Interpreting effect sizes and clinical relevance of pharmacological interventions for fibromyalgia

Duloxetine, milnacipran, and pregabalin are approved by the United States Food and Drug Administration for the management of fibromyalgia. A number of meta-analyses, pooled analyses, and systematic reviews have been published in recent years involving the efficacy of these three medications for pain in fibromyalgia. Despite being based on the same clinical data, some analyses found these treatments to have a clinically relevant effect on pain, while others concluded that the advantages were small or of questionable clinical relevance. This commentary discussed possible reasons behind these differing conclusions and explored ways of evaluating the clinical relevance of pharmacological treatments for fibromyalgia. In particular, we considered: (1) the importance of judicious and careful interpretation of average treatment effect size and the recognition that average treatment effect sizes do not always tell the whole story; (2) the utility of individual patient response data to assess clinical relevance; and (3) the importance of considering pain reduction within the context of other benefits due to the presence of associated symptoms in patients with fibromyalgia.