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Content 7


The Doctor and the Pharmacist

Radio Show Articles:
June 27, 2015

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News About Chronic Fatigue Syndrome: We're Making Progress
Chronic Fatigue Syndrome: Biology, Diagnosis, and Management
Medical Marijuana Evidence Sketchy, Edible Products Mislabeled
Synthetic Marijuana Deaths Increased Three-fold

As this is Low Dose Naltrexone (LDN) Awareness Week, I thought that our lead articles should address one of the conditions that has been terribly mis-characterized and mis-diagnosed but has seen a remarkable clinical response to LDN: Chronic Fatigue Syndrome

MM: Although this article is a refreshing approach to recognizing the existence of CFS, it fails to recognize that there are approaches that have shown remarkable benefits to the condition such as LDN (Low Dose Naltrexone) and high CBD/Low THC forms of edible cannabis. When a more complete approach to understanding this condition is achieved, then perhaps, we will come to a better understanding how to treat and potentially reverse this life tormenting condition.
News About Chronic Fatigue Syndrome: We're Making Progress
Dispelling the myth that CFS is “all in your head”
Chronic fatigue syndrome (CFS) is a devastating illness that can interfere with all facets of life. It's not clear how many people suffer from CFS, but a recent estimate suggests the number is between 836,000 and 2.5 million in the U.S. According to the Centers for Disease Control and Prevention (CDC), women are two to four times as likely as men to get a diagnosis of this condition. You might also see CFS called by an older name, myalgic encephalomyelitis (ME), or a combination of the two names (ME/CFS).
Yes, It's “Real”
When we first began hearing about CFS decades ago, many clinicians (doctors, nurse practitioners, physician assistants), and even friends and relatives of people with CFS questioned whether it was a “real disease” or “just a mental health condition” or a “figment of the imagination.” They had a hard time believing that a condition that couldn't be diagnosed with a blood test, x-ray, or physical examination could be real. Diagnosis depended (and still depends) solely on what the patient reports.
Recently the Institute of Medicine (IOM) and the National Institutes of Health took a strong stand on CFS. Based on more than 9000 research studies, these organizations concluded that CFS has a biological basis (occurs because of one or more body malfunctions), declaring it “a serious, chronic, complex systemic disease that can profoundly affect the lives of patients.” They also stated that CFS is not “a psychological problem.”
The studies identified many differences between people with CFS and healthy people or those with other conditions that cause severe fatigue (such as depression or multiple sclerosis). Differences were identified in the brain and nervous system, the immune system (which defends the body against infection), and the endocrine system (which regulates body function through glands and hormones). The IOM also noted that CFS sometimes occurs following infection with the Epstein-Barr virus and possibly infections with other viruses, bacteria, and protozoa. Learning more about these factors may help researcher develop tests for diagnosing CFS, as well as medications and other approaches for treating it.
Diagnosing CFS
A diagnosis of CFS still relies on the patient's description of symptoms. CFS is identified when what you are experiencing matches guidelines developed in 1994. According to those guidelines, you have CFS if, for 6 months, you have had severe, constant, unexplained fatigue that interferes significantly with daily activities and work, and four or more additional symptoms from a list of eight that includes unrefreshing sleep (awakening as tired as you were when you went to bed) and fatigue made worse by exertion.
The IOM proposed a simpler definition for identifying people with CFS, which may become the new standard. If you fit the criteria listed below, if no other cause can be found, and if the problems are moderate, substantial, or severe and happen frequently (at least half the time), the likely diagnosis is CFS:
A substantial loss of ability to engage in pre-illness levels of work-related, educational, social, or personal activities that persists for more than 6 months and is accompanied by fatigue, which is often profound, is of new or definite onset (not lifelong), is not the result of ongoing excessive exertion, and is not substantially relieved by rest

Treating CFS
No specific medication or other treatment can reliably relieve or cure CFS — but since CFS affects lives to such an extent, doing nothing is not acceptable. Treatment is aimed at easing at least some of the symptoms. For instance, a very low dose of a medication called a “tricyclic” may allow you to get more hours of deep, restorative sleep at night, resulting in more energy the following day. Graded exercise therapy (supervised physical activity starting at a low level and increasing gradually) may improve fatigue and function, although it doesn't help everyone and sometimes causes problems. Counseling, including cognitive behavioral therapy (CBT), may also help. CBT is a therapist-guided method of changing your thinking and fears about your health situation, which may make CFS easier to live with.
The lack of treatment options may make complementary and alternative treatments, such as acupuncture, massage, and herbal and botanical products, seem attractive. There is little research proving that these approaches are safe and helpful, but some women report relief with them. If you choose to try these options, find out about any possible negative effects. Advertising might claim that herbal and botanical remedies will help you, but the quality, safety, and content of these products is not regulated by the U.S. Food and Drug Administration. If you are considering such a product, check it out at National Center for Complementary and Integrative Health (see Resources below). And be sure to let your clinician know.
You may also want to consider participating in a research program investigating possible treatments for CFS. Places to look for such programs include hospitals associated with universities, or the CDC and support groups such as Solve ME/CFS Initiative (see Resources below).
Coming Soon: A New Name for CFS?
Some experts believe that the term “chronic fatigue syndrome” makes light of an illness that so profoundly interferes with peoples' lives. Because CFS is a systemic (affecting the whole body) illness marked by exertional intolerance, the IOM proposed a new name that acknowledges the true problem: “Systemic Exertion Intolerance Disease (SEID).” That name has not yet been formally adopted, but you may see it used in the future.
In Conclusion
There is still no cure, or even any reliably effective treatment, for CFS. But the IOM report should dispel the myth that CFS is “all in your head.” With more research, more clinician education, and more support for those who have CFS, this illness should receive the validation and attention it deserves.
Resources Solve ME/CFS Initiative http://solvecfs.org/g Centers for Disease Control and Prevention http://www.cdc.gov/cfs/general/index.html National Center for Complementary and Integrative Health https://nccih.nih.gov/ Institute of Medicine, Beyond Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: Redefining an Illness https://www.iom.edu/~/media/Files/Report%20Files/2015/MECFS/MECFS_ReportBrief.pdf
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Chronic Fatigue Syndrome: Biology, Diagnosis, and Management
Despite progress in understanding the biological basis of CFS, there are no good diagnostic tests or treatments that help all patients.
Is Chronic Fatigue Syndrome (CFS) “Real”?
The most widely used case definition of chronic fatigue syndrome, published in 1994, consists entirely of symptoms.1
Because anyone can say they have symptoms, clinicians have asked whether objective evidence of underlying biological abnormalities exists.
The Institute of Medicine (IOM) and the National Institutes of Health (NIH) recently concluded that CFS has a biological basis.(2,3) Based on a survey of >9000 research articles, the IOM states that CFS “is a serious, chronic, complex systemic disease that often can profoundly affect the lives of patients.”(2) Moreover, CFS “is not, as many clinicians believe, a psychological problem,”(4) although some patients certainly have psychiatric co-morbidities requiring diagnosis and treatment.
Neurologic Abnormalities
Many objective, measurable differences distinguish patients with CFS from healthy individuals or patients with other fatiguing illnesses (ranging from major depression to multiple sclerosis).(5) Cognitive studies reveal slowed information processing and deficits of attention and memory in patients with CFS, and functional MRI shows that cognitive tasks require recruitment of more areas of the brain. Standard MRI studies point to white matter abnormalities and decreased gray matter volume. Encephalographic analyses have distinguished unmedicated CFS patients from healthy individuals and from patients with major depression.
The IOM has concluded that the hypothalamic-pituitary-adrenal axis (and possibly several other neuroendocrine axes) is disordered. Compared with healthy individuals and patients with major depression, CFS patients have lower levels of overnight cortisol, 24-hour urinary cortisol, corticotropin-releasing hormone or arginine vasopressin (or both), and adrenocorticotropin hormone. Defects in the autonomic nervous system are clinically manifested by orthostatic intolerance (heart rate and blood pressure abnormalities when standing or during head-up tilt testing).(2)
Immune Abnormalities
Many patients with CFS have poorly functioning NK cells (a lymphocyte subset that defends against viral infections and malignancy) as well as altered blood levels of various cytokines.(2) In a study of 298 CFS cases compared with 348 healthy controls, analysis of 51 different cytokines and related analytes suggests that CFS is driven by an immune system that is chronically activated for several years following onset and then perhaps “exhausted” from this chronic activation as the duration of the illness lengthens.(6)These results are provocative because the symptoms of CFS could well reflect cytokine production in the brain from a neuroinflammatory process. Indeed, a positron emission tomography study demonstrated brain neuroinflammation (activated microglia or astrocytes) in patients with CFS. (7) Moreover, when cytokines are given therapeutically (e.g., interferon for hepatitis B and C), the infusion often produces fatigue and other CFS-like symptoms.
CFS can follow infection with Epstein-Barr virus (and possibly other specific viral, bacterial, and perhaps protozoal infections).(2) However, no infectious agent has been proven to cause the ongoing symptoms of CFS — and a single, novel infectious cause is unlikely to explain most cases. It is plausible (but unproven) that a significant proportion of cases are triggered and perpetuated by any of several chronic infections of the brain and infection of immune cells associated with peripheral nerves.
Diagnostic Tests
Although multiple objective biological abnormalities distinguish people with CFS as a group from individuals who are healthy or who have other diseases, none of these biomarkers are sufficiently sensitive and specific to constitute a diagnostic test. Currently, the role of diagnostic testing in patients suspected of having CFS is to rule out other fatiguing illnesses. In contrast to people with major depression, patients with CFS generally do not appear downcast or express feelings of hopelessness and helplessness or describe anhedonia. The exceptions are those suffering from both CFS and a secondary (reactive) depression.
Relatively few pharmacologic or other therapies for CFS have been tested in large randomized trials. A report commissioned by the Agency for Healthcare Research and Quality (AHRQ) concluded that no available pharmacotherapy is of proven benefit in CFS — including hydrocortisone, immunoglobulin G, valganciclovir, isoprinosine, fluoxetine, galantamine, and various complementary therapies — and that corticosteroids and galantamine can have serious adverse effects. (8) Randomized trials have demonstrated benefit from very-low-dose tricyclic drugs in fibromyalgia, a condition similar to CFS. Although this treatment has not been tested in patients with CFS, anecdotal experience suggests that it may give patients more hours of deep, restorative sleep at night, and more energy the next day.
The AHRQ report concluded that counseling therapies and graded exercise therapy help improve fatigue and function in some patients. These approaches are not curative, and exercise therapy must be pursued very cautiously as it led to more adverse events and withdrawals in several trials.
New Case Definition and Name
The IOM committee has proposed a new case definition that is simpler and likely to identify a more homogeneous and sicker group of patients. This recommendation is generally supported by empirical research, but must be tested in patients with other fatiguing illnesses to ensure it does not produce false positive results. Nonetheless, it is likely to become the most widely used case definition in the next several years. The diagnostic criteria are as follows:
Diagnosis requires all of the following three symptoms:

At least one of the following two manifestations is also required:

Frequency and severity of symptoms should be assessed. The diagnosis should be questioned if patients do not have these symptoms with moderate, substantial, or severe intensity at least half of the time.
The name “chronic fatigue syndrome” is thought by many to trivialize this often devastating illness. Because the IOM found evidence that CFS is a systemic illness marked by exertional intolerance, the IOM proposed a new name: systemic exertion intolerance disease (SEID). The Department of Health and Human Services, which commissioned the IOM report, will take this recommendation under advisement.
In patients who meet the case definition of CFS, we must still pursue other possible comorbid fatiguing illnesses, including depression. Although we don't understand the pathogenesis of CFS and we don't have a diagnostic test or proven cure, ample evidence shows that CFS is a true illness characterized by biological aberrations. Thus, although we still have little to offer, let's not tell CFS patients, “There is nothing wrong with you.” That statement is neither accurate nor therapeutic.
1.Fukuda K et al. The chronic fatigue syndrome: A comprehensive approach to its definition and study. Ann Intern Med 1994 Dec 15; 121:953.
CrossRefPubMed abstract (Free)Web of Science
2.Institute of Medicine.Beyond myalgic encephalomyelitis/chronic fatigue syndrome: Redefining an illness (2015). The National Academies Press; 2015. (http://www.nap.edu/catalog/19012/beyond-myalgic-encephalomyelitischronic-fatigue-syndrome-redefining-an-illness)
3.Green CR et al. National Institutes of Health Pathways to Prevention Workshop: Advancing the Research on Myalgic Encephalomyelitis/Chronic Fatigue Syndrome — executive summary. Ann Intern Med 2015 Jun 15 [e-pub]. (http://dx.doi.org/10.7326/M15-0338)
4.Ganiats TG.Redefining the chronic fatigue syndrome. Ann Intern Med 2015 May 5; 162:653. (http://dx.doi.org/10.7326/M15-0357)PubMed abstract (Free)
5.Komaroff AL and Cho TA.Role of infection and neurologic dysfunction in chronic fatigue syndrome. Semin Neurol 2011 Jul; 31:325.
(http://dx.doi.org/10.1055/s-0031-1287654) CrossRefPubMed abstract (Free)
6.Hornig M et al. Distinct plasma immune signatures in ME/CFS are present early in the course of illness. Sci Adv 2015 Feb 1; 1:e1400121.
(http://dx.doi.org/10.1126/sciadv.1400121) FREE Full Text
7.Nakatomi Y et al. Neuroinflammation in patients with chronic fatigue syndrome/myalgic encephalomyelitis: An 11C-(R)-PK11195 PET study. J Nucl Med 2014 Jun; 55:945. (http://dx.doi.org/10.2967/jnumed.113.131045)
Abstract/FREE Full Text
8.Smith MEB et al. Treatment of myalgic encephalomyelitis/chronic fatigue syndrome: A systematic review for a National Institutes of Health Pathways to Prevention Workshop. Ann Intern Med 2015 Jun 15; [e-pub].
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MM: This is an example of why the "pharmacist model" of medical marijuana dispensaries is the most appropriate model for this industry. Pharmacists pay close attention to the component and potency make-up of the products that they dispense. They realize the importance of accurate strength data when it comes to the appropriate treatment and to obtaining the desired results from a product. When a pharmacist is responsible for the quality of the product that is to be dispensed, there is both a professional responsibility and a detail oriented culture that is ingrained in the dispensing process.
Medical Marijuana Evidence Sketchy, Edible Products Mislabeled
By Joe Elia , Edited by David G. Fairchild, MD, MPH, and Lorenzo Di Francesco, MD, FACP, FHM
Advocates of medical marijuana won't be cheered by the latest JAMA findings: evidence supporting its use is weak, and edible products with delta-9-tetrahydrocannabinol (THC) are often mislabeled.
A meta-analysis found only low-quality evidence favoring use to treat chemotherapy-related nausea or to stimulate appetite in HIV, for example. The evidence in other conditions, such as chronic pain, was of moderate quality at best.
In addition, the authors of a research letter analyzed 75 edible marijuana products purchased in Los Angeles, San Francisco, and Seattle. They found that 60% of the labels overstated THC content and about a quarter understated it.
Editorialists decry the quality of evidence supporting THC's medical use and the lack of research into its hazards. They suggest that states could be using medical marijuana "as a veiled step" toward allowing recreational access and that "the medical community should be left out of the process, and instead marijuana should be decriminalized."
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MM: The dangers of synthetic products emphasizes why "whole" natural products may be both safer and more effective approaches to many conditions. This has been demonstrated with the statin drugs when compared to Red Yeast Rice and may also be true with medical marijuana when compared to synthetic psychoactive products. It is also important to remember that not all medical marijuana contains an abundance of THC, the chemical component that produces a "high" sensation. The many other chemical components that are present in the whole flower such as the CBD's and CBN's (cannabadiols and cannabinoids) oftentimes are the active components that confer the other benefits of the product. And, the controlled cultivation of the different species or strains of plants may be manipulated to obtain an optimal combination of this mixture of components.
Synthetic Marijuana Deaths Increased Three-fold
So far, 15 people have died in 2015 from using synthetic cannabinoids, a threefold increase from that period in 2014, as reported by the Centers for Disease Control and Prevention. Poison Center calls about the substances have also skyrocketed in the past year, confirming the federal government's view that this is a growing public health threat that needs to be eliminated.

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