Objective: To develop evidence-based recommendations for the management of fibromyalgia syndrome.
Methods: A multidisciplinary task force was formed representing 11 European countries. The design of the study, including search strategy, participants, interventions, outcome measures, data collection and analytical method, was defined at the outset. A systematic review was undertaken with the keywords “fibromyalgia”, “treatment or management” and “trial”. Studies were excluded if they did not utilise the American College of Rheumatology classification criteria, were not clinical trials, or included patients with chronic fatigue syndrome or myalgic encephalomyelitis. Primary outcome measures were change in pain assessed by visual analogue scale and fibromyalgia impact questionnaire. The quality of the studies was categorised based on randomisation, blinding and allocation concealment. Only the highest quality studies were used to base recommendations on. When there was insufficient evidence from the literature, a Delphi process was used to provide basis for recommendation.
Results: 146 studies were eligible for the review. 39 pharmacological intervention studies and 59 non-pharmacological were included in the final recommendation summary tables once those of a lower quality or with insufficient data were separated. The categories of treatment identified were antidepressants, analgesics, and “other pharmacological” and exercise, cognitive behavioural therapy, education, dietary interventions and “other non-pharmacological”. In many studies sample size was small and the quality of the study was insufficient for strong recommendations to be made.
Conclusions: Nine recommendations for the management of fibromyalgia syndrome were developed using a systematic review and expert consensus.
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Competing interests: FB has been reimbursed by Laboratoires Procter and Gamble, Sanofi-Aventis, Roche and Bristol Meyers Squibb for attending medical conferences and had honorarias for speaking for Laboratoires Pierre Fabre, Servier and Roche. JB has been paid by Pierre Fabre and Pfizer for running educational programmes and for speaking at international conferences and reimbursed by Eli Lilly for attending international conferences. DB has been reimbursed by Pierre Fabre Company, the manufacturer of Milnacipran, for attending several symposiums and by Pfizer for consulting. EC has served on advisory panels of Pierre Fabre Medicament, Jazz Pharmaceutical, Allergan and Pfizer. EC has also lectured in meetings organised by Pierre Fabre Medicament, Eli Lilly and Pfizer. The Rheumatology Department received a research grant from Pierre Fabre Medicament. CH has participated in symposia organised by Laboratoires Pierre Fabre and received reimbursement for participation. She has also received fees for written material in proceedings from these symposia. KH has participated in symposia organised by Laboratoires Pierre Fabre and received reimbursement for participation. He has also received fees for written material in proceedings from these symposia. He has held a lecture on pain mechanisms and received a fee from Pfizer. EK has participated as a consultant in advisory board meetings (total of four) for the following pharmaceutical companies: Pfizer, Wyeth and Pierre Fabre. She gave a speech on a satellite symposium organised by Pfizer. She has currently research collaboration with Pierre Fabre. SP has been paid by Pfizer, Eli Lilly, Grunenthal, Pierre Fabre and Sanofi Aventis for running educational programmes and participating in advisory boards. MS has served on advisory panels of Pierre Fabre Medicament, Jazz Pharmaceuticals and Allergan. MS has also lectured in meetings organised by Novartis, Pierre Fabre Medicament and Lilly.