Migraine prevention in children and adolescents: results of an open study with a special butterbur root extract.
- 2005-03
- Headache 45(3)
- Raymund Pothmann
- Ulrich Danesch
- PubMed: 15836592
- DOI: 10.1111/j.1526-4610.2005.05044.x
Study Design
- Type
- Clinical Trial
- Sample size
- n = 289
- Population
- 108 children and adolescents between the ages of 6 and 17 with migraines
- Methods
- multicenter prospective open-label study, treated with 50 to 150 mg of butterbur root extract depending on age for a period of 4 months
- Blinding
- Open-label
- Duration
- 4 months
- Funding
- Unclear
- Large Human Trial
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.Research Insights
About 90% of each, doctors and patients, reported well-being or even improved well-being.
- Effect
- Beneficial
- Effect size
- Large
- Dose
- 50 to 150 mg/day
91% of patients felt substantially or at least slightly improved after 4 months of treatment.
- Effect
- Beneficial
- Effect size
- Large
- Dose
- 50 to 150 mg/day
77% of all patients reported a reduction in the frequency of migraine attacks of at least 50%.
- Effect
- Beneficial
- Effect size
- Large
- Dose
- 50 to 150 mg/day