Fibromyalgia

By Tara E. Dymon, Pharm.D., BCACP

Reviewed by Susan J. Rogers, Pharm.D., BCPS; and Dina M. Hunsinger-Norris, Pharm.D., BCPS (AQ-Cardiology)

Learning Objectives considerable patient impact, no medical specialty has yet

claimed the disease. These patients are most often seen by
1. Demonstrate an understanding of the epidemiology
rheumatologists. Fibromyalgia is often managed as part of
of fibromyalgia, its impact on patient health, and the
primary care, and ambulatory care pharmacists can con-
clinical controversy surrounding the syndrome.
tribute an important role to its optimal management.
2. Evaluate available treatment options and design a
treatment plan for the patient with fibromyalgia.
3. Evaluate the available evidence regarding comple- Epidemiology and Impact
mentary and alternative medicine for fibromyalgia.
An estimated 2%–3% of Americans are affected by fibro-
4. Justify the role of patient self-care in the treatment of
myalgia, with a higher prevalence in women than men. The
fibromyalgia.
highest prevalence occurs between the ages of 60 and 79
5. Construct a patient education strategy to aid patients
years (Wolfe 1995). Patients may exhibit symptoms of fibro-
in fibromyalgia self-management.
myalgia for 5 years before a diagnosis is made. A significant
reduction in the quality of life may occur for patients with
Introduction fibromyalgia. Fibromyalgia symptoms are worse and the
Fibromyalgia is a syndrome characterized by chronic quality of life is poorer for young (younger than 39 years) or
widespread pain. First described more than 100 years ago, middle-age (40–59 years) patients with fibromyalgia versus
the American College of Rheumatology (ACR) published older (older than 60 years) patients (Jiao 2014).
official diagnostic guidelines in 1990. The first treatment In an Internet survey by the National Fibromyalgia
guidelines were published 15 years later by the American Association, 1735 patients age 31–78 years reported
Pain Society (APS). Since then, many controversies have being diagnosed with fibromyalgia; of those women, 25%
surrounded both the diagnosis and management of fibro- reported difficulty with everyday tasks such as personal
myalgia syndrome. Although the condition imposes care and bathing (Jones 2008). More than 60% of those

Baseline Knowledge Statements

Readers of this chapter are presumed to be familiar with the following:
• Pain pathways and mechanisms of treating neuropathic pain
• Basic pathophysiology and treatment of fibromyalgia
• Commonly used tools for assessment of pain and/or quality of life, such as the Medical Outcomes Study
36-Item Short-Form Health Survey and Brief Pain Inventory
• Use of motivational interviewing and other communication techniques

Additional Readings
The following free resources are available for readers wishing additional background information on this topic.
• Mayo Clinic. Framework for Fibromyalgia Management for Primary Care Providers.
• Boomershine CS. A comprehensive evaluation of standardized assessment tools in the diagnosis of
fibromyalgia and in the assessment of fibromyalgia severity. Pain Res Treat 2012; 2012: 653714.

ACSAP 2015 • Neurologic and Psychiatric Care I 5 Fibromyalgia

 tender-point criteria. A strong genetic component has
Abbreviations in This Chapter been suggested (Arnold 2013). Environmental factors
ACR American College of Rheumatology such as physical trauma, infections, and stressors have
APS American Pain Society been implicated as well (Mease 2005).
BPI Brief Pain Inventory The diagnosis of fibromyalgia is made through clin-
CBT Cognitive behavior therapy ical evaluation because, to date, no laboratory tests,
FIQ Fibromyalgia Impact Questionnaire radiographic studies, or biological markers have been
SF-36
Medical Outcomes Study 36-Item established. Certain conditions (e.g., hypothyroidism,
Short-Form Health Survey rheumatic diseases) can mimic the symptoms of fibromy-
SS Symptom severity (scale) algia and should be assessed and excluded. Similarly, pain
WPI Widespread Pain Index related to drug use (e.g., statin-induced myopathies, opi-
oid-induced hyperalgesia) should be excluded.
The 1990 ACR diagnostic criteria were initially devel-
oped as research classification criteria and were not
diagnosed with fibromyalgia reported difficulty with light intended for use as a strict diagnostic tool in clinical prac-
household tasks, walking up or down one flight of stairs, tice. In an effort to differentiate fibromyalgia from other
lifting or carrying 4.5 kg (10 lbs), and walking 0.5 miles; widespread pain, the concept of tender points was intro-
more than 90% reported difficulty with heavy household duced (Wolfe 1990). Widespread pain of at least 3 months’
tasks, lifting or carrying 11.3 kg (25 lbs), and doing stren- duration and tenderness on pressure applied in at least
uous activities. On average, the women surveyed reported 11 of 18 prespecified points on the body (termed tender
less functional ability in activities of daily living than the points) were considered diagnostic for fibromyalgia, with
average community-dwelling woman in her 80s. Women sensitivity and specificity of 88% and 81%, respectively.
with fibromyalgia report higher depression scores, greater Criticism centered around the finding that 19% of patients
perceived distress, and more frequent unsupportive rela- who had at least 11 tender spots did not truly have fibromy-
tionships than women with a chronic (but medically algia and the concern that an individual with fibromyalgia
recognized) autoimmune illness. pain that waxes and wanes does not meet the definition for
chronic pain.
Pathophysiology and Diagnosis New diagnostic criteria for fibromyalgia were intro-
duced in 2010 by the ACR and included 19 pain locations
Chronic widespread pain is the hallmark symptom of and 41 somatic symptoms (Wolfe 2010). These crite-
fibromyalgia and has been proposed to be of neurogenic ria were modified in 2011: most notably, the inclusion of
origin (Russell 2009). A central amplified pain percep- tender points in the diagnosis was removed. Concerns
tion is linked with allodynia and hyperalgesia. Fatigue regarding whether primary care providers were perform-
and sleep disturbances are also common components of ing the tender point examination, as well as the accuracy
the syndrome. Other key symptoms include tenderness, of the examination as administered in primary care, led
mood disturbances, and cognitive difficulties. The cogni- to removal of that criterion (Wolfe 2011). Instead, the
tive impairment, manifested as a difficulty to concentrate focus became a symptom-based assessment. Symptoms
and loss of memory, is often referred to as the fibro fog. All are now evaluated using the widespread pain index (WPI)
of these symptoms may fluctuate in intensity. Anxiety and (Box 1-1) and the symptom severity (SS) scale (Box 1-2).
other mood disorders are common comorbid conditions. These are combined for the proposed new definition of
Studies have shown the prevalence of lifetime anxiety dis- fibromyalgia: WPI of 7 or greater and SS score of 5 or
order is 35% to 62% of patients with fibromyalgia, lifetime greater; or WPI of 3–6 and SS of 9 or greater. The authors
major depressive disorder in 58% to 86%, and lifetime of the ACR criteria suggest that the SS scale may also be
bipolar disorder in 11% (Arnold 2006, Thieme 2004). used to measure the current status of symptom severity
Irritable bowel syndrome and tension headaches may once a diagnosis has been made. Although released in
also be comorbid conditions in patients with fibromyal- 2010, updated in 2011, and approved by the ACR Board
gia. Survey results showed the 10 most common factors of Directors, the ACR authors note that these criteria are
perceived by patients to worsen symptoms of fibromyal- still considered preliminary until external validation has
gia were: emotional distress, weather changes, sleeping been completed.
problems, strenuous activity, mental stress, worrying, Compared with the original 1990 ACR criteria, the
car travel, family conflicts, physical injuries, and physical 2011 criteria provided 83% sensitivity, 67% specificity, and
inactivity (Bennett 2007). a correct classification of 74% (Bennett 2014). However,
Family history appears to be a risk factor for fibromy- another set of diagnostic criteria has been developed since
algia, as does female sex. The latter factor is controversial then and is used to assess pain location and symptom
because the incidence is similar between sexes when newer impact. For the 2013 alternative criteria, patients use a
diagnostic criteria are used that do not include the pain location inventory to note in which of the 28 specific

ACSAP 2015 • Neurologic and Psychiatric Care I 6 Fibromyalgia

areas they have experienced pain in the past 7 days and
complete a 10-item questionnaire regarding symptom Box 1-1. Widespread Pain Index
impact (Bennett 2014). Evaluation of these criteria report Note the number of areas in which the Points
sensitivity of 81%, specificity of 80%, and correct classifi- patient has had pain over the last week.
cation of 80% for fibromyalgia diagnosis. Shoulder girdle, left
The Fibromyalgia Diagnostic Screen has been devel- Shoulder girdle, right
oped specifically for use by primary care providers and Upper arm, left
combines clinical assessment with patient-reported data. Upper arm, right
This primary care screen includes mild pain in at least Lower arm, left
three of five classified body regions, duration of pain 3 Lower arm, right
months or longer, pain exacerbated by exercise or physi- Hip (buttock, trochanter), left
cal activity, and a SS score (Arnold 2012). The SS screen Hip (buttock, trochanter), right
includes an abbreviated tender point examination. Five Upper leg, left
supplemental models have also been developed, some of Upper leg, right
which address confounding factors such as elevated eryth- Lower leg, left
rocyte sedimentation rate, thyroid-stimulating hormone Lower leg, right
levels, and joint swelling. Evaluation of this tool showed Jaw, left
that it performed similarly to the 2010 modified ACR cri- Jaw, right
teria but with greater sensitivity than the modified ACR Chest
criteria and with higher specificity than the Fibromyalgia Abdomen
Diagnostic Screen (Martin 2014). Further studies are Upper back
warranted to evaluate the accuracy and value of this tool Lower back
in primary care practice. Neck
The Fibromyalgia Impact Questionnaire (FIQ ) is a val- Total Score (will be 0 to 19)
idated, 10-item instrument used to evaluate the impact
of fibromyalgia on patient health and functional ability.
Questions relate to physical function, pain level, fatigue,
sleep disturbance, anxiety, and depression. Baseline scores Box 1-2. Symptoms Severity Scale
can be obtained and then compared with subsequent Score is the sum of the severity of the three symptoms
scores after treatments are initiated. Many fibromyalgia plus the extent (severity) of somatic symptoms in
studies use the FIQ as the primary or secondary outcome. general. Score will be between 0 and 12.
Studies may also use the Brief Pain Inventory (BPI) or Fatigue Waking Unrefreshed Cognitive
Medical Outcomes Study 36-Item Short-Form Health Symptoms
Survey (SF-36) as assessments of the syndrome’s impact For each of the 3 symptoms above, indicate the level of
on patient well-being. severity over the past week using the following scale:
0 = no problem
1 = slight or mild problems, generally mild or
Clinical Controversy intermittent
Fibromyalgia is a common yet contested condition. 2 = moderate, considerable problems, often present
Despite advances in research, fibromyalgia may be regarded and/or at a moderate level
3 = severe: pervasive, continuous, life-disturbing
as a default diagnosis rather than a distinct syndrome.
problems
Lack of laboratory criteria, uncertain clinical diagnostic
tools, and the suggestion that the condition is “all in one’s Considering somatic symptoms in general, indicate
whether the patient has:
head” contribute to this discussion. Patients may feel stig-
0 = no symptoms
matized by the medical and nonmedical community alike, 1 = few symptoms
especially given that treatment centers on symptom relief 2 = a moderate number of symptoms
rather than management of a disease process. 3 = a great number of symptoms
The release of the Diagnostic and Statistical Manual of
Mental Disorders, 5th edition (DSM-5) raised a new contro-
versy with the identification of a new mental disease known time and energy devoted to these symptoms or health
as somatic symptom disorder. In short, this disorder could concerns (APA 2013). Because many patients with fibro-
be diagnosed if a patient had at least one severe somatic myalgia likely meet these criteria, concern arose that these
symptom (e.g., limb or joint pain, headache) as well as one patients would now receive the diagnosis of a mental dis-
of the following: disproportionate and persistent thoughts order. Some clinicians think that the term fibromyalgia
about the seriousness of one’s symptoms; persistently high should be abandoned altogether in favor of alternative
level of anxiety about health or symptoms; or excessive diagnosis as a somatic symptom disorder (Bass 2014).

ACSAP 2015 • Neurologic and Psychiatric Care I 7 Fibromyalgia

Pharmacotherapy Improvements in pain, measured by a numeric pain sever-
ity scale, were consistently demonstrated (for 600 mg, odds
Several organizations have developed treatment guidelines
for fibromyalgia, with notable heterogeneity in the recom- ratio [OR] 1.70, 95% confidence interval [CI], 1.27–2.29;
mendations. A comparison of the strongest recommendations for 450 mg, OR 1.92, CI, 1.49–2.48; for 300 mg, OR 1.53,
from each guideline is presented in Table 1-1. Of note, the first CI, 1.18–1.98). Conflicting results were shown in regard to
drug to have a labeled indication for fibromyalgia gained the improvements in fatigue and various scales for symptom
designation in June 2007. Both the APS and European League severity. Treatment with pregabalin caused significantly
Against Rheumatism guidelines were developed before that more dizziness, somnolence, dry mouth, weight gain, and
time and therefore do not reflect these U.S. Food and Drug peripheral edema than placebo, especially for the patients
Administration (FDA) label approvals. taking 600 mg daily (Tzellos 2010).
A comparison between traditional twice-daily dos-
Drugs with FDA Label Approval for Fibromyalgia ing and once-nightly dosing of pregabalin in 177 patients
Three drugs have a labeled indication for the treatment with fibromyalgia for a mean duration of around 4 years
of fibromyalgia: pregabalin, duloxetine, and milnacipran. showed no significant differences. Both dosing strate-
gies significantly reduced pain as measured by a standard
Pregabalin 0–10 rating scale and caused similar rates of adverse
Pregabalin’s effects on the release of excitatory neu- effects. Simply from a convenience standpoint, once-
rotransmitters such as glutamate, norepinephrine, and nightly dosing of pregabalin may be preferable, although
substance P may contribute to pain reduction in patients adherence rates in the study were similar (Nasser 2014).
with fibromyalgia. The manufacturer-recommended
starting dosage is 75 mg twice daily, eventually titrated Duloxetine and Milnacipran
to 225 mg twice daily. Varying dose adjustments are The exact mechanism is unknown, but it is theorized that
required for patients with a CrCl less than 60 mL/minute. duloxetine and milnacipran may improve fibromyalgia symp-
A meta-analysis of three studies investigating the use of toms through their analgesic properties, which result from
pregabalin for fibromyalgia found that patients taking pre- effects on descending inhibitory pathways. Benefits may also
gabalin 300 mg, 450 mg, or 600 mg daily were significantly occur because of their efficacy in improving the anxiety and
more likely to respond to treatment than patients taking depression that commonly accompanies fibromyalgia pain.
placebo. The three randomized controlled trials included For both agents, dosages that improve fibromyalgia symp-
1890 patients, and response was defined as a greater toms are generally lower than those needed to provide
than 30% decrease in the main pain score from baseline. antidepressant efficacy. In vitro milnacipran is slightly more

Table 1-1. Comparison of Strong Recommendations from Guidelines

American Pain Society European League Against German (2012) Canadian (2013)
(2005) Rheumatism (2008)
Tricyclic antidepressants: Tramadol Aerobic exercise Tricyclic antidepressants
amitriptyline Antidepressants: Cognitive behavior therapy Serotonin norepinephrine
Cyclobenzaprine amitriptyline, fluoxetine, Antidepressants reuptake inhibitors
Aerobic exercise duloxetine, milnacipran Multicomponent therapy Selective serotonin
Cognitive behavior therapy Pregabalin or pramipexole reuptake inhibitors
Multicomponent therapy Anticonvulsants
Cognitive behavior therapy
Multimodal approach
to treatment
Interventions that
improve self-efficacy
Graduated exercise program

Information from: Burckhardt CS, Goldberg D, Crofford L et al. Guideline for the management of fibromyalgia syndrome pain in adults and
children, APS Clinical Practice Guideline Series, No 4, 2005; Carville SF, Arendt-Nielsen S, Bliddal H, et al. EULAR evidence based recom-
mendations for the management of fibromyalgia syndrome. Ann Rheum Dis 2008;67:536-541; Winkelmann A, Häuser W, Friedel E, et al.
Physiotherapy and physical therapies for fibromyalgia syndrome. systematic review, meta-analysis and guideline. Schmerz 2012;26:276-86;
and Fitzcharles MA, Ste-Marie PA, Goldenberg DL, et al. 2012 Canadian guidelines for the diagnosis and management of fibromyalgia syn-
drome: executive summary. Pain Research&Management 2013;18:119-26.

ACSAP 2015 • Neurologic and Psychiatric Care I 8 Fibromyalgia

noradrenergic than duloxetine and therefore might show chronic neuropathic pain has supported the use of this
more benefits for fatigue and memory problems, although this class. Amitriptyline is recommended by all treatment
hypothesis has not been proven clinically. guidelines shown in Table 1-1. A systematic review of
According to manufacturer recommendations, mil- 10 randomized controlled trials evaluated amitripty-
nacipran should be started at a dosage of 12.5 mg once line, at dosages of 25 or 50 mg daily, in 615 patients
daily and titrated up to 50 mg twice daily. Dosage (Nishishinya 2008). Six of the 10 trials used 25 mg daily,
adjustments are needed for patients with severe kidney which significantly improved pain, sleep disturbances,
impairment (CrCl 5–29 mL/minute). In a 15-week ran- and fatigue, and both patient and physician global assess-
domized double-blind trial comparing milnacipran with ments. Amitriptyline 50 mg daily did not show a benefit
placebo, milnacipran demonstrated significant improve- over placebo, possibly because of a large adverse event-re-
ments in the Patient’s Global Impression of Change scale, lated drop out rate. As expected, adverse effects included
physical function, and fatigue (Clauw 2008). A 6-month dry mouth, somnolence, gastrointestinal disturbances,
trial showed that milnacipran was more likely to reduce and weight gain. No dosage adjustments are required for
pain and fatigue than placebo (Mease 2009). Milnacipran impaired kidney function.
may cause increased blood pressure or heart rate, nausea,
hot sweats and/or diaphoresis, and headache. Sustained Cyclobenzaprine
effects of milnacipran were evaluated in an open-la- Structurally similar to tricyclic antidepressants,
bel, flexible-dosing study. Tolerability and symptom cyclobenzaprine has been studied for the treatment of
improvements in terms of pain score and SF-36 physical fibromyalgia. Five trials were included in a meta-analy-
component score were maintained over the study dura- sis comparing cyclobenzaprine, at dosages of 10–30 mg
tion of up to 3.25 years (Arnold 2013). daily, with placebo. Sleep and pain symptoms improved
The recommended starting dosage of duloxetine for for three times the number of patients taking cycloben-
fibromyalgia is 30 mg once daily, titrated after 1 week to zaprine versus placebo (Tofferi 2004). Fatigue or tender
60 mg once daily. Use of duloxetine is not recommended points did not improve with cyclobenzaprine, and 85%
for patients with CrCl less than 30 mL/minute. In a study of the patients taking cyclobenzaprine reported adverse
of duloxetine versus placebo for fibromyalgia, statistically effects. The first treatment guidelines for fibromyalgia
significant improvements were seen in BPI and Patient’s published by the APS in 2005 included cyclobenzaprine
Global Impression of Change scale scores with duloxe- with a strong recommendation supporting its use.
tine (Russell 2008). A similar trial noted improvements in
FIQ and BPI scores, as well as a decreased number of ten- Gabapentin
der points and an increased quality of life (Arnold 2004). Data are limited regarding the role of gabapentin in
Adverse effects of duloxetine include dry mouth, fatigue the treatment of fibromyalgia. Although not extensively
and somnolence, nausea, constipation, and headache. studied, gabapentin’s similarity to pregabalin suggests
a potential benefit. Compared with placebo, gabapentin
Direct Comparisons titrated to a dosage of 1200–2400 mg/day significantly
No direct clinical comparisons between pregabalin, dulox- improved the pain severity score as measured by BPI
etine, and milnacipran for fibromyalgia have been conducted. Short Form and showed significant difference in response
A systematic review compared their efficacy using stud- rates (Arnold 2007). Other scales for symptom severity,
ies published on each drug individually. In general, all drugs including an assessment of sleep, showed benefits with
were superior to placebo. Duloxetine was similar to placebo gabapentin compared with placebo. Dizziness, weight
for fatigue, similar to milnacipran for sleep disturbances, and gain, and sedation were noted with gabapentin.
similar to pregabalin for depressed mood (Hauser 2010).
Symptom reduction differed among the drugs, with duloxe- Venlafaxine
tine and pregabalin superior to milnacipran for pain reduction Two small open-label studies with venlafaxine have
and improvements in sleep disturbance; duloxetine superior been conducted, one using immediate release venlafaxine
to pregabalin and milnacipran for reducing depressed mood, 37.5–375 mg daily in 15 patients and one using venlafax-
and duloxetine inferior to milnacipran and pregabalin for ine 75 mg daily in 20 patients. In both trials, pain improved
fatigue. Adverse effect profiles were similar, although head- from baseline using a visual scale and pain questionnaire
ache and nausea were more common with duloxetine and (Dwight 1993, Sayar 2003). More data are needed to rec-
milnacipran than pregabalin. ommend venlafaxine as an alternative to duloxetine or
milnacipran for fibromyalgia.
Off-label Drug Therapies
Selective Serotonin Reuptake Inhibitors
Tricyclic Antidepressants Fluoxetine, paroxetine, and citalopram have been stud-
Tricyclic antidepressants have long been the mainstay ied for the treatment of fibromyalgia. In general, they are
of fibromyalgia treatment. Their low cost and benefit in better tolerated than tricyclic antidepressants, especially

ACSAP 2015 • Neurologic and Psychiatric Care I 9 Fibromyalgia

for those experiencing anticholinergic adverse effects, but use updated criteria, making direct comparisons between
these drugs have less efficacy for fibromyalgia symptoms studies and patient populations difficult. A search in
(Sarzi-Puttini 2008). the clinical trials database available at clinical trials.gov
revealed many ongoing studies investigating treatment
Dopamine Agonists options for fibromyalgia, such as extended-release cyclo-
Dopamine agonists may decrease adrenergic arousal benzaprine, cannabinoids, neurotrophin, etoricoxib,
that may contribute to disordered sleep in patients with memantine, naltrexone, and lidocaine.
fibromyalgia. Pramipexole and ropinirole have been stud-
ied for the treatment of fibromyalgia. In a small 14-week
trial of 60 patients initiated on treatment with pramipex- Beyond Pharmacotherapy
ole, 42% of patients had a 50% or more reduction in their Given the modest benefits of most drugs, many patients
pain score using a visual analog scale, compared with 14% may use nonpharmacologic approaches. Survey report-
of patients taking placebo (Holman 2005). A trial of rop- ing showed 91% of patients with fibromyalgia were using
inirole found no benefit; however, the discontinuation nonpharmacologic therapies to manage symptoms, with
rate was high (63%) for both intolerance and lack of effi- two-thirds using more than one complimentary therapy
cacy (Holman 2003). (Pioro-Boisset 1996).

Pain Medications Nonpharmacologic Therapy

Although pain is a characteristic feature of fibromyal- Cognitive Behavior Therapy
gia, analgesics are often of limited clinical value. Cognitive behavior therapy (CBT) is the combination
of cognitive therapy to modify maladaptive thoughts with
Tramadol behavioral therapy to increase adaptive behavior. This
For those patients who can tolerate its adverse effects, therapy is often employed as a treatment for depression
tramadol may be beneficial in reducing the severity of and anxiety. Its role in fibromyalgia management has been
pain associated with fibromyalgia. A trial of tramadol in suggested as an adjunct to drug therapy. Several random-
the treatment of fibromyalgia pain found that 69% of the ized controlled trials of 6 to 30 months in duration found
100 patients were able to tolerate the drug in an open-la- that CBT improved function and decreased the severity
bel run-in phase (Russell 2000). Of those 69 patients, 35 of pain in fibromyalgia (Creamer 2000, Hadhazy 2000,
were randomized to tramadol in the double-blind place- Nielson 1992, Singh 1998, White 1995). Two system-
bo-controlled phase. Compared with placebo, the patients atic reviews showed improved pain, mood, fatigue, and
receiving tramadol showed statistically significant function when CBT was used for fibromyalgia treatment
improvements in pain intensity, pain relief, and myalgic (Rossy 1999, Williams 2003).
scores. A careful consideration of adverse effects and the A meta-analysis of mindfulness-based stress reduction
abuse potential should be considered before tramadol is used in chronic pain and stress disorders for fibromyalgia
used for fibromyalgia pain relief. showed minimal benefit (Lauche 2013). This finding suggests
that behavioral therapy alone is insufficient and further sup-
Opioids ports the use of the combined therapy offered in CBT.
Opioids are not recommended for fibromyalgia because
these drugs may actually worsen symptoms such as fatigue Exercise
and cognitive impairment. A 1-year observational study Exercise as a therapy for fibromyalgia may appear para-
evaluated the use of opioids in 1700 adults with fibromyal- doxical given the syndrome’s classic symptoms of pain and
gia and found that patients taking nonopioid pain relievers fatigue. However, strong evidence supports exercise as an
demonstrated greater improvements in assessments such effective treatment. Aerobic exercise is most often recom-
as the BPI and FIQ (Peng 2014). mended, but resistance and flexibility exercise may also be
of benefit. A review of 16 trials that focused on exercise as
Other Pain Medications a treatment for fibromyalgia divided exercise interventions
Nonsteroidal anti-inflammatory drugs and acetamino- into categories of single exercise (aerobic training, strength
phen act peripherally and are therefore less likely to be of training, flexibility training) or more than one type of exer-
benefit for the centrally mediated pain mechanisms that cise (mixed training). Benefits were noted in all exercise
are associated with fibromyalgia. groups compared with control groups with regard to aer-
obic performance, tender-point pain pressure threshold,
Potential Future Pharmacotherapy Options and pain (Busch 2002). A review that focused specifically
Most trials have used the 1990 ACR criteria as the on resistance training showed improvements in overall
basis for diagnosis of fibromyalgia. The newer criteria as well-being, physical function, pain reporting, tenderness,
modified in 2011 may capture more patients with fibro- and muscle strength, thereby supporting a role for resis-
myalgia than the original 1990 criteria. New studies may tance training in fibromyalgia treatment (Busch 2013).

ACSAP 2015 • Neurologic and Psychiatric Care I 10 Fibromyalgia

 In one study, intervention with motivational interview- of acupoint stimulation including acupuncture, cupping
ing added to an exercise program improved outcomes, therapy, moxibustion, point injection, point embedding, or
notably improvements in FIQ scores and 6-minute walk test a combination had similar findings (Cao 2013).
results, compared with exercise plus standard self-manage-
ment lessons (Ang 2013). Lifestyle physical activity is often Other Complementary Modalities
recommended and may be more appealing than a struc- Music has been suggested to help provide an analge-
tured exercise program to many patients with fibromyalgia. sic effect and improve functional mobility measured by
However, compared with standard education and support, the “timed-up and go task” in patients with fibromyal-
a lifestyle intervention integrating short bouts of activity gia (Garza-Villarreal 2014). Evidence also suggests that
into the day by increasing walking or using the stairs did not hydrotherapy may be of benefit for the treatment of fibro-
show sustained benefit (Fontaine 2011); therefore a struc- myalgia in regards to pain, health status, and tender point
tured exercise program is recommended. Patients should count (McVeigh 2008). A review of nine randomized
be counseled to seek professional help when attempting an controlled trials found patients with fibromyalgia had sig-
exercise program for fibromyalgia in order to avoid injury. nificant improvements in pain, anxiety, and depression
after massage therapy treatment (Li 2014). Manual ther-
Vitamin D apy, which includes massage therapy and joint (spinal and
Evidence is conflicting regarding the role of vitamin D in extremity) manipulation or mobilization, has been shown
the pathophysiology of fibromyalgia. In one study, patients to be beneficial for fibromyalgia symptoms, but with sex
with fibromyalgia and vitamin D deficiency, defined as a differences in response. Manual therapy improved qual-
vitamin D level less than 32 ng/mL, were randomized to ity of sleep and tender point count in men and women,
cholecalciferol or placebo. Cholecalciferol dosages were although women showed a greater reduction in pain and
adjusted to achieve a target serum calcifediol concentration of perceived impact of fibromyalgia symptoms and men
32 to 48 ng/mL. Reductions in pain and improvements in the showed greater decreases in pressure hypersensitivity and
SF-36 score occurred in patients who had achieved the target depressive symptoms (Castro-Sanchez 2013).
values (Wepner 2014). Given the small study size and lack of
supporting studies, more evidence is needed to routinely rec-
ommend vitamin D supplementation for fibromyalgia. Patient Education and Resources
Education provided to patients about the chronic and
Complementary Medicine waxing/waning nature of fibromyalgia symptoms has
Tai Chi been shown to lead to fewer symptoms reported and
Originally a Chinese martial art, tai chi is a mind-body decreased symptom intensity (Huynh 2008). Therefore
practice that combines meditation, slow movements, and patient education plays a vital role in fibromyalgia man-
deep breathing. It is thought to move energy throughout agement. Survey reporting showed the most common
the body. In a randomized single-blind study compar- interventions used by responders for their fibromyalgia
ing classic tai chi with control (wellness education and were rest, distraction, heat modalities, nutritional supple-
stretching exercises), tai chi showed greater benefit with ments, nonprescription and prescription analgesics, gentle
regards to FIQ scores, SF-36 physical-component scores, walking, prescription antidepressants, stretching, and
and SF-36 mental-component scores (Wang 2010). prayer (Bennett 2007). Interventions with more support-
Benefits seen at 12 weeks were sustained at 24 weeks. Tai ing evidence, such as aerobic and/or resistance exercise,
chi adapted as pool-based therapy—with the thought that cognitive behavior therapy, and tai chi were not listed
the warm pool water and increased buoyancy would help by patients on the survey. Patients should be educated
minimize pain—also showed significant improvement in on the potential benefits of these treatment options and
the FIQ scores that was not seen in pool-based stretch- encouraged to try them. Patients should also be encour-
ing (Calandre 2009). Significant improvements were also aged to identify stressors that worsen symptoms and to try
seen in Pittsburgh Sleep Quality Index scores in those approaches to lessen these stressors. Counseling on proper
who participated in pool-based tai chi but not for those sleep hygiene can assist patients with improving sleep-re-
doing stretching exercises in the pool. lated symptoms. The National Fibromyalgia Association
offers many free resources for patients, including online
Acupuncture support forums, a digital magazine, and information
Acupuncture, defined as the stimulation of specific about local support groups.
points of skin on the body using heat, pressure, laser, or
small needles, has been suggested as a complementary treat-
ment for fibromyalgia, although efficacy data are lacking. A Conclusion
review of nine trials concluded acupuncture had no better Despite developments in research, fibromyalgia remains
effect for pain relief than sham acupuncture, suggesting a a challenging condition for many clinicians and patients.
placebo effect (Deare 2013). A broadened review of 16 trials Understanding of the nuances between treatment options

ACSAP 2015 • Neurologic and Psychiatric Care I 11 Fibromyalgia

is the key to proper patient care. Nonpharmacologic treat- Arnold L, Stanford S, Welge J. Development and testing of the
ments may improve symptoms. The choice of treatment fibromyalgia diagnostic screen for primary care. J Womens
should be patient-specific and should be focused on symp- Health 2012;21:231-9.
tom relief. Patient education and self-care are equally as
Arnold LM, Fan J, Russell IJ, et al. The fibromyalgia family
important as pharmacotherapy when treating fibromyal- study: a genome-wide linkage scan study. Arthritis Rheum
gia symptoms. The ambulatory care pharmacist can play 2013;65:1122-28.
an integral role in managing fibromyalgia.
Arnold LM, Palmer RH, Ma Y. A 3-year, open-label,
flexible-dosing study of milnacipran for the treatment of fibro-
myalgia. Clin J Pain 2013;29:1021-8.
Practice Points
In determining the optimal pharmacotherapy for the Bass C, Henderson M. Fibromyalgia: an unhelpful diagnosis
treatment of fibromyalgia, practitioners should consider the for patients and doctors. BMJ 2014;348:g2168
following:
• Treatment should be chosen based upon the patient’s Bennett RM, Jones J, Turk DC, et al. An internet survey of
most bothersome symptom(s) and the adverse effect 2596 people with fibromyalgia. BMC Musculoskelet Discord
profiles of available drug options. 2007;8:27.
• Nonpharmacologic and complementary treatments
should be encouraged when appropriate. Bennett R, Friend R, Marcus D, et al. Criteria for the diagnosis
• A multimodal treatment approach is recommended. of fibromyalgia: validation of the modified 2010 prelimi-
• Patients should be involved in treatment making deci- nary ACR criteria and the development of alternative criteria.
sions. Arthritis Care Res 2014; Accepted article
• Patient education is an important component of fibro-
myalgia treatment. Burckhardt CS, Goldberg D, Crofford L, et al. Guideline for
• The ambulatory care pharmacist can use motivational inter- the management of fibromyalgia syndrome pain in adults and
viewing techniques to assist patients with self-treatment. children, APS Clinical Practice Guideline Series, No 4, 2005.

Busch AJ, Webber SC, Richards RS, et al. Resistance exer-

cise training for fibromyalgia. Cochrane Database Syst Rev
2013;12,CD010884
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White KP, Nielson WR. Cognitive behavioral treatment of Wolfe F, Clauw DJ, Fitzcharles MA, et al. Fibromyalgia crite-
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ACSAP 2015 • Neurologic and Psychiatric Care I 14 Fibromyalgia

Self-Assessment Questions
1. A 49-year-old man with fibromyalgia has been treated with 20% of the 35 matched controls who did not
with pregabalin 225 mg twice daily for 4 weeks. The receive education. Which one of the following best
patient is pleased with how his symptoms of pain have describes the number needed to treat for this new
improved. His fatigue has also improved, but only service?
marginally. Which one of the following is best to rec- A. 2
ommend for this patient? B. 4
A. Increase pregabalin to 600 mg daily. C. 7
B. Change to duloxetine 30 mg daily. D. 10
C. Continue pregabalin 450 mg daily.
D. Change to milnacipran 12.5 mg daily. Questions 6 and 7 pertain to the following case.
J.A. is a 51-year-old woman with a new diagnosis of fibro-
2. A patient with fibromyalgia has a medical history of myalgia after 2 years of unexplained pain, sadness, and
stage IV chronic kidney disease. Which of the follow- fatigue. J.A. is discouraged with her situation, stating “I
ing would be safest to use at standard recommended guess I’m just going to have to get used to the fact I will
doses to manage this patient’s fibromyalgia? be in pain for the rest of my time on earth” and “I feel
A. Amitriptyline. this has taken over my life.” Her medical history includes
B. Duloxetine. hypertension, which is controlled by lisinopril 20 mg/
C. Milnacipran. hydrochlorothiazide 25 mg daily, and menopausal vaso-
D. Pregabalin. motor symptoms.

3. A patient with fibromyalgia complains of decreased 6. Which one of the following is best to recommend for
sleep quality as her most bothersome symptom. She J.A.?
does not want to use duloxetine, milnacipran, or pre- A. Duloxetine.
gabalin based on the boxed warnings with each drug. B. Sertraline.
Which one of the following is best to recommend for C. Milnacipran.
this patient? D. Pregabalin.
A. Acupuncture.
B. Tai chi. 7. Which one of the following nonpharmacologic treat-
C. Amitriptyline. ments would be best to recommend for J.A.?
D. Pramipexole. A. Tai chi.
B. Massage therapy.
Questions 4 and 5 pertain to the following case. C. Aerobic and resistance exercise.
As the lead pharmacist in the AllFam family medicine D. Cognitive behavior therapy.
clinic, you and your team plan to offer educational sessions
for patients who are receiving a drug for fibromyalgia. 8. A 38-year-old woman who received a diagnosis of
fibromyalgia 1 year ago presents to your clinic. Her
4. Which one of the following best justifies establishing pain related to her fibromyalgia is well controlled on
this new service in the AllFam clinic? hydrocodone 10 mg/acetaminophen 325 mg 1 tablet
A. Education is recommended as part of a treatment every 6 hours. However, she has increasing concern
regimen for fibromyalgia. with her cognitive abilities and thinks she has “fibro
B. Education will ensure the patient’s safe use of the fog,” which she read about online. Which one of the
drug. following is best to recommend for this patient?
C. Education added to drugs has been shown to A. Discontinue hydrocodone/acetaminophen.
reduce symptoms and symptom intensity. B. Discontinue hydrocodone/acetaminophen and
D. Education may increase adherence to drugs. start milnacipran.
C. Discontinue hydrocodone/acetaminophen and
5. One year later, the AllFam clinic pharmacists have start duloxetine.
educated 35 patients with fibromyalgia. Of these D. Add either duloxetine or milnacipran.
patients, 60% noted significant improvements in their
Fibromyalgia Impact Questionnaire score, compared

ACSAP 2015 • Neurologic and Psychiatric Care I 15 Fibromyalgia

9. A 45-year-old woman presents to the clinic with C. The patient should avoid CAM in favor of more
complaints of fatigue, overall aches and pains, and efficacious drug treatment options.
constipation. Which of the following laboratory tests D. Encourage a trial of CAM for relief of symptoms,
would be best to obtain for this patient before making either in addition to or in place of drug treatment
a diagnosis of fibromyalgia? options.
A. Thyroid-stimulating hormone (TSH).
B. Erythrocyte sedimentation rate (ESR). 14. A patient inquires about the use of vitamin D to treat
C. TSH and vitamin D. her fibromyalgia symptoms, stating that she read
D. TSH, ESR, and vitamin D. about its potential benefit online and has just started
taking an over-the-counter supplement. What is best
10. Which of the following is most consistent with crit- to recommend to this patient?
icism surrounding the use of “tender points” in the A. She should discontinue vitamin D until she
diagnosis of fibromyalgia? discusses with her physician.
A. It may mask the true incidence of fibromyalgia in B. Vitamin D supplements should be tried by
men. everyone with fibromyalgia for symptom
B. It does not capture that the pain is widespread. management.
C. It takes a specially-trained clinician to C. Supplemental vitamin D may provide symptom
administer the examination. relief if she is deficient, but first she should have
D. Patients may falsely report tender points to a blood test to determine her current vitamin D
obtain medication. levels.
D. There is not enough evidence to say whether or
11. A patient with fibromyalgia has her pain symptoms not she should take vitamin D supplements.
well controlled on pregabalin and reports minimal
adverse effects. The patient is switching jobs and will Questions 15–17 pertain to the following case.
be without insurance coverage for 6 months. Which P.T. is a 47-year-old woman new to your clinic. She presents
one of the following is best to recommend for this with complaints of sleep disturbances, fatigue, and pain;
patient? she feels these symptoms are affecting her overall quality
of life. She states the sleep disturbances cause her to feel
A. Change to gabapentin.
unrested even after a full night’s sleep, and she is fatigued
B. Discontinue pregabalin until insurance benefits
throughout the day on most days of the week. P.T. has
return.
greatly increased her caffeine intake to make up for this.
C. Replace pregabalin with cognitive behavior
She has not noticed cognitive symptoms related to her lack
therapy.
of sleep. In regards to the pain, she says it is most noticeable
D. Continue pregabalin.
in her entire arms, hips, upper legs, and upper and lower
back. Most days of the week she also notices gastrointes-
12. For which one of the following patients would ami-
tinal symptoms as well. This has been ongoing for about
triptyline be preferred over milnacipran?
6 months. The resident physician performs a tender point
A. A 37-year-old woman with a high insurance examination on P.T. and finds 12 tender points present
deductible. .
B. A 66-year-old man with glaucoma. 15. Which one of the following best describes P.T.’s score
C. A 75-year-old woman with orthostatic on the Widespread Pain Index?
hypotension.
A. 4
D. A 41-year-old man with altered sleep pattern
B. 5
because of shift work.
C. 6
D. 10
13. A patient with newly diagnosed fibromyalgia inquires
about complementary and alternative medicine
16. Which one of the following best describes P.T.’s score
(CAM) after researching fibromyalgia on the Inter-
on the Symptom Severity Scale?
net. What would be the most appropriate response to
the patient regarding CAM? A. 5
B. 6
A. There is not enough evidence to suggest CAM is
C. 7
beneficial for fibromyalgia.
D. 8
B. All CAM options provide the same results,
which are not much better than placebo.

ACSAP 2015 • Neurologic and Psychiatric Care I 16 Fibromyalgia

17. Based upon available diagnostic criteria for fibromy-
algia, which one of the following criteria is P.T. most
likely to satisfy?
A. 1990 ACR Criteria.
B. 2011 Modified ACR Criteria.
C. Both 1990 and 2011 ACR Criteria.
D. Neither 1990 nor 2011 ACR Criteria.

18. You have just completed motivational interviewing

training and decide to try this communication tech-
nique with a patient with fibromyalgia. Which of the
following statements would be most appropriate in a
dialogue promoting patient self-care?
A. “Why do you think I’m suggesting you start
exercising?”
B. “Do you mind if I share some information
with you about the benefits of exercise for
fibromyalgia?”
C. “Don’t you want to improve your symptoms?”
D. “Why are you so against taking care of yourself?”

19. A 57-year-old woman was diagnosed with fibro-

myalgia about 5 years ago. For the past 2 years her
fibromyalgia symptoms have been well controlled
with pregabalin 300 mg daily and a regular exercise
program. In the past 3 months she has had to deal
with several life stressors and now feels her fibromyal-
gia symptoms (namely pain and cognitive symptoms)
have worsened. Which one of the following is most
likely to improve her symptoms?
A. Increase pregabalin to 450 mg daily.
B. Change to duloxetine 30 mg.
C. Cognitive behavior therapy.
D. Tai chi.

20. Which one of the following patients with fibromyalgia

is most likely to benefit from milnacipran?
A. A 38-year-old man with a new diagnosis of
fibromyalgia and a primary complaint of sleep
disturbances.
B. A 47-year-old woman who had fatigue symptom
relief from duloxetine but could not tolerate the
drug’s adverse effects.
C. A 51-year-old woman being treated with
amitriptyline but still experiencing pain.
D. A 44-year-old man who has most of his
symptoms relieved through exercise but
complains of depressed mood.

ACSAP 2015 • Neurologic and Psychiatric Care I 17 Fibromyalgia

Learner Chapter Evaluation: Fibromyalgia.
As you take the posttest for this chapter, also evaluate the Use the 5-point scale to indicate whether this chapter pre-
material’s quality and usefulness, as well as the achieve- pared you to accomplish the following learning objectives:
ment of learning objectives. Rate each item using this
5-point scale: 12. Demonstrate an understanding of the epidemiology
of fibromyalgia, its impact on patient health, and the
• Strongly agree clinical controversy surrounding the syndrome.
• Agree 13. Evaluate available treatment options and design a
• Neutral treatment plan for the patient with fibromyalgia.
• Disagree 14. Evaluate the available evidence regarding comple-
• Strongly disagree mentary and alternative medicine for fibromyalgia.
15. Justify the role of patient self-care in the treatment of
1. The content of the chapter met my educational needs. fibromyalgia.
2. The content of the chapter satisfied my expectations. 16. Construct a patient education strategy to aid patients
3. The author presented the chapter content effectively. in fibromyalgia self-management.
4. The content of the chapter was relevant to my practice
and presented at the appropriate depth and scope. 17. Please provide any specific comments related to any
5. The content of the chapter was objective and balanced. perceptions of bias, promotion, or advertisement of
6. The content of the chapter is free of bias, promotion, commercial products.
or advertisement of commercial products. 18. Please expand on any of your above responses, and/
7. The content of the chapter was useful to me. or provide any additional comments regarding this
8. The teaching and learning methods used in the chap- chapter:
ter were effective.
9. The active learning methods used in the chapter were
effective.
10. The learning assessment activities used in the chapter
were effective.
11. The chapter was effective overall.

ACSAP 2015 • Neurologic and Psychiatric Care I 18 Fibromyalgia