Butterbur root extract and music therapy in the prevention of childhood migraine: An explorative study

Background: 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. Objective: This study was to assess efficacy of a butterbur root extract (Petadolex(R)) and music therapy in primary school children with migraine. Design: Prospective, randomized, partly double-blind, placebo-controlled, parallel-group trial. Methods: 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. Results: 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. Conclusion: Butterbur root extract and music therapy might be superior to placebo and may represent promising treatment approaches in the prophylaxis of paediatric migraine. (C) 2007 European Federation of Chapters of the International Association for the Study of Pain. Published by Elsevier Ltd. All rights reserved.