Why Is Butterbur No Longer Recommended For Migraine Prevention?

This is an article by Britt Talley Daniel MD, member of the American Academy of Neurology and the American Headache Society, text book author and blogger on Migraine.

What is Butterbur?

Butterbur, marketed in the US as Petadolex, is a perennial shrub, found throughout Europe and in parts of Asia and North America. It is usually found in wet, marshy ground, in damp forests, and adjacent to rivers or streams. The common name is attributed to the large leaves used to wrap butter during warm weather.  It is a supplement that has been used for years for treatment of migraine.

Why Is Butterbur No Longer Recommended For Migraine Prevention?  The American Academy of Neurology and the American Headache Society performed high-quality studies that led to the endorsement of the use of Butterbur extract as a migraine preventive drug. In short term clinical studies (16 weeks) Butterbur reduced the frequency of migraines.

Butterbur is a supplement which was thought be generally well tolerated but now it is known that Butterbur may have adverse toxic effects on the liver which have changed its recommendation for use. The long-term safety of Butterbur is suspicious.

It has been banned in several European countries and is unavailable in the UK and Germany.  Its safety is being evaluated by the American Headache Society.  Unfortunately, because of these concerns, Butterbur should not be recommended.

1.What are the toxic liver problems with butterbur?  Some butterbur products contain liver-toxic pyrrolizidine alkaloids (PAs) and potential cancer causing chemicals. These chemicals may be removed by a special patented treatment and only marked under the name Petadolex. Only Petadolex, which is labeled as free of PAs has been used in the research studies which established its effectiveness. 

2.What are the side effects of PAs?  PAs can damage the liver, lungs, blood circulation, and possibly cause cancer.

3.What is the dose for using Butterbur for migraine prevention? The dose is 75 mg of Petadolex twice a day for 4 months.  This was used in a clinical trial where the maximum response was achieved after 3 months with a migraine attack reduction of 58%. 

4.Butterbur is a supplement. Have there been successful controlled trials demonstrating migraine prevention?  Yes, two randomized, placebo-controlled migraine prevention trials with a total of 289 patients demonstrated the short-term safety and efficacy of the butterbur root extract in adults.  The first study was published in Neurology. 2012;78(17):1346-1353 by Holland, et al.  The second study may be found at Butterbur. National Center for Complementary and Integrative health.  https://nccih.nih.gov/health/butterbur.

5.Butterbur was approved only for safely short-term oral use for up to 16 weeks in adults.  Currently it should not be used.

What are the side effects of Butterbur when used for migraine prevention?  Butterbur is generally tolerated well, but it can cause belching, headache, itchy eyes, diarrhea, asthma, upset stomach, fatigue, and drowsiness.  Persons who are allergic to ragweed, marigolds, and daisies may get an allergic reaction from Butterbur.

Related Questions.

1.Since Butterbur shouldn’t be used for migraine prevention any more does it treat anything else in medicine?  As a supplement, available over the counter, Butterbur was used for pain, upset stomach, stomach ulcers, ongoing cough, chills, anxiety, plague, fever, insomnia (insomnia), hay fever, irritable bladder, urinary tract spasms, and to stimulate the appetite. Hopefully the FDA will ban the import and use of Butterbur.

2.What does the FDA say about supplements?   The FDA has encouraged medical doctors and the public to not use supplements because purity of what is in them is not assured.  The United States Pharmacopeia, USP, guarantees the purity of all supported drugs.  If I go to CVS and get an aspirin tablet, I can be sure it is 5 gr of aspirin or 325 mg.  But if I buy a supplement at CVS, I’m not certain what is in the supplement.

At a Texas Neurology meeting in Austin several years ago I heard a story by a physician from Houston who had a patient with an uncertain illness who had been taking a supplement.  When the supplement was analyzed it was found to have nothing in it, which is a charlatan business practice.  Supplements that promise health for energy and fatigue usually have caffeine or Sudafed in them although it won’t be found on the label of the box.  In the future look to the FDA to cut down on supplement use and advertising.

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Britt Talley Daniel MD