Background
Petasites Hybridus, commonly known as butterbur is a small bush grown natively in Europe and temperate parts of Asia.1 The name comes from the broad leaves historically used to wrap butter.1 There is evidence for its use in allergic rhinitis, migraines and somatic symptom disorder.1 Butterbur prevents and treats migraines by inhibiting the opening of L-type voltage-gated calcium channels which decreases vasoconstriction of blood vessels and excites neurons.2 The active components also have been found to have anti-inflammatory effects through the inhibition of COX-2.2 Butterbur is usually well tolerated.1 Most common adverse effects are upset stomach, diarrhea, belching, itchy eyes, rash, headache, and fatigue.1 In rare cases, liver injury has been reported.1 Some drug interactions of butterbur include CYP3A4 inducers such as carbamazepine, phenobarbital and phenytoin.1 These drugs are thought to increase the conversion of pyrrolizidine alkaloids to toxic metabolites.1 There also may be an allergic cross reaction in patients with an allergy to ragweed.1 Butterbur may also worsen liver disease.1 The objective of this poster is to determine the effectiveness of butterbur in the prophylactic treatment of migraines based on results of studies that have been conducted.
Clinical Evidence
In the first study, the objective was to determine if Petasites hybridus (butterbur) is an effective treatment for preventing migraines.3 A randomized controlled trial was conducted in 245 patients with migraine between the ages of 18 and 65.3 Study participants were given Petasites (butterbur) extract 75 mg twice daily, Petasites (butterbur) extract 50 mg twice daily or placebo. The main outcome was migraine attack frequency. The study showed that the patients taking the 75 mg Petasites twice daily had significant reduction in migraine frequency. Reduction with this dose was 48% compared to reduction with placebo of 26%. The patients taking the 50 mg Petasites twice daily did not have a statistically significant reduction in headache frequency when compared to placebo.
The second study evaluated a specific CO2 extract of the rhizome of Petasites hybridus called Petadolex for efficacy and tolerance.4 60 patients were randomized to receive either 2 capsules (25 mg) twice daily over 12 weeks of Petadolex or placebo.4 The outcomes evaluated frequency, intensity and duration of migraines.4 This study showed up to a 60% decrease in frequency of migraines over treatment with placebo.4 It also showed some benefit for patients in the intensity and duration of migraines.4 However, the study size was small and the evaluations of intensity of the migraines was reported by patients and may be subjective.
The third study compared the efficacy of butterbur, music therapy and placebo.5 58 pediatric patients were monitored for 8 weeks as baseline then randomly sorted into the 3 interventions.5 6 months after the therapy ended, butterbur had a significant decrease in the number of migraines (p value: 0.044).5 Limitations to this study include its small size and an intention to treat analysis was not performed.5
Conclusions:
In the 2012 AHS/AAN Guidelines for Prevention of Episodic Migraine, the use of butterbur was recommended as level A: established as effective.6 According to this guideline and the studies mentioned above, butterbur may be an effective treatment for prophylaxis of migraines. However, the guidelines and the studies are all several years old and no newer studies could be found. Current studies are needed to definitively show that butterbur is effective in prophylaxis for migraine, but because of the available evidence and good safety profile butterbur could be recommended to patients as a treatment option.
Recommend0 recommendationsPublished in College of Pharmacy, Virtual Poster Session Spring 2021
Responses
Hello Soren and Jennie – what are the two main things you learned from preparing and developing this topic?
Hey Dr. Shane-McWhorter,
For me the most interesting things were the change in the AHS/AAN guidelines and that the liver-damaging compound is removable.
To explain, the 2012 had a rating of A for the use of butterbur for migraine prevention. That was later removed due to the hepatotoxicity. The pyrrolizidine alkaloids that cause the liver damage are removable without changing the effect. Most of the studies that we looked at used the brand Petadolex which has the alkaloids removed.
One of the main things I learned from studying this topic is that butterbur may have some efficacy, but it was not as effective as I was hoping it would be. Also, it is interesting that I couldn’t find any recent studies on butterbur. I am wondering if it is just because there are a lot of other options for treating migraines at this time. I didn’t realize when we first found our articles that all the studies were done in Germany with a product marketed there. I was surprised that I didn’t find any studies done in the United States on this topic.
Interesting topic. Who would be a candidate for treatment with butterbur? Can you calculate NNT in the first study for the two different doses? What type of music was used for music therapy in the third study? What would you say to a person who wants to use butterbur?
Great questions.
According to current guidelines, a good candidate would be patients who are not at risk of liver damage, are not currently taking CYP3A4 inducers, and do not have an allergy to ragweed.
The NNT of the the first 2 studies are 6 patients and 4 patients respectfully. I will add the side note that I am not the best at calculating NNT.
The third study’s music therapy used the Heidelberg model. This is comprised of relaxation, body awareness and conflict training aided by music.
To a person wanting to use butterbur, I would say to make sure that the manufacturer removes the pyrrolizidine alkaloids. I would not recommend this for anyone taking seizure medicines without the consultation of a doctor or pharmacist. I should note that with the recent advances in migraine medications, there could be better options for prevention.
Very interesting poster Jennie and Soren! What is your connection to this topic? Also, are you aware of any evidence on the efficacy of butterbur past a 12 week period?
Great questions, both of use know people or have had experience with migraines ourselves.
In answer to your second question, in the third study they saw that butterbur decreased the amount of migraines 6 months after the study ended. It was unclear however in the wording, if the patients were still using butterbur at this point or if it was a lingering effect from the 12 weeks of therapy.
Thanks for your explanation! Maybe I will try it for my migraines sometime!
Migraines run in my family for several generations and I got a lot when I was a teenager and still get them occasionally. I guess you could say I have been doing first hand research for several years now. I was hoping to find a magic bullet, but unfortunately I don’t think this is it. We did not find any long term studies on the efficacy of butterbur. I think this may be because there have been so many new medications for migraines recently that there is not as much of a need to study butterbur.
Hi Soren and Jennie! Great poster. Can patients take Butterbur in addition to another chronic migraine medications, such as propranolol?
Yes. Butterbur can be used with propranolol. There are no interactions between the two.
Can this be used as adjunctive therapy to other prophylactic migraine medications?
Yes. Butterbur is generally well tolerated and can be used with other prophylactic migraine medications.
Were you able to find any studies comparing butterbur to FDA-approved anti migraine drugs?
I did not. I was hoping to find some studies on that. Because so many options are available recently for migraines it seems that butterbur is not really be studied currently.
Hello Soren and Jennie!
Has butterbur been shown to be more effective in one type of migraine/headache versus another (example: Tension, tension, migraine, cluster)?
Unfortunately the only references we were able to find were in regards to migraines. I am unaware of if there is any effect in other headaches (tension, or cluster).
Hey Soren and Jennie! Were you able to find any studies that talked about taking this at the onset of a migraine?
Good question Brenae! We only found studies that looked at prophylactic use of butterbur.
Hey Brenae! There were mentions about taking it as a cure, but the studies we found looked more at prevention of the headaches.
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