Reply to L. Gianni et al.

Abstract

We thank Gianni et al for their interest in our recent report “Randomized Multicenter Placebo-Controlled Trial of Omega-3 Fatty Acids for the Control of Aromatase Inhibitor–Induced Musculoskeletal Pain: SWOG S0927.” Many of the points raised were addressed in the discussion section of our article. In all trials, difficult choices must be made with regard to the design of the study that may influence the results, such as the choice of outcome measure, the duration of therapy, the dose of drug, the formulation of the drug, the inclusion criteria, and the choice of placebo. In addition, overall negative findings do not preclude the fact that some subsets may achieve more of a benefit than others. In our trial, ongoing analyses will explore factors that may differentiate patients who did and did not achieve an improvement in symptoms over time, both in the active arm as well as the placebo arm, which may inform future studies. But importantly, the patients in the randomized arms of this large multicenter trial were well balanced across multiple domains of potential confounding factors, and overall, the trial did not find a benefit of omega-3 fatty acids compared with placebo. Although it is possible that another rigorous trial could observe a benefit, we do not feel there is sufficient evidence to suggest there is a role for omega-3 fatty acids for treating aromatase inhibitor–induced arthralgias.