Mindfulness-based stress reduction (MBSR) can be a safe and effective means of lessening the effect of migraine headache and can be carried out while patients continue to take migraine medication, results of a pilot study suggest.
"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," the authors, led by Rebecca Erwin Wells, MD, Wake Forest School of Medicine, Winston-Salem, North Carolina, conclude.
"Future studies with larger sample sizes are warranted to further evaluate this intervention for adults with migraines."
The study was published online July 18 in the journal Headache.
This pilot study included 19 adult patients with migraine, with or without aura, who had initially been evaluated with a telephone screen and then during an in-person visit. They had maintained a paper headache log for a 28-day run-in period, which was reviewed by headache experts to confirm study eligibility.
Patients were randomly assigned to usual care (n = 9) or an 8-week MBSR program (n = 10). They were allowed to continue taking prophylactic and abortive medications but were asked not to change dosages. All participants kept daily headache logs and completed a batter of standardized, validated instruments to assess headache-related disability and depression, among other things.
Mindfulness is defined as nonjudgmental, moment-to-moment awareness. The MBSR program used in the study is a standardized protocol that has been used both clinically and in numerous research studies. It consists of 8 weekly 2-hour group sessions led by a trained instructor, followed by a 6-hour mindfulness retreat.
Classes incorporate mindful eating, sitting and walking meditation, body scan (mindful attention to different body parts), and mindful movement or yoga. Patients in this group are given information about stress and stress relief.
"A central theme of the course involves teaching participants to use the MBSR skills as a means to reduce the negative effects of stress reactivity and to develop more effective ways of responding positively and proactively in stressful situations and experiences," write the authors.
Participants are encouraged to incorporate mindfulness into their daily lives so that daily routines, such as brushing teeth or taking a shower, become a meditative practice, they said.
Patients who continued with their usual care were unaware that they were the control group for the study. In an attempt at blinding, researchers told this group that there were 2 start times for the MBSR course.
There were no adverse events associated with MBSR, no drop outs, and excellent adherence rates.
Despite inadequate power due to small sample size, MBSR participants had 1.4 fewer migraines per month compared with the control group (3.5 to 1.0 vs 1.2 to 0 in controls; 95% confidence interval, –4.6 to 1.8; P =.38).
The severity and duration of all headaches decreased in the MBSR group (–1.3 points/headache on a 0- to 10-point scale [P = .053] and 2.9 fewer hours per headache). Disability also decreased with the intervention compared with the control group.
It's not known how mindfulness meditation might reduce migraines. It may work by changing how migraineurs interpret pain or through a therapeutic effect on other factors playing a role in headache, such as improved emotion regulation, less pain catastrophizing, and increased pain acceptance, said the authors.
As well having a small sample size, the study was also limited by baseline differences in headache frequency, the primary outcome being based on headache logs that didn't account for associated symptoms or treatment medication (possibly leading to headache misclassification), and the lack of an active/sham control group.
In addition, said the authors, the changes seen in the MBSR group may have been due to something other than mindfulness meditation — for example, instructor attention or group support.
"These limitations mean that our results must be interpreted cautiously, and their generalizability to the broader clinical population of patients with headache is uncertain," write the authors. "Nonetheless, our findings in this pilot trial support the potential safety, feasibility, and efficacy of a standardized mind/body intervention for migraineurs."
Only about half of migraineurs have clinically meaningful responses to preventive drug treatments, more than 10% discontinue drugs because of adverse events, and half report dissatisfaction with their current treatment strategies, according to background information in the paper.
The study was supported financially by the American Headache Society Fellowship and the Headache Research Fund of the John Graham Headache Center, Brigham and Women's Faulkner Hospital. A coauthor received research support from Glaxo/SmithKline, Merck and Depomed. The remaining authors have disclosed no relevant financial relationships.
Headache. Published online July 18, 2014. Abstract