OBJECTIVES: The aim of the current study was to compare the efficacy of pharmacological treatments for the management of fibromyalgia with particular focus on outcomes considered most important by the Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) symposium. METHODS: A systematic review was conducted to identify randomised controlled trials (RCTs) evaluating pharmacological treatments in adults with fibromyalgia. A Bayesian MTC was performed in WinBUGS to estimate the relative efficacy of the evaluated treatments. The primary efficacy outcome was the absolute reduction in pain score at study endpoint, based on visual analogue or numerical rating scales. Secondary efficacy outcomes included proportion of patients responding, changes in Fibromyalgia Impact Questionnaire (FIQ) total score, sleep and quality of life measures. Random-effects models were used to account for any heterogeneity; fixed-effects models were evaluated in sensitivity analysis. RESULTS:  Forty-five RCTs were included in the review, with 21 RCTs meeting criteria for inclusion in the meta-analysis (fixed-dosing regimen, parallel-group study design, and high quality [Jadad score ≥3]). Eleven RCTs reported data on the primary outcome measure suitable for inclusion in the MTC. These trials evaluated nine treatment regimens: alprazolam, citalopram, duloxetine, ibuprofen, milnacipran, paroxetine, placebo, pregabalin, ibuprofen + alprazolam. Results from a random-effects MTC found that only pregabalin 300, 450, 600 mg/day and duloxetine 20, 60, 120 mg/day produced significantly greater reductions in pain score (p<0.05) than placebo. Duloxetine 120 mg/day was significantly superior to citalopram 20 mg/day and milnacipran 100 mg/day (p<0.05), with no other statistically significant differences reported between active treatments. CONCLUSIONS: Only 21 studies met the inclusion criteria for the MTC reflecting the relatively poor quality of the majority of published studies. Of the treatments included in the MTC of the primary outcome, only pregabalin and duloxetine were significantly superior to placebo for pain relief.