Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio3Headache Center, Cincinnati Children's Hospital Medical Center4Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, Ohio.
Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio4Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, Ohio.
JAMA. 2013 Dec 25;310(24):2622-30. doi: 10.1001/jama.2013.282533.
Early, safe, effective, and durable evidence-based interventions for children and adolescents with chronic migraine do not exist.
To determine the benefits of cognitive behavioral therapy (CBT) when combined with amitriptyline vs headache education plus amitriptyline.
DESIGN, SETTING, AND PARTICIPANTS: A randomized clinical trial of 135 youth (79% female) aged 10 to 17 years diagnosed with chronic migraine (≥15 days with headache/month) and a Pediatric Migraine Disability Assessment Score (PedMIDAS) greater than 20 points were assigned to the CBT plus amitriptyline group (n = 64) or the headache education plus amitriptyline group (n = 71). The study was conducted in the Headache Center at Cincinnati Children's Hospital between October 2006 and September 2012; 129 completed 20-week follow-up and 124 completed 12-month follow-up.
Ten CBT vs 10 headache education sessions involving equivalent time and therapist attention. Each group received 1 mg/kg/d of amitriptyline and a 20-week end point visit. In addition, follow-up visits were conducted at 3, 6, 9, and 12 months.
The primary end point was days with headache and the secondary end point was PedMIDAS (disability score range: 0-240 points; 0-10 for little to none, 11-30 for mild, 31-50 for moderate, >50 for severe); both end points were determined at 20 weeks. Durability was examined over the 12-month follow-up period. Clinical significance was measured by a 50% or greater reduction in days with headache and a disability score in the mild to none range (<20 points).
At baseline, there were a mean (SD) of 21 (5) days with headache per 28 days and the mean (SD) PedMIDAS was 68 (32) points. At the 20-week end point, days with headache were reduced by 11.5 for the CBT plus amitriptyline group vs 6.8 for the headache education plus amitriptyline group (difference, 4.7 [95% CI, 1.7-7.7] days; P = .002). The PedMIDAS decreased by 52.7 points for the CBT group vs 38.6 points for the headache education group (difference, 14.1 [95% CI, 3.3-24.9] points; P = .01). In the CBT group, 66% had a 50% or greater reduction in headache days vs 36% in the headache education group (odds ratio, 3.5 [95% CI, 1.7-7.2]; P < .001). At 12-month follow-up, 86% of the CBT group had a 50% or greater reduction in headache days vs 69% of the headache education group; 88% of the CBT group had a PedMIDAS of less than 20 points vs 76% of the headache education group. Measured treatment credibility and integrity was high for both groups.
Among young persons with chronic migraine, the use of CBT plus amitriptyline resulted in greater reductions in days with headache and migraine-related disability compared with use of headache education plus amitriptyline. These findings support the efficacy of CBT in the treatment of chronic migraine in children and adolescents.
clinicaltrials.gov Identifier: NCT00389038.
目前尚无针对儿童和青少年慢性偏头痛的早期、安全、有效且持久的循证干预措施。
确定认知行为疗法（CBT）联合阿米替林与头痛教育加阿米替林的疗效。
设计、地点和参与者：这是一项针对 135 名年龄在 10 至 17 岁之间、被诊断为慢性偏头痛（每月头痛天数≥15 天）和儿童偏头痛残疾评估量表（PedMIDAS）评分大于 20 分的青少年（79%为女性）的随机临床试验。将他们随机分配至 CBT 联合阿米替林组（n=64）或头痛教育联合阿米替林组（n=71）。该研究在辛辛那提儿童医院头痛中心进行，时间为 2006 年 10 月至 2012 年 9 月；129 名患者完成了 20 周随访，124 名患者完成了 12 个月随访。
CBT 组进行 10 次治疗，头痛教育组进行 10 次治疗，两组治疗涉及的时间和治疗师关注程度相同。两组患者均接受 1mg/kg/d 的阿米替林治疗，并在 20 周时进行终点评估。此外，还在 3、6、9 和 12 个月时进行了随访。
主要结局为头痛天数，次要结局为 PedMIDAS（残疾评分范围：0-240 分；0-10 分为轻度至无，11-30 分为轻度，31-50 分为中度，>50 分为重度），这两个结局都在 20 周时评估。在 12 个月的随访期间，评估了疗效的持久性。以头痛天数减少 50%或更多和残疾评分在轻度至无范围内（<20 分）作为临床显著的衡量标准。
在基线时，平均（SD）头痛天数为 21（5）天/28 天，平均（SD）PedMIDAS 为 68（32）分。在 20 周的终点评估时，CBT 联合阿米替林组头痛天数减少了 11.5 天，而头痛教育联合阿米替林组减少了 6.8 天（差异，4.7[95%CI，1.7-7.7]天；P=0.002）。CBT 组的 PedMIDAS 评分下降了 52.7 分，头痛教育组下降了 38.6 分（差异，14.1[95%CI，3.3-24.9]分；P=0.01）。在 CBT 组中，66%的患者头痛天数减少 50%或更多，而头痛教育组中这一比例为 36%（比值比，3.5[95%CI，1.7-7.2]；P<0.001）。在 12 个月的随访中，CBT 组中有 86%的患者头痛天数减少 50%或更多，而头痛教育组中有 69%；CBT 组中有 88%的患者 PedMIDAS 评分低于 20 分，而头痛教育组中有 76%。两组的治疗可信度和完整性都很高。
在慢性偏头痛的年轻患者中，与使用头痛教育加阿米替林相比，CBT 联合阿米替林可更有效地减少头痛天数和偏头痛相关残疾。这些发现支持 CBT 在儿童和青少年慢性偏头痛治疗中的疗效。
clinicaltrials.gov 标识符：NCT00389038。
