1. Note that this consensus statement from the European League Against Rheumatism (EULAR) notes that exercise should be a mainstay of therapy for the treatment of fibromyalgia.
Broadly, the group did not endorse most pharmaceutical interventions, especially drugs with a high potential for abuse.
Updated recommendations on the management of fibromyalgia by the European League Against Rheumatism (EULAR) emphasize exercise as the strongest evidence-based therapy. The revised recommendations consider nonpharmacologic measures as the focus of initial therapy, with an individualized approach in cases of non-response.
Led by Gary Macfarlane of the University of Aberdeen in Scotland, a multidisciplinary panel of 18 members from 12 European countries reviewed the evidence, mostly from systematic reviews and meta-analyses, on the management of fibromyalgia. The findings and recommendations, informed by 107 reviews, appear online in Annals of the Rheumatic Diseases.
The recommendations are concordant with other recent guidelines from Canada, Israel, and Germany. "These guidelines and our EULAR recommendations are in agreement on the principles of approach to management, the need for tailored therapy to the individual, and the first-line role of nonpharmacological therapies," the panel wrote.
The original EULAR recommendations assessed evidence up to and including 2005; at that time, the evidence base was sparse, leading to a document in which most recommendations were considered "expert opinion," the panel members noted.
Despite a large increase in the amount of trial data since the original recommendations, however, "there are no major changes to the approach of managing patients with fibromyalgia, although we provide new evidence in support for some additional non-pharmacological therapies."
The use of exercise was endorsed unanimously -- "particularly given its effect on pain, physical function and well-being, availability, relatively low cost, and lack of safety concerns." The available evidence did not allow the panel to distinguish between the benefits of aerobic or strengthening, Macfarlane et al explained.
Specific recommendations were also given in favour of meditative movement therapies (e.g. Yoga) for their ability to improve sleep, fatigue, and quality of life, and mindfulness-based stress reduction based on improvements in pain relief and quality of life.
Non-pharmacological therapies not endorsed due to either lack of effectiveness or the low quality of existing studies were biofeedback, capsaicin, hypnotherapy, massage, the dietary supplement S-adenosylmethionine (SAMe), and other complementary and alternative therapies. In addition, a "strong against" recommendation was given for chiropractic manipulation, based on safety concerns.
Individualized treatment "according to patient need" is recommended with lack of effect of the aforementioned therapies. A weak recommendation in favour of psychological therapies was given to help patients with mood disorder or who had not responded to other coping strategies; in particular, cognitive behavioral therapy is considered effective at producing modest, long-term reductions in pain and disability and in improving mood, the panel said.
The evidence to support pharmacotherapy is weak, they wrote. Patients with severe pain may be considered for duloxetine, pregabalin, or tramadol, and those with sleep disturbance may benefit from amitriptyline, cyclobenzaprine, or pregabalin, although the evidence to support any of these treatments is weak.
Several pharmacological therapies including nonsteroidal anti-inflammatory drugs, monoamine oxidase inhibitors, and selective serotonin reuptake inhibitors were not recommended because of lack of efficacy. The panel specifically advised against growth hormone, sodium oxybate, strong opioids, and corticosteroids "based on lack of efficacy and high risk of side effects."
In updating previous recommendations, the panel was able to build a base of evidence from recent published literature that largely support those of other professional societies, commented Leslie J. Crofford, MD, of Vanderbilt University in Nashville, Tenn.
The lesser emphasis on medications "emphasizes a cultural difference between the U.S. and other countries," she told MedPage Today. "It is also of note that there was a strong recommendation against most opioids and other drugs with high risk for misuse and abuse such as sodium oxybate. The risk-benefit ratio for these agents weighs heavily against their use for fibromyalgia."
"In general, the likelihood of a good outcome for patients relies on early diagnosis, patient education, and behavioral changes including maintaining physical activity" Crofford stated.