Pharmacy TimesOctober 2011 Diabetes
Volume 77
Issue 10

This chronic, painful disorder has a complex symptom profile that can make diagnosis and treatment complicated.

This chronic, painful disorder has a complex symptom profile that can make diagnosis and treatment complicated.

Fibromyalgia has been—and still is—a controversial diagnosis; many believe it is more appropriately aligned with psychiatric conditions or other disorders. Regardless, the American Medical Association recognized its validity in 1987, and in 1990, the American College of Rheumatology (ACR) published diagnostic criteria.1,2 Today, fibromyalgia is the second most common disorder seen by rheumatologists, the first being osteoarthritis.3


Fibromyalgia’s core symptoms include widespread diffuse pain and heightened pain sensitivity to various stimuli, such as pressure, noise, cold, and heat, at threshold levels not considered aversive; and an absence of inflammatory or structural musculoskeletal abnormalities.4 Widespread pain, defined as pain on both sides of the body and above and below the waist for a duration of at least 3 months, must be present in 11 of the 18 designated locations that are outlined in the ACR diagnostic guidelines.2

Heightened pain sensitivity is not psychological; studies confirm that patients with fibromyalgia react to stimuli at lower threshold levels than controls.5 Along with fibromyalgia’s core components, many patients report fatigue, sleep disturbances, and mood swings. Fatigue and sleep disturbances are almost universal in patients seeking treatment.6 Symptom clusters are patient specific and easily confused with chronic fatigue syndrome, irritable bowel syndrome, and various rheumatoid conditions.7

Disability from fibromyalgia ranges from mild to severe, and up to 90% of patients report difficulty with activities of daily living and household tasks. Many patients manifest balance problems, which increase the risk of falling. One small study found that patients with fibromyalgia fell 6 times more frequently than controls.8 Etiology Fibromyalgia’s etiology remains unknown, but a genetic component is implicated.9 Although many patients believe past trauma is a causative factor, studies have failed to find an association.6 Research findings suggest fibromyalgia is a neurosensory disorder—not a musculoskeletal or a psychiatric disorder.10 Patients appear to have an imbalance in excitatory and inhibitory neurotransmitters, which helps explain patients’ pain sensitivity and fatigue. Studies also confirm abnormalities in blood flow to the cingulate cortex, thalamus, and basal ganglia.9


Accurate prevalence is not known, but the Centers for Disease Control and Prevention estimates fibromyalgia’s prevalence at 2%, affecting 5 million adults.11 Most patients receive the diagnosis during middle age, and women are disproportionally affected (female-to-male ratio, 7 to 1).6 Co-occurrence with other rheumatic disorders, such as rheumatoid arthritis, systemic lupus erythematosus, and ankylosing spondylitis, may be as high as 65%.11 Comorbid affective disorders and anxiety disorders are also common.12 Adults with fibromyalgia are 3.4 times more likely to have symptoms of major depression.11


Diagnosis can be challenging because pain waxes and wanes and patients have seemingly unrelated symptoms on presentation, such as insomnia, weight fluctuations, nasal and sinus congestion, hearing and visual distortions, dry eyes and mouth, shortness of breath, syncope, and hypotension.13 Many patients also experience cognitive impairment resulting in decreased attention and performance. The average duration of symptoms before a diagnosis of fibromyalgia is made is 5 years.14,15


Treatment for fibromyalgia targets the several symptom domains of the disease, namely pain, psychiatric comorbidities, fatigue, physical disabilities, and other related symptoms.16 Effective treatment provides a range of interventions, including pharmacotherapy, psychological therapy, and exercise. Because of symptom variability, a patient-centered approach is required, consisting of realistic goals and patient education. Treatment outcomes and effectiveness are measured by changes in pain, effective coping skills, disability, and overall quality of life.


Because fibromyalgia is a chronic, centrally mediated pain disorder and not an inflammatory response, corticosteroids, nonsteroidal anti-inflammatory drugs, and opioids are ineffective. Tramadol lessens fibromyalgia pain, probably because this weak opioid agonist has effects on serotonin and norepinephrine receptors.17 In many postmenopausal women, the selective estrogen receptor modulator raloxifene reduces pain and fatigue.6

Tricyclic antidepressants are effective for many patients with fibromyalgia. Amitriptyline and cyclobenzaprine are the 2 most studied tricyclic agents, resulting in comparable outcomes.13 Serotonin reuptake inhibitors and dual serotoninnorepinephrine reuptake inhibitors have moderate evidence supporting their utility.17,18 Before FDA agents for fibromyalgia were approved, practitioners typically used a combination of antidepressants, anti-anxiety agents, muscle relaxants, pain medications, and sleep medicines. The Table 19 lists the FDA-approved agents for fibromyalgia.

Psychological Approaches

Psychological issues frequently dominate the clinical picture. Poor coping skills and anxiety are especially problematic.12 Heightened pain sensitivity leads many patients with fibromyalgia to become hypervigilant and anxious about potential unpleasant sensory stimuli. Cognitive behavioral therapy (CBT) is very effective, especially when combined with exercise. CBT targets the perception and belief systems surrounding hypervigilance, reaction to pain, and coping skills. Patients often make modest gains in the areas of pain, fatigue, and physical functioning.11


Low-intensity exercises, such as walking, improve functioning without exacerbating symptoms.20 For those finding exercise difficult or painful, a recommended alternative is water aerobics, with studies reporting decreased pain, anxiety, and depression, and overall improvement in functioning compared with controls.21

Complementary Interventions

Studies examining complementary and alternative interventions report mixed results, but providers generally do not discourage the 90% of patients who turn to these approaches. Acupuncture, biofeedback, chiropractic care, hypnosis, tai chi, massage therapy, and herbal and vitamin supplements are especially popular.22 Vitamin supplements may be beneficial; vitamin D deficiency, which can exacerbate symptoms, is common in patients with fibromyalgia.4

Today’s Controversy

The lead author of the ACR 1990 guidelines, Frederick Wolfe, MD, is now a leading skeptic. He and others focus on 2 facts, which they believe refute the legitimacy of fibromyalgia: symptoms overlap with symptoms associated with other chronic diseases, and the extreme variability in onset, symptom constellation, and treatment response in fibromyalgia suggests the pathogenesis is both physical and psychological. As a result, a new nomenclature, central sensitivity syndrome (CSS), has been proposed for fibromyalgia. Advocates for changing this label emphasize that CSS is more descriptive.7

Pharmacists may be drawn into this debate by patients who hear comments like, “It’s all in your head.” Pharmacists need not take sides, but they should point out that studies definitely confirm heightened pain sensitivity in fibromyalgia patients, and that the pain is real.

Final Thoughts

Fibromyalgia is a chronic illness characterized by persistent pain and fatigue, with few remissions.22 Regardless of the controversy surrounding the diagnosis, challenges persist in treating this painful disorder. A multidisciplinary approach is mandatory for a condition with many seemingly unrelated symptoms. PT

Ms. Wick is a senior clinical research pharmacist at the National Cancer Institute, National Institutes of Health, Bethesda, Maryland.


1. Bennett RM. Fibromyalgia. JAMA. 1987;257:2802-2803.

2. Wolfe F, Smythe HA, Yunus MB, et al. The American College of Rheumatology 1990 criteria for the classification of fibromyalgia. Report of the Multicenter Criteria Committee. Arthritis Rheum. 1990;33:160-172.

3. Rao SG, Gendreau JF, Kranzler JD. Understanding the fibromyalgia syndrome.

Psychopharmacol Bull. 2007;40:24-67.

4. Wood PB. Symptoms, diagnosis, and treatment of fibromyalgia. Virtual Mentor. 2008;10:35-40.

5. Diers M, Koeppe C, Yilmaz P, et al. Pain ratings and somatosensory evoked responses to repetitive intramuscular and intracutaneous stimulation in fibromyalgia syndrome. J Clin Neurophysiol. 2008;25:153-160.

6. Winfield JB. Fibromyalgia. Accessed August 11, 2010.

7. Yunus MB. Fibromyalgia and overlapping disorders: the unifying concept of central sensitivity syndromes. Semin Arthritis Rheum. 2007;36:339-356.

8. Jones KD, Horak FB, Winters-Stone K, et al. Fibromyalgia is associated with impaired balance and falls. J Clin Rheumatol. 2009;15:16-21.

9. National Fibromyalgia Association. About fibromyalgia. Accessed August 11, 2010.

10. Kuchinad A, Schweinhardt P, Seminowicz DA, et al. Accelerated brain gray matter loss in fibromyalgia patients: premature aging of the brain? J Neurosci. 2007;27:4004-4007.

11. Williams DA. Psychological and behavioural therapies in fibromyalgia and related syndromes. Best Pract Res Clin Rheumatol. 2003;17:649-665.

12. Bradley LA. Psychiatric comorbidity in fibromyalgia. Curr Pain Headache Rep. 2005;9:79-86.

13. Clauw D. Fibromyalgia: correcting the misconceptions: not a “phantom illness” but a real condition that can have devastating effects. J Musculoskel Med. 2003;20:467-472.

14. Goldenberg DL. Fibromyalgia syndrome. An emerging but controversial condition. JAMA. 1987;257:2782-2787.

15. Yunus MB, Holt GS, Masi AT, Aldag JC. Fibromyalgia syndrome among the elderly: comparison with younger patients. J Am Geriatr Soc. 1988;36:987-995.

16. Aaron LA, Buchwald D. Chronic diffuse musculoskeletal pain, fibromyalgia and co-morbid unexplained clinical conditions. Best Pract Res Clin Rheumatol. 2003;17:563-574.

17. Goldenberg DL. Pharmacological treatment of fibromyalgia and other chronic musculoskeletal pain. Best Pract Res Clin Rheumatol. 2007;21:499-511.

18. Sumpton JE, Moulin DE. Fibromyalgia: presentation and management with a focus on pharmacological treatment. Pain Res Manag. 2008;13:477-483.

19. Medical News Today, January 19, 2009. FDA approves fibromyalgia drug - Savella(TM) (milnacipran HCl), a selective serotonin and norepinephrine dual reuptake inhibitor [press release]. Accessed August 11, 2010.

20. Mannerkorpi K, Iversen MD. Physical exercise in fibromyalgia and related syndromes. Best Pract Res Clin Rheumatol. 2003;17:629-647.

21. Tomas-Carus P, Gusi N, Häkkinen A, et al. Eight months of physical training in warm water improves physical and mental health in women with fibromyalgia: a randomized controlled trial. J Rehabil Med. 2008;40:248-252.

22. National Center for Complementary and Alternative Medicine. Fibromyalgia and CAM: at a glance. Accessed August 11, 2010.

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