REVIEW ARTICLE

Management of fibromyalgia: key messages

from recent evidence­‑based guidelines
Winfried Häuser1,2 , Jacob Ablin3 , Serge Perrot4 , Mary­‑Ann Fitzcharles5,6
1 Department Internal Medicine 1, Klinikum Saarbrücken, Saarbrücken, Germany
2 Department Psychosomatic Medicine and Psychotherapy, Technische Universität München, Munich
3 Institute of Rheumatology, Tel Aviv Sourasky Medical Center and Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel
4 Centre de la douleur, Hôpital Cochin­‑Hôtel Dieu, Assistance Publique Hôpitaux de Paris, Université Paris Descartes, Paris, France
5 Division of Rheumatology, McGill University Health Centre, Quebec, Canada
6 Alan Edwards Pain Management Unit, McGill University Health Centre, Quebec, Canada

KEY WORDS ABSTRACT

diagnosis, Fibromyalgia (FM) is a prevalent and costly condition worldwide, affecting approximately 2% of the gen‑
fibromyalgia, eral population. Recent evidence- and consensus­‑based guidelines from Canada, Germany, Israel, and
guidelines, systematic the European League Against Rheumatism aim to support physicians in achieving a comprehensive
review, therapy diagnostic workup of patients with chronic widespread (generalized) pain (CWP) and to assist patients
and physicians in shared decision making on treatment options. Every patient with CWP requires, at the
first medical evaluation, a complete history, medical examination, and some laboratory tests (complete
blood count, measurement of C­‑reactive protein, serum calcium, creatine phosphokinase, thyroid­
‑stimulating hormone, and 25­‑hydroxyvitamin D levels) to screen for metabolic or inflammatory causes
of CWP. Any additional laboratory or radiographic testing should depend on red flags suggesting some
other medical condition. The diagnosis is based on the history of a typical cluster of symptoms (CWP,
nonrestorative sleep, physical and/or mental fatigue) that cannot be sufficiently explained by another
medical condition. Optimal management should begin with education of patients regarding the current
knowledge of FM (including written materials). Management should be a graduated approach with the aim
of improving health­‑related quality of life. The initial focus should ensure active participation of patients
Correspondence to: Winfried Häuser,
MD, Department Internal Medicine 1,
in applying healthy lifestyle practices. Aerobic and strengthening exercises should be the foundation
Klinikum Saarbrücken, Winterberg 1, of nonpharmacologic management. Cognitive behavioral therapies should be considered for those with
D-66119 Saarbrücken, Germany,
phone: +49 681 9632020, e-mail:
mood disorder or inadequate coping strategies. Pharmacologic therapies may be considered for those
whaeuser@[Link] with severe pain (duloxetine, pregabalin, tramadol) or sleep disturbance (amitriptyline, cyclobenzaprine,
Received: December 22, 2016.
pregabalin). Multimodal programs should be considered for those with severe disability.
Revision accepted:
December 22, 2016.
Published online: January 4, 2017.
Conflict of interest: WH received
one honorarium from Grünenthal Background  Fibromyalgia (FM) is a frequent, ex­ pharmacologic therapies. The costs related to FM
for an educational lecture in the
last 3 years. JA has performed
pensive, and controversial condition.1 Studies re­ can be substantial, with over 75% attributed to
professional consulting on behalf of port varied prevalence depending on diagnostic indirect costs from lost productivity and with in­
BrainSet Ltd. SP received honoraria criteria used, a country, and a setting. One review creased costs related to increased severity of FM.5
from Pfizer, Lilly, and Grünenthal reported a global mean prevalence of 2.7% (range, The concept of FM continues to stimulate de­
in the last 3 years. MAF received
consulting fees, speaking fees,
0.4%–9.3%), with a mean in the Americas of 3.1%, bate amongst researchers and clinicians alike.
and/or honoraria (<$10 000) from in Europe of 2.5%, and in Asia of 1.7%.2 The prev­ Advances in the field of functional neuroimaging
ABBVIE, Abbott, Amgen, Bristol‑­ alence rates of FM in Poland are unknown. FM is over the last 2 decades, as well as other lines of
-Myers Squibb Canada, Janssen,
Johnson & Johnson, Lilly, and Pfizer
more common in women, with a female to male physiological experimentation, have highlighted
in the last 3 years. ratio of 3:1 in epidemiology studies2 and of 8:1 to the role of central sensitization (or pain central­
Pol Arch Intern Med. 2017; 10:1 in clinical settings.1 ization), that is, increased processing of pain, as
127 (1): 47-56
Patient surveys in the  United States3 and the main pathogenetic process in FM (and related
doi:10.20452/pamw.3877
Copyright by Medycyna Praktyczna, Germany4 demonstrated that most patients conditions).6,7 Some authors have reported a more
Kraków 2017 use a great variety of pharmacologic and non­ peripheral abnormality with changes consistent

REVIEW ARTICLE  Management of fibromyalgia 47

 A

FIGURE 1  Pain diagrams for patients with chronic widespread pain: painful areas are marked by the patient with grey (A) and blue colors (B)

48 POLISH ARCHIVES OF INTERNAL MEDICINE  2017; 127 (1)

TABLE 1  Fibromyalgia survey questionnaire21 was to synthesize and summarize the recom­
mendations of the Canadian,15 German,16,17 and
I. Using the following scale, indicate for each item the level of severity over the past
week by checking the appropriate box. Israeli14 guidelines for the diagnosis and of the Eu­
0: No problem ropean League Against Rheumatism (EULAR)18
1: Slight or mild problems; generally mild or intermittent recommendations for the management of FM.
2: Moderate; considerable problems; often present and/or at a moderate level
Diagnosis Challenges There is often a consid­
3. Severe: continuous, life­‑disturbing problems
erable delay in the diagnosis of FM.19 Potential
Fatigue  0  1  2 3 reasons are as follows: some physicians may sim­
Trouble thinking or remembering  0  1  2 3 ply fail to recognize that a patient with chronic
Waking up tired (unrefreshed)  0  1  2 3 widespread (generalized) pain (CWP) would sat­
II. During the past 6 months have you had any of the following symptoms? isfy FM criteria; others omit to use the diagnos­
tic label of “fibromyal­gia” because they disagree
Pain or cramps in lower abdomen  Yes  No
with the concept of FM; and some physicians be­
Depression  Yes  No lieve that the diagnosis will be harmful to the pa­
Headache  Yes  No tient or health care sys­tem.10 However, making
III. Joint/body pain a valid diagnosis of FM and communicating em­
Please indicate below if you have had pain or tenderness over the past 7 days in each pathetically with a patient can often decrease anx­
of the areas listed below. Please make an X in the box if you have had pain or iety, reduce unnecessary fur­ther investigations,
tenderness. Be sure to mark both right side and left side separately and provide a rational framework for a manage­
 Shoulder, left  Upper leg, left  Lower back ment plan.15
 Shoulder, right  Upper leg, right  Upper back
 Neck Screening  It is useful to screen patients with
chronic pain for CWP, which can be recognized
 Hip, left  Lower leg, left
at a glance using a pain diagram completed by
 Hip, right  Lower leg, right
the patient (FIGURES 1A and 1B ).
 Upper am, left  Jaw, left N
 o pain in any of these In case of CWP, a screening tool for FM (Fi­
 Upper arm, right  Jaw, right areas
broDetect®, Pfizer, New York, United States)20 or
 Lower arm, left  Chest the Fibromyalgia Survey Questionnaire21 (TABLE 1 )
 Lower arm, right  Abdomen (capturing the 2011 and 2016 diagnostic crite­
IV. Overall, were the symptoms listed in I–III above generally present for at least ria of FM)21,22 can be completed by the patient
3 months? to further complement the clinical assessment.
 Yes  No
Diagnostic workup of a patient with chronic wide-
spread (generalized) pain  No confirmatory blood
with small fiber neuropathy.8 In the disciplines tests (biomarkers) or imaging or histological anal­
of psychiatry and psychosomatic medicine, FM yses are available for FM. At the initial assessment
symptoms are characterized as a functional so­ of a patient with CWP, national (Canadian, Ger­
matic syndrome, a bodily distress syndrome, or man, and Israeli) guidelines have proposed that
as a somatoform disorder.9 There are even some a complete medical and psychosocial history be
psychiatrists who question the value of assigning obtained, including pharmacologic drug use, fol­
a diagnostic label to a specific patient.10 Overlap lowed by a comprehensive physical examination.
with other chronic pain conditions is now recog­ A limited number of laboratory tests will allow for
nized with the United States Congress and the Na­ screening for medical conditions that can mimic
tional Institutes of Health having recently creat­ FM symptoms. All 3 guidelines were in agreement
ed the term “chronic overlapping pain conditions that the diagnosis remains clinical and the pur­
(COPCs)”.11 Conditions that overlap with FM in­ pose of the physical examination and laboratory
clude temporomandibular joint disorders, irrita­ investigations is to rule out alternative diagno­
ble bowel syndrome, chronic migraine and ten­ ses.23 The recommendations for the clinical diag­
sion headache, and painful bladder syndrome.11 nosis of FM of the Canadian, German, and Israe­
Furthermore, the International Association for li guideline are summarized in TABLE 2 .
the Study of Pain has suggested to include FM as In most cases, the diagnosis can be established
primarily a pain syndrome.12 Physician uncertain­ based on a history, physical examination that
ty about recognizing symptoms of FM, differen­ demonstrates general tenderness (muscle, joints,
tiating FM from conditions with similar symp­ tendons), the absence of some other pathology
toms, and developing an FM treatment plan was that could explain pain and fatigue, and normal
noted for a survey of European physicians con­ basic laboratory tests.
ducted in 2008.13 Common points to note when taking a history
With the aim of addressing this care gap, 4 from a patient with FM may include the following:
evidence­‑based guidelines have been published in a family history of early chronic pain (eg, low back
the past 5 years with the aim to assist physicians pain, “rheumatism”, etc); personal history of pain
in establishing a correct diagnosis and to assist (head, abdomen, joints) in childhood and adoles­
patients and physicians in shared decision making cence; long history of local pain; onset of wide­
on treatment options.14-18 The aim of this review spread pain related to physical or psychosocial

REVIEW ARTICLE  Management of fibromyalgia 49

TABLE 2  Comparison of the recommendations of the Canadian, German, and Israeli guidelines on the clinical diagnosis of fibromyalgia23

Feature Canada Germany Israel

history of a typical diffuse body pain present for chronic widespread pain and presence of pain in muscles, joints, connective
cluster of at least 3 months, and possible fatigue (physical and or tissues, various areas of the upper and lower limbs,
symptoms symptoms of fatigue, sleep mental) and sleeping neck, shoulders, upper and lower back
disturbance, cognitive problems/unrefreshed sleep typical symptoms of sleep disturbances, difficulty
changes, mood disorder, and falling asleep, frequent awakening during the night,
other somatic symptoms to disturbed sleep patterns, unrefreshing sleep,
a variable degree chronic fatigue complaints throughout the day,
difficulties with concentration and memory
exclusion other illness explaining somatic disease sufficiently other disorders explaining the symptoms have been
the symptoms explaining the symptoms ruled out
the diagnosis of a mental FM may develop in coexistence with additional
disorder does not exclude disorders, be they somatic, inflammatory,
the diagnosis of FM psychiatric, or otherwise
recommended complete physical examination, obtaining history of complete physical examination
methods for full blood count, ESR, CRP, pharmacologic agents used complete blood count, renal function tests (creatinine
exclusion of creatine kinase, and TSH complete physical examination and urea), serum calcium and phosphorous levels,
a somatic disease liver function tests, CPK, ESR, CRP, TSH, and
complete blood count, CRP,
serum calcium, CPK, TSH, vitamin D
vitamin D
further tests any additional laboratory or only in case of clinical hints at the discretion of the physician performing
radiographic testing should pointing at a somatic disease the evaluation, based on clinical hints pointing at a
depend on the clinical somatic disease (low threshold for serological tests,
evaluation in an individual eg, ANA and RF)
patient that may suggest some
other medical condition
tender point not required facultative no requirement to document the number of tender
examination points; however, assessment of tenderness
recommended as part of physical examination
screening for no statement recommended recommended
mental disorders

Abbreviations: ANA, antinuclear antibodies; CPK, creatine phosphokinase; CRP, C­‑reactive protein; ERS, erythrocyte sedimentation rate; FM,
fibromyalgia; RF, rheumatoid factor; TSH, thyroid­‑stimulating hormone

stress (or both); history of physical or psychoso­ of symptoms such as fatigue, sleep disturbance,
cial stress (eg, child abuse); general hypersensi­ or cognitive symptoms. Therefore, the presence
tivity to touch, smell, noise, taste; hypervigilance; of 11 out of 18 tender points and the simultane­
multiple somatic symptoms (gastrointestinal, ous presence of CWP for at least 3 months were
urology, gynecology, neurology) with a previous identified as the classi­fication criteria for FM.
diagnosis of functional dyspepsia, irritable bow­ Although initially intended for research purpos­
el syndrome, painful bladder syndrome, tension es, these criteria were soon widely used for clini­
headache, migraine, temporomandibular disor­ cal diagno­sis. Con­cerns about the reliability and
der; and high symptom­‑related emotional strain. validity of the tender point examnination (TPE)
were raised, leading to the suggestion to refrain
Diagnostic criteria  To reassure the clinician re­ from use in the clinical setting.25
garding a clinical diagnosis of FM, a reference
may be made to one of the published classifica­ 2010 American College of Rheumatology preliminary di‑
tion or diagnostic FM criteria. These various cri­ agnostic criteria  The 2010 ACR preliminary diag­
teria for FM have undergone numerous revisions nostic criteria addressed the various problems of
since first reported (TABLE 3 ). the 1990 ACR criteria. Most importantly, the 2010
ACR preliminary criteria eliminated the TPE,
The 1990 American College of Rheumatology criteria  which was replaced by the Widespread Pain In­
A group of rheumatologists of the American Col­ dex (WPI). The WPI is a 0–19 count of the num­
lege of Rheumatology (ACR) with expertise in ber of body regions that are reported as painful
FM compared patients with FM diagnosed by or sensitive to pressure (“tender”) by the patient.
their individual criteria with age­‑matched and sex­ Second, the criteria assessed, on a 0–3 severi­
‑matched controls (who had local pain syndromes ty scale, a series of additional key symptoms of
or [potential] inflammatory rheumatic diseases). FM: fatigue, unrefreshing sleep, cognitive prob­
The ACR committee found that the presence of lems, and the extent of somatic symptom report­
widespread pain combined with at least 11 out of ing. The items were com­bined into a 0–12­‑point
18 tender points best differentiated patients with Symptom Severity Scale (SSS). Finally, the WPI
FM from controls.24 These criteria, however, failed and SSS could be combined. In addi­tion, the di­
to acknowledge and incorporate the coexistence agnostic criteria require that the patient has had

50 POLISH ARCHIVES OF INTERNAL MEDICINE  2017; 127 (1)

TABLE 3  The 1990, 2010 preliminary, and modified 2010 American College of Rheumatology criteria (2011) and 2016 Revisions to the 2010/2011
fibromyalgia diagnostic criteria

Criteria (reference) Diagnostic items Comments

ACR 1990 classification widespread pain (bilateral, above and Tender points are found at the spine, shoulders, ribs, hips, and knees and often
criteria24 below the waist, and axial) pain in at the sites of insertions of ligaments, muscles, and tendons; tenderness
11 out of 18 tender points (on at 11 or more of 18 tender points is required to meet criteria.
palpation with a force of ~4 kg)
ACR 2010 preliminary widespread pain and substantial Pain is scored by the physician according to the NAA (total score, 0–19), and
diagnostic criteria26 somatic symptoms SSS score ranges from no problem (0) to severe symptoms (3) in 4 domains
symptoms present for ≥3 months (fatigue, unrefreshing sleep, cognitive and somatic symptoms; total score,
0–12); total score, 0–31
no other disorder that could explain
the pain Criteria are met if NAA is 3–6 and SSS ≥9 or of NAA is ≥7 and SSS is ≥5.
modified 2010 ACR modified version of the 2010 ACR WPI is scored by the patient according to the NAA (total score, 0–19). The SSS
criteria (research or preliminary criteria (entirely self­ score is scored by the patient and is modified to include headaches, pain, or
survey criteria or ‑reported assessment of cramps in the lower abdomen and depression (total score, 0–12). Total score,
2011)21 symptoms) 0–31.
Criteria are met if WPI 3–6 and SSS ≥9 or of WPI is ≥7 and SSS is ≥5.
2016 Revisions to modified version of research WPI is scored by the patient according to the NAA (total score, 0–19). The SSS
the 2010/2011 (survey/2011) criteria (entirely score is scored by the patient and includes headaches, pain, or cramps in
fibromyalgia diagnostic self­‑reported assessment of the lower abdomen and depression (total score: 0–12). Total score, 0–31.
criteria22 symptoms) Criteria are met if WPI is 4–6 and SSS ≥9 or if WPI is ≥7 and SSS is ≥5 and
there is generalized pain in at least 4 of 5 body regions (4 quadrants and axial)
except the face and abdomen

Abbreviations: ACR, American College of Rheumathology; NAA, number of affected areas; SSS, Symptom Severity Scale; WPI, Widespread Pain Index

symptoms present at a similar level for at least the FSQ is strongly discouraged. The combination
3 months and the patient does not have anoth­ of the continuous scale WPI and SSS score (ie,
er disorder that would otherwise sufficiently ex­ the Fibromyalgia Symptom Scale) enables the as­
plain the pain.26 sessment of the severity and symptom burden in
individual patients instead of classifying patients
Modified 2010 ACR diagnostic criteria (research or survey as FM positive or negative.21
or 2011 criteria)  The application of the modified
2010 ACR diagnostic criteria in the clinical set­ 2016 Revisions to the 2010/2011 fibromyalgia diagnostic
ting was time consuming. The WPI and SSS items criteria  The 2010/2011 criteria led to misclassifi­
required a detailed and thoughtful interview, ac­ cation when applied to regional pain syndromes.
knowledging that symptom assessment by phy­ Therefore, a further modification has been pro­
sicians is inherently sub­jective. This led to a fur­ posed. The 2016 criteria require a WPI between
ther modification of the 2010 ACR diagnostic cri­ 4 (2011 required 3) and 6 pain sites and an SSS
teria, which was completed in entirety by the pa­ score of 9 or higher. In addition, generalized pain
tient. The Fibromyalgia Survey Questionnaire should be present, defined as pain sites in at least
(FSQ; also known as the Fibromyalgia Symptom 4 of 5 body regions (4 quadrants and axial) except
Scale and the Polysymptomatic Distress Scale) as­ the face and the abdomen. The 2016 critera also
sessed, by patient self­‑report, the key symptoms removed the exclusion regarding disorders that
of FM that could be used in survey research or could sufficiently explain the pain stating explic­
other settings.21 itly that a diagnosis of FM is valid irrespective of
The FSQ therefore substituted the assessment other diagnoses and that a diagnosis of FM does
of somatic symptom intensity, previously com­ not exclude the presence of other clinically im­
pleted by physicians, with a questionnaire assess­ portant ilnesses.22
ing the number of pain sites and somatic symp­
tom severity now completed by the patient. Pa­ Different fibromyalgia classification and diagnostic
tients satisfying the research criteria (a diagnosis criteria: do they matter?  The concordance rates of
of FM in a research context) meet the following the different criteria in clinical poulations vary,
conditions: a WPI of ≥7 out of 19 pain sites and depending on the context.22,27 The 2010, 2011,
an SSS score of ≥5 out of 12, or a WPI between 3 and 2016 eliminated the TPE and enabled a diag­
and 6 pain sites and an SSS score of ≥9 (TABLE 1 ). nosis to be established by physicians other than
The symptoms should be present for at least 3 rheumatologists. However, the newer 2010 and
months, and there is no other disorder present 2011 criteria allow for increased diagnosis rates
that could sufficiently explain the pain. Given that in men, as women are on average more tender
the WPI and SSS comprise the FSQ, this question­ than men, and thus any criteria that include a ten­
naire can be used to assist medical diag­nosis, but derness threshold will selectively diagnose more
the interpretation and assessment of the valid­ women more often.1 For women, it makes no dif­
ity of the questionnaire must be determined by ference in the clinic which criteria are used. It is
the physician. Self­‑diagnosis of FM based only on worth keeping in mind that in related symptoms,

REVIEW ARTICLE  Management of fibromyalgia 51

TABLE 4  Red flags (history, clinical examination, basic laboratory tests) for internal phosphokinase level, although this measurement
diseases underlying chronic widespread pain may be normal. In case of moderate to severe
Inflammatory rheumatic diseases (basic laboratory test results: anemia, elevated ESR muscle pain and/or weakness, discontinuation of
and/or CRP levels) the drug is recommended. If the symptoms are
rheumatoid arthritis associated with statins, they should disappear
• history: pain more localized to the joints, especially the joints of the hands and feet;
within 2 months of terminating the medication.33
presence of extraarticular features (eg, enthesitis); weight loss; progressive Of note, the diagnosis of other medical condi­
increase in the severity of symptoms tions that contribute and possibly act as a pain
• clinical examination: symmetrical swollen peripheral joints generator to widespread pain is important for
polymyalgia rheumatica the management of the patient, because, for
• history: older age of onset (>60 years); a more clearly defined time of onset over example, severe osteoarthritis of the knee as
a few weeks; prominent night pain the cause of knee pain would require treatment
• clinical examination: limitation of range of motion of shoulders; swollen peripheral strategies other than those for FM.
joints
inflammatory back pain Management  General treatment principles  Prompt
• history: nocturnal pain; increased pain at rest; relief with physical activity; diagnosis  EULAR recommendations state that
prolonged stiffness after rest that can last well over an hour; abdominal pain and optimal management requires prompt diagno­
diarrhea sis. A full understanding of FM requires a com­
• clinical examination: limitation of range of motion of spinal column prehensive assessment of pain, function, and
Endocrine diseases (basic laboratory test results: anemia, elevated ESR and/or CRP the psychosocial context.18
levels, elevated calcium levels; elevated or lowered TSH levels)
acromegalia Patient education  All 4 guidelines14-18 state that
• clinical examination: increased size of the hands and feet, coarsening of facial patients should be educated about the condition
features and treatment options discussed. The Canadi­
hypothyreoidism an, German, and Israeli guidelines14-17 explicitly
• clinical examination: myxedema, rough voice recommended that the diagnostic label “FM” or
• history: weight gain “FMS” should be communicated to patients after
initial diagnosis and that patients should be pro­
hyperthyreoidism
vided with a clear explanation regarding the na­
• history: weight loss
ture of the disorder, planned treatment strategy,
• clinical examination: exophtalmus, tachycardia and expected outcome. This approach is intend­
hyperparathyreoidism ed to reduce anxiety, which inherently accompa­
• history: abdominal pain, constipation, previous kidney stones, gastrointestinal nies chronic pain.15 There is also consensus that
ulcers patients should be informed about the concept of
Malignancies a biopsychosocialmodel for FM whereby biological
• history: fever, weight loss, or night sweats factors (eg, genetic predisposition) and psychoso­
• clinical examination: peripheral lymphoma cial factors (eg, stress) contribute to the predis­
position, triggering, and perpetuation of symp­
Abbreviations: see TABLE 1 toms. The Canadian guidelines discouraged exces­
sive focus on a triggering event (such as a phys­
such as irritable bowel syndrome, different clin­ ical or psychological traumatic event) that could
ical and classification (Rome I, II, III) criteria are compromise patient care.15 The German guide­
available.28 lines suggested that the following information
should be included in the education of patients17 :
Differential diagnosis  Chronic pain of varied de­ 1  Reassurance that the symptoms are not caused
gree is a common symptom in patients present­ by an organic disease (such as abnormality of
ing to internal medicine physicians. While some the muscles or joints) but are instead based on
patients may be specifically referred for a possi­ a functional disorder of the brain (altered process­
ble diagnosis of FM, physicians must be aware ing of pain and other external stimuli);
that numerous medical conditions can present 2  The legitimacy of the ailment should be ac­
with diffuse body pain and masquerade as FM. knowledged. The symptoms are “real“.
Internal diseases such as inflammatory rheu­ 3  The symptoms are persistent in most adult
matic diseases, endocrine diseases, or maling­ patients.
nancies might cause or contribute to CWP and 4  Total relief of symptoms is seldom achieved.
fatigue. Red flags indicating an internal somatic 5  The symptoms should not lead to disablement
diseases are outlined in TABLE 4 . and do not shorten life expectancy.
Some medications may have an adverse effect 6  Most patients learn to adapt to the symp­
of body pain that may be confused with FM. These toms over time.
include lipid­‑lowering agents in the category of 7  The  patient can learn to improve symp­
statins, aromatase inhibitors29,30 and bisphos­ toms and health­‑related quality of life via self­
phonates,31 and, paradoxically, even opioids.32 ‑management strategies.
Characteristically, the myopathy associated with The EULAR recommended providing the pa­
statin use is painful, occurs early in the treatment tient with information (including written materi­
phase, and is associated with an elevated creatine al) about the condition.18 The German guidelines

52 POLISH ARCHIVES OF INTERNAL MEDICINE  2017; 127 (1)

FIGURE 2 Stepwise
patient education and information sheet
and individualized
treatment according to
the European League if insufficient
Against Rheumatism
recommendations for
the management of physical therapy with individualized graded physical exercise
(can be combined with other recommended nonphamacologic therapies, such as hydrotherapy, acupuncture)
fibromyalgia18

if insufficient

reassessment of patient to tailor individualized treatment

additional individualized FM treatment

pain-related depression, severe pain/sleep problems severe dysfunction

anxiety, catastrophizing, sick leave
overly passive or active
coping

• severe pain: duloxetine, multimodal rehabilitation

pregabalin, tramadol programs
• mainly cognitive behav‑ (or in combination with
ioral therapy paracetamol)
•  for more severe depres‑ • severe sleep problems:
sion/anxiety, consider low-dose amitriptyline, cy‑
psychopharmacologic clobenzaprine, pregabalin
treatment at night

group developed a patient version of the guide­ tailored according to pain intensity, function, as­
line and handouts for patients and their signifi­ sociated features (such as depression), fatigue,
cant others, which should be distributed to the pa­ sleep disturbance, and patient preferences and
tient after establishing the diagnosis.17 comorbidities.18

Defining individual and realistic goals of treatment All Graduated approach The EULAR18 and German
guidelines emphasized that the goals of treat­ guidelines16,17 recommend that treatment should
ment are to improve the quality of life, main­ focus first on nonpharmacologic modalities with
tain function (functional ability in everyday sit­ active patient participation championing self­
uations), and reduce symptoms. Some patients ‑management strategies. This is based on avail­
with FM may have unrealistic expectations such ability, cost, and safety issues, and also patient
as complete symptom relief.34 Therefore, indi­ preferences.
vidualized and realistic outcome goals should be Stepwise and individualized treatment accord­
developed together with the patient, such as im­ ing to the EULAR recommendations for the man­
proved daily functioning or symptom reduction agement of FM are outlined in FIGURE 2 .
(eg, 30% pain relief).17 Another important as­
pect is the management of activity and energy, Nonpharmacologic therapies  The EULAR­‑recom­
also termed “pacing”, which aims to avoid exces­ mended nonpharmacologic therapies are outlined
sive activity or inadequate rest.15 in TABLE 5 . The only intervention with a strong
EULAR recommendation was for aerobic and
Individualized approach  Identifying the symptom strengthening training.
of major importance to an individual patient
can help the physician to develop an anchor on Pharmacologic management  General principles  All
which to base a treatment strategy. The manage­ drug treatments must balance efficacy and ad­
ment of FM often requires a multidisciplinary verse effects, especially for those that affect cog­
approach with a combination of nonpharmaco­ nition and fatigue. Drug treatments must be be
logic and pharmacologic treatment modalities reevaluated to ensure the need for continuation

REVIEW ARTICLE  Management of fibromyalgia 53

 TABLE 5  The European League Against Rheumatism recommendations of nonpharmaoclogic therapies of fibromyalgia18

Type of therapy Level of evidence Strength of recommendation Agreement

aerobic and strengthening training Ia strong 100%
cognitive behavioral therapies Ia weak 100%
multicomponent therapies Ia weak 93%
defined physical therapies: acupuncture Ia weak 93%
or spa therapy
meditative movement therapies (qigong, Ia weak 71%–73%
yoga, tai chi) and mindfulness­‑based
stress reduction

and should be prescribed in the lowest effective Patients with FM use on average at least 2
dose, which is often lower than the doses reported classes of medications, with some being pre­
for clinical trials, and ideally for a limited time.15,17 scribed even 5 or more classes.3,4 However, the ev­
One should differentiate between pharmaco­ idence for a combination of drugs with different
logic treatment for continuous pain and pharma­ modes of action is limited to one small study com­
cologic treatment for incident pain, eg, exercise­ bining pregabalin with duloxetine.43
‑related pain. In the first case, treatments acting
on pain modulation are probably more relevant, Tailored treatment  Cognitive behavioral therapies
while classic analgesics are likely to be considered (“weak for”) should be considered for those with
in the second case, for intermitent use.15 mood disorder or poor coping strategies. Pharma­
cologic therapies (all “weak for”) should be consid­
Nonrecommended drugs  Pain is traditionally treat­ ered for those with severe pain (duloxetine, prega­
ed with simple analgesics, nonsteroidal anti­ balin, tramadol) or sleep disturbance (amitripty­
‑inflammatory drugs (NSAIDs), or opioid medi­ line, cyclobenzaprine, pregabalin). Multimodal re­
cations. However, NSAIDs are frequently used by habilitation (“weak for”) programs should be con­
patients,3,4 without evidence for effect and there­ sidered for those with severe disability (FIGURE 2 ).18
fore not recommended.18 We speculate, however, The updated German guidelines recommend
that access to over­‑the­‑counter NSAIDs in many that treatment should be tailored to patients’
countries has led patients to develop familiarity preferences, comorbidities, and experience with
with these agents and thereby promoted their use. and response to previous treatments.17 The rec­
Another explanation is that patients take NSAIDs ommendation of the type of aerobic exercise can
because of comorbid osteoarthritis or other local­ depend on the comorbidities of the patient (eg,
ized inflammatory comorbidities, such as bursi­ aqua jogging is more suited for patients with obe­
tis, tendinitis, and others. The EULAR commit­ sity and /or osteoarthritis of the hip and the knee
tee made a “strong against” evaluation regard­ than walking).17 Of note, some peripheral pain
ing the use of strong opioids, sodium oxybate, generators in FM might need a different approach
corticosteroids, or growth hormone for FM, on than the ones recommended for FM (eg, NSAIDs
the basis of the lack of evidence for efficacy and and strong opioids are not recommended for FM
high risk of side effects/addiction reported in in­ but can be effective for comorbid osteoarthritis).44
dividual trials.18 In addition, the EULAR did not Trigger point injections are not recommended for
recommend several pharmacologic therapies, in­ FM but can relieve overall pain in patients with
cluding nonsteroidal agents (NSAIDs), monoami­ FM and myofascial pain syndromes.45 Contrain­
nooxidase inhibitors and serotonine reuptake in­ dications related to the use of particular drugs
hbitors, because of the lack of efficacy.18 should be kept in mind (eg, duloxetine should be
avoided in patients with severe liver damage or
Recommended drugs  Recommended drugs typi­ amitriptyline in patient with glaucoma). Mental
cally include pain­modulators such as the sero­ disorders such as depression and anxiety disor­
tonin and noradrenaline reuptake inhibitors du­ ders are common in FM and can be diagnosed—
loxetine and milnacipran,35-37 the tricyclic agent depending on the setting and the instrument
amitriptyline,36,38 and antiepileptic agents such as used—in up to 80% of patients. Psychological dis­
pregabalin.36,39,40 However, it is noteworthy that tress and mental disorders have a negative impact
the proportion of patients who achieve worth­ on FM outcome.1 Therefore, the German guide­
while pain relief (typically at least 50% reduction line recommends the collaboration with a men­
in pain intensity) is small, generally 10% to 25% tal health care specialist in case of moderate or
more than with placebo, with numbers needed to severe mental disorders.17
treat for an additional beneficial outcome usual­
ly between 4 and 10.41 FM is not dissimilar from Is there a target for disease outcome for fibromyalgia? 
other chronic pain disorders in that only a small A target should be a standard outcome measure­
proportion of trial participants have a good re­ ment that is reliable, easy to perform, clinically
sponse to treatment.42 meaningful, captures disease severity, and has

54 POLISH ARCHIVES OF INTERNAL MEDICINE  2017; 127 (1)

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mains defined by the patients themselves. As pa­ 751, 750. Hebrew.
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56 POLISH ARCHIVES OF INTERNAL MEDICINE  2017; 127 (1)