Guideline:
Management of fibromyalgia syndrome
Bibliographic Source(s)
- Goldenberg DL Burckhardt C Crofford L. Management of fibromyalgia syndrome. JAMA 2004 Nov 17;292(19):2388-95. [118 references] PubMed
Guideline Status
This is the current release of the guideline.
Guideline Category
Management
Treatment
Intended Users
Advanced Practice Nurses
Nurses
Pharmacists
Physical Therapists
Physician Assistants
Physicians
Psychologists/Non-physician Behavioral Health Clinicians
Guideline Objective(s)
To provide up-to-date evidence-based guidelines for the optimal treatment of fibromyalgia syndrome (FMS)
Target Population
Patients suffering from fibromyalgia syndrome
Interventions and Practices Considered
- Fibromyalgia syndrome diagnosis confirmation
- Pharmacological treatment including:
- Amitriptyline and cyclobenzaprine
- Tramadol with or without acetaminophen
- Serotonin reuptake inhibitors (SSRIs) such as fluoxetine
- Serotonin and epinephrine reuptake inhibitors (SNRIs) such as venlafaxine milnacipran duloxetine
- Pregabalin
- Guideline developers considered but did not recommend the following pharmacological therapies with weak evidence for efficacy: Growth hormone 5-hydroxytryptamine (serotonin) tropisetron and S-adenosyl-methionine.
- Guideline developers considered but did not recommend the following pharmacological therapies with no evidence for efficacy: opioids corticosteroids nonsteroidal anti-inflammatory drugs benzodiazepine and nonbenzodiazepine hypnotics melatonin calcitonin thyroid hormone guaifenesin dehydroepiandrosterone magnesium
- Non-pharmacological therapies including:
- Cardiovascular exercise
- Cognitive behavioral therapy
- Patient education using lectures written materials demonstrations
- Multidisciplinary therapy such as exercise and cognitive behavioral therapy or education and exercise
- Strength training acupuncture hypnotherapy biofeedback balneotherapy
- Guideline developers considered but did not recommend the following non-pharmacological therapies with weak evidence for efficacy: Chiropractic manual and massage therapy electrotherapy ultrasound.
- Guideline developers considered but did not recommend the following non-pharmacological therapies with no evidence of efficacy: Tender (trigger) point injections flexibility exercise
- Specialist referral
Major Outcomes Considered
Effect of treatment on visual analog pain scores pain threshold psychological function (depression anxiety) quality of life fatigue sleep and 6-minute walk
Methods Used to Collect/Select Evidence
Searches of Electronic Databases
Description of Methods used to Collect/Select the Evidence
A search of all human trials (randomized controlled trials and meta-analyses of randomized controlled trials) of FMS was made using Cochrane Collaboration Reviews (1993-2004) MEDLINE (1966-2004) CINAHL (1982-2004) EMBASE (1988-2004) PubMed (1966-2004) Healthstar (1975-2000) Current Contents (2000-2004) Web of Science (1980-2004) PsychInfo (1887-2004) and Science Citation Indexes (1996-2004). The literature review was performed by an interdisciplinary panel composed of 13 experts in various pain management disciplines selected by the American Pain Society (APS) and supplemented by selected literature reviews by APS staff members and the Utah Drug Information Service. References were consistently checked electronically for any relevant articles.
Number of Source Documents
Not stated
Methods Used to Assess the Quality and Strength of the Evidence
Weighting According to a Rating Scheme (Scheme Given)
Rating Scheme for the Strength of the Evidence
Strength of Evidence
Strong - positive results from a meta-analysis or consistently positive results from more than 1 randomized controlled trial (RCT)
Moderate - positive results from 1 RCT or largely positive results from multiple RCTs or consistently positive results from multiple non-RCT studies
Weak - positive results from descriptive and case studies inconsistent results from RCTs or both
Methods Used to Analyze the Evidence
Review of Published Meta-Analyses
Systematic Review
Description of the Methods Used to Analyze the Evidence
Not stated
Methods Used to Formulate the Recommendations
Expert Consensus
Description of Methods Used to Formulate the Recommendations
Not stated
Rating Scheme for the Strength of the Recommendations
Not applicable
Cost Analysis
A formal cost analysis was not performed and published cost analyses were not reviewed.
Method of Guideline Validation
Peer Review
Description of Method of Guideline Validation
Not stated
Major Recommendations
Strength of evidence (strong moderate weak) definitions are repeated at the end of "Major Recommendations" field.
There is strong evidence to support the use of low-dose tricyclic medications such as amitriptyline and cyclobenzaprine as well as cardiovascular exercise cognitive behavioral therapy (CBT) patient education or a combination of these for the management of fibromyalgia syndrome (FMS). There is moderate evidence that tramadol selective serotonin reuptake inhibitors (SSRIs) serotonin and epinephrine reuptake inhibitors (SNRIs) and certain anticonvulsants are effective but the complete results of some trials are not available and systematic reviews have not been reported. Moderate evidence exists for the efficacy of strength training exercise acupuncture hypnotherapy biofeedback massage and warm water baths. Many of the commonly used FMS therapies have not been carefully evaluated. Based on these reports a stepwise FMS management guideline can be recommended.
Stepwise Fibromyalgia Management
Step 1
- Confirm the diagnosis.
- Explain the condition.
- Evaluate and treat comorbid illness such as mood disturbances and primary sleep disturbances.
Step 2
- Trial with low-dose tricyclic antidepressant or cyclobenzaprine
- Begin cardiovascular fitness exercise program.
- Refer for cognitive behavior therapy or combine that with exercise.
Step 3
- Specialty referral (e.g. rheumatologist physiatrist psychiatrist pain management)
- Trials with selective serotonin reuptakes inhibitors serotonin and norepinephrine reuptake inhibitors or tramadol
- Consider combination medication trial or anticonvulsant.
The FMS diagnosis first must be confirmed and the condition explained to the patient and family. Any comorbid illness such as mood disturbances or primary sleep disturbances should be identified and treated. Medications to consider initially are low doses of tricyclic antidepressants or cyclobenzaprine. Some SSRIs SNRIs or anticonvulsants may become first-line FMS medications as more RCTs are reported. All patients with FMS should begin a cardiovascular exercise program. Most patients will benefit from CBT or stress reduction with relaxation training.
A multidisciplinary approach combining each of these modalities may be the most beneficial. Other medications such as tramadol or combinations of medications should be considered. Patients with FMS not responding well to these steps should be referred to a rheumatologist physiatrist psychiatrist or pain management specialist.
Treatment of Fibromyalgia Syndrome
Medications
Strong Evidence for Efficacy
- Amitriptyline: often helps sleep and overall well-being; dose 25-50 mg at bedtime
- Cyclobenzaprine: similar response and adverse effects; dose 10-30 mg at bedtime
Modest Evidence for Efficacy
- Tramadol: long-term efficacy and tolerability unknown; administered with or without acetaminophen; dose 200-300 mg/d
- Serotonin reuptake inhibitors (SSRIs):
- Fluoxetine (only one carefully evaluated at this time): dose 20-80 mg; may be used with tricyclic given at bedtime; uncontrolled report of efficacy using sertraline.
- Dual-reuptake inhibitors (SNRIs):
- Venlafaxine: 1 RCT ineffective but 2 case reports found higher dose effective
- Milnacipran: effective in single randomized control trial (RCT)
- Duloxetine: effective in single RCT
- Pregabalin: second-generation anticonvulsant; effective in single RCT
Weak Evidence for Efficacy
- Growth hormone: modest improvement in subset of patients with FMS with low growth hormone levels at baseline
- 5-Hydroxytryptamine (serotonin): methodological problems
- Tropisetron: not commercially available
- S-adenosyl-methionine: mixed results
No Evidence for Efficacy
- Opioids corticosteroids nonsteroidal anti-inflammatory drugs benzodiazepine and nonbenzodiazepine hypnotics melatonin calcitonin thyroid hormone guaifenesin dehydroepiandrosterone magnesium.
Nonmedicinal Therapies
Strong Evidence for Efficacy (Wait-List or Flexibility Controls But Not Blinded Trials)
- Cardiovascular exercise: efficacy not maintained if exercise stops
- CBT: improvement often sustained for months
- Patient education: group format using lectures written materials demonstrations; improvement sustained for 3 to 12 months
- Multidisciplinary therapy such as exercise and CBT or education and exercise.
Moderate Evidence for Efficacy
- Strength training acupuncture hypnotherapy biofeedback balneotherapy
Weak Evidence for Efficacy
- Chiropractic manual and massage therapy; electrotherapy ultrasound
No Evidence for Efficacy
- Tender (trigger) point injections flexibility exercise
Definitions
Strength of Evidence
Strong - positive results from a meta-analysis or consistently positive results from more than 1 randomized controlled trial (RCT)
Moderate - positive results from 1 RCT or largely positive results from multiple RCTs or consistently positive results from multiple non-RCT studies
Weak - positive results from descriptive and case studies inconsistent results from RCTs or both
Clinical Algorithm(s)
None provided
Type of Evidence supporting the Recommendations
The type of supporting evidence is identified and graded for each recommendation (see "Major Recommendations").
Potential Benefits
Improved management of fibromyalgia syndrome
Potential Harms
Adverse effects of medications
Qualifying Statements
There are major limitations to the fibromyalgia syndrome (FMS) literature with many treatment trials compromised by short duration and lack of masking. There are no medical therapies that have been specifically approved by the US Food and Drug Administration for management of FMS. Nonetheless current evidence suggests efficacy of low-dose tricyclic antidepressants cardiovascular exercise cognitive behavioral therapy and patient education. A number of other commonly used FMS therapies such as trigger point injections have not been adequately evaluated.
Description of Implementation Strategy
An implementation strategy was not provided.
Implementation Tools
Staff Training/Competency Material
For information about availability see the "Availability of Companion Documents" and "Patient Resources" fields below.
IOM Care Need
Living with Illness
IOM Domain
Effectiveness
Patient-centeredness
Bibliographic Source(s)
- Goldenberg DL Burckhardt C Crofford L. Management of fibromyalgia syndrome. JAMA 2004 Nov 17;292(19):2388-95. [118 references] PubMed
Adaptation
Not applicable: The guideline was not adapted from another source.
Source(s) of Funding
American Pain Society
Guideline Committee
Not stated
Composition of Group that Authored the Guideline
Primary Authors: Don L. Goldenberg MD Department of Rheumatology Newton-Wellesley Hospital Newton Mass and Department of Medicine Tufts University School of Medicine Boston Mass; Carol Burckhardt PhD Psychiatric Mental Health Nursing Oregon Health and Science University School of Nursing Portland; Leslie Crofford MD Department of Internal Medicine Rheumatology Division University of Michigan School of Medicine Anne Arbor
Financial Disclosures/Conflicts of Interest
Although this guideline was sponsored by the American Pain Society the group did not participate in the design and conduct of the study in the collection analysis and interpretation of the data or in the preparation review or approval of the manuscript.
Guideline Status
This is the current release of the guideline.
Guideline Availability
Electronic copies: Available to subscribers only from the Journal of the American Medical Association Web site.
Print copies: Available from Don L. Goldenberg MD Department of Rheumatology Newton-Wellesley Hospital 2000 Washington St Newton MA 02462 (dgoldenb@massmed.org)
Availability of Companion Documents
A continuing medical education (CME) course on the management of fibromyalgia syndrome is available by subscription from the Journal of the American Medical Association Web site.
Patient Resources
None available
NGC STATUS
This NGC summary was completed by ECRI on March 23 2005. The information was verified by the guideline developer on March 30 2005. This summary was updated by ECRI on October 20 2005 following the U.S. Food and Drug Administration advisory on Cymbalta (duloxetine hydrochloride). This summary was updated by ECRI on November 22 2006 following the FDA advisory on Effexor (venlafaxine HCl). This summary was updated by ECRI Institute on November 9 2007 following the U.S. Food and Drug Administration advisory on Antidepressant drugs.
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