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An Herbal? Really?
Dr. Wilner:I am astonished that there is level A evidence for this herb. This might be the first instance in the world that there is level A evidence for a supplement, because supplements by their very nature are not controlled, in terms of their potency. They come from different manufacturers, and usually no sponsor is willing to put in the effort to do a double-blind, randomized study to get level A evidence. How did butterbur, which is a plant, end up with level A evidence?
Dr. Dodick: Butterbur is a plant extract. Three placebo-controlled studies have been conducted with butterbur. My hat is off to the investigators who took it upon themselves to get support necessary to conduct the studies. That shows you the pioneering spirit of some of these neurologists in headache medicine who strive to provide the best evidence possible. It looks to be, at least according to the data, as effective as the more conventional prescription medications that we use.
Dr. Wilner:I have 3 questions about butterbur. How do we know how much to take? Do we know the active ingredient? What side effects should be anticipated?
Dr. Dodick: The active ingredients are petasin and isopetasin, which appear to have anti-inflammatory properties. It can be ordered online or purchased at health food stores. Sometimes pharmacies will carry it and you can get it off the shelf. Generally, it is dosed twice or 3 times daily, usually 75 mg.
Dr. Wilner:Is it a tea, a drink, or a capsule?
Dr. Dodick: It is a capsule. Most of the side effects are gastrointestinal. It can cause dyspepsia, bloating, or diarrhea, but generally it is well tolerated.
In a headache specialist's hands, butterbur is used mainly as adjunctive therapy. We use it in addition to conventional prophylactic or preventive medication that we select. As an adjunctive therapy, it can be useful.
I have used it in children. Parents, in particular, don't want their children taking prescription medication, but they are more than happy to have their child take a supplement, so I have used it effectively and successfully in children.
Dr. Wilner:How should neurologists use this guideline?
Dr. Dodick: First of all, neurologists should use the guideline. They should use it as a guide to discuss with their patients the options that are available, and that is what I do. I talk about the classes of medication and which agents have level A evidence. I start with the agents that have the highest level of evidence. I tell patients that in very robust clinical trials, these medications have been found to have the most evidence to support their use. I talk about the side-effect profile associated with each class or each drug and engage the patient in the decision-making.
I follow the dosage recommendations. You heard from the patient today [who spoke at the meeting] that it wasn't until she saw another neurologist who increased her dose of topiramate that she went from having almost daily headaches to having 2-3 headache days per month. That is the other thing that the guideline provides -- not just what drugs have the highest level of evidence, but the dosages at which they have been found to be effective. So, it is very useful from that standpoint too. The efficacy of a lot of these drugs is dose dependent. The efficacy goes up as the dose goes up. We aren't able to get every patient to an effective dose, but for patients who are tolerating it and having partial success, keep moving the dose up.
I can't tell you how common it is for patients to be underdosed. They are started on a medication -- for example, topiramate. They are given a prescription for 25 mg. Sometimes, that's it. They are not even told to titrate the dose. You have to engage the patient to enhance compliance. Let the patient make the decision about the preventive medication they would like to try, because it turns out that 6 months to 1 year after a patient is started on a preventive medication, only approximately 25% of patients are still taking it.
Dr. Wilner:The message has gotten out with topiramate and other drugs that it is important to start with a low dose to avoid side effects, but maybe the follow-through still needs some work. You start with a low dose, but then you need to increase to efficacy and/or tolerance.
Dr. Dodick: Exactly.
Dr. Wilner:How should patients use this guideline?
Dr. Dodick: You heard from a patient here that she used the guideline as a way to discuss her options with her neurologist. So, even if the neurologist wasn't using the guideline, the patient has to be his or her own advocate.
It is very important that the message get out to patients that there actually is a preventative therapy that works, as well as a guideline for physicians that was developed over the course of about 6 years by the AAN and the American Headache Society. If a patient goes into a physician's office with the primary complaint of migraine, he or she should take along the guideline.
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