Chronic Fatigue Syndrome
Novel and Emerging Therapies
Rintatolimod (Ampligen) is a drug with antiviral and immunomodulating properties. In a double-blind study, 234 subjects with severe CFS were treated with either 400 mg rintatolimod or placebo twice weekly. After 40 weeks of treatment, the rintatolimod-treated subjects had significantly higher exercise tolerance compared to subjects given placebo (Strayer 2012). An earlier study with 92 CFS subjects reported that after 24 weeks of rintatolimod treatment, subjects showed improved cognitive and physical performance, better functioning, and decreased symptoms compared to placebo (Strayer 1994). However, the US Food and Drug Administration (FDA) has stated that the data provided by these two trials was insufficient to allow approval of rintatolimod to go to market. More studies on the safety and efficacy of rintatolimod are needed (FDA 2013).
Valacyclovir (Valtrex) is an oral antiviral drug used to treat herpes virus infections. In one study, 27 CFS patients were treated with valacyclovir four times daily or placebo. After six months, the treatment group was judged to be more active, based on an estimate of energy expended in one day, compared to the placebo group (Lerner 2007). In another study, 15 children aged 8-18 years with treatment-resistant depression who met the CDC definition for CFS were treated with valacyclovir. After an average of over two years of treatment with 500-1000 mg twice daily, subjects experienced significant improvements in fatigue and vigor and markedly increased natural killer cell counts in their blood. Fourteen of fifteen study participants experienced a positive response after eight months of treatment. The author concluded “The study’s data support an intriguing hypothesis that a portion of treatment-resistant depression may in fact be undiagnosed CFS or other chronic viral infection” (Henderson 2014).
Valganciclovir (Valcyte), another oral antiviral medication, was the subject of an uncontrolled study in 61 CFS patients. Roughly half the subjects reported substantial improvement in physical and mental functioning, and their response was independent of initial viral infection severity tests (titers). Longer treatment yielded better results in this population (Watt 2012). A randomized controlled trial of valganciclovir treatment for six months was conducted in 30 CFS patients with elevated immunoglobulin G antibody titers against HHV-6 and EBV. Treatment produced significant improvements in mental fatigue, fatigue severity, and cognitive function. The improvement was noted within three months and was still present after an additional nine months (Montoya 2013).
Brain-centered therapies such as biofeedback may be helpful for individuals with fibromyalgia and CFS (James 1996; Babu 2007; Boyer 2014). Biofeedback is a system in which several physiological parameters (such as brain waves and heart rate) are monitored with electrodes and computers while the patient receives visual and auditory feedback. The goal of biofeedback is to help the patient consciously control, at least to some degree, autonomous physiological functions. A case report of a CFS patient treated with an electroencephalography (EEG)-based biofeedback regimen indicated significant improvements in cognitive ability, functional skill level, and quality of life (James 1996). As mentioned earlier, 20-70% of people with fibromyalgia meet US CDC criteria for CFS, which makes the following study of interest regarding biofeedback therapy for CFS: six days of biofeedback training in a group of 15 fibromyalgia subjects was associated with significant reductions in tender points compared with 15 fibromyalgia subjects given a placebo treatment that imitated biofeedback but without therapeutic value (Babu 2007).
Repetitive Transcranial Magnetic Stimulation
Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive treatment that involves passing an electromagnetic field through parts of the brain to modulate neural circuitry. rTMS has been successfully used for several conditions, including treatment-resistant depression, schizophrenia, and recovery in stroke patients (Hovington 2013; Hsu 2012). rTMS may also be helpful for those with fibromyalgia and CFS. One study compared rTMS treatment in 20 fibromyalgia patients to sham rTMS treatment (placebo). After 14 rTMS treatments, fatigue, pain, and stiffness were significantly reduced, and sleep significantly improved in the treatment but not the placebo group (Mhalla 2011). Although more studies are needed to evaluate the efficacy of rTMS in CFS, some researchers suggest this modality may be useful in conditions involving “unexplained” pain, such as CFS, as it may alter central pain processing (Nijs 2011).
Hormone Replacement Therapy
Deficiencies of testosterone and estrogen are common in aging adults, and low levels of these hormones are associated with fatigue (Stanworth 2008; Thornton 2013; Moller 2013; Schwartz 2011). In addition, dehydroepiandrosterone (DHEA) levels have been found to be significantly lower in individuals with CFS compared to healthy controls (Scott 1999; Kuratsune 1998).
DHEA, a hormone produced mostly by the adrenal glands, declines with age to as little as 10-20% of the amount of a 30-year old by the 8th decade of life (Racchi 2003; Himmel 1999; Maggio 2013). DHEA is a precursor to several other hormones including testosterone and estrogens (Himmel 1999). DHEA has important antiviral, pro-immunity, and insulin-regulating effects (Torres 2012; Chang 2005; Mauriege 2003; Weiss 2011; Sawalha 2008; Himmel 1999). A study of 23 women who had CFS and levels of DHEA-S below 2 mcg/mL reported that six months of supplementation with 25 mg of oral DHEA daily was associated with significant improvements in fatigue, pain, memory, and concentration (Himmel 1999). A study that interviewed individuals with unexplained chronic fatigue reported that 11 of 17 subjects who self-treated with DHEA supplementation experienced positive results (Bentler 2005).
There is some evidence that CFS may be accompanied or partially caused by a dysfunction in the hypothalamic-pituitary-adrenal (HPA) axis (Papadopoulos 2012). HPA axis hormone regulation abnormalities often seen in CFS include modest but clinically meaningful reductions in cortisol levels; changes in 24-hour cortisol patterns; and inadequate cortisol response to stimuli that should provoke cortisol release, known as enhanced negative feedback (Nijhof 2014; Papadopoulos 2012).
More information about the benefits of hormone replacement can be found in the Male Hormone Restoration and Female Hormone Restoration protocols, and a comprehensive discussion of strategies to manage stress and help balance the HPA axis is available in the Stress Management protocol.
Immune/Stem Cell Mobilization Therapy
There is an FDA-approved drug called granulocyte colony stimulating factor given to certain cancer patients that helps protect their immune system against the toxic effects of chemotherapy (NCI 2013).
Granulocyte colony stimulating factor induces the bone marrow to produce and release huge numbers of stem cells and immune cells into the circulation (Xu 2000; Ozguner 2014; Maharaj 1995).
A pioneering doctor wondered what would happen if granulocyte colony stimulating factorwere given to patients who suffered from diseases other than cancer. His hypothesis was that the mobilization of stem cells from one’s own bone marrow might have a systemic regenerative effect.
A before and after SPECT scan of the brain of a chronic fatigue syndrome patient showed remarkable restoration of cerebral blood flow and metabolic activity, along with marked clinical and symptomatic improvement.
Below is a case history report of this chronic fatigue syndrome patient successfully treated with granulocyte colony stimulating factor:
The patient, identified as patient LS, began experiencing total body pain in 2010 and later received a diagnosis of fibromyalgia. In early 2013, she was diagnosed with heavy metal toxicity, gut dysbiosis, severe micronutrient deficiencies, food sensitivities, hormone imbalance, immune dysfunction, H. pylori infection, and chronic fatigue syndrome.
After undergoing extensive treatment (eg, opioid pain medication, IV nutrient therapy, hormone replacement therapy, etc.), patient LS continued to experience chronic pain in her head, neck, arms, and legs.
On 7/29/2013, patient LS began undergoing six weeks of treatment with a “stem cell mobilization protocol” in conjunction with an anti-inflammatory diet, stress management techniques, and nutritional supplementation.
Just two weeks after completing her treatment, patient LS noted relief of her total body and neck/back pain. She was able to significantly decrease her pain medication dosage and reported improved cognition.
A single-photon emission computed tomography (SPECT) scan of patient LS’s brain on 7/18/2013, before treatment, revealed reduced blood flow to parts of the brain or an ongoing neuroinflammatory process. The follow up SPECT scan on 9/12/2013, after treatment, revealed a significant improvement in blood flow to parts of the brain (BMSCTI 2014).
This doctor has now treated about 100 patients with various disorders including Parkinson’s, diabetes, and chronic fatigue syndrome. Clinical improvements in these diseased patients have ranged from good to astounding. Not only was their primary disorder responding to granulocyte colony stimulating factor, but they are reporting alleviation or elimination of other age-associated debilities like chronic pain, cognitive impairment and frailty (BMSCTI 2014).
These were not mere placebo effects, as clinical measurements of blood pressure, inflammation, gait, body composition, and cerebral perfusion markedly improved. Blood levels of glucose and lipids fell while HDL levels rose.
These are all indications of systemic age-reversal occurring in response to the mobilization and release of stem cells and healthy immune cells from the bone marrow of these patients.
A downside to this treatment is that drug expenses are quite high and not covered by most health insurance programs. To inquire about this program, contact the South Florida Bone Marrow/Stem Cell Transplant Institute at 561-752-5522. Their website is www.bmscti.org