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) 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.