SAN DIEGO—The high degree of consistency among recent national fibromyalgia guidelines developed independently by multispecialty panels in Canada, Israel, and Germany suggests that the conceptualization and treatment of this syndrome are undergoing significant changes, according to a lecture given at the annual meeting of the American College of Rheumatology.

“There is somewhat of a paradigm change in the recommendations regarding [the] 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,” said Jacob N. Ablin, MD, Senior Physician at the Tel Aviv Sourasky Medical Center. “The emphasis is on the necessity of self-management strategies, which include aerobic exercise, cognitive behavioral therapy, and multicomponent exercise and psychologic therapies,” he added.

A New Emphasis on Nonpharmacologic Treatment
“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.

The three medications approved by the FDA for the treatment of fibromyalgia—pregabalin, duloxetine, and milnacipran—received only a grade C recommendation in the German guidelines because all three failed to achieve their primary end points 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 various complementary and alternative medicine (CAM) practices, including Tai Chi, guided imagery, acupuncture, yoga, and spa therapy. In contrast, the Canadian guidelines deem current evidence insufficient to support the use of CAM practices in fibromyalgia.

Differences Between the Guidelines
The German guidelines recommend a graded approach to treatment. Patients with mild fibromyalgia are to be managed by primary care physicians, who are advised to recommend physical exercise and social activities, but no additional treatment or specialist care. The treatment plan for moderate fibromyalgia involves aerobic exercise, time-limited psychologic 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 aforementioned 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 intensive services because of their proven track record in reducing occupational disability.

The Israeli approach is different, in that it is not based on the initial severity of fibromyalgia. In step 1, patients receive education about their disorder and the principles involved in its treatment. They also initiate an individualized aerobic exercise program and are referred for aquatic exercise. Physicians prescribe 10–25 mg of amitriptyline at bedtime and refer patients for cognitive behavioral therapy.

Step 2 begins with a reassessment of the patient at 12 weeks after the start of step 1. If the patient is not significantly better, physicians consider substituting a serotonin–norepinephrine reuptake inhibitor for amitriptyline, or adding a selective serotonin reuptake inhibitor to amitriptyline, along with prescribing pregabalin to improve sleep and reduce pain. Physicians also refer patients for spa therapy and yoga or another meditative movement practice.

Like the German guidelines, the Canadian guidelines recommend that fibromyalgia diagnosis and care be centered in the primary care setting, and that only certain patients be referred for specialist care.

Reevaluating the Tender Point Examination
All three guidelines, developed independently on three continents, share 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,” said Mary-Ann Fitzcharles, MD, rheumatologist at McGill University Health Centre in Montréal, and lead author of the new Canadian guidelines.

The Canadian and German guidelines advise replacing the tender point examination with an examination for generalized soft tissue tenderness during the patient evaluation. The Israeli guidelines include the tender point examination.

In response to neurologists who object to the elimination of the tender point examination, Dr. Fitzcharles responded, “Depending upon who is doing the trigger point exam and how hard you’re pressing, you can make positive trigger points or you can cool them down.” The trigger point exam is an inaccurate clinical assessment, and “we now have to think very hard about putting something back in its place for the average primary practitioner to use in the office,” she added. “The conundrum of fibromyalgia is that we have no defining biomarker as yet,” she concluded.

—Bruce Jancin

New International Fibromyalgia Guidelines Indicate Shifting Focus