Migraine Headache Clinical Trial Report on Children & Teens

By: Darrell Miller

A new clinical trial published in the journal Headache stated that a proprietary extract of butterbur root, an herbal remedy from Europe, has been able to successfully lower the occurrence of migraines in children and adolescents. Three to seven percent of all children experience migraines. Since most migraine therapies are not effective when given to children, it is a necessity for further research on new promising therapies that can help to prevent migraines in children. Although there have been numerous studies testing therapies for adults with migraines, there have only been a few controlled trials investigating the prophylactic treatment of migraines in children and adolescents.

Butterbur, which is a native European plant, has most successfully been used for its ability to relieve pain and spasms in conditions such as migraines, asthma, urinary tract spasms, and lower back pain. This trial, which took place in Germany, was an open-label study, as getting approval for placebo-controlled trials in children is very difficult to obtain. Unlike a placebo-controlled trial, in which both the patients and researchers are unaware of who is using the real active agent and who is using a placebo, a open-label trial gives all patients the active treatment with both the patients and researchers being aware of it.

This study, which was conducted in five pediatric clinics and thirteen medical practices, included a total of 108 subjects. Twenty-nine were children between the ages of six and nine years, and seventy-nine were adolescents between the ages of ten and seventeen years. Only those patients who had been suffering from migraines for at least a year were included in the trial. Each patient was treated with 50-150mg, depending on age and tolerance to medication, of butterbur root extract for four months. The treatment progression was recorded in migraine journals which were especially designed for children and adolescents.

The use of butterbur extract substantially reduced the number of migraine attacks in children and adolescents. The rate of attacks fell from 9.4 in the 6-9 year olds and 9.7 in the 10-17 year olds in the last three months prior to the study, to 4.0 and 5.8 attacks after four months of treatment. Of all the patients, seventy-seven percent of them reported a reduction in the frequency of their migraine attacks by at least half. The butterbur extract showed little adverse effects throughout the trial. Belching was the most commonly reported side-effect and the only well known adverse effect to the butterbur extract. The results of this study concluded that butterbur extract may be an effective treatment to migraines in children and adolescents. However, the researchers do caution that, since the study had an uncontrolled design, the positive results may not be sufficient enough to draw any definite conclusions regarding the effectiveness of the treatment. But, when this trial is combined with the results of two previously published clinical trials in adults, it seems that the extract is a safe and effective alternative to migraine treatment in children and adolescents.

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