Background Evidence-based guidelines rely on randomised controlled trials (RCTs) of pharmacological and non-pharmacological therapies (1,2). The external validity of RCTs in fibromyalgia syndrome (FMS) is limited: Most studies excluded patients with inflammatory rheumatic diseases and severe mental disorders and were conducted in research and university centers. Consumer reports, in which non-selected patients assess the effectiveness and side effects of interventions, can supplement the results of RCTs on the benefits and harms of therapies (3).
Objectives We conducted the first European FMS consumer reports including patients with inflammatory rheumatic diseases and severe mental disorders.
Methods The study was carried out from November 2010 to April 2011. Participants diagnosed with FMS rated the effectiveness and side effects of pharmacological and non-pharmacological FMS interventions on a 0 to 10 scale, with 10 being most efficacious (harmful). Demographic and clinical data were assessed by a se-f-constructed questionnaire. Anxiety and depression were assessed by the Patient Health Questionnaire PHQ 4. The questionnaires were distributed by the German League for people with Arthritis and Rheumatism and the German Fibromyalgia Association to their members and to all consecutive FMS patients of nine clinical centers of different levels of care.
Results 1661 questionnaires (95% women, mean age 54 years, mean duration since FMS diagnosis 6.8 years) were analysed. 276/1351 (20.4%) of participants reported to be diagnosed with an inflammatory rheumatic disease. 881/1633 (54.6%) participants scored ≥3 on the PHQ 4 depression scale and 889/1633 (54.4%) scored ≥3 on the PHQ 4 anxiety scale. The most frequently used therapies were activity-based self-management strategies (promenading, distraction) (95.3%), prescription pain medication (81.5%), self-management physical modalities (local and whole body warmth, thermal bathes) (67%) and aerobic exercise (Aquatic exercise, walking/jogging, swimming, cycling) (58.0%). The highest average effectiveness was attributed to whole body and local warmth therapies, thermal bathes, FMS education and resting. The highest average side effects were attributed to strong opioids, local cold therapy, gamma-amino-butyric acid analogues (pregabalin and gabapentin), tramadol and opioid transdermal systems
Conclusions The German fibromyalgia consumer reports highlight the importance of non-pharmcological therapies in the long-term management of FMS and challenges the high recommendations for drug therapies given by FMS-guidelines (1,2).
Evidence-based guidelines should take into account the results of consumer reports for their recommendations.
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Disclosure of Interest None Declared
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