has the standing to begin to attempt to challenge the CDC’s dominance in this area.  The CDC with its  reputation in the medical community, considerable financial assets, professionally designed website,  broad reach, etc. has a distinct advantage.

With its low budget (do donate to them when you pick up the Primer), anemic website and generally low visibility outside of the ME/CFS community, the IACFS/ME hardly seems to have a chance…but it  has something the CDC doesn’t have; expertise and credibility within the ME/CFS community.

A 42 page document, the Primer took  two years of work from prominent ME/CFS physicians and researchers with hundreds of years of experience in CFS between them, and a $10,000 grant from Hemispherx (the producer of Ampligen) to get done.  On the other hand the CDC’s 16-page, large print Toolkit, appears to have been put together by staff.

Let’s take a brief  look at the basics of two documents

Basics

• CDC Toolkit – https://www.cdc.gov/cfs/toolkit/index.html
• IACFS/ME  Primer – https://iacfs.net/Home/Primer/tabid/509/Default.aspx

Authors

• CDC Toolkit – authors not stated
• IACFS/ME Primer –   Seven ME/CFS practitioners, 3 researchers (Fred Friedberg, Ph.D., Lucinda Bateman, B.S., M.D., Alison C. Bested, M.D. F.R.C.P.C., Todd Davenport, D.P.T., O.C.S., Kenneth J. Friedman, Ph.D., Alan Gurwitt, M.D., Leonard A. Jason, Ph.D., Charles W. Lapp, M.D., Staci R. Stevens, M.A. Rosemary A. Underhill, M.B., B.S., Rosamund Vallings, M.B., B.S.)

Size

• CDC Toolkit – 16 pages, extra-large  type
• IACFS/ME Primer – 42 pages, normal type

DIAGNOSING AND DIFFERENTIATING CHRONIC FATIGUE SYNDROME FROM OTHER ILLNESSES

• CDC Toolkit uses the  International Case Definition developed 18 years ago and unchanged since then. In order to be diagnosed with CFS under this definition someone must have severe unexplained fatigue lasting 6 months or more (not substantially relieved by rest)  and  4 or more of 8 symptoms (impaired memory or concentration, postexertional malaise (extreme, prolonged exhaustion and sickness following physical or mental activity), unrefreshing sleep, muscle pain, multi-joint pain without swelling or redness, headaches of a new type or severity, sore throat that’s frequent or recurring, tender cervical or axillary lymph nodes)

• IACFS/ME  Primer – uses the  ‘core symptoms’ identified in the 2003 Canadian Consensus Criteria to differentiate ME/CFS from other disorders. To qualify for a diagnosis of ME/CFS a person must have ‘pathological fatigue, post-exertional malaise, sleep problems and pain plus symptoms from two other categories. These can include such symptoms as orthostatic intolerance, irritable bowel syndrome, low body temperature, sensitivities to chemicals, hypersensitivity to light, slowness of thought, etc.

DIAGNOSTIC TESTS

Both organizations recommend a similar series of routine lab tests to rule out other disorders. The IACFS/ME Treatment Primer makes the point that the presence of post-exertional malaise – increased symptoms after exertion – greatly increases the likelihood that the patient has ME/CFS.

Tests to Be Considered Depending on Symptoms

The Treatment Primer suggests a wide variety of further tests depending on which symptoms are present. The CDC does not believe any symptoms warrant further tests (even though many presenting with a possible diagnosis will have other disorders.)

COMORBID ILLNESSES

CoMorbid illnesses are other disorders CFS patients can have which physicians should keep an eye out for.   Surprisingly, little agreement existed on which disorders co-occur with chronic fatigue syndrome, with the Treatment Primer proposing far more disorders occur alongside ME/CFS than the CDC does.

Several CDC studies employing random sampling of the general population suggested increased levels of obesity, insulin resistance and metabolic syndrome are present in CFS. The IACFS/ME physicians creating the primer did not cite obesity and insulin resistance but did cite metabolic syndrome as a possible comorbid disorder.

The Treatment Primer, on the other hand, cited a long list of what are sometimes called ‘central sensitivity disorders’  as well as other disorders which are often allied with ME/CFS in the scientific literature.

Among the disorders the CDC does not agree co-occur with ME/CFS are orthostatic intolerance,  interstitial cystitis, TMJ,  vulvodynia, Ehlers-Danlos syndrome, migraine,  restless leg syndrome, endometriosis, myofascial pain syndrome are more commonly found in ME/CFS.

• CDC Toolkit – obesity, insulin resistance, metabolic syndrome, irritable bowel disease, non-melancholic depression, fibromyalgia, chemical-sensitivity disorder.

• IACFS/ME  Primer – provides a list of 48 conditions which overlap with ME/CFS including  fibromyalgia, multiple chemical sensitivity, irritable bowel syndrome, metabolic syndrome, irritable bladder syndrome, interstitial cystitis, temporomandibular joint syndrome, migraine headache, allergies, thyroiditis, Sicca syndrome, Raynaud’s phenomenon, and prolapsed mitral valve, endometriosis, vulvodynia, autonomic dysfunction (POTS, NMH, OI), celiac disease, gut motility disorder, hypoglycemia, Ehlers-Danlos syndrome, myofascial pain syndrome,  restless leg syndrome, Sjogren’s Syndrome, etc.

EXCLUSIONARY CONDITIONS

Exclusionary conditions are conditions that can mimic the symptoms of chronic fatigue syndrome which physicians should  rule out before they make an ME/CFS diagnosis.

Neither organization purported to provide a complete list.  There was something of  a physiological/psychological split between the two approaches with the Treatment Primer tending to identifying more medical conditions (intestinal disorders, cardiac disease, anemia, pulmonary disease) that mimic ME/CFS and the Toolkit identifying more psychological conditions (depression, alcohol and substance abuse).

DIFFERENTIAL DIAGNOSES

Differential Diagnoses are disorders which can mimic the symptoms of ME/CFS but are rarely found in ME/CFS patients. These are disorders physicians may need to weed out before they can make a diagnosis of CFS.

• CDC Toolkit – provides a list of 10 illnesses that can resemble chronic fatigue syndrome (sleep disorders, depression, alcohol/substance abuse, diabetes, hypothyroidism, mononucleosis (mono), lupus, multiple sclerosis (MS), chronic hepatitis and various malignancies)
• IACFS/ME Primer – lists over 55 potential disease mimics including 5 cardiovascular disorders, 3 autoimmune, 8 endocrine, 12 infections, etc.

Conclusion – the Treatment Primer provides a much more complete and detailed approach to diagnosis in ME/CFS than does the Toolkit.

TREATMENT

Once a diagnosis has been established the next step, obviously is determining how to treat the patient. Once a doctor has a bonified ME/CFS patient  in his/her office what’s next?

Tests to Inform A Doctor’s Treatment

Neither group specifically provides a lists of tests physicians might use to inform treatment options.

• CDC Toolkit  – The  CDC does not recommend any further tests after their initial  simple blood tests or a sleep study to inform treatment options after a diagnosis has been made.
• IACFS/ME  – The IACFS/ME has already recommended a variety of possible tests  based on the symptoms present in their Laboratory Test section (Table II). They include such things as tilt table tests, sleep tests, hormone tests, infectious disease tests, etc.

DRUGS

The difference in the emphasis on drug use in the two treatment documents is remarkable.

• CDC Toolkit – The CDC does endorse the use pharmaceutical drugs to treat ME/CFS but aside from some general recommendations provides no information on which drugs to use. Some recommendations are helpful (use as few drugs as possible, start with small doses, in general do not use narcotics, be careful about prescribing anti-depressants) while others are questionable (medicine for pain or discomfort should be limited to NSAIDS). A doctor reading the Toolkit would have to assume drugs do not play an important role in his/her treatment of ME/CFS.

  

• IACFS/ME – The IACFS/ME primer, on the other hand, provides recommendation and doses for 18 drugs to use in assisting sleep, 14 for reducing pain, five for enhancing energy, 6 for enhancing cognition and 3  for orthostatic and cardiovascular problems. Treatment Primer states that the use of antivirals, antibiotics and antiparasitics can be beneficial in patients where pathogens have been confirmed but provides no diagnostic guidelines or guidelines for drug use.

SLEEP

• CDC Toolkit –  provides recommendations for sleep hygiene and states that if sleep hygiene does not work sleep drugs may be tried but recommends trying antihistamines first. It does recommend seeing a sleep specialist if sleep problems persist.

• IACFS/ME – provides similar recommendations on sleep hygiene and provided a list of 18 sleep drugs, recommended doses and short comments on each.  It also suggest rotating drugs. Oddly enough the sleep section does not include information on Xyrem (sodium oxybate).

PAIN

• CDC Toolkit – provides no section on pain. Its general recommendation is to use NSAID’s.
• IACFS/ME  – the Primer highlights headaches and their potential for being ‘migrainous’, notes that widespread pain may be a indication of fibromyalgia and provides a variety of non-pharmacologic interventions and drugs. Non-pharmacological recommendations include pacing, physical therapy, hydrotherapy, chiropractic, yoga, Tai-chi, meditation, trans-cranial magnetic stimulation.  The Primer provides dosage and comments on 13 drugs or classes of drugs. Narcotics are not generally recommended but may be needed for severe pain states.  The Primer notes that treating localized pain – before it transforms into widespread pain – is important.   In contrast to the CDC’s suggestion of using NSAIDS, the Treatment Primer states they are often ineffective.

COGNITIVE PROBLEMS

• CDC Toolkit – provides no information on treating cognitive problems
• IACFS/ME Primer – suggests a few basic tips (using a memory book, staying away from high-stimulation environments), provides dosage information and comments on six medications (methylphenidate, modafanil, armoadafanil, dextroamphetamines, amphetamine salts, caffeine). Notes that medications seem to work better in patients with ‘sleepiness’ rather than ‘tiredness’ and suggests using the Epworth sleep scale to determine if a patient is more sleepy than tired.

DEPRESSION, ANXIETY AND DISTRESS

• CDC Toolkit – a section on’ Emotional Issues’ suggests professional counseling and joining a support group.  About a quarter  of the treatment section of the Toolkit is devoted to CBT. (Of the ten pages in the Treatment section, CBT and GET get two pages, Emotional Issues gets one, Coping gets one and Sleep two.) The CBT section in the Toolkit is quite short; it states that ‘some people with CFS may find CBT effective’, that it is used for a wide variety of disorders, that it requires trained professionals, etc.

• IACFS/ME Primer – after noting that approximately 40% of people with ME/CFS suffer from anxiety or depression ( a rate similar to other chronic illnesses), the Primer focuses on education, developing coping skills to reduce catastrophizing, etc., identifying and engaging in high pleasure/low effort activities, counseling and support groups. The primer states CBT may improve coping strategies and/or assist in rehabilitation, but the idea that changing “illness beliefs” or graded exercise therapy  can “reverse” or cure the illness is not supported by data. Furthermore they state that in ‘routine’  medical practice, CBT has not produced ‘clinically significant outcomes’.  Finally they note that the lack of CBT providers specializing in ME/CFS means the therapy is rarely available anyway.

EXERCISE

• CDC Toolkit – recommends pacing and a modified GET program which advises patients not to increase exercise/activity levels if symptoms increase afterwards or that causes patients to feel tired at the end of exercise. The Toolkit refers to the Saint Bart’s GET 2008 Guide.

• IACFS/ME Primer – Does not mention GET,  ties fatigue and post-exertional malaise to reduced aerobic functioning, recommends against exercises lasting more than 90 seconds at a time, recommends using heart rate monitor, activity and pacing.  Provides specfic ‘exercise’ recommendations for severely ill and higher functioning patients.

FATIGUE

• CDC Toolkit –  no recommendations
• IACFS/ME Primer – Provides dosage information and comments on five medications (similar to those suggested for cognition.)

ORTHOSTATIC INTOLERANCE

• CDC Toolkit – no recommendations
• IACFS/ME Primer – recommends fluid, salt and a drug (fludrocortisone)

DIETARY SUPPLEMENTS

• CDC Toolkit – no recommendations
• IACFS/ME Primer – short sections on Vit D, Vit B12, essential fatty acids and herbs

GASTROINTESTINAL PROBLEMS

• CDC Toolkit – no recommendations
• IACFS/ME Primer – provides dietary advice, no advice on drugs

DIET

• CDC Toolkit – no recommendations
• IACFS/ME Primer – balanced diet, small frequent meals, mentions lactose intolerance, celiac, rotation diets, reduced sugar, alcohol intolerance

URINARY PROBLEMS, MULTIPLE CHEMICAL SENSITIVITIES, ALLERGIES

• CDC Toolkit – no recommendations
• IACFS/ME Primer – short paragraph on each

LOW FUNCTIONING PATIENTS

• CDC Toolkit – no recommendations
• IACFS/ME Primer –   suggests perhaps one in four patients are confined to their bed/wheelchair and rarely leave their house and are unable to attend regular office visits.  A few are unable to tolerate light, noise and much movement and a variety of chemicals.  Home-based caregivers are needed.  Recommends quiet environment, limited mental activity, minimizing use of medications (starting in very low doses). Activity suggestions begin with range of motion stretches proceeding very slowly.

PREGNANCY

• CDC Toolkit – no recommendations
• IACFS/ME Primer – notes that most mothers with ME/CFS have an uneventful pregnancy, that the ME/CFS symptoms of some patients may get worse, some may get better and others show no change. Obstetric problems (lowered fertility, miscarriage, exhaustion during labor, post-partum depression, etc.)  may be more common.  Children may have an increased risk of ME/CFS.

GYNECOLOGICAL PROBLEMS

• CDC Toolkit – no recommendations. (Ironically the CDC presented a study at the Ottawa IACFS/ME conference showing marked gynecological abnormalities may be present).

• IACFS/ME Primer – some studies suggest increased incidence of gynecological problems (premenstrual syndrome; anovulatory and oligo-ovulatory cycles; low estrogen levels leading to a multitude of CNS symptoms, loss of libido, and in later years, osteoporosis, dysmenorrhea, pelvic pain, endometriosis, interstitial cystitis, dyspareunia and vulvodynia and a history of hysterectomy). Peri and postmenopausal patients may benefit from hormone replacement therapy. Estrogen use in pre-menopausal patients can improve brain circulation, enhance cognition and provide significant relief from hot flashes, fatigue and insomnia.  A progesterone only regimen such as a progesterone-only pill, or impregnated intra-uterine device may benefit some women.  Hormonal therapy, however, should be limited in duration due to increased risk of breast, ovarian and uterine cancer.

PEDIATRIC ME/CFS

• CDC Toolkit – no recommendations
• IACFS/ME Primer – recommends using the Pediatric definition of ME/CFS (based on the Canadian Consensus Criteria).  Suggests diagnosis after 3 months of illness.  States ME/CFS is rarely diagnosed below the age of 10.  While prevalence  appears to lower than in adults, management is largely the same.  Notes that adolescents may meet the Individuals with Disabilities Education Act  (IDEA)

IMMUNIZATIONS

• CDC Toolkit –  no recommendations
• IACFS/ME Primer – recommends that people with ME/CFS avoid all but essential vaccinations and be particularly careful about ‘live’ vaccinations

BLOOD AND TISSUE DONATION

• CDC Toolkit – no recommendations
• IACFS/ME Primer – based on their lack of ‘wellness’ recommends people with ME/CFS do not donate blood

RECOMMENDATIONS FOR SURGERY

• CDC Toolkit – no recommendations
• IACFS/ME Primer -Discussions with surgeon and anesthesiologists prior to surgery is important. Issues such as depleted blood volume, orthostatic intolerance, pain control, and sensitivity to anesthetic medications should be addressed. A Guide to Anesthesia and ME/CFS by Dr. Lapp is found in Appendix E.

CONCLUSIONS

More Missing Than Present – With few tools in its kit there’s more  missing from the CDC toolkit than is present. Somehow the CDC has lopped a simple and rather vague treatment plan onto a rich, complex, notably difficult-to-treat disorder. The simplicity of the CDC’s conception of this illnesses treatment is shocking. More brochure than ‘toolkit’ the CDC guide for treating ME/CFS is so sparse that if one removed the name of the disorder from both publications one could easily assume they were focusing on different disorders.

Even the CDC’s sections on co-morbid illnesses and exclusionary diagnoses seem perfunctory. The CDC’s main treatment recommendations involve CBT and GET – two treatment approaches the authors of the Primer had little faith in and noted were difficult to find in the US. Remarkably, once a diagnosis is made the CDC does not recommend any further laboratory tests be taken. (Depending on which symptoms are present the Primer recommends 30 possible tests).

The Toolkit’s Impact -It takes only a brief look at CFS sections of the Mayo Clinic and WebMd websites to understand how thoroughly the treatment options in the medical community  have been dominated by the CDC’s research and Toolkit.

In 2012 WebMd’s “Chronic Fatigue Syndrome Health Center”  lists the 2009 CDC study on sexual abuse as one of it’s ‘Top Stories’ (“CFS Linked to Childhood Trauma‘ ). WebMD’s  medications section consists of all of 3 pain relievers and ‘antidepressants’ and the Mayo Clinics Treatment section recommends  antidepressants, sleeping pills, graded exercise and psychological counseling.

Neither recommends anything more than basic lab tests and/or a sleep study to guide diagnosis and treatment. One would never guess, based on these sites that some people with ME/CFS suffer from orthostatic intolerance, migraines, severe pain or infections. In fact one wonders why, given the simple treatment recommendations, physicians would be loath to take on ME/CFS ….it looks like a very easy disorder to treat.

Changes in the Works? – The CDC is now consulting with ME/CFS physicians and two CDC/ME/CFS Physician teams are producing two video’s on managing CFS. Eileen Holderman, the patient representative for the CFSAC committee,  went to some pains to note how open the CDC has been to suggestions from the CFSAC panel. The CDC is willing to listen but in its present state, the Toolkit has a long, long way to go and its simplistic orientation to the disorder can only be doing more harm than good.  Unfortunately the CDC rep at the meeting stated that over 17,000 copies have been sent out – ensuring that a good chunk of the medical community – has received an introduction to ‘CFS-lite’.

The IACFS/ME Primer is not perfect. For one thing it’s a ‘primer’, an introduction to ME/CFS treatment not a compendium of it, and some subjects are sketchily reviewed. Viral issues received a scanty overview, with no information  given on diagnosis (admittedly a difficult subject) and,  despite Dr. Lerner’s printed recommendations (also found on the Montoya website) no information is provided for  dosing – a critical factor.  The section on  orthostatic intolerance mentioned only one of the several drugs that are used and Xyrem is not mentioned in the sleep section.

The primer, though, provides a rich overview of this complex disorder with recommendations for many of the  symptoms and conditions associated with it.  Sections on low-functioning patients,  pregnancy, pediatrics, immunizations, gynecological problems, recommendations for surgery and diet are noteworthy additions. The seriousness of the disorder is clearly delineated both in the introductory section and in the long list of treatments provided.

The Primer is a big step forward for the ME/CFS community and will, if it gets out to the physician community, radically change both their perception of, and their treatments for, ME/CFS.

The Future

The CDC has the money and the ‘reach’ (and better graphics) but a big content problem.  The IACFS/ME Primer has the content but little reach outside the ME/CFS community and little money to do outreach.  The best way for the IACFS/ME primer to gain wide recognition would be to incorporate parts of it in the CDC Toolkit.  That may seem like a dream given how far apart the two documents are at this point but the CDC is collaborating with some of the same physicians and researchers that created the primer….and the Toolkit is being revised.  Anything less than a substantial revision would mean CDC would be  ignoring the advice of the very physicians they are working with.

With the Toolkit stating ME/CFS is a ‘complex and serious illness’ on the one hand, while protraying it as some sort of mild, mind-management disorder on the other, the Toolkit is a paradox. Unfortunately given the paltry treatment options offered physicians will undoubtedly believe  the second is true long before they believe the first.

———————————————–

(Phoenix Rising has updated many of its treatments to include information from the IACFS/ME Treatment Primer. We’ve also added new pages on

• Antihistamines
• Doxepin Elixir (Sinequan)
• Flexeril (Cyclobenzaprine)
• Gabapentin (Neurontin)
• Quetiapine (Seroquel))

Support Phoenix Rising

One Time Donation

Recurring Monthly Donations

(Why not support Phoenix Rising with a $5 , $10, $15, $20 or more monthly ‘subscription’. Click on the Subscribe button and look on the right hand side of the page for options :))