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F ibromyalgia (FMS), a syndrome characterized by widespread muscle pain, fatigue, and multiple tender

points, affects approximately 3 - 6 million Americans. Nearly 80 - 90 percent of all reported cases are in middle-aged women; however, men and children may also develop symptoms. Due to lack of measurable inflammation or damage to joints, muscles, and other tissues, fibromyalgia is not considered a true form of arthritis. However, because of the involvement of joints and soft tissue and the presence of chronic pain, it has been considered a rheumatic condition. The cause of fibromyalgia is not well understood, but may be related to environmental factors that trigger the onset of symptoms. The Arthritis Foundation states that most patients correlate symptoms with a “stressor, such as acute injury, an illness with fever, surgery, or long-term psychosocial stress (sometimes childhood trauma).” Some researchers agree that improper functioning of the central nervous system and imbalance in chemicals such as substance P, serotonin, and norepinephrine may play a role in the development of symptoms.

Patients often experience pain that begins in one region, but eventually affects other areas as well. For some, the pain may subside only to recur and develop elsewhere. Muscle and tissue pain have been described by the Arthritis Foundation as “tender, aching, throbbing, sore, burning and gnawing,” sometimes accompanied by “tingling, numbness, burning, or prickling.” Approximately 75 - 80 percent of patients with fibromyalgia experience chronic fatigue. Nearly 50 percent of patients with fibromyalgia also possess several of the characteristics of chronic fatigue syndrome. Many patients with fibromyalgia are able to fall asleep at night, but wake easily and feel tired the following morning. Some patients with fibromyalgia experience frequent interruption in deep sleep and, unlike most adults, get their best sleep in the hour or two before waking. Because patients often complain of inadequate sleep at night, it is

Fibromyalgia: A Pain for Millions

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tender points Associated with Fibromyalgia

From: Mayo Clinic – Fibromyalgiahttp://www.mayoclinic.com/health/fibromyalgia/DS00079/DSECTION=6(accessed 24 August 2007)

unknown whether the chronic fatigue is a result of the syndrome itself or due to lack of sleep. Other symptoms of fibromyalgia are identified in the accompanying table.

There is no specific test for identifying fibromyalgia. Physicians make a diagnosis through physical examination, evaluation of symptoms, and ruling out other conditions. The American College of Rheumatology (ACR) has identified two major criteria for establishment of a diagnosis of fibromyalgia. They include the presence of widespread pain for a period of more than three months and the presence of tender points in eleven or more designated areas of the body (see accompanying figure).

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TreaTmenT of fibromyalgiaPregabalin (Lyrica) is currently the only FDA-approved treatment for fibromyalgia. The drug reduces pain and fatigue and improves the quality of sleep. Its exact mechanism is unknown, but may be related to its ability to decrease the concentration of substance P. This compound amplifies pain signals and is frequently elevated in those with fibromyalgia. In one study, 77% of patients reported improvement in fibromyalgia symptoms as opposed to 47% receiving placebo. The most common adverse effects of pregabalin are dizziness and sleepiness. The recommended total daily dose is 300 – 450 mg.

Medications that increase the effects of serotonin and norepinephrine appear to reduce pain in patients with fibromyalgia. Duloxetine (Cymbalta), an antidepressant that enhances the activity of serotonin and norepinephrine, has been shown to significantly reduce both the number of tender points and the average tender point pain threshold. Improvement was also seen in secondary measures defined as pain severity in the preceding 24 hours and the interference of pain in daily activities. These patients had not been previously diagnosed with depression. The manufacturer of duloxetine has submitted a request to the FDA to approve the drug for treatment of fibromyalgia.

Many other compounds have been evaluated for managing fibromyalgia. These include sedative-hypnotic medications that can reduce the sleep disorders commonly associated with this condition. Zolpidem (Ambien) has improved sleep in patients with

fibromyalgia, but does not appear to reduce pain. Sodium oxybate (Xyrem), a substance with marked sedative properties, has also been evaluated because of its ability to reduce pain and fatigue. It is important to note that there is a direct relationship between pain and sleep; a reduction of pain generally leads to an improvement in sleep. The abuse potential of this drug limits its use in fibromyalgia. The administration of opiates in the treatment of pain in fibromyalgia is not well supported by clinical studies. A recent report indicated that patients taking opiates did not experience significant improvement in pain, but did complain of increased depression. Tramadol, an analgesic that also increases the activity of serotonin and norepinephrine, has been shown to improve pain when used by itself or in combination with acetaminophen. The addition of dextromethorphan to tramadol may also enhance pain relief in patients with fibromyalgia. Ondansetron (Zofran), a drug often used to treat nausea, has been effective in decreasing the pain of fibromyalgia and pramipexole (Mirapex), generally prescribed for Parkinson’s disease and restless legs syndrome, has also provided benefit in fibromyalgia by improving the quality of sleep.

Exercise is recommended early in the treatment of fibromyalgia; however, compliance is generally low and factors such as pain, barriers to exercise, and depression must be considered before initiating an exercise regimen. Additionally, patients with symptoms such as fatigue and pain should be treated pharmacologically before beginning an exercise program as these patients may actually experience a worsening of pain upon exercising. For these reasons, recent studies suggest that exercise does not lead to consistent improvements in pain, fatigue, sleep disturbance, or psychological symptoms. If an exercise program is initiated, it should consist of 30-60 minutes of low-moderate intensity aerobic exercise at least two to three times a week as tolerated.

In summary, a patient must first be carefully evaluated in order to establish a diagnosis of fibromyalgia. Many alternative remedies have been suggested (e.g. vitamins, magnesium supplements, SAM-e, etc.); however, there is little evidence to support

For additional information on fibromyalgia, please visit the following Web sites:• www.arthritis.org/disease-center

• www.niams.nih.gov/hi/topics/fibromyalgia/fibrofs.htm

• www.rheumatology.org/public/factsheets/fibromya_new.asp

• www.mayoclinic.com

Fibromyalgia: A Pain for Millions

Newsletter ContributorsJohn g. lech, Pharm.D.renee r. roberts, Pharm.D. CandidateCatherine m. Weber, Pharm.D. Candidate

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Questions about screenings or programs:Christine o’Neil, Pharm.D, b.C.P.S.412-396-6417

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their consistent efficacy in this condition. Pregabalin is the only prescription drug now labeled for treating fibromyalgia. Duloxetine or a similar medication can be added if treatment with pregabalin is insufficient. If there is still limited improvement, addition of other agents identified above may provide further benefit. Non-drug measures such as acupuncture, cognitive-behavioral therapy, group education, and exercise can also play a major role in improving the management of fibromyalgia. An excellent review of the treatment of fibromyalgia may be obtained from the following citation: Arnold LM. New therapies of fibromyalgia. Arthritis Res Ther. 2006;8(4). http://arthritis-research.com/content/8/4/212. Accessed August 21, 2007.

other symptoms oF FibromyAlgiA*

Headache•

Cognitive or memory difficulties •including poor attention span, trouble with short-term memory, and inability to think clearly (possibly due to lack of sleep)

Abdominal pain, bloating, and •alternating constipation and diarrhea (symptoms similar to irritable bowel syndrome)

Sensitivity to loud noise and •temperature

Morning stiffness•

Weight fluctuation, night sweats, •weakness

Multiple chemical sensitivities, nasal •congestion, rhinitis (inflammation of the nasal passages)

Numbness or tingling of the •extremities including restless legs syndrome

Urinary urge and frequency•

Painful menstrual periods•

*Adapted from Arthritis Foundation: http://www.arthritis.org/disease-center (accessed 24 August 2007)

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