Commentary—Promising Results Should Prompt Further Study

During the past 20 years, mindfulness-based training has become an increasingly popular treatment for many conditions, including migraine. In the February online issue of the Journal of Headache and Pain, Dr. Grazzi addresses medication overuse chronic migraine (CM-MO) and provides initial evidence for the consideration of mindfulness training to help reduce headache symptoms.

However, the reader should take seriously the authors’ caution that “although our findings are encouraging and suggestive of the independent value of mindfulness for headache care, certain design limitations preclude us [from] making unequivocal claims.”

Since the goal of a noninferiority trial is to assess whether a new therapy is at least as beneficial as standard treatment, extra caution is necessary when interpreting findings from an underpowered feasibility study. In general, a useful approach to noninferiority is to determine whether the confidence intervals include effect sizes that one might consider clinically meaningful. Instead of focusing on whether the mindfulness-based training group performed the same as the comparison group, we should accept the valuable information that is presented. The take away message from this pilot study is threefold. Mindfulness-based training is potentially acceptable to patients with CM-MO. Patients with CM-MO might be amenable to participating in a fully powered randomized controlled trial of mindfulness-based training. Finally, it is possible that mindfulness-based training may show improvement similar in magnitude to pharmaceuticals. Overall, Grazzi et al have laid the groundwork for a fully powered, randomized version of their study.

—Alice R. Pressman, PhD
Director of Analytics and Evaluation
Sutter Health
Walnut Creek, California