Background Recommendations for first line treatment options of fibromyalgia syndrome (FMS) are hampered by the lack of head-to-head comparisons of pharmacological versus non-pharmacological treatments. Network meta-analyses with an integration of all randomised trials that compared either of these treatments head-to-head or with a control intervention have not been performed in FMS until now.
Objectives To synthesise the available evidence on pharmacological and non-pharmacological interventions recommended for FMS by a systematic review and network meta-analyses.
Methods Electronic databases included MEDLINE, PsycINFO, Scopus, the Cochrane Controlled Trials Registry (CENTRAL) and the Cochrane Library, all from inception to 2010. All randomised controlled trials comparing any therapeutic approach as recommended in FMS-guidelines (except complementary and alternative medicine) with control interventions in patients with FMS were analysed. Primary outcomes were pain and quality of life. We expressed treatment effects as standardised mean differences (SMD) by dividing the difference in mean values at the end of follow-up by the pooled standard deviation. We used Bayesian hierarchical random effects models which fully preserve randomised treatment comparisons within trials. Analyses were performed using Markov chain Monte Carlo methods with non-informative prior distributions (1).
Results 93 trials in 14’367 patients and 8 active interventions (tricyclic antidepressants [TCAs], selective serotonin reuptake inhibitors [SSRIs], serotonin noradrenaline reuptake inhibitors [SNRIs], gamma-amino butyric acid [GABA] analogues, aerobic exercise, balneotherapy, cognitive behavioural therapy [CBT], multicomponent therapy) were included. Most of the trials were small and hampered by methodological quality, introducing heterogeneity and inconsistency in the network. When restricted to large trials with ≥100 patients per group, benefits for SNRIs and GABA analogues compared to placebo were statistically significant, but small and not clinically relevant. No large trials were available for any of the non-pharmacological interventions. In medium sized trials with ≥50 patients per group, multicomponent therapy, showed small to moderate benefits over placebo, followed by aerobic exercise and CBT.
Conclusions We deem the small advantages of GABA-analogues and SNRIs over placebo of questionable clinical relevance. Our results do not necessarily support EULAR-recommendations, which currently favour drug therapy over other treatment options. (2). We found a potentially important benefit of aerobic exercise and multicomponent therapy in the management of FMS, which is in line with the recommendations of the Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften (AWMF) in Germany (3).
Additional large scale randomised trials of high methodological quality of promising non-pharmacological interventions, such as aerobic exercise and multicomponent therapy, are warranted.
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Carville SF et al. EULAR evidence-based recommendations for the management of fibromyalgia syndrome. Ann Rheum Dis 2008;67(4):536-41.
Häuser W et al. Fibromyalgia syndrome: classification, diagnosis, and treatment. Dtsch Arztebl Int 2009;106(23):383-91.
Disclosure of Interest None Declared
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