Kroner John W, Hershey Andrew D, Kashikar-Zuck Susmita M, LeCates Susan L, Allen Janelle R, Slater Shalonda K, Zafar Marium, Kabbouche Marielle A, O'Brien Hope L, Shenk Chad E, Rausch Joseph R, Kroon Van Diest Ashley M, Powers Scott W
Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.
Division of Neurology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.
Headache. 2016 Apr;56(4):711-6. doi: 10.1111/head.12795. Epub 2016 Mar 18.
The objective of this secondary analysis of results from a previously published trial (Clinical Trials Registration Number: NCT00389038) in chronic migraine in children and adolescents was to examine if participants who received cognitive behavioral therapy and amitriptyline reached a greater level of reduction in headache frequency that no longer indicated a recommendation for preventive treatment as compared to those who received headache education and amitriptyline.
Chronic migraine negatively affects children's home, school, and social activities. Preventive medication therapy is suggested for 5 or more headaches per month. Reduction to one headache day per week or less may suggest that preventive treatment is no longer indicated and provide a clinically relevant outcome for treatment efficacy and patient care.
Randomized study participants (N = 135) kept a daily record of their headache frequency during 20 weeks of treatment and during a 1 year follow-up period. Baseline headache frequency was determined at the end of a 28 day screening period. Post treatment frequency was determined at 20 weeks (N = 128 completed) and post treatment follow-up was measured 12 months later (N = 124 completed). A chi-square test of independence was conducted by treatment group and by time point to determine group differences in the proportion of headache days experienced.
At 20 weeks (post treatment), 47% of the cognitive behavioral therapy plus amitriptyline group had ≤4 headache days per month compared to 20% of the headache education plus amitriptyline group, (P = .0011), and 32% of the cognitive behavioral therapy plus amitriptyline group had ≤3 headache days per month at 20 weeks compared to 16% of the headache education plus amitriptyline group, (P = .0304). At the month 12 follow-up, 72% of the cognitive behavioral therapy plus amitriptyline group had ≤4 headache days per month compared to 52% of the headache education plus amitriptyline group, (P = .0249), and 61% of the cognitive behavioral therapy plus amitriptyline group had ≤3 headache days per month at their month 12 follow-up compared to 40% of the headache education plus amitriptyline group, (P = .0192).
Participants who received cognitive behavioral therapy and amitriptyline were more likely than participants who received headache education plus amitriptyline to reach the clinically meaningful outcome of less than or equal to 4 headache days per month at both time points. These results may help inform what treatment outcomes are possible for children and adolescents suffering from chronic migraine and provides further evidence for behavioral treatment to be considered as a key part of a first line treatment regimen.
本研究是对一项先前发表的关于儿童和青少年慢性偏头痛试验（临床试验注册号：NCT00389038）结果的二次分析，目的是检验接受认知行为疗法和阿米替林治疗的参与者与接受头痛教育和阿米替林治疗的参与者相比，头痛频率降低的程度是否更大，以至于不再需要预防性治疗。
慢性偏头痛对儿童的家庭、学校和社交活动产生负面影响。对于每月发作5次或更多次头痛的情况，建议采用预防性药物治疗。将头痛天数减少到每周1天或更少可能表明不再需要预防性治疗，并为治疗效果和患者护理提供具有临床意义的结果。
随机研究参与者（N = 135）在20周的治疗期间和1年的随访期内每天记录头痛频率。在28天的筛查期结束时确定基线头痛频率。在20周时（N = 128完成）确定治疗后频率，并在12个月后（N = 124完成）测量治疗后随访情况。按治疗组和时间点进行独立性卡方检验，以确定头痛天数比例的组间差异。
在20周（治疗后）时，认知行为疗法加阿米替林组中47%的参与者每月头痛天数≤4天，而头痛教育加阿米替林组为20%，（P = 0.0011）；在20周时，认知行为疗法加阿米替林组中32%的参与者每月头痛天数≤3天，而头痛教育加阿米替林组为16%，（P = 0.0304）。在12个月随访时，认知行为疗法加阿米替林组中72%的参与者每月头痛天数≤4天，而头痛教育加阿米替林组为52%，（P = 0.0249）；在12个月随访时，认知行为疗法加阿米替林组中61%的参与者每月头痛天数≤3天，而头痛教育加阿米替林组为40%，（P = 0.0192）。
在两个时间点上，接受认知行为疗法和阿米替林治疗的参与者比接受头痛教育加阿米替林治疗的参与者更有可能达到每月头痛天数小于或等于4天这一具有临床意义的结果。这些结果可能有助于了解患有慢性偏头痛的儿童和青少年可能取得的治疗效果，并为将行为治疗视为一线治疗方案的关键部分提供进一步证据。
