SAN DIEGO – The high degree of consistency among recent national fibromyalgia guidelines developed independently by multispecialty panels in Canada, Israel, and Germany suggests big changes are afoot in how this common and vexing syndrome is conceptualized and treated, according to Dr. Jacob N. Ablin.
"I hope to convey the feeling that there is somewhat of a paradigm change in the recommendations regarding treatment of fibromyalgia as expressed by these three guidelines. All three emphasize an individually tailored approach based upon the key symptoms and severity, with nonpharmacologic therapies as the major positive first choice for all. The emphasis is on the necessity of self-management strategies, which include aerobic exercise, cognitive-behavioral therapy, and multicomponent exercise and psychologic therapies," he said at the annual meeting of the American College of Rheumatology.
"Pharmacologic therapies were less enthusiastically recommended by all three groups. Contrary to popular perception, the drugs actually achieve only relatively modest effects. And all three groups caution about the side effects of drugs, which may mimic fibromyalgia symptoms," added Dr. Ablin of the Tel Aviv Sourasky Medical Center.
The three medications approved by the Food and Drug Administration for the treatment of fibromyalgia – pregabalin (Lyrica), duloxetine (Cymbalta), and milnacipran (Savella) – received only a weak grade C recommendation in the German guidelines (Schmerz 2012;26:287-90) because all three failed to achieve their primary endpoints in pivotal European clinical trials.
"While drug treatments absolutely continue to play a role in the management of fibromyalgia, the long-term safety and efficacy of nonpharmacologic treatments should be appreciated and stressed. Fibromyalgia is not rheumatoid arthritis: We don’t have true disease-modifying antirheumatic drugs for fibromyalgia. And until we do, pharmacologic treatment is a very useful adjunct, not an imperative. This is an important message for patients, who will probably need treatment for many years to come," Dr. Ablin explained.
The German and Israeli guidelines contain detailed recommendations for a variety of complementary and alternative medicine (CAM) practices, including Tai Chi, guided imagery, acupuncture, yoga, and spa therapy. In contrast, the Canadian guidelines (CMAJ 2013;185:E645-51) deem current evidence insufficient to support the use of CAM practices in fibromyalgia.
The German guidelines recommend a graded approach to treatment. Patients with mild fibromyalgia are to be managed by primary care physicians, with advice given to engage in physical exercise and social activities, with no additional treatment recommended and no specialist care. In moderate fibromyalgia, the treatment plan involves aerobic exercise, time-limited psychological therapy, and referral to a specialist, with drug therapy optional. Patients with severe fibromyalgia symptoms, as well as those with moderate fibromyalgia unresponsive to the earlier-stage interventions, are best managed in a specialized day clinic or inpatient service that emphasizes psychiatric treatment of mental comorbidities, according to the German guidelines. In Germany, insurance companies cover these more intensive services because of their proven track record in reducing occupational disability.
The Israeli approach is different in that it is not based upon the initial severity of fibromyalgia. In step 1, patients receive education about their disorder and the principles involved in its treatment. They also get an individualized aerobic exercise program and are referred for aquatic exercise. Amitriptyline at 10-25 mg at bedtime is prescribed, and a referral is to be made for cognitive-behavioral therapy.
Step 2 is based upon a reassessment 12 weeks after starting step 1. If the patient isn’t doing significantly better, consideration is given to substituting a serotonin-norepinephrine reuptake inhibitor for the amitriptyline, or adding a selective serotonin reuptake inhibitor to amitriptyline, along with prescribing pregabalin to improve sleep and reduce pain. Referral is made for spa therapy and yoga or another meditative movement practice.
As in the German guidelines, the Canadian guidelines also recommend that fibromyalgia diagnosis and care be centered in the primary care setting, with only selective referrals for specialist care.
Dr. Mary-Ann Fitzcharles, lead author of the new Canadian guidelines, said all three guidelines, developed independently on three continents, share in common the same broad clinical concept of fibromyalgia.
"We are all speaking with one voice with the same message: We accept that fibromyalgia is neither a distinct rheumatic nor mental disorder, but rather a cluster of symptoms spanning a broad range of medical disciplines. We’re saying that just focusing on pain is taking away from a large component of the suffering of many of these patients," according to Dr. Fitzcharles of McGill University, Montreal.
The Canadian and German guidelines advise dropping the tender point examination from the patient evaluation, replacing it with an examination for generalized soft tissue tenderness. The Israeli guidelines retain the tender point exam.