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Source: Medscape Medical News
Date: September 21, 2007
Author: Laurie Barclay, MD
URL: http://www.medscape.com/viewarticle/563161
Ref: EULAR Paper: Annals of the Rheumatic Diseases,
http://ard.bmj.com


EULAR Issues Guidelines for the Treatment of Fibromyalgia Syndrome
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September 21, 2007 - The European League Against Rheumatism (EULAR) has
issued the first guidelines for the treatment of fibromyalgia syndrome
(FMS) and published them in the September 17 Online First issue of the
Annals of the Rheumatic Diseases.

"Although effective treatments are available no guidelines exist for
management of FMS," write Serena F. Carville, from King's College London,
United Kingdom, and colleagues. "The objectives were to ascertain the
strength of the research evidence on effectiveness of treatment of FMS and
develop recommendations for its management based on the best available
evidence and expert opinion to inform healthcare professionals."

The authors of these guidelines consisted of a multidisciplinary task
force from 11 European countries. This panel defined the study design a
priori, using standard operating procedures published by EULAR. These
included search strategy, which was a systematic review using the keywords
"fibromyalgia," "treatment or management," and "trial"; "participants";
"interventions"; "outcome measures"; "data collection"; and "analytical
method."

Exclusion criteria for identified studies were failure to use
classification criteria from the American College of Rheumatology (ACR),
studies that were not clinical trials or studies comprising inclusion of
patients with chronic fatigue syndrome or myalgic encephalomyelitis. The
main endpoints were change in pain measured by the visual analog scale
(VAS), and the fibromyalgia impact questionnaire (FIQ).

The panel categorized the studies by quality, based on whether they were
randomized, blinded, and concealed allocation, and they used only the
highest-quality studies as a basis for their recommendations. The panel
used a Delphi process to provide a basis for recommendation when evidence
from the literature was inadequate.

Of 146 studies eligible for review, 39 pharmacologic intervention studies
and 59 nonpharmacologic studies were used to create the final
recommendation summary tables, after those of lower quality or with
insufficient data were excluded. Identified categories of treatment were
antidepressants, analgesics and "other pharmacological," and exercise,
cognitive behavioral therapy, education, dietary interventions, and "other
nonpharmacological interventions."

Using this systematic review process and expert consensus, the panel
developed 9 recommendations for the management of FMS. However, many
studies reviewed had insufficient sample size and study quality to allow
the panel to issue strong recommendations. EULAR plans to update the
guidelines every 5 years and incorporate findings from good-quality
clinical trials that will add to currently available evidence.

"These recommendations are the first to be commissioned for FMS, although
previous reviews have addressed the area," the review authors conclude.
"These recommendations should assist health care providers, with a
secondary intention to incorporate information into materials for
patients. The 9 recommendations included 8 management categories, 3 of
which had strong evidence from the current literature, and 3 were based on
expert opinion."

Specific recommendations in these guidelines regarding general
considerations for management of FMS are as follows:
* Comprehensive evaluation of pain, function, and psychosocial context
is needed to understand FMS completely, because it is a complex,
heterogeneous condition involving abnormal pain processing and other
secondary features (level of evidence, IV D).
* Optimal treatment of FMS mandates a multidisciplinary approach, which
should include a combination of nonpharmacologic and pharmacologic
interventions. After discussion with the patient, treatment modalities
should be specifically tailored based on pain intensity, function, and
associated features such as depression, fatigue, and sleep disturbance
(level of evidence, IV D).

Specific recommendations on nonpharmacologic management of FMS are as
follows:
* Heated pool treatment, with or without exercise, is effective (level
of evidence, IIa B).
* For some patients with FMS, individually tailored exercise programs
can be helpful. These may include aerobic exercise and strength training
(level of evidence, IIb C).
* For certain patients with FMS, cognitive behavioral therapy may be
beneficial (level of evidence,IV D).
* Based on the specific needs of the patient, relaxation, rehabilitation,
physiotherapy, psychological support, and other modalities may be
indicated (level of evidence, IIb C).

Specific recommendations on pharmacologic management are as follows:
* Tramadol is recommended for management of pain (level of evidence,
Ib A). Although other treatment options may include simple analgesics
(eg, paracetamol) and other weak opioids, corticosteroids and strong
opioids are not recommended (level of evidence, IV D).
* Antidepressants are recommended for the treatment of FMS because
they decrease pain and often improve function (level of evidence, Ib A).
Appropriate options may include amitriptyline, fluoxetine, duloxetine,
milnacipran, moclobemide, and pirlindole.
* Tropisetron, pramipexole, and pregabalin are recommended for the
treatment of FMS because they reduce pain (level of evidence, Ib A).

Limitations of these recommendations are that some are based only on
expert opinion; basis from clinical trial data limited to changes in pain
measured by the VAS and function evaluated with the FIQ; failure to
consider positive effects on other outcome measures of pain or on function
evaluated with different instruments; and high variability in outcome
measures used, results reporting, and poor methodologic quality precluding
meta-analysis.

"Guidance on how to conduct good RCTs [randomized controlled trials] in
FMS, including standardised outcome measures and validated, sensitive
instruments is important for future research," the review authors
conclude. "The assessment of strength of evidence tends to favour
pharmacological studies as double blinding and placebo controls are
impossible in many non-pharmacological studies. However, most
non-pharmacological interventions are safe and have other health
benefits."

EULAR provided financial support for creation of these guidelines. Some of
the review authors have disclosed various financial relationships with
Procter and Gamble, Sanofi-Aventis, Roche, Bristol Meyers Squibb, Pierre
Fabre, Servier, Pfizer, Eli Lilly, Jazz Pharmaceutical, Allergan, and
Wyeth.

- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Ann Rheum Dis. Published online September 17, 2007.


Clinical Context
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The predominant rheumatologic features of FMS include chronic, widespread
pain and lowered pain threshold, with hyperalgesia and allodynia. Other
features often accompanying FMS include fatigue, depression, anxiety,
sleep problems, headache or migraine, bowel irregularity, diffuse
abdominal pain, and urinary frequency.

The most frequently used research classification criteria for FMS are
those developed by the ACR. However, no previous guidelines have addressed
management of FMS, despite the availability of effective treatments. EULAR
sought to evaluate the strength of the research evidence on the
effectiveness of FMS treatment and to develop management recommendations
for healthcare professionals based on the best evidence and expert
opinion.


Study Highlights
----------------

* Studies were excluded that were not clinical trials, did not use ACR
classification criteria, or included patients with chronic fatigue syndrome
or myalgic encephalomyelitis.
* Main outcomes studied were change in pain on the VAS and the FIQ.
* The panel based its recommendations on only the highest-quality studies.
A Delphi process was used for consensus opinion when evidence from the
literature was inadequate.
* Of 146 eligible studies reviewed, those of lower quality or with insufficient
data were excluded, and 39 pharmacologic and 59 nonpharmacologic studies were
used to create the 9 final recommendations.
* The 9 recommendations included 8 management categories, 3 of which
had strong evidence from the current literature, and 3 that were based on
expert opinion.
* The 9 recommendations were as follows:
o Comprehensive evaluation of pain, function, and psychosocial context
are needed to understand FMS completely, because of its complex,
heterogeneous nature.
o Optimal treatment of FMS mandates a multidisciplinary approach,
including nonpharmacologic and pharmacologic interventions.
Treatments should be specifically tailored to patient reports of pain
intensity, function, and associated features such as depression, fatigue,
and sleep disturbance.
o Heated pool treatment, with or without exercise, is effective.
Individually tailored exercise programs, which may include aerobic
exercise and strength training, may be helpful for some patients.
o Cognitive behavioral therapy, relaxation, rehabilitation, physiotherapy,
psychological support, and other modalities may be indicated for certain
patients.
o Tramadol is recommended for management of pain from FMS. Simple analgesics
(eg, paracetamol) and other weak opioids may be considered, but
corticosteroids and strong opioids are not recommended.
o Antidepressants are recommended to decrease pain and improve function
(eg, amitriptyline, fluoxetine, duloxetine, milnacipran, moclobemide,
and pirlindole).
o Tropisetron, pramipexole, and pregabalin are recommended to reduce
pain of FMS.
* EULAR plans to update the guidelines every 5 years and incorporate findings
from good-quality clinical trials that will add to currently available evidence.


Pearls for Practice
-------------------

* Pharmacologic interventions recommended for FMS include tramadol for pain
management, with simple analgesics and weak opioids if needed. Corticosteroids
and strong opioids are not recommended. Antidepressants are recommended to
decrease pain and improve function.
* Nonpharmacologic interventions recommended for FMS include comprehensive
evaluation; multidisciplinary, specifically tailored therapy; and heated
pool treatment, with or without exercise. Individually designed exercise
programs, cognitive behavioral therapy, relaxation, rehabilitation,
physiotherapy, psychological support, and other modalities may be helpful
for some patients.

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(c) 2007 Medscape Medical News