On behalf of the European League Against Rheumatism [EULAR], a multidisciplinarytask force of Fibromyalgia experts at 18 research centers in 11 countries has unanimously agreed on a set of Evidence-Based Recommendations for the Management of Fibromyalgia Syndrome. The article detailing these recommendations was published online July 20, 2007 in Annals of the Rheumatic Diseases.*
The recommendations reflect the findings of rigorously screened Fibromyalgia research reports published through 2005. They are based on the highest quality trials with the greatest strength of evidence, selected out of 146 eligible studies – 39 on pharmacologic interventions and 59 on non-pharmacologic therapies. In some areas where evidence was lacking owing to few or poor quality studies – e.g., exercise – the evaluation considered expert consensus opinion.
• All the eligible studies involved Fibromyalgia patients diagnosed according to the American College of Rheumatology (ACR) classification criteria established in 1990.
• Studies that included patients with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome were excluded “unless they were divided into separate comparison groups for analysis.”
• Importantly, only two main outcome measures – pain and function – were considered. The cited studies assessed pain using the visual analogue scale (VAS), and assessed function using the Fibromyalgia Impact Questionnaire (FIQ). Other symptoms/measures were not considered.
• Additionally, the investigators reviewed abstracts of articles that had not been fully published “to guard against non-inclusion of any negative studies” owing to possible publication bias.
The Nine Recommendations – A Synopsis
(Graded A, B, C, and D according to strength of high-quality trial-based evidence; not ordered by importance.)
1. Recognize that Fibromyalgia is a complex and heterogeneous condition; it involves “abnormal pain processing and other secondary features.” Full understanding must be based on a comprehensive assessment of the patient’s pain, function, and “psychosocial context.” (D – Based on expert opinion.)
2. A multidisciplinary treatment approach with a combination of non-pharmacological and pharmacological modalities is optimal. It should be tailored – based on discussion with the patient – to reflect pain intensity, function, and such associated features as fatigue, depression, and sleep disturbances. May require patient education for self-management. (D – Reflects expert opinion, general practice.)
3. Heated pool treatment (or balneotherapy) is effective in improving pain and function, both with and without exercise. (B – Small number of studies; fairly high quality.)
4. Exercise programs tailored to the individual – including strength training and aerobic exercise – can be of benefit to some FM patients. (C – Largely expert opinion; variable quality studies likely mask positive outcomes, and general health benefits, safety argue for inclusion.)
5. Cognitive behavioral therapy (CBT) may be helpful for some patients. (D – Based on expert opinion. “Another area in which the poor quality of trials has masked what experts believe to be a realistic reflection of possible benefits.”)
6. Other therapies that may be used depending on the individual patient’s needs include relaxation, rehabilitation, physiotherapy, and psychological support. (C – Based on expert opinion, some experimental evidence.)
7. Tramadol is recommended for pain management. This is an “atypical opioid” in that it is not considered a controlled substance in many countries, though possibility of withdrawal symptoms with discontinuation should be noted. (A – Evidence includes a large, high quality study.)
Simple analgesics can be considered, such as “paracetamol & other weak opioids” – while strong opioids and corticosteroids are not recommended. (D – Based mostly on expert opinion, owing to insufficient trial data.)
8. Antidepressants – amitriptyline, fluoxetine, duloxetine, milnacipran, moclobemide, and pirlindole – often improve Fibromyalgia patient function and reduce pain, and are therefore recommended. (A – Based on large, high quality studies of these drugs.)
9. Tropisetron, pramipexole, and pregabalin (LyricaR) reduce pain and are recommended for FM. (A – Recent studies suggest these are promising drugs for FM. Studies of longer term effects suggested.)
* Source: “EULAR Evidence Based Recommendations for the Management of Fibromyalgia Syndrome,” Annals of the Rheumatic Diseases. 2007 Jul 20; [E-publication ahead of print] PMID: 17644548, by Carville SF, Arendt-Nielsen S, Bliddal H, Blotman F, Branco JC, Buskilla D, Da Silva JA, Danneskiold-Samsøe B, Dincer F, Henriksson C, Henriksson K, Kosek K, Longley K, McCarthy GM, Perrot S, Puszczewicz MJ, Sarzi-Puttini P, Silman A, Spath M, Choy EH. King’s College London, United Kingdom (and 17 other centers). [E-mail: email@example.com ]<