Austin, Texas (March 17, 2005). A proprietary extract of butterbur root, an herbal remedy from Europe, has successfully lowered the incidence of migraines in children and adolescents in a new clinical trial published in the recent issue of the journal Headache.1
Migraines occur in an estimated 3% to 7% of all children. Because most migraine therapies seem to be ineffective when given to children, there is a strong need for further research on promising new therapies that can prevent migraines in children. Numerous studies have evaluated therapies for adults with migraines; however, only a few controlled trials have investigated the prophylactic treatment of migraines in either children or adolescents.
Butterbur (Petasites hybridus), a native European plant, has been used successfully for its ability to relieve pain and spasms in conditions like migraine, 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 German Federal Institute for Drugs and Medical Devices.) Because approval of placebo-controlled trials in children is difficult to obtain from an ethical review board in Germany, the researchers chose to conduct an open-label study. Unlike a placebo-controlled trial in which neither patients nor researchers know who is using the real active agent or a placebo, in an open-label trial, all patients receive the active treatment (in this case, butterbur root extract) and both the patients and researchers are aware of this.
The new study was conducted in five pediatric clinics and 13 medical practices and included a total of 108 subjects: there were 29 children: (ages 6-9 years) and 79 adolescents (10-17 years). Only patients suffering from migraines for at least 1 year were included in the trial. They were treated with 50 to 150 mg of butterbur root extract (Petadolex® Weber & Weber GmbH & Co, KG, Germany*) for 4 months. The dose of butterbur extract was dependent on the subjects’ age and tolerance to the medication. Treatment progression was recorded in migraine journals especially designed for children and adolescents.
The number of migraine attacks in children and adolescents were substantially reduced by the use of the butterbur root extract. The rate of attacks fell from 9.4 in the 6-9 year olds and 9.7 in the 10-17 year olds-the rate during the last 3 months prior to the study-to 4.0 and 5.8 attacks, for each group respectively, after 4 months of treatment. Of all patients, 77% reported a reduction in the frequency of migraine attacks by at least half. Ninety-one percent of patients reportedly felt substantially or at least slightly improved after 4 months of butterbur treatment. The butterbur extract was very well tolerated with only few adverse events. Belching was the most commonly reported adverse effect and is the only significant and well-known side effect of the standardized butterbur extract. All other adverse events were mild and did not lead to premature termination of the study.
The results of this study indicated that butterbur root extract may be an effective and well-tolerated prophylactic treatment of migraines in children and adolescents. Furthermore, the data reported here confirm the results found in other clinical studies and drug-monitoring trials in adults. (A randomized controlled trial in adults in which Petadolex successfully lowered the frequency of migraines was recently published in the journal Neurology.2,3)
Overall, the results of this study with a natural product are promising for young patients affected by migraines. 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 effectiveness of butterbur in children and adolescents. However, the results of this open trial, when combined with the data available from two previously published randomized clinical trials with the same butterbur root extract in adults,2,4 demonstrate that the extract appears to be a safe and effective alternative for preventive migraine treatment also in children and adolescents. The authors suggest that the results of this trial warrant a placebo-controlled trial in children and adolescents to further document butterbur's efficacy in migraine prevention in this patient group.
Note: the standardized butterbur root extract used in this trial (Petadolex®) was purified to remove all naturally occurring pyrrolizidine alkaloids (PAs) according to the quality control requirements of the German government. Various types of PAs are known to be toxic to the liver.
About the American Botanical CouncilEstablished in 1988, the American Botanical Council (ABC) is the leading nonprofit, member-based international organization working to educate consumers, healthcare professionals, researchers, educators, industry, and the media on the safe and effective use of herbs and medicinal plant products. ABC is located on a 2.5 acre site in Austin, Texas where it publishes HerbalGram, a peer-reviewed quarterly journal. ABC is also the publisher of The ABC Clinical Guide to Herbs and other books and publications. More information is available at www.herbalgram.org.
*Note: Petadolex® is imported and marketed in the United States by Weber & Weber GmbH USA of Windermere, Florida.
1 Pothmann R, Danesch U. Migraine prevention in children and adolescents: results of an open study with a special butterbur root extract. Headache. 2005;45:1-8.
2 Lipton RB, Gobel H, Einhaupl KM, Wilks K, and Mauskop A. Petasites hybridus root (butterbur) is an effective preventive treatment for migraine. Neurology. December. 28, 2004;63:2240-2244.
3 Herbal extract effective in migraine prevention: new study by international research team shows positive benefits [press release]. Austin, TX: American Botanical Council; January 21, 2005. Available at http://www.herbalgram.org/default.asp?c=petadolex. Accessed March 17, 2005.
4 Diener HC, Rahlfs VW, Danesch U. The first placebo-controlled trial of a special butterbur root extract for the prevention of migraine: reanalysis of efficacy criteria. Eur Neurol. 2004;51:89-97.