Mindfulness Meditation vs. Headache Education for Migraine: A Randomized Clinical Trial
Rebecca Erwin Wells1, Nathaniel O'Connell1, Charles Pierce1, Paige Estave1, Donald Penzien1, Elizabeth Loder2, Fadel Zeidan3, Timothy Houle4
1Wake Forest Baptist, 2Brigham and Women’s Hospital, Harvard Medical School, 3University of California San Diego, 4Massachusetts General Hospital, Harvard Medical School
Objective:

Determine if Mindfulness-Based Stress Reduction (MBSR) improves migraine outcomes and affective/cognitive processes compared to Headache (HA) Education.

Background:

Migraine is the second leading cause of disability worldwide. Most patients with migraine discontinue medications due to inefficacy or side effects. Mindfulness meditation may provide benefit.

Design/Methods:
Randomized clinical trial of 8 weekly in-person classes of MBSR or HA Education (n=89) in adults with 4-20 migraines/month. Blinding occurred of participants (to active vs. comparator group assignments) and PI/data analysts. Primary outcome: change in migraine day frequency (baseline to 12 weeks). Secondary outcomes: changes in disability, quality of life, self-efficacy, pain catastrophizing, depression scores, and experimentally induced pain intensity and unpleasantness (baseline to 12, 24, 36 weeks). 
Results:
Most participants were female (92%), 43.9 years (SD 13.0), with 7.3 (SD 2.7) migraines/month. Participants in both groups had fewer migraine days at 12 weeks (MBSR: -1.6 migraine days/month; 95% CI: [-0.7, -2.5]; HA Education -2.0; [-1.1, -2.9]), without group differences (p=0.51). Compared to HA Education, MBSR participants had improvements from baseline at all time points (on point estimates of effect differences between groups) in disability (5.92 (95% CI 2.8, 9.0) p<0.001); quality of life (5.1 (1.2, 8.9) p=0.01); self-efficacy (8.2 (0.3, 16.1, p=0.04); pain catastrophizing (5.8 (2.9, 8.8), p<0.001); depression scores (1.6 (0.4, 2.7) p=0.008), and decreased experimentally induced pain intensity and unpleasantness (p= 0.004 and 0.005, respectively, at 36 weeks).One reported adverse event was deemed unrelated to study protocol. 
Conclusions:
MBSR did not improve migraine frequency more than HA Education, as both groups had clinically meaningful decreases. Only MBSR improved disability, quality of life, self-efficacy, pain-catastrophizing, and depression out to 36 weeks, with decreased experimentally induced pain suggesting a potential shift in pain appraisal. MBSR may help treat total migraine burden; a larger more definitive study is needed to further investigate these results.