Oelkers-Ax Rieke, Leins Anne, Parzer Peter, Hillecke Thomas, Bolay Hans V, Fischer Jochen, Bender Stephan, Hermanns Uta, Resch Franz
Department of Child and Adolescent Psychiatry, University of Heidelberg, Blumenstrasse 8, D-69115 Heidelberg, Germany.
Eur J Pain. 2008 Apr;12(3):301-13. doi: 10.1016/j.ejpain.2007.06.003. Epub 2007 Jul 30.
Migraine is very common in school-aged children, but despite a number of pharmacological and non-pharmacological options for prophylaxis, randomized controlled evidence in children is small. Evidence-based prophylactic drugs may have considerable side effects.
This study was to assess efficacy of a butterbur root extract (Petadolex) and music therapy in primary school children with migraine.
Prospective, randomized, partly double-blind, placebo-controlled, parallel-group trial.
Following a 8-week baseline patients were randomized and received either butterbur root extract (n=19), music therapy (n=20) or placebo (n=19) over 12 weeks. All participants received additionally headache education ("treatment as usual") from the baseline onwards. Reduction of headache frequency after treatment (8-week post-treatment) as well as 6 months later (8-week follow-up) was the efficacy variable.
Data analysis of subjects completing the respective study phase showed that during post-treatment, only music therapy was superior to placebo (p=0.005), whereas in the follow-up period both music therapy and butterbur root extract were superior to placebo (p=0.018 and p=0.044, respectively). All groups showed a substantial reduction of attack frequency already during baseline.
Butterbur root extract and music therapy might be superior to placebo and may represent promising treatment approaches in the prophylaxis of paediatric migraine.
偏头痛在学龄儿童中非常常见，但尽管有多种药物和非药物预防选择，儿童中的随机对照证据却很少。循证预防药物可能有相当多的副作用。
本研究旨在评估小白菊提取物（Petadolex）和音乐疗法对偏头痛小学生的疗效。
前瞻性、随机、部分双盲、安慰剂对照、平行组试验。
在8周基线期后，患者被随机分组，并在12周内接受小白菊提取物（n = 19）、音乐疗法（n = 20）或安慰剂（n = 19）治疗。所有参与者从基线期开始还额外接受头痛教育（“常规治疗”）。治疗后（治疗后8周）以及6个月后（8周随访）头痛频率的降低是疗效变量。
对完成各自研究阶段的受试者进行数据分析显示，在治疗后期间，只有音乐疗法优于安慰剂（p = 0.005），而在随访期，音乐疗法和小白菊提取物均优于安慰剂（分别为p = 0.018和p = 0.044）。所有组在基线期就已显示发作频率大幅降低。
小白菊提取物和音乐疗法可能优于安慰剂，可能是预防儿童偏头痛的有前景的治疗方法。
