• FM and CFS/ME Descriptions
• Demographics
• Disability Studies

Fibromyalgia (FM), pronounced: fy-bro-my-AL-ja, is a chronic, body-wide pain disorder coupled with other symptoms, such as severe daytime fatigue, un-refreshed sleep (likely due to a number of sleep anomalies), irritable bowel, chronic headaches, morning stiffness, cognitive or memory impairments, reduced coordination and decreased physical endurance.

FM has been recognized by the National Institutes of Health and the American College of Rheumatology. FM experts estimate that about 10 million Americans and approximately 3-6% of the population worldwide suffer with FM. While it is most common in women, the illness strikes men, women, and children of all ages and ethnic backgrounds. For those with severe symptoms, FM can be extremely debilitating and interfere with even routine daily activities.

The American College of Rheumatology published the diagnostic criteria for FM in 1990. This selection criteria was shown to be 88% accurate in identifying patients with this syndrome. Researchers have noted a significant overlap between FM, Chronic Fatigue Syndrome (CFS), and Myalgic Encephalopathy (ME). A majority of these patients meet both the diagnostic criteria for FM and the CDC (Center for Disease Control) criteria for CFS & ME. In fact, the American Association for CFS has elected to combine the three syndromes as part of their research education mission.

CFS/ME Description:

Chronic Fatigue Syndrome / Myalgic Encephalopathy (CFS/ME) is a poorly understood, highly debilitating disorder of uncertain causes. The meaning of Myalgic-Encephalo-Pathy: Myalgic - means muscle, indicating the pain involved in the muscles. Encephalo - means brain, indicating that the brain functioning is involved. Pathy - means sickness or illness.

CFS/ME is marked by chronic mental and physical exhaustion, often severe, and by other specific symptoms, arising in previously healthy and active persons. Despite promising avenues of research, there remains no objective pathological finding which is widely accepted to be diagnostic of CFS/ME. It remains largely a diagnosis of exclusion, made on the basis of patient history and symptomatic criteria, although a number of tests exist which can help aid diagnosis.

FM experts estimate that about 10 million Americans and approximately 3-6% of the population worldwide suffer with FM. While it is most common in women, the illness strikes men, women, and children of all ages and ethnic backgrounds. For those with severe symptoms, FM can be extremely debilitating and interfere with even routine daily activities. It is estimated that the average care cost per patient per year is close to $2,300.

Chronic Fatigue Syndrome / Myalgic Encephalopathy (CFS/ME), also known as Post-Viral Fatigue Syndrome (PVFS) are several names given to a poorly understood, highly debilitating disorder of uncertain cause/causes, which is thought to affect approximately 4 per 1,000 adults in the United States and other countries, and a smaller fraction of children.

Research studies indicate that the average FM and/or CFS/ME patient takes three different drugs daily in an attempt to control their symptoms, yet no single therapeutic agent was found to be effective in relieving the symptoms during the seven-year duration of the study (1989 to 1996).

Four reports have shown that FM and CFS/ME can be as disabling as rheumatoid arthritis (RA). RA is listed in the Social Security Disability law book, and while FM pain is acknowledged, the condition is not specifically listed. Due to the difficulties in gaining recognition for FM and CFS/ME as a disabling illness, the percentage of patients drawing SSD payments based on FM and CFS/ME is only 16.2%. Yet, nearly 30% of FM and CFS/ME patients claim that they cannot hold down a steady job due to this condition. The total yearly drain on the U.S. economy is estimated to be over $20 billion. Preliminary findings indicate that the cancer risk is also doubled in people with FM and/or CFS/ME.

Pain is the predominant feature of FM and CFS/ME, but its cause is unknown. Significant abnormalities in the central and peripheral nervous systems have been uncovered in recent years and most researchers in the field consider FM and CFS/ME to be a central pain state (e.g., central sensitization).

Substance P (SP) in the spinal fluid is three times that of normal healthy people. Nerve growth factor (NGF) in the spinal fluid is four times that of healthy people. Increased production of nitric oxide in the spinal fluid and the peripheral blood of FM and CFS/ME patients has also been found. Pro-inflammatory cytokines are excessively produced in patients with FM and CFS/ME, pointing to an immune system Th1/Th2 axis disruption.

The 2003 study by Ali Gur et al. demonstrated that the cytokine elevations correlated with abnormalities in brain blood flow based on SPECT scan analysis. Gur's 2002 study showed that elevated IL-8 levels corresponded with pain intensity. It is proposed that pro-inflammatory cytokines produced by activated glial cells within the central nervous system may play an aetiopathogenetic role in FM and CFS/ME.

Indeed IL-8 has been implicated in a genetic profiling study using micro-arrays in patients meeting the CFS criteria. Although the findings of elevated SP and NGF are substantial, recent research by the author of the NGF finding (Alice Larson, Ph.D.) clearly indicates that elevated SP and NGF are not at the heart of the etiology of FM and CFS/ME. In fact, NK1 receptor antagonists are only likely to help FM and CFS/ME patients when they are co-administered with an opioid and noradrenaline (whose metabolite is abnormally low in the spinal fluid of FM and CFS/ME patients - and the same holds true for serotonin and dopamine). Other significant abnormalities in FM and CFS/ME patients include:

• Sleep disorder


• Autonomic nervous system dysfunction


• Elevated activity of CRH neurons which is believed to cause disruption of many hormonal axes including the HPAaxis


• Impaired brain blood flow to the thalamus and other pain-processing centers.


• Substantially reduced production of growth hormone overall, and additional blunting of growth hormone during exercise.


• Abnormal windup (or temporal summation) at rest and significantly exacerbated windup during exercise, which may explain the exercise intolerance that FM patients exhibit.


• Failure of the diffuse noxious inhibitory control (DNIC or spatial summation) to respond to a painful stimulus.

Most FM and CFS/ME research at NIH (National Institute of Health) is sponsored by NIAMS (National Institute of Arthritis, Musculoskeletal and Skin diseases). The 1997 FM and CFS/ME research funding level at NIAMS measured out to only 0.6% of their annual budget of $257 million - not much for the second most common rheumatic disease.

That same year, however, NIH created a Special Emphasis Panel (SEP) specifically for the review of FM and CFS/ME research grant applications, and this continues to lead to increased funding for the condition. In 1999, the National Institute of Neurological Diseases and Stroke (NINDS) and the Department of Defense (because of overlapping conditions such as Gulf War Illness) became involved in funding research on FM and CFS/ME as well.

While the increase in research funding on FM and CFS/ME is encouraging, the NIH funded research projects are, for the most part, still not focused on the patient-relevant issue of providing improved therapy options. A review of the NIH online CRISP system abstracts confirms that less than 10% of government sponsored research on FM and CFS/ME pertains to therapeutic interventions. However, the combined NIH and DOD expenditures on FM and CFS/ME-related research are estimated to be roughly $7 million annually.

At the October 2002 American College of Rheumatology (ACR) meeting, several researchers presented successful treatment trials in FM and CFS/ME patients. In particular, a multi center pregabalin study demonstrated that FM and CFS/ME is a condition that can be evaluated and that clinical improvement is possible.

Single bolus doses of fentanyl and dextromethorphan (tested individually) were documented to show clinical improvement and were also capable of substantially reducing windup in people with FM and CFS/ME. However, highly effective therapies that specifically target the central pain state in FM and CFS/ME patients are in high demand. Human growth hormone, a therapy that targets problems in the peripheral tissues, was shown in a 9 month trial to be helpful in reducing muscular pain and relieving problems of exercise intolerance. A novel immune modulation Staphylococcal vaccine-type therapy to target the cytokines in the periphery has also shown effectiveness.

Sodium Oxybate (a compounded version of the natural brain chemical gamma-hydroxybutyrate) has been tested in a placebo controlled crossover trial involving 17 overnight sleep tests for each of the 20 FM and CFS/ME participants and showed amazing results. It produced significant increases in slow-wave sleep, decreased alpha-wave intrusion, decreased pain, and is suspected to also increase growth hormone secretion during sleep. The high prevalence, disability rate and health care costs associated with FM and CFS/ME should be motive enough to encourage the pharmaceutical industry to become involved in developing effective therapies for this condition.