Meditation for Migraines: A Pilot Randomized Controlled Trial

Rebecca Erwin Wells MD, MPH; Rebecca Burch MD; Randall H. Paulsen MD; Peter M. Wayne PhD; Timothy T. Houle PhD; Elizabeth Loder MD, MPH

Disclosures

Headache. 2014;54(9):1484-1495. 

In This Article

Discussion

This small pilot study suggests that the standardized intervention of MBSR is safe, feasible, and can be done concurrently with pharmacological treatment. Although the small sample size of this pilot trial did not provide power to detect statistically significant changes in migraine frequency or severity, secondary outcomes demonstrated this intervention had a beneficial effect on headache duration, disability, self-efficacy, and mindfulness. Future studies with larger sample sizes are warranted to further evaluate this intervention for adults with migraines.

In a randomized controlled trial of yoga in patients with migraine without aura, yoga resulted in a significant decrease in headache frequency, pain index, and symptomatic medication usage compared to a self-care group.[41] However, the yoga protocol used was not specified, and participants were instructed to practice yoga only during the prodromal phase of a headache. Our study adds to the literature by reporting the use of a standardized protocol (MBSR) that has been used both clinically and in numerous research studies across many conditions.[43,44] Furthermore, the design of our study tested MBSR as a prophylactic treatment and allowed participants to continue with their customary migraine medications, increasing the external validity and generalizability of the results.

Our study has several limitations. This study has limitations of all pilot studies (eg, small sample size, etc). This small sample size limited the ability of randomization to balance groups at baseline, resulting in groups that had baseline differences in headache frequency. A longer run-in period beyond 28 days may have provided less baseline variability of migraine frequency. The inclusion criterion for migraine frequency was based on a patient's interpretation of their headaches as migraines, while results were analyzed according to diagnostic criteria for migraine. As such, our primary outcome of migraine was determined by assessing the severity and duration of each individual headache from the headache logs, which did not account for associated symptoms or treatment medications. Thus, some headaches might have been misclassified. Given that this was a pilot study, we are primarily interested in effect sizes for outcomes (rather than values of significance from P values) in order to evaluate for trends in this non-confirmatory trial. In addition, we clearly defined a priori our primary and secondary outcomes, thus we did not correct for multiple comparisons. Many of the numerous comparisons on secondary outcomes would likely be considered nonsignificant had the P value been adjusted on the secondary outcomes, although means, variances, and trends would not have changed. Self-reported paper headache logs were used. There was no active/sham control group; our control group continued in usual care. The intervention of MBSR is a multifaceted intervention that, in addition to teaching mindfulness, involves a weekly and daily time commitment, social and intellectual engagement, and instructor attention. Since our usual care control group did not adequately control for these factors, the changes seen in the MBSR group may be reflective of something other or more than just mindfulness meditation, such as common factors inherent to any group treatment (eg, instructor attention, group support, experience of universality, etc). Although participants were aware of receiving MBSR, we attempted to blind participants regarding treatment allocation by offering two dates for MBSR; those randomized to the later date were not told they were the control group. These limitations mean that our results must be interpreted cautiously, and their generalizability to the broader clinical population of patients with headache is uncertain. Nonetheless, our findings in this pilot trial support the potential safety, feasibility, and efficacy of a standardized mind/body intervention for migraineurs.

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