Treatment

Dr. Klimas first reviewed treatments (mainly anti-virals) which are still in clinical trials and/or which are approved for use in ME/CFS outside of the U.S. 

Isoprinosine is an immunomodulator that helps to improve natural killer cell function. (It is available in Canada and Ireland). 

Ampligen is another immunomodulator that helps to improve RNase-L response to viral infection. (It is still awaiting FDA approval in the U.S., though it is used in Canada and some European countries).

Valcyte (valganciclovir) is a type of anti-viral used to counteract Epstein-Barr virus reactivation (Montoya J). The FDA has approved this medication as treatment of other conditions, but not for ME/CFS. Phase II of a clinical trial for use in ME/CFS was recently finished (results not yet published). This trial is a pharmaceutical company-sponsored study and considering the fact that the patent on Valcyte will run out in about 2 ½ years, there is concern about the ME/CFS studies being completed before that happens.

Other clinicians, like Dr. Daniel Peterson, use anti-virals in an IV form.  Dr. Klimas remarked anti-virals have demonstrated considerable improvement in a number of ME/CFS patients, but these treatments carry a risk of fairly serious side effects.

Treatments that are more commonly used or prescribed by Dr. Klimas herself, include the following:

• Low-dose Naltraxone—this medication, at a regular dose, is used to block reception of opioid hormones in the treatment of opioid addiction, but at much lower doses, it can boost immune system response. It is also being studied in the treatment of neuropathic pain, because it blocks sensory fibers along the spinal cord. This drug, at the lower dose, can be obtained from compounding pharmacies.

• Low-dose Estrogen— Dr. Klimas supports the use of this hormone treatment, at the lowest dose, in women who are going through menopause, as long as there is no known cancer risk. She has found the changes of menopause can greatly exacerbate ME/CFS symptoms.

• Xyrem—(sodium oxybate, a form of Gamma hydroxy butyrate (GHB), also known as the "date rape drug") is a central nervous system depressant with rapid onset, used to induce sleep. In fact, studies were recently completed for its specific use in ME/CFS that demonstrated that this drug can help improve deep sleep and reduce sleep disturbances as well as fatigue (Univ. of Medicine and Dentistry, NJ and Jazz Pharmaceuticals). Its use requires special registration by prescribing physicians.

• Sleep medications—Dr. Klimas generally prefers to use medications that are not in the benzodiazepine family because they do not promote deepest level of sleep. She prescribes medications like Remeron or Trazodone (both of these are tetracyclic antidepressants), Doxepin in liquid form (its mechanism is similar to a tricyclic antidepressant), and the newer non-benzodiazepine hypnotics, like Lunesta or Ambien. 

• Pain and combinations of FM symptoms—Dr. Klimas prescribes one of the newer medications, like Cymbalta or Savella (both are classified as serotonin-norepinephrine reuptake inhibitors, although the mechanism might be slightly different between the two of these products) for the multiple symptom relief provided by these medications. She also prescribes Lyrica and/or its predecessor, Neurontin. The benefits of Lyrica can be achieved at a lower dose than in Neurontin, but many patients do experience weight gain. 

• Fatigue—Provigil (a unique central nervous system stimulant) was found to only modestly improve cognition in ME/CFS, according to Dr. Klimas. Some ME/CFS clinicians find it can negatively impact sleep, while several others prescribe it and find it to be fairly helpful.

• Supplements—the following three vitamins/dietary supplements are thought to be of particular importance in managing ME/CFS, because so many ME/CFS patients have been found to be deficient in these. Dr. Klimas recommends incorporating Vitamin D3 at 2000 I.U, B12 (in sublingual form) and Coenzyme Q10 (Co-Q10).  Vitamin D helps to improve immune system function, maintain bone mass and muscle strength and provide protection against certain types of cancer. B12 in ME/CFS patients can often be lower or even depleted at the cellular level as opposed to how it appears in serum. This vitamin can help with production of red blood cells, provide protection for nerve cells and their function, as well as boost energy. A recent Japanese study of Co-Q10 benefits was cited by Dr. Klimas which demonstrated increased performance and less fatigue after exercise. Co-Q10 at 60 mg can help to generate energy at cellular level as well as provide antioxidant protection.  [Editor's Note: Even though only these particular three vitamins were highlighted during this presentation, it is important to remember that vitamins work together and depend on each other for proper absorption and optimal function within the body. Not taking the right combination could create imbalances and deficiencies in others.]

• Other interventions—exercise that focuses on muscle bulk/"core muscles" is recommended and it can be increased in small 5-minute increments. Neuromuscular massage can be very beneficial. This type of treatment focuses on trigger points and is achieved by applying steady pressure on fixed points and areas within taut bands of muscle.

Centers for Chronic Fatigue and Immune Disorders

In closing, Dr. Klimas made an exciting announcement: the "Centers for Chronic Fatigue & Immune Disorders" will open during Summer 2009 with Dr. Klimas serving as Chief Medical Officer. This is a new state-of-the-art medical clinic, located in the Miami area, which will focus on the assessment and treatment of ME/CFS. She will be personally training the Center physicians with particular attention to the pathology and etiology of ME/CFS.

Some of the available services include the metabolic cart, tilt table test, sleep study, actigraph (a monitor worn by the patient that measures activity level and sleep time), DEXA scan and neurocognitive assessment. Patients will need to get a referral from their primary care physician in order to be seen at the clinic. The goal of this Center is not only to provide each patient with a very thorough evaluation, but to also create a custom treatment and maintenance program for each patient

We highly commend Dr. Klimas for her continued compassion, care and work with ME/CFS and congratulate her on this outstanding accomplishment, making the Centers for Chronic Fatigue & Immune Disorders a reality.