Effectiveness of Mindfulness Meditation vs Headache Education for Adults With Migraine: A Randomized Clinical Trial.

Importance: Migraine is the second leading cause of disability worldwide. Most patients with migraine discontinue medications due to inefficacy or adverse effects. Mindfulness-based stress reduction (MBSR) may provide benefit. Objective: To determine if MBSR improves migraine outcomes and affective/cognitive processes compared with headache education. Design, Setting, and Participants: This randomized clinical trial of MBSR vs headache education included 89 adults who experienced between 4 and 20 migraine days per month. There was blinding of participants (to active vs comparator group assignments) and principal investigators/data analysts (to group assignment). Interventions: Participants underwent MBSR (standardized training in mindfulness/yoga) or headache education (migraine information) delivered in groups that met for 2 hours each week for 8 weeks. Main Outcomes and Measures: The primary outcome was change in migraine day frequency (baseline to 12 weeks). Secondary outcomes were changes in disability, quality of life, self-efficacy, pain catastrophizing, depression scores, and experimentally induced pain intensity and unpleasantness (baseline to 12, 24, and 36 weeks). Results: Most participants were female (n = 82, 92%), with a mean (SD) age of 43.9 (13.0) years, and had a mean (SD) of 7.3 (2.7) migraine days per month and high disability (Headache Impact Test-6: 63.5 [5.7]), attended class (median attendance, 7 of 8 classes), and followed up through 36 weeks (33 of 45 [73%] of the MBSR group and 32 of 44 [73%] of the headache education group). Participants in both groups had fewer migraine days at 12 weeks (MBSR: -1.6 migraine days per month; 95% CI, -0.7 to -2.5; headache education: -2.0 migraine days per month; 95% CI, -1.1 to -2.9), without group differences (P = .50). Compared with those who participated in headache education, those who participated in MBSR had improvements from baseline at all follow-up time points (reported in terms of point estimates of effect differences between groups) on measures of disability (5.92; 95% CI, 2.8-9.0; P < .001), quality of life (5.1; 95% CI, 1.2-8.9; P = .01), self-efficacy (8.2; 95% CI, 0.3-16.1; P = .04), pain catastrophizing (5.8; 95% CI, 2.9-8.8; P < .001), depression scores (1.6; 95% CI, 0.4-2.7; P = .008), and decreased experimentally induced pain intensity and unpleasantness (MBSR group: 36.3% [95% CI, 12.3% to 60.3%] decrease in intensity and 30.4% [95% CI, 9.9% to 49.4%] decrease in unpleasantness; headache education group: 13.5% [95% CI, -9.9% to 36.8%] increase in intensity and an 11.2% [95% CI, -8.9% to 31.2%] increase in unpleasantness; P = .004 for intensity and .005 for unpleasantness, at 36 weeks). One reported adverse event was deemed unrelated to study protocol. Conclusions and Relevance: Mindfulness-based stress reduction did not improve migraine frequency more than headache education, as both groups had similar decreases; however, 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. In conclusion, MBSR may help treat total migraine burden, but a larger, more definitive study is needed to further investigate these results. Trial Registration: ClinicalTrials.gov Identifier: NCT02695498.

Meditation for migraines: a pilot randomized controlled trial.

OBJECTIVE: Our objective was to assess the safety, feasibility, and effects of the standardized 8-week mindfulness-based stress reduction (MBSR) course in adults with migraines. BACKGROUND: Stress is a well-known trigger for headaches. Research supports the general benefits of mind/body interventions for migraines, but there are few rigorous studies supporting the use of specific standardized interventions. MBSR is a standardized 8-week mind/body intervention that teaches mindfulness meditation/yoga. Preliminary research has shown MBSR to be effective for chronic pain syndromes, but it has not been evaluated for migraines. METHODS: We conducted a randomized controlled trial with 19 episodic migraineurs randomized to either MBSR (n = 10) or usual care (n = 9). Our primary outcome was change in migraine frequency from baseline to initial follow-up. Secondary outcomes included change in headache severity, duration, self-efficacy, perceived stress, migraine-related disability/impact, anxiety, depression, mindfulness, and quality of life from baseline to initial follow-up. RESULTS: MBSR was safe (no adverse events), with 0% dropout and excellent adherence (daily meditation average: 34 ± 11 minutes, range 16-50 minutes/day). Median class attendance from 9 classes (including retreat day) was 8 (range [3, 9]); average class attendance was 6.7 ± 2.5. MBSR participants had 1.4 fewer migraines/month (MBSR: 3.5 to 1.0 vs control: 1.2 to 0 migraines/month, 95% confidence interval CI [-4.6, 1.8], P = .38), an effect that did not reach statistical significance in this pilot sample. Headaches were less severe, although not significantly so (-1.3 points/headache on 0-10 scale, [-2.3, 0.09], P = .053) and shorter (-2.9 hours/headache, [-4.6, -0.02], P = .043) vs control. Migraine Disability Assessment and Headache Impact Test-6 dropped in MBSR vs control (-12.6, [-22.0, -1.0], P = .017 and -4.8, [-11.0, -1.0], P = .043, respectively). Self-efficacy and mindfulness improved in MBSR vs control (13.2 [1.0, 30.0], P = .035 and 13.1 [3.0, 26.0], P = .035 respectively). CONCLUSIONS: MBSR is safe and feasible for adults with migraines. 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. This study was prospectively registered (ClinicalTrials.gov identifier NCT01545466).

Behavioral and mind/body interventions in headache: unanswered questions and future research directions.

BACKGROUND: Many unanswered questions remain regarding behavioral and mind/body interventions in the treatment of primary headache disorders in adults. METHODS: We reviewed the literature to ascertain the most pressing unanswered research questions regarding behavioral and mind/body interventions for headache. RESULTS: We identify the most pressing unanswered research questions in this field, describe ideal and practical ways to address these questions, and outline steps needed to facilitate these research efforts. We discuss proposed mechanisms of action of behavioral and mind/body interventions and outline goals for future research in this field. CONCLUSIONS: Although challenges arise from the complex nature of the interventions under study, research that adheres to published study design and reporting standards and focuses closely on answering key questions is most likely to lead to progress in achieving these goals.

Mind/Body and behavioral treatments: the evidence and approach.

Nonpharmacological treatments may help many patients with headaches. This review addresses the most common questions about nondrug treatment options from the perspective of patients by (1) defining behavioral and mind/body treatments, (2) discussing the research evidence supporting their use, and (3) describing their role in the management of headaches. Research suggests that mind/body and behavioral treatments may decrease the frequency of migraine or tension-type headaches by 35-50%, an effect size comparable with those observed in medication trials but with fewer side effects than drugs. Most benefit seems to occur in those who combine medications with nonpharmacological treatments. Despite the fact that research evidence for behavioral treatment of headaches is stronger than that for specific mind/body treatments, research shows that adults with headache in the general population are more likely to use mind/body treatments. Nondrug treatments may have a longer time to onset of benefits than drugs, but their effect may be broader and more durable because they may improve stress, coping, and self-efficacy. Additional research is needed to address other questions that patients and their physicians may have about these interventions.

The 2012 AHS/AAN guidelines for prevention of episodic migraine: a summary and comparison with other recent clinical practice guidelines.

BACKGROUND: Updated guidelines for the preventive treatment of episodic migraine have been issued by the American Headache Society (AHS) and the American Academy of Neurology (AAN). We summarize key 2012 guideline recommendations and changes from previous guidelines. We review the characteristics, methods, consistency, and quality of the AHS/AAN guidelines in comparison with recently issued guidelines from other specialty societies. METHODS: To accomplish this, we reviewed the AHS/AAN guidelines and identified comparable recent guidelines through a systematic MEDLINE search. We extracted key data, and summarized and compared the key recommendations and assessed quality using the Appraisal of Guidelines Research and Evaluation-II (AGREE-II) tool. We identified 2 additional recent guidelines for migraine prevention from the Canadian Headache Society and the European Federation of Neurological Societies. All of the guidelines used structured methods to locate evidence and linked recommendations with assessment of the evidence, but they varied in the methods used to derive recommendations from that evidence. RESULTS: Overall, the 3 guidelines were consistent in their recommendations of treatments for first-line use. All rated topiramate, divalproex/sodium valproate, propranolol, and metoprolol as having the highest level of evidence. In contrast, recommendations diverged substantially for gabapentin and feverfew. The overall quality of the guidelines ranged from 2 to 6 out of 7 on the AGREE-II tool. CONCLUSION: The AHS/AAN and Canadian guidelines are recommended for use on the basis of the AGREE-II quality assessment. Recommendations for the future development of clinical practice guidelines in migraine are provided. In particular, efforts should be made to ensure that guidelines are regularly updated and that guideline developers strive to locate and incorporate unpublished clinical trial evidence.

American headache through the decades: 1950 to 2008.

As the American Headache Society approaches its 50th anniversary, it seems worthwhile to step back and survey the many changes in the headache field since the 1950s. Many, perhaps most, of the trends, ideas, and changes we review in this article cannot easily be assigned to a particular decade but we have nonetheless chosen a by-the-decade format because it is a familiar and useful way of understanding history. Our focus is on events in the United States and the American Headache Society; space and the need to limit the scope of the article preclude a full description of the many parallel and influential trends, personalities, and ideas in other parts of the world or in other professional organizations. The authors hope you will find this summary of American Headache Medicine in the last half of the 20th and the beginning of the 21st centuries entertaining and educational.

Cluster headache treatment dilemmas: the experts respond.

When conventional treatment approaches to cluster headache are unsuccessful, expert recommendations are relevant but may not be easily accessible to treating clinicians. We conducted a study of expert recommendations in response to standardized vignettes. Ten expert headache clinicians were asked what treatment they would recommend for a hypothetical 55-year-old male cluster headache patient in the following five situations: 1) known coronary artery disease with response only to sumatriptan; 2) strictly unilateral headaches unresponsive to preventive treatment; 3) effective abortive treatment not covered by insurance; 4) patient request to obtain methysergide from Canada; and 5) headaches responsive only to steroid treatment.

Hormonal management of migraine associated with menses and the menopause: a clinical review.

OBJECTIVE: This article reviews hormonal strategies used to treat headaches attributed to the menstrual cycle or to peri- or postmenopausal estrogen fluctuations. These may occur as a result of natural ovarian cycles, or in response to the withdrawal of exogenously administered estrogen. BACKGROUND: A wide variety of evidence indicates that cyclic ovarian sex steroid production affects the clinical expression of migraine. This has led to interest in the use of hormonal treatments for migraine. METHODS: A PubMed search of the literature was conducted using the terms "migraine,""treatment,""estrogen,""hormones,""menopause," and "menstrual migraine." Articles were selected on the basis of relevance. RESULTS: The overarching goal of hormonal treatment regimens for migraine is minimization of estrogen fluctuations. For migraine associated with the menstrual cycle, supplemental estrogen may be administered in the late luteal phase of the natural menstrual cycle or during the pill-free week of traditional combination oral contraceptives. Modified contraceptive regimens may be used that extend the duration of active hormone use, minimize the duration or extent of hormone withdrawal, or both. In menopause, hormonally associated migraine is most likely to be due to estrogen-replacement regimens, and treatment generally involves manipulating these regimens. Evidence regarding the safety and efficacy of these regimens is limited. CONCLUSIONS: Hormonal treatment of migraine is not a first-line treatment strategy for most women with migraine. Evidence is lacking regarding its long term harms and migraine is a contraindication to the use of exogenous estrogen in all women with aura and those aged 35 or older. The harm to benefit balances of several traditional nonhormonal therapies are better established.