EULAR Issues Guidelines for the Treatment of Fibromyalgia Syndrome CME

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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.

Learning Objectives for This Educational Activity

Upon completion of this activity, participants will be able to:

1. Describe pharmacologic measures that may be indicated for management of fibromyalgia syndrome.


2. Describe nonpharmacologic measures that may be indicated for management of fibromyalgia syndrome.

Clinical Context

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

• A multidisciplinary task force from 11 European countries wrote these guidelines using EULAR standard operating procedures.


• 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:
  
  
  
  
  • Comprehensive evaluation of pain, function, and psychosocial context are needed to understand FMS completely, because of its complex, heterogeneous nature.
  
  
  • 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.
  
  
  • 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.
  
  
  • Cognitive behavioral therapy, relaxation, rehabilitation, physiotherapy, psychological support, and other modalities may be indicated for certain patients.
  
  
  • 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.
  
  
  • Antidepressants are recommended to decrease pain and improve function (eg, amitriptyline, fluoxetine, duloxetine, milnacipran, moclobemide, and pirlindole).
  
  
  • 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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New Guidelines for Treatment of Irritable Bowel Syndrome in Adults

May 11, 2007 — The British Society of Gastroenterology has issued guidelines for diagnosing and treating irritable bowel syndrome (IBS), including dietary and psychological treatments, in primary care and other settings. The new recommendations for IBS, a chronic, relapsing gastrointestinal problem characterized by abdominal pain, bloating, and changes in bowel habit, are published in the May 8 Online First issue of Gut.

"While the precise prevalence and incidence depends on the criteria used, all studies agree that it is a common disorder, affecting a substantial proportion of individuals in the general population, and presenting frequently to general practitioners and to specialists," write Robin Spiller, MD, from the University Hospital in Nottingham, United Kingdom, and colleagues. "IBS is troublesome, with a significant negative impact on quality of life and social functioning in many patients, but is not known to be associated with the development of serious disease or with excess mortality. IBS generates significant healthcare costs both direct, due to IBS symptoms and associated disorders as well as indirect, due to time off work."

In most countries, IBS affects 5% to 11% of the population, with prevalence peaking from age 20 to 45 years with a female predominance (female:male ratio approximately 2:1). The disorder may account for approximately 3% of all consultations referred from primary care.

The current recommendations were issued at the request of the Chairman of the Clinical Services Committee of The British Society of Gastroenterology to provide guidelines for the evaluation and treatment of adult patients with IBS. Members of the committee were assigned specific areas to review. Literature search of PubMed, EMBASE, MEDLINE, Web of Science, and Cochrane databases and search of extensive personal reference databases focused on high-quality studies that used established methodology and substantial patient numbers with clearly defined entry criteria. Criteria for inclusion of treatment trials were randomization and placebo control.

The predominant bowel habit (diarrhea or constipation) is a useful classification scheme. When diarrhea is a prominent feature, few investigations are needed, although alarm features may warrant further investigations.

Careful attention to history is of vital importance to the diagnosis. Abdominal pain or discomfort is typically relieved by defecation and associated with change in stool form (usually looser) and change in stool frequency.

Associated features that may be helpful in making the diagnosis include frequent consultation for medically unexplained symptoms, somatization, and past history of anxiety or depression. Psychological assessment to evaluate current anxiety and depressive symptoms is also important.

The presence of alarm symptoms, though nonspecific, should mandate further investigations. These include age older than 50 years, symptom duration less than 6 months, weight loss, nocturnal symptoms, family history of colon cancer, rectal bleeding, anemia, and recent antibiotic usage.

When these alarm symptoms are present, further investigations may be useful in primary care settings. Before these are undertaken, however, patients should be told that IBS is the most likely diagnosis and that these tests are designed to rule out celiac and inflammatory bowel disease. Useful tests may include full blood count and erythrocyte sedimentation rate, as well as testing for endomysial antibodies.

Many patients fear that their symptoms may reflect serious disease. These fears should be elicited and specifically addressed in an adequate consultation including exploration of patient anxieties and concerns.

Because of accompanying adverse psychological features and somatization, IBS is often best managed by evaluating the patients' concerns and explaining symptoms in simple terms the patient can understand. Giving the patient a positive diagnosis and reassuring them of the benign nature of IBS without denying the significance of their symptoms tends to improve outcomes. Treatment of associated anxiety and depression often improves bowel and other symptoms.

Irritable bowel syndrome is a heterogeneous condition with a wide spectrum of treatments, each benefiting a small proportion of patients. Dietary management should begin with a thorough dietary history and moderation of excessive consumption of any 1 component. If intake of lactose, wheat, and/or insoluble fiber appears to be above average for the population, trial exclusion of these foods may be helpful.

Psychological therapies should be first-line treatment when anxiety, panic attacks, and depression are prominent features. Based on evidence from randomized placebo-controlled trials, cognitive behavioral therapy and psychodynamic interpersonal therapy improve coping, and hypnotherapy benefits global symptoms in otherwise refractory patients. Relaxation therapy may also be beneficial.

In terms of drug therapies, antispasmodic drugs are safe, but offer only a small improvement relative to placebo. Soluble fiber supplements may benefit those with constipation, whereas bran and other insoluble fiber may aggravate symptoms.

Loperamide is helpful for symptoms of urgency and frequency but may exacerbate abdominal pain and discomfort. Antispasmodic and tricyclic antidepressant drugs improve pain, whereas ispaghula improves pain and bowel habit.

Although 5HT₃ antagonists improve global symptoms, diarrhea, and pain, they may rarely cause unexplained colitis. 5HT₄ Agonists improve global symptoms, constipation, and bloating, whereas selective serotonin reuptake inhibitors improve global symptoms.

"Patients [with IBS] comprise such a large proportion of gastroenterology outpatients that their streamlined and effective management would impact favourably on any gastroenterology department's overall performance and hence improve the management of all GI [gastrointestinal] diseases," the authors write. "Better ways of identifying which patients will respond to specific treatments are urgently needed."

Warning signs indicating that the primary care clinician should refer the patient with suspected IBS to a specialist are as follows:

• Rectal bleeding requires rectal examination and usually referral for a flexible sigmoidoscopic examination
  
  


• Presence of several alarm features
  
  


• Uncertainty concerning the diagnosis
  
  


• Failure to respond to initial management strategies
  
  


• Disabling health-related anxiety
  
  


• Long-standing symptoms with impaired quality of life

The authors have disclosed various financial relationships with Novartis, Mundi Pharma, GlaxoSmithKline, Pfizer Pharmaceuticals, Eli Lilley & Co, Solvay, Clasado, AstraZeneca, Tillots Pharma, Ferring, Rotta Research, Proctor & Gamble, and/or Astellas.

Gut. Published online May 8, 2007.

Learning Objectives for This Educational Activity

Upon completion of this activity, participants will be able to:

• Identify alarm features of patients presenting with suspected irritable bowel syndrome that should trigger referral to a specialist by a primary care clinician.


• Describe treatment strategies for irritable bowel syndrome.

Clinical Context

IBS is a chronic, relapsing gastrointestinal syndrome, with key features of abdominal pain, bloating, and changes in bowel movements. IBS has a high prevalence in the general population and is seen commonly in clinical practice both by general practitioners and by specialists.

Although IBS is not known to lead to serious disease or excess mortality, it has a significant negative impact on quality of life and social functioning and generates significant direct and indirect healthcare costs. The Chairman of the Clinical Services Committee of The British Society of Gastroenterology convened an expert panel to provide guidelines for the evaluation and treatment of adult patients with IBS.

Study Highlights

• When diarrhea is a prominent feature of IBS, few investigations are needed unless alarm features are present.


• Diagnosis is made by history of abdominal pain or discomfort typically relieved by defecation and associated with change in stool form (usually looser) and in stool frequency.


• Associated features that may aid in diagnosis include frequent consultation for medically unexplained symptoms, somatization, and past history of anxiety or depression. Psychological assessment should evaluate current anxiety and depressive symptoms.


• Alarm features mandating further investigations include age older than 50 years, symptom duration less than 6 months, weight loss, nocturnal symptoms, family history of colon cancer, rectal bleeding, anemia, and recent antibiotic usage.


• Warning signs indicating that the primary care clinician should refer the patient with suspected IBS to a specialist include rectal bleeding (warrants referral for flexible sigmoidoscopy), presence of several alarm features, uncertainty concerning the diagnosis, failure to respond to initial management strategies, disabling health-related anxiety, and longstanding symptoms with impaired quality of life.


• Before additional testing (eg, for full blood count, erythrocyte sedimentation rate, and endomysial antibodies), patients should be told that IBS is the most likely diagnosis. Patients' fears that their symptoms may reflect serious disease should be elicited and specifically addressed. Without denying the significance of their symptoms, giving the patient a positive diagnosis and reassuring them that IBS has a benign course tends to improve outcomes.


• Treatment of associated anxiety and depression often improves bowel and other symptoms.


• IBS is a heterogeneous condition with a wide spectrum of treatments including dietary modifications and psychological and pharmacologic therapies. Each of these therapeutic approaches benefits a small proportion of patients.


• Dietary management should begin with moderation of excessive consumption of any 1 component, especially lactose, wheat, and/or insoluble fiber.


• When anxiety, panic attacks, and depression are key symptoms, psychological therapies should be first-line treatment, including cognitive behavioral therapy and psychodynamic interpersonal therapy to improve coping, hypnotherapy to reduce global symptoms in otherwise refractory patients, and relaxation therapy.


• Antispasmodic drugs are safe but only slightly more effective than placebo. Soluble fiber supplements may improve constipation, but bran and other insoluble fiber may aggravate symptoms.


• Loperamide may reduce urgency and frequency but increase abdominal pain and discomfort. Antispasmodic and tricyclic antidepressant drugs improve pain, and ispaghula improves pain and bowel habit.


• 5HT₃ Antagonists improve global symptoms, diarrhea, and pain but may rarely cause unexplained colitis. 5HT₄ Agonists improve global symptoms, constipation, and bloating, while selective serotonin reuptake inhibitors improve global symptoms.

Pearls for Practice

• The primary care clinician should refer the patient with suspected IBS to a specialist for rectal bleeding (for flexible sigmoidoscopy), presence of several alarm features, uncertainty concerning the diagnosis, failure to respond to initial management strategies, disabling health-related anxiety, and longstanding symptoms with impaired quality of life.


• Treatments of IBS may be dietary (moderation of lactose, wheat, and/or insoluble fiber), psychological (first-line therapy when psychiatric symptoms present), or pharmacologic (may be effective but aggravate some symptoms), each benefiting a small proportion of patients.

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WFSBP Treatment Guidelines on Bipolar Disorders

• World Federation of Societies of Biological Psychiatry (WFSBP) guidelines for biological treatment of bipolar disorders, part I: Treatment of bipolar depression.
  The World Journal of Biological Psychiatry 3: 115-124

• World Federation of Societies of Biological Psychiatry (WFSBP) guidelines for
  biological treatment of bipolar disorders, part II: Treatment of mania.
  The World Journal of Biological Psychiatry 4: 5-13

• World Federation of Societies of Biological Psychiatry (WFSBP) guidelines for
  the biological treatment of bipolar disorders, part III: Maintenance treatment.
  The World Journal of Biological Psychiatry 5: 120-135