2005-03-18
German Federal Institute for Drugs and Medical Devices.

Two randomised and placebo-controlled trials on adult migraine patients have demonstrated that a proprietary butterbur root extract made by Weber and Weber (Petadolex) reduces migraine attacks. But many herbal medicines, like drugs, are not tested on children, despite the need to take into account the different physiology of children.

An estimated 3-7 per cent of all children get migraines but most migraine therapies seem to be ineffective when given to children.

Writing in this month's issue of Headache: The Journal of Head and Face Pain (volume 45, issue 3, p196), German researchers said that 77 per cent of the children and teenagers recruited in their trial had at least half the number of attacks as previously.

The 108 patients, made up of 29 children aged between 6-9 years and 79 adolescents, had suffered from migraines for at least a year before entering the prospective open-label study. They were treated with 50 to 150 mg of the butterbur root extract depending on age for a period of 4 months.

The researchers chose to conduct an open-label study - where all patients receive the active treatment and both the patients and researchers are aware of this - becuase approval of placebo-controlled trials in children is difficult to obtain from an ethical review board in Germany.

Frequency of the attacks was also reduced by 63 per cent, said Dr Raymund Pothmann, and Ulrich Danesch, falling from 9.4 in the 6-9 year olds and 9.7 in the 10-17 year olds to 4.0 and 5.8 attacks, for each group respectively, after treatment.

More than 90 per cent of the patients also reported feeling substantially or at least slightly improved after four months of taking the extract.

"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," concluded the researchers.

"Butterbur root extract shows a potential as an effective and well-tolerated migraine prophylaxis also for children and teenagers."

The authors caution that because of the uncontrolled study design, the positive results of this trial are not sufficient to draw any definite conclusions regarding the herbal's efficacy.

But when combined with data from previous clinical trials on the same extract in adults, they offer support for its use in preventing migraines among children and adolescents.

The authors suggest that a placebo-controlled trial in this group could add further evidence of its efficacy.

The findings follow a review of herbal remedies and evidence of their benefit to children, which highlighted the lack of research on this population group by the herbals sector.

Butterbur or Petasites hybridus is native to Europe and has also been used to relieve pain and spasms in conditions like asthma, urinary tract spasms, and lower back pain. The use for urinary spasms has been approved by the German Commission E, an expert advisory panel of the