New Study by International Research Team Shows Positive Benefits
Austin, Texas. (January 21, 2005) Medical scientists have found that the extract of the traditional herb butterbur (Petasites hybridus) can help prevent painful migraine headaches. According to a new study published in the December 28 issue of the journal Neurology, a proprietary standardized extract of the root of butterbur, was effective in preventing migraines in a randomized, placebo-controlled clinical trial of 245 migraine sufferers.
The results of the trial concluded that the use of two 75 mg tablets per day of the proprietary butterbur extract Petadolex® (Weber & Weber International, Windmere, FL) in migraine patients helped to reduce the occurrence of migraines by an average of 48% during the four months of the trial. This compared to a reduction of only 26% in the group that received a placebo. To test whether the efficacy of the herbal extract depended on the dosage, a third group of patients was given a lower dosage (50 mg) of Petadolex twice daily, and the occurrence of migraine headaches was reduced by 36%, but this was not considered significant compared to the placebo group, thereby supporting the efficacy of the higher dose of two 75 mg tablets.
Another endpoint that this trial measured was the number of patients who experienced a reduction of migraines of at least 50% or more. In the 75 mg Petadolex group, 68% met this criterion compared to only 49% in the placebo group. In addition, this outcome was measured at 1, 2, and 3 months, indicating that the herbal extract effects took place early in the trial and lasted throughout. The researchers noted that the efficacy for the butterbur extract was equivalent to the levels of effectiveness shown for conventional pharmaceutical anti-migraine drugs.
Patients from ages 18 to 65, who met the International Headache Society criteria for migraine headaches with or without the aura that often accompanies a migraine, were chosen. Each patient had experienced 2 to 6 migraines per month for at least 3 months prior to the study.
According to the lead researcher, Richard B. Lipton, MD, vice chair and professor of neurology at the Albert Einstein College of Medicine, “Our study shows that butterbur really does reduce the frequency of migraine attacks, so it’s a welcome addition to the therapeutic arsenal we have available to combat migraine.”
Previous research and clinical use of the special butterbur root extract show that it has a high safety profile. There were few adverse side effects from butterbur in the new clinical trial; the most commonly observed side effects involved the gastrointestinal tract, e.g., burping.
“This is really good news for migraine sufferers,” said Mark Blumenthal, founder and executive director of the American Botanical Council, an independent nonprofit herb research and education organization. “This natural medicine has been shown to be safe and reliable,” he said. “This trial supports previous research conducted in Europe and helps to ensure that butterbur will become more widely known and accepted by physicians and consumers alike.” Blumenthal also noted that scientific research is continuing around the world on many herbal preparations, many of which, like butterbur root, have been virtually unknown in the United States.
The randomized, double-blind, three-arm, parallel group, placebo controlled trial was carried out in nine medical centers, including the Departments of Neurology and Epidemiology and Population Health at the Albert Einstein College of Medicine, Bronx, NY; the New York Headache Center, New York, NY; Innovative Medical Research, a Division of Advance PCS, Baltimore, MD; and the Pain Clinic and Christian Albrechts University Kiel and Charite, Department of Neurology, Humboldt University Berlin, Germany.
Petadolex is a patented extract of the traditional butterbur root (Petasites hybridus) standardized to contain a minimum of petasins. The extract is manufactured in Germany by Weber and Weber, a phytomedicine company.
About the American Botanical Council
The American Botanical Council is the nation's leading nonprofit organization addressing research and educational issues regarding herbs and medicinal plants. The 16-year-old organization occupies a 2.5 acre site in Austin, Texas, where it publishes HerbalGram, a peer-reviewed journal. ABC is also the publisher of The ABC Clinical Guide to Herbs, a continuing education and reference book, which contains extensive monographs on the safety and efficacy of 29 popular herbs.
Anon. International team of researchers finds herbal extract to be effective in preventing migraine (press release). Bronx, NY: Albert Einstein College of Medicine. Dec. 28, 2004.
Lipton RB, Gobel H, Einhaupl KM, Wilks K, and Mauskop A. Petasites hybridus root (butterbur) is an effective preventive treatment for migraine. Neurology Dec. 28, 2004;63:2240-2244.