The butterbur plant (Petasites hybridus) is a shrub found throughout Europe as well as parts of Asia and North America. Butterbur that has been used medicinally for centuries to treat cough, asthma, and inflammatory diseases. The butterbur plant can grow to a height of three feet and is usually found in wet, marshy ground, in damp forests, and adjacent to rivers or streams.

Active ingredients in butterbur extract
Petasin, a kind of sesquiterpene ester, appears to be a major active compound of Butterbur extract. It has inhibitory activities on leukotriene generation in eosinophils and neutrophils. This indicates that it may have anti-inflammatory and anti-allergy properties although butterbur does not seem to be effective in blocking histamine release. Butterbur also helps reduce smooth muscle spasm.

Petadolex ( Butturbur ) 60 Softgels - Enzymatic Therapy

Petadolex contains the patented extract of butterbur that supports healthy blood vessel tone in the brain, as well as normal blood flow in the brain.* Butterbur has been the subject of several placebo-controlled clinical studies.

Recommendations: One butterbur softgel three times daily, or 2 softgels 2 times daily for the first four weeks. Thereafter, one softgel twice daily.

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Butterbur Safety
Butterbur has not been studied extensively enough to determine its side effects, but thus far it appears to be safe.

Medical uses for Butterbur

Allergies - Allergic Rhinitis
Butterbur may be helpful for allergic rhinitis although the research thus far with butterbur leading to relief of allergies has not been consistent. Most, but not all, studies support the use of butterbur for allergic rhinitis.

Butterbur and Asthma / Bronchitis
Various parts of the butterbur plant have been used for centuries to treat bronchial asthma and whooping cough. Butterbur's possible effectiveness in treating respiratory disorders such as asthma and bronchitis is attributed to the antispasmodic and anti-inflammatory properties of the petasin constituent. (see below)

Butterbur and Migraine Headache
Two clinical studies using 50 mg and 75 mg of a standardized butterbur extract twice daily for 12 weeks demonstrated its effectiveness as a prophylactic treatment for migraines. When used to treat migraines, administration is prophylactic and supplementation should be carried out daily for a few weeks and then tapered until migraine incidence begins to increase. Butterbur may work by preventing peptidoleukotriene biosynthesis.

Butterbur Herb Research Update
Treating intermittent allergic rhinitis: a prospective, randomized, placebo and antihistamine-controlled study of Butterbur extract Ze 339.
Phytother Res. 2005 Jun;19(6):530-7.
Intermittent allergic rhinitis causes patients distress and impairs their work performance and quality of life. Prospective, randomized, double-blind, parallel group comparison study of Butterbur extract (Ze 339; 8 mg total petasine; one tablet thrice-daily), fexofenadine (Telfast 180, one tablet once-daily) and placebo in 330 patients. Protocol and analysis were according to the latest guidelines on new treatments for allergic rhinitis. Findings: Both active treatments were individually significantly superior to placebo in improving symptoms of allergic rhinitis, while there were no differences between the two active treatments. Superiority to placebo was similarly shown during the evening/night, by physicians' own assessment and by responder rates. Both treatments were well tolerated. Conclusione: Butterbur and Fexofenadine are comparably efficacious relative to placebo. Despite being a herbal drug, Butterbur has now been subject to a series of well controlled trials and should be considered as an alternative treatment for allergic rhinitis.

An extract of the root of a plant called butterbur (Petasites hybridus) significantly reduces the frequency of migraine headaches. An article published in the December 2004 issue of Neurology reports a trial that compared butterbur with an inactive placebo. Researchers compared the efficacy of two different doses of butterbur extract to that of a placebo in about 230 migraine patients. They had experienced two to six attacks per month for the 3 months prior to the study. The number of migraine headache attacks per month was reduced by 45 percent in the group that took 75 milligrams of butterbur twice daily, compared with a reduction of 28 percent in the placebo group during the 16-week trial. A group that took 50 milligrams of butterbur twice daily experienced a 32 percent decrease, not significantly different from placebo. The butterbur extract was well tolerated, the team reports, with burping as the only adverse event occurring more frequently in the active treatment groups. There were no changes in blood pressure, heart rate, or routine laboratory tests.

Petasites hybridus root ( butterbur ) is an effective preventive treatment for migraine.
Neurology. 2004 Dec 28;63(12):2240-4.
To evaluate the clinical efficacy of a standardized special root extract from the plant  butterbur as a preventive therapy for migraine. This is a three-arm, parallel-group, randomized trial comparing butterbur extract 75 mg bid, butterbur extract 50 mg bid, or placebo bid in 245 patients with migraine. Eligible patients met International Headache Society criteria for migraine, were ages 18 to 65, and had at least two to six attacks per month over the preceding 3 months. The main outcome measure was the decrease in migraine attack frequency per month calculated as percentage change from baseline over a 4-month treatment period. Over 4 months of treatment, in the per-protocol analysis, migraine attack frequency was reduced by 48% for butterbur extract 75 mg bid, 36% for butterbur extract 50 mg bid, and 26% for the placebo group. The proportion of patients with a > or =50% reduction in attack frequency after 4 months was 68% for patients in the butterbur extract 75-mg arm and 49% for the placebo arm. Results were also significant in favor of butterbur 75 mg at 1, 2, and 3 months based on this endpoint. The most frequently reported adverse reactions considered possibly related to treatment were mild gastrointestinal events, predominantly burping. Butterbur extract 75 mg bid is more effective than placebo and is well tolerated as a preventive therapy for migraine. Butterbur 50 mg PO bid was not significantly more effective than placebo on the primary study endpoints.

Butterbur Ze339 for the treatment of intermittent allergic rhinitis: dose-dependent efficacy in a prospective, randomized, double-blind, placebo-controlled study.
Arch Otolaryngol Head Neck Surg. 2004 Dec;130(12):1381-6.
To investigate whether the efficacy and safety of Butterbur extract Ze339 are related to dosage when administered to patients with intermittent allergy rhinitis. One hundred eighty-six patients were randomized (Butterbur Ze339 high dose, 60; low dose, 65; and placebo, 61 patients). Established diagnostic criteria for intermittent allergic rhinitis were confirmed by skin allergy tests in all patients. High-dose butterbur group, 1 tablet 3 times daily; low-dose group, 1 tablet twice daily; or matching placebo. All groups were treated for 2 consecutive weeks. The main efficacy variable was change in allergy symptoms from baseline to end point during the daytime. The secondary efficacy variables were Clinical Global Impression score, change in symptoms from baseline to treatment day 7, and responder rates. Butterbur Ze339 is an effective treatment for intermittent allergic rhinitis symptoms and is well tolerated. The effects of butterbur are clear to allergy patients and physicians in a double-blind evaluation against placebo. butterbur migraines.

Effects of butterbur treatment in intermittent allergic rhinitis: a placebo-controlled evaluation.
Ann Allergy Asthma Immunol. 2004 Jul;93(1):56-60.
Butterbur (Petasites hybridus) contains the active ingredient petasin, which exhibits antileukotriene and antihistamine activity. Previous studies of intermittent allergic rhinitis (IAR) have demonstrated a comparable response to butterbur compared with a histamine H1-receptor antagonist on the 36-Item Short-Form Health Survey quality-of-life score. However, there has been no placebo-controlled study of the effects of butterbur use on objective and subjective outcomes in IAR. There was no significant clinical efficacy of butterbur use vs placebo use on objective and subjective outcomes in IAR. Further studies are now indicated to investigate the use of butterbur in persistent allergic rhinitis.

Petasites hybridus (Butterbur root) extract in the treatment of asthma - an open trial.
Danesch UC. Altern Med Rev. 2004 Mar;9(1):54-62.
The efficacy and tolerability of a butterbur root extract (Petadolex) for the treatment of asthma was analyzed in a prospective, non-randomized, open trial. Subjects included 64 adults and 16 children/adolescents treated for two months with the extract, followed by two months during which the intake of the extract was optional. Concomitant asthma medication was permitted. The number, duration, and severity of asthma attacks decreased, while peak flow, forced expiratory volume (FEV1), and all measured symptoms improved during therapy. In addition, more than 40 percent of patients using asthma medications at baseline reduced intake of these medications by the end of the study. This study suggests the Butterbur extract Petadolex is an effective and safe therapy for the treatment of asthma.

A placebo-controlled evaluation of butterbur and fexofenadine on objective and subjective outcomes in perennial allergic rhinitis.
Clin Exp Allergy. 2004;34:646-9.
There are presently no placebo-controlled data regarding the effects of butterbur on subjective and objective outcomes in patients with perennial allergic rhinitis. Objective We performed a placebo-controlled evaluation of the effects of Butterbur and fexofenadine (FEX) on subjective and objective outcomes in patients with perennial allergic rhinitis. Methods Sixteen patients with perennial allergic rhinitis and house dust mite sensitization were randomized in double-blind cross-over fashion to receive for 1 week either Butterbur 50 mg twice daily, FEX 180 mg once daily and placebo (PL) once daily, or PL twice daily. Conclusion: Butterbur and FEX, in comparison to placebo, were equally effective in attenuating the nasal response to AMP and in improving nasal symptoms, highlighting a potential role for butterbur in the treatment of allergic rhinitis.

Butterbur, a herbal remedy, confers complementary anti-inflammatory activity in asthmatic patients receiving inhaled corticosteroids.
Clin Exp Allergy. 2004 Jan;34(1):110-4.
The effects of butterbur, a herbal remedy, as add-on therapy to inhaled corticosteroids in patients with atopic asthma is currently unknown. We evaluated the effects of butterbur, given as add-on therapy to asthmatic patients maintained on inhaled corticosteroids, assessing adenosine monophosphate (AMP) bronchoprovocation (primary outcome variable) along with other surrogate inflammatory markers such as exhaled nitric oxide, serum eosinophil cationic protein and peripheral blood eosinophil count. Chronic dosing with butterbur conferred complementary anti-inflammatory activity in atopic asthmatic patients maintained on inhaled corticosteroids. Further studies are now required to assess the potential role for butterbur as either monotherapy in milder patients or add-on therapy in more severe asthmatics.

Safety of a patented special butterbur root extract for migraine prevention.
Headache. 2003 Jan;43(1):76-8.
To report on the safety of a patented special butterbur root extract used for migraine prevention. Two placebo-controlled clinical trials have been conducted supporting the beneficial use in humans. CONCLUSION: The patented special butterbur root extract is safe for the treatment in humans.

In the News
Butterbur was found to be no more effective than placebo at relieving symptoms of intermittent allergic rhinitis, more commonly known as hay fever. However, lead author Dr. Brian J. Lipworth of the University of Dundee in Scotland found that the herb was more effective than placebo and as effective as the allergy drug Allegra (fexofenadine) at treating year-round allergic rhinitis. "We need much bigger studies in intermittent allergic rhinitis in more severe patients comparing butterbur versus placebo," Lipworth said. He said he was sure that larger studies would show that the herb is more effective than placebo. The active ingredient in butterbur, also known as Petasites hybridus, is petasin, which has been shown to block leukotrienes, substances that are thought to play a role in lung inflammation. Petasin has also been shown to inhibit compounds called histamines that are released by the immune system during allergic reactions. Previous research has found that butterbur may be as effective as some allergy medications, but studies in which the herb is compared with a placebo have not been performed. Therefore, Lipworth and his colleagues compared butterbur to placebo in 35 men and women with seasonal allergies to grass pollen. Participants were randomly assigned to take butterbur or a placebo twice a day for 2 weeks. Symptoms did not improve significantly in people taking butterbur or the placebo. There were also no significant differences in quality of life or nasal air flow. Despite the lack of a significant effect, the researchers did detect signs that butterbur may have been more helpful than placebo for people with the most severe symptoms. This trend was not statistically significant, which means it could have been a result of chance, but Lipworth's team speculates that the herb may have real benefits for people with severe allergy symptoms. Neither treatment caused serious side effects. SOURCE: Annals of Allergy, Asthma and Immunology, July 2004.

Butterbur for Migraine Headaches
An extract of the root of a plant called butterbur (Petasites hybridus) reduces the frequency of migraine headaches. An article published in the December 2004 issue of Neurology reports a trial that compared butterbur with an inactive placebo. Researchers compared the effectiveness of two different doses of butterbur extract in about 230 migraine patients. They had experienced two to six attacks per month for the 3 months prior to the study. The number of migraine headache attacks per month was reduced by 45 percent in the group that took 75 milligrams of butterbur twice daily, compared with a reduction of 28 percent in the placebo group during the 16-week trial. A group that took 50 milligrams of butterbur twice daily experienced a 32 percent decrease, not significantly different from placebo. The butterbur extract was well tolerated, the team reports, with burping as the only adverse event occurring more frequently in the active treatment groups. There were no changes in blood pressure, heart rate, or routine laboratory tests.
    My comments: As with many herbs and medicines, it is likely that some users will find butterbur reduces the severity or frequency of their migraine headache, whereas others may not find it to be helpful. How butterbur interacts with standard pharmaceutical medicines -- such as beta blockers or triptans -- used for prevention or treatment of migraines is currently not known.