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Migraine Prevention in Children and Adolescents: Results of an Open Study With a Special Butterbur Root Extract

Authors

  • Raymund Pothmann MD,

  • Ulrich Danesch PhD


  • From the Klinikum Heidberg, Zentrum für Kinderschmerztherapie, Hamburg, Germany (Dr. Pothmann); and Weber & Weber GmbH & Co, KG, Research & Development, Herrsching, Germany (Dr. Danesch).

Address all correspondence to Dr. Raymund Pothmann, MD, Klinikum Heidberg, Zentrum für Kinderschmerztherapie, Tangstedter Landstrasse 400, 22417 Hamburg, Germany.

Abstract

Objective.—To explore the role of a special butterbur root extract for migraine prevention in children and adolescents with severe migraines.

Background.—Two randomized and placebo-controlled trials with a total of 289 migraine patients have demonstrated the efficacy and safety of a special butterbur root extract in the reduction of migraine attacks in adults. We studied whether butterbur had the potential as an efficient and well-tolerated migraine preventive in children and adolescents.

Design/Methods.—108 children and adolescents between the ages of 6 and 17 were included in a multicenter prospective open-label study. Participants suffered from migraines diagnosed according to IHS classifications for at least 1 year. Patients were treated with 50 to 150 mg of the butterbur root extract depending on age for a period of 4 months. Treatment progression was recorded in migraine journals especially designed for children and adolescents.

Results.—77% of all patients reported a reduction in the frequency of migraine attacks of at least 50%. Attack frequency was reduced by 63%. 91% of patients felt substantially or at least slightly improved after 4 months of treatment. About 90% of each, doctors and patients, reported well-being or even improved well-being. Undesired effects (7.4%) included mostly eructation. No serious adverse events occurred and no adverse event caused a premature termination.

Conclusions.—The results and low rate of adverse events in this open prospective migraine prevention study in children and adolescents are similar to the results of two multicenter placebo-controlled butterbur studies in adults. Butterbur root extract shows a potential as an effective and well-tolerated migraine prophylaxis also for children and teenagers.

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