'Dramatic Impact' of Mindfulness on Migraine

Mindfulness-based stress reduction (MBSR) may significantly reduce the negative impact of migraine, new research suggests.

Results of a randomized trial show that MBSR reduced pain intensity, disability, and depression and improved quality of life.

"Migraine is a severely debilitating condition and the second leading cause of disability worldwide. Recognizing and mitigating its impact on a person's life is critical. Mindfulness may be an additional tool that helps treat the total burden of migraine," Rebecca Erwin Wells, MD, associate professor, Department of Neurology, and founder and director, Comprehensive Headache Program, Wake Forest School of Medicine, Winston-Salem, North Carolina, told Medscape Medical News.

The study was published online December 14 in JAMA Internal Medicine.

Many Turn to Opioids for Relief

The American Headache Society recommends against prescribing opioids for migraine, owing to risks for opioid use disorder and medication overuse headache (a refractory condition). However, one third of migraine patients still turn to opioids for relief.

"At a time when opioids are still being used against recommendations for migraine treatment, finding safe nondrug options is really important," said Wells.

MBSR may be one such option. MBSR typically includes mindfulness practices such as meditation "body scans" that focus on different parts of the body, as well as gentle Hatha yoga.

The practice is associated with improvement in many chronic pain conditions but may be particularly helpful for migraine because it diminishes responses to stress, which is the most common migraine trigger, the authors note.

The study included 89 patients who had experienced four to 20 migraines per month for at least 1 year. Prospective participants were not aware they were participating in a mindfulness study. They only knew the researchers were investigating nondrug options for migraine.

Participants were randomly assigned to receive headache education or mindfulness. Each group received an active intervention.

In addition to engaging in mindfulness exercises 2 hours per week for 8 weeks, participants in the MBSR group received electronic audio files and were encouraged to use them to practice at home 30 minutes per day.

The length of the headache education intervention was the same as that of the mindfulness intervention. Participants in the education group received instruction on headaches, pathophysiology, triggers, stress, and treatment approaches.

More Common in Women

After screening and evaluation, 96 participants were included (mean age, 43.9 years). Of those patients, 89 attended at least one class and completed one headache log. Most participants were White (89%), college educated (94%), and female (92%).

About twice as many women as men suffer migraine (20% vs 8% to 10%); 85% to 95% of participants in migraine trials "across the board are women," said Wells.

In this study, participants initially experienced a mean of 7.3 migraine days and 9.6 headache days per month with a high level of headache-related disability.

"We had distinct criteria to differentiate headaches from migraine in this study," Wells noted.

About 71% of headache education participants were using prophylactic medications, compared to only 40% of the mindfulness group. In both groups, current or past history of depression was common (43%), as was anxiety (38%).

Study participants could continue their acute and preventive migraine medications and were asked to maintain stable medications for the study's duration. Follow-up occurred at 12, 24, and 36 weeks.

The primary outcome was a change in the number of migraine days per month from baseline to 12 weeks. A migraine day was one on which occurred a moderate to severe headache (degree of pain, 6 – 10 on a scale of 0 –10) that lasted more than 4 hours or was treated with acute medication.

Participants maintained daily headache logs to capture headache presence, duration, intensity, unpleasantness, symptoms, and medication use.

"Dramatic Impact"

At 12 weeks, the mindfulness group had fewer migraine days per month (-1.6; 95% CI, -0.7 to -2.5), but so did the headache education group (-2.0; 95% CI, -1.1 to -2.9). There was no statistically significance difference between groups (P = .50).

Wells was somewhat surprised by these results. "We didn't expect to see the impact we did in the headache education group," she said, "but it goes to show that headache education was an active intervention, and participants learned information that made a difference."

The between-group difference in prophylactic treatments had no difference on the results, said Wells.

The study also included a number of secondary outcomes. These included headache-related disability, assessed using the Migraine Disability Assessment (MIDAS); quality of life, assessed with the Migraine-Specific Quality of Life Questionnaire, version 2.1; depression, assessed with the Patient Health Questionnaire–9; anxiety, assessed with the Generalized Anxiety Disorder–7; and pain catastrophizing (magnification of pain-related thoughts and feelings), assessed with the Pain Catastrophizing Scale.

In addition, the investigators measured self-efficacy, defined as a belief in the ability to manage one's migraines, using the Headache Management Self-Efficacy Scale, and trait mindfulness, which is the innate capacity to experience mindfulness, which was measured with the Five-Facet Mindfulness Questionnaire.

Compared to headache education, the mindfulness group had statistically significant improvements in headache-related disability (point estimate of effect difference: 5.9; 95% CI, 2.8 – 9.0; P < .001) and quality of life (5.1; 95% CI, 1.2 – 8.9; P = .01). The mindfulness group also had comparative improvements in self-efficacy, pain catastrophizing, and depression scores, which also had medium to large effect sizes that lasted to 36 weeks.

"These results are very important," said Wells. "When you look at effect sizes, the impact was very clinically meaningful. The changes that we're seeing in these secondary outcomes had a pretty dramatic impact on patients' lives."

The researchers also used an experimental pain test. At each visit, healthcare workers applied a thermal probe, set at various temperatures, to the arm or leg of patients, who were asked to rate the pain intensity and pain unpleasantness.

On this measure, participants in the MBSR group demonstrated decreased perceptions of pain intensity and unpleasantness, whereas there was no significant change among patients in the headache group. Mindfulness adherents may learn a new way of processing or perceiving pain or new ways to respond to stress, said Wells.

The fact that the education group did not experience the same improvements on these secondary outcomes as the mindfulness group was "quite striking," she said.

Pioneering Researchers

In an accompanying commentary, Daniel C. Cherkin, PhD, Kaiser Permanente Washington Health Research Institute, Seattle, Washington, said the authors are among a growing group of "pioneers" evaluating nonpharmacologic treatments for chronic pain conditions.

Cherkin noted a number of study strengths, such as inclusion of a moderate sample size, moderately long follow-up, diverse outcome measures, and evaluation of experimentally induced pain.

However, he took issue with the choice of primary outcome measure ― migraine frequency. Although the conclusion based on this measure is "likely valid," it wouldn't be appropriate to conclude from this trial that mindfulness is ineffective for migraine, given the positive results for multiple secondary outcomes, he said.

"In fact, the preponderance of evidence from this trial suggests otherwise. This raises an important question: what outcome should be considered primary in trials of nonpharmacological treatments for migraine?"

Another study limitation, said Cherkin, is the absence of a usual-care comparison group.

"Although the authors included a reasonable active control group, HAE [headache education], the absence of a usual-care comparator makes it impossible to estimate the effect of incorporating MBSR as a treatment option for migraine into usual care."

Commenting on the study for Medscape Medical News, headache specialist Dawn C. Buse, PhD, clinical professor, Albert Einstein College of Medicine Department of Neurology, New York City, described it as "carefully designed and well conducted."

The study is part of a "small but expanding" body of literature examining MBSR as well as mindfulness-based cognitive therapy to prevent migraine, said Buse, who is board member at large of the American Headache Society.

The study highlights the clinical value of MBSR and patient education for migraine prevention "alongside the well-valued, guideline-approved 'big three' of behavioral migraine management: biofeedback, CBT [cognitive-behavioral therapy], and relaxation training," she said.

Although behavioral therapies are "well validated" and have "a long history of empirical evidence and excellent safety profiles," they are "are grossly underutilized," said Buse.

The authors and editorialists have disclosed no relevant financial relationships. Buse has received grant support and honoraria from Allergan, Amgen, Biohaven, Lilly, Novartis, and Promius/Dr Reddys and holds stock in Unison Mind and Biotrak Health Halo. She serves on the editorial board of Current Pain and Headache Reports

JAMA Intern Med. Published online December 14, 2020. Abstract, Commentary

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Cite this: 'Dramatic Impact' of Mindfulness on Migraine - Medscape - Dec 17, 2020.