Multiple systematic reviews of randomised controlled trials (RCTs) demonstrated that no therapy (complementary/alternative, drug, physical, psychological) in FM “really works” in the sense of substantial symptom relief in the majority of patients. On average, the effects of all these treatments on FM-symptoms are small and from a clinical point of view not meaningful. Network meta-analyses demonstrated that “old drugs” such as amitryptiline or fluoxetine did not differ from “new” drugs such as duloxetine, milnacipran and pregabalin in terms of symptom reduction and tolerability. In the short run, the effects of these drugs were comparable to the ones of aerobic exercise and cognitive behavioral therapies. However, there is only evidence of sustained (but declining) positive effects of aerobic exercise and cognitive behavioral therapies after the end of treatment.
Clinicians should not treat average values, but treatment responders. Detailed analysis of RCTs of pharmacological and non-pharmacological studies demonstrated that there is a minority of patients with substantial symptom relief with no or tolerable side effects (sustained responders). Until now, there are no predictors of sustained responders available. It is the art of medicine to identify treatment responders.
Recent guidelines (Canada, Germany, Israel) emphasized graduated treatment according to the severity of FM. Patients with mild FM do not need a specific treatment. In severe cases, drug therapy should cover not only pain and be tailored to the symptoms of the patient. Duloxetine might be preferred in patients with co-morbid major depression and amitriptyline or pregabalin in case of severe sleeping problems. A recent study which combined aerobic exercise with tailored psychological therapies showed promising long-term results.
Finally treatment recommendation of FM should balance potential benefits, harms (tolerability, safety) and availability of treatment options. Traditional RCTs may not be the method of choice to answer all these questions. Alternative approaches should be developed and evaluated, e.g. systematic comparative effectiveness studies of health care registry data, use of patient registries and consumer reports.
Conflicts of interest I received a consulting honorarium by Daiichi Sankyo and honororia for educational lectures by Abbott, MSD Sharp&Dhome and Pfizer within the previous three years. I am member of medical associations of internal medicine, psychosomatic medicine, psychotherapy and sports medicine. I am the head of the steering committee of the German guideline on the management of FMS.
Disclosure of Interest None declared
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