Comprehensive Headache Program, Department of Neurology, Wake Forest Baptist Health, Winston-Salem, North Carolina.
Department of Biostatistics and Data Science, Division of Public Health Sciences, Wake Forest Baptist Health, Winston-Salem, North Carolina.
JAMA Intern Med. 2021 Mar 1;181(3):317-328. doi: 10.1001/jamainternmed.2020.7090.
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.
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).
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.
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).
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.
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.
ClinicalTrials.gov Identifier: NCT02695498.
偏头痛是全球第二大致残原因。大多数偏头痛患者由于无效或不良反应而停止使用药物。基于正念的减压（MBSR）可能会带来益处。
确定 MBSR 是否比头痛教育更能改善偏头痛的结局以及情感/认知过程。
设计、地点和参与者：这项 MBSR 与头痛教育的随机临床试验纳入了 89 名每月偏头痛发作 4 至 20 天的成年人。参与者和主要研究者/数据分析师（组分配）均被设盲（到主动组与对照组的分配）。
参与者接受 MBSR（正念/瑜伽的标准化培训）或头痛教育（偏头痛信息），每周 2 小时，共 8 周。
主要结局是偏头痛发作频率的变化（基线至 12 周）。次要结局是残疾、生活质量、自我效能、疼痛灾难化、抑郁评分以及实验诱导的疼痛强度和不适（基线至 12、24 和 36 周）的变化。
大多数参与者为女性（n = 82，92%），平均年龄（SD）为 43.9（13.0）岁，每月平均偏头痛发作天数为 7.3（2.7）天，残疾程度较高（头痛影响测试-6：63.5 [5.7]），上课出勤率（中位数出勤率，8 节课中的 7 节）和 36 周随访（MBSR 组 33 例[73%]和头痛教育组 32 例[73%]）。两组参与者在 12 周时偏头痛发作天数减少（MBSR：每月减少 1.6 天偏头痛；95%CI，-0.7 至-2.5；头痛教育：每月减少 2.0 天偏头痛；95%CI，-1.1 至-2.9），但组间无差异（P = .50）。与参加头痛教育的参与者相比，参加 MBSR 的参与者在所有随访时间点（以组间效应差异的点估计值表示）的残疾（5.92；95%CI，2.8-9.0；P < .001）、生活质量（5.1；95%CI，1.2-8.9；P = .01）、自我效能（8.2；95%CI，0.3-16.1；P = .04）、疼痛灾难化（5.8；95%CI，2.9-8.8；P < .001）、抑郁评分（1.6；95%CI，0.4-2.7；P = .008）和实验诱导的疼痛强度和不适（MBSR 组：强度降低 36.3%[95%CI，12.3%至 60.3%]和不适降低 30.4%[95%CI，9.9%至 49.4%]；头痛教育组：强度增加 13.5%[95%CI，-9.9%至 36.8%]和不适增加 11.2%[95%CI，-8.9%至 31.2%]；强度 P = .004，不适 P = .005，36 周）方面均有改善。有 1 例不良事件被认为与研究方案无关。
与头痛教育相比，基于正念的减压并未改善偏头痛发作频率，因为两组的偏头痛发作频率都有类似的减少；然而，MBSR 改善了残疾、生活质量、自我效能、疼痛灾难化和抑郁，直至 36 周，实验诱导的疼痛减轻表明疼痛评估可能发生了变化。综上所述，MBSR 可能有助于治疗偏头痛总负担，但需要更大、更明确的研究来进一步调查这些结果。
ClinicalTrials.gov 标识符：NCT02695498。
