What to Expect from a Preventative Headache Medication Expectations are very important. As a physician, I was trained to say, “Take this medication; it will help prevent your headaches.” As a patient seeking headache relief, I might interpret this as: “Great! I can expect to have a lot fewer headaches in the future.” When it comes to medical care, often people don’t comparison shop when it comes to their medications or treatments. They seem to believe that just because a doctor says, “You need to take this pill, or you need this surgery,” there is no question that the pill or procedure will be of benefit. Maybe it’s true for medications like antibiotics, but for most medications we prescribe, the chance they will do anything for you is much less than you would expect. Preventative Headache Medications and Two Headache Patterns I’m going to discuss the use of preventative headache medications in two types of headache. One group is people with 15 or fewer headaches per month. This type of headache is called episodic tension headache or episodic migraine. The other group is people with more than 15 days of headache per month. This type of headache pattern is called either chronic daily headache or chronic daily migraine. As you might expect, the episodic pattern responds better to the medications than does the more chronic daily form. There are preventative medications used for unusual headaches like cluster headaches but that will not be covered in this article. The focus here will be on prevention of migraine and tension type headaches. Preventative Headache Medications Used in People with 15 or Fewer Headaches Per Month Before we get started discussing the potential benefits, we must agree on an acceptable goal that we think the medication can achieve. Complete elimination of headaches with these medications is an unrealistic goal. No medication studied so far has this ability. The outcome that is most often used in scientific studies is the ability of a medication to decrease your number of headaches per month by 50%. The goal of the study is to figure out what percentage of people taking the medication are actually helped---meaning how many people met the goal. Let’s do an example. In this case of headache Drug A, 50% of the people taking the medication reached this goal. Imagine that John has 10 headaches per month. He has about a 50% chance that Drug A will give him some benefit after taking it for one to three months. The benefit he’d most likely experience is a reduction in his headaches to only 5 headaches per month. If he is especially lucky, he could have even fewer headaches. Don’t forget though, John also runs a 50% chance that this medication will prove to be worthless to him. Tables: Preventative Headache Medications for Episodic Tension Headache or Migraine Below is a table of common headache medications, supplements, and procedures I employ to on a regular basis. The column labeled “Number of Studies” will tally the number of studies looked at to come up with the total number of patients in the next column. All the studies listed in this table are randomized controlled trials. One thing to note is as the number of total patients increases so does the probability that the results seen in the studies is real. Often in studies with small numbers of patients there is a chance that the data (the percent reduction in headaches in this case) is incorrect. Most physicians give higher credence to large studies. Also, if there is more than one trial showing a favorable outcome, its much more likely to be believed. Too often one study is done showing a positive outcome and everyone gets quite excited. Unfortunately, often in such cases when the study is repeated, it fails to show any benefit Note: Caution interpreting the data from medications with only one study reported. Often with subsequent studies the percentages will change, sometimes dramatically. What about People with Very Frequent Headaches -- More than 15 per Month? There are just a few medication trials looking at patients with more than 15 days of headache per month. This group of patients is not well studied. Most of the studies done on the prevention of headaches involve patients with less than 10 headaches per month. The reason why the drug companies like to study those patients with fewer headaches is that most studies on people with more frequent headaches are less successful. Most often, they fail to find that the prescription medication can reduce the number of headaches by 50% in most patients. Since these studies cannot meet the goal, they often pick a less impressive goal. On average, these studies show 2-4 headaches fewer per month with the prescription medication than with placebo. Perhaps someone would go from 20 headaches a month to 16 headaches a month. It may take up to three months to see the difference. Of course, there are some lucky people in both the prescription medication group and the placebo group that see a more dramatic reduction in headaches. Of course, there will be other people who get no benefit at all. For instance, take this trial with Topiramate in patients with more than 15 days of headache per month at a target dose of 100 mg per day. The trial lasted 16 weeks. It showed that Topiramate reduced the number of headaches by an average of 3.5 days per month while the placebo failed to reduce the number of headaches. The benefit was going from 20 headaches a month to 16 headaches a month after taking Topiramate for three months. My criticism of this trial with Topiramate is that it’s difficult to fool people as to which pill is a placebo. Topiramate when taken at a useful dose almost always causes some sort of noticeable side effect. This may have an effect on its perceived benefit. It may be an advantage over the placebo which as a sugar pill has no side effect. Why Do the Placebo Procedures Appear to Do So Well? Procedures such as Botulinum Toxin injections, salt water injections, and real and fake acupuncture seem to have similar results in episodic headache. About 50% of the people get better. These studies are harder to analyze because the placebo effect may be different. They also seem to do as well as some medications for chronic daily headache. For instance, in a large study looking at patients with more than 20 headaches per month, the average reduction in number of headaches with Botox was 8.4 headaches and with saltwater injections 6.4. Why does it seem that Botulinum Toxin and salt water injections result in people experiencing more days per month reduction in headaches than Topiramate? In this last Botox study I mentioned they used patients who had no success with taking pills. So, it’s possible that some people respond better to a placebo if it’s painful. I will tell you that injections with either Botulinum Toxin or salt water are very painful. There is no doubt in your mind as a patient that the doctor just gave you something potentially powerful. Or maybe there is something beneficial in having needles put into the forehead muscles that helps to cut down on the number of headaches. This may be why all the studies that involve some type of needle to the forehead muscles have similar results. I think it doesn’t matter if you inject anything at all, its the needle that matters. A good study would be to look at the effect of Topiramate versus injections with salt water or just using acupuncture needles at trigger points on the head. I don’t think there will be much difference. If true this could greatly simplify the treatment of headaches. It’s much cheaper and safer to use acupuncture needles once a month than to take Topiramate every day. Don’t worry acupuncture needles are very small and not really painful. So Where Do I Go from Here? Now you know a little about the effectiveness of these medications. Hopefully you can use this to help you decide how you’d like your treatment to proceed. Maybe you can see why I am such a big proponent of lifestyle change. While most lifestyle changes such as diet, relaxation training, or sleep hygiene instruction, have not been studied as rigorously as these medications and procedures, they certainly have none of the negative side effects. In fact, you’ll find that life style changes have only positive side effects. For instance, if you change you diet, lose a few pounds, and unfortunately your headaches don’t improve, at least you’ve gotten something good out of the deal. Take a headache medication for three months and you’re about 50% likely to see no benefit, except a lighter wallet. Though, if you do take the preventative medication, remember that it may take one to three months before you realize any benefits. If you want the benefits, you’ll have to take it consistently. I use these medications frequently and I think they work for many people. However, I’ve found that having correct expectations and making a commitment to a proper trial for three months are important factors in predicting a successful outcome. References: Bandolier, http://www.jr2.ox.ac.uk/bandolier/booth/booths/migraine.html. Data found in Table 1 on Topirimate, Depakote, Carbamezapine, Gabapentin, Propanolol. Neurology, 2005 Feb 22; 64(4):713-5. Efficacy of coenzyme Q10 in migraine prophylaxis: a randomized controlled trial. Neurology, 1998 Feb; 50(2):466-70. Effectiveness of high-dose riboflavin in migraine prophylaxis: a randomized controlled trial. Headache, 2004 Oct; 44(9):885-90. A combination of riboflavin, magnesium, and feverfew for migraine prophylaxis: a randomized trial. Headache, 2007 Nov 28, “Botulinum Toxin Type A as Migraine Preventive Treatment in Patients Previously Failing Oral Prophylactic Treatment Due To Compliance Issues.” Mayo Clinic Proceedings, 2005 Sep; 80(9):1126-37. Botulinum toxin type A for the prophylactic treatment of chronic daily headache: a randomized, double-blind, placebo-controlled trial. Lancet Neurology, 2006 Apr; 5(4):310-6. Efficacy of acupuncture for the prophylaxis of migraine: a multicentre randomized controlled clinical trial. Cephalagia, 2007 Jul; 27(7):814-23.Topiramate reduces headache days in chronic migraine: a randomized, double-blind, placebo-controlled study. Arch Neurology, 1979 Nov; 36(11):695-9. Amitriptyline in migraine prophylaxis. Clin J Pain, 2008 Feb; 24(2):98-105. Acupuncture in migraine prevention: a randomized sham controlled study with 6-months post-treatment follow-up. Return to Headaches

What to Expect from a Preventative Headache Medication

Expectations are very important. As a physician, I was trained to say, “Take this medication; it will help prevent your headaches.” As a patient seeking headache relief, I might interpret this as: “Great! I can expect to have a lot fewer headaches in the future.”

When it comes to medical care, often people don’t comparison shop when it comes to their medications or treatments. They seem to believe that just because a doctor says, “You need to take this pill, or you need this surgery,” there is no question that the pill or procedure will be of benefit. Maybe it’s true for medications like antibiotics, but for most medications we prescribe, the chance they will do anything for you is much less than you would expect.

Preventative Headache Medications and Two Headache Patterns

I’m going to discuss the use of preventative headache medications in two types of headache. One group is people with 15 or fewer headaches per month. This type of headache is called episodic tension headache or episodic migraine. The other group is people with more than 15 days of headache per month. This type of headache pattern is called either chronic daily headache or chronic daily migraine. As you might expect, the episodic pattern responds better to the medications than does the more chronic daily form.

There are preventative medications used for unusual headaches like cluster headaches but that will not be covered in this article. The focus here will be on prevention of migraine and tension type headaches.

Preventative Headache Medications Used in People with 15 or Fewer Headaches Per Month

Before we get started discussing the potential benefits, we must agree on an acceptable goal that we think the medication can achieve. Complete elimination of headaches with these medications is an unrealistic goal. No medication studied so far has this ability.

The outcome that is most often used in scientific studies is the ability of a medication to decrease your number of headaches per month by 50%. The goal of the study is to figure out what percentage of people taking the medication are actually helped---meaning how many people met the goal.

Let’s do an example. In this case of headache Drug A, 50% of the people taking the medication reached this goal. Imagine that John has 10 headaches per month. He has about a 50% chance that Drug A will give him some benefit after taking it for one to three months. The benefit he’d most likely experience is a reduction in his headaches to only 5 headaches per month. If he is especially lucky, he could have even fewer headaches. Don’t forget though, John also runs a 50% chance that this medication will prove to be worthless to him.

Tables: Preventative Headache Medications for Episodic Tension Headache or Migraine

Below is a table of common headache medications, supplements, and procedures I employ to on a regular basis. The column labeled “Number of Studies” will tally the number of studies looked at to come up with the total number of patients in the next column. All the studies listed in this table are randomized controlled trials.

One thing to note is as the number of total patients increases so does the probability that the results seen in the studies is real. Often in studies with small numbers of patients there is a chance that the data (the percent reduction in headaches in this case) is incorrect. Most physicians give higher credence to large studies. Also, if there is more than one trial showing a favorable outcome, its much more likely to be believed. Too often one study is done showing a positive outcome and everyone gets quite excited. Unfortunately, often in such cases when the study is repeated, it fails to show any benefit

Note: Caution interpreting the data from medications with only one study reported. Often with subsequent studies the percentages will change, sometimes dramatically.

What about People with Very Frequent Headaches -- More than 15 per Month?

There are just a few medication trials looking at patients with more than 15 days of headache per month. This group of patients is not well studied. Most of the studies done on the prevention of headaches involve patients with less than 10 headaches per month. The reason why the drug companies like to study those patients with fewer headaches is that most studies on people with more frequent headaches are less successful. Most often, they fail to find that the prescription medication can reduce the number of headaches by 50% in most patients. Since these studies cannot meet the goal, they often pick a less impressive goal.

On average, these studies show 2-4 headaches fewer per month with the prescription medication than with placebo. Perhaps someone would go from 20 headaches a month to 16 headaches a month. It may take up to three months to see the difference. Of course, there are some lucky people in both the prescription medication group and the placebo group that see a more dramatic reduction in headaches. Of course, there will be other people who get no benefit at all.

For instance, take this trial with Topiramate in patients with more than 15 days of headache per month at a target dose of 100 mg per day. The trial lasted 16 weeks. It showed that Topiramate reduced the number of headaches by an average of 3.5 days per month while the placebo failed to reduce the number of headaches. The benefit was going from 20 headaches a month to 16 headaches a month after taking Topiramate for three months.

My criticism of this trial with Topiramate is that it’s difficult to fool people as to which pill is a placebo. Topiramate when taken at a useful dose almost always causes some sort of noticeable side effect. This may have an effect on its perceived benefit. It may be an advantage over the placebo which as a sugar pill has no side effect.

Why Do the Placebo Procedures Appear to Do So Well?

Procedures such as Botulinum Toxin injections, salt water injections, and real and fake acupuncture seem to have similar results in episodic headache. About 50% of the people get better. These studies are harder to analyze because the placebo effect may be different. They also seem to do as well as some medications for chronic daily headache. For instance, in a large study looking at patients with more than 20 headaches per month, the average reduction in number of headaches with Botox was 8.4 headaches and with saltwater injections 6.4.

Why does it seem that Botulinum Toxin and salt water injections result in people experiencing more days per month reduction in headaches than Topiramate? In this last Botox study I mentioned they used patients who had no success with taking pills.

So, it’s possible that some people respond better to a placebo if it’s painful. I will tell you that injections with either Botulinum Toxin or salt water are very painful. There is no doubt in your mind as a patient that the doctor just gave you something potentially powerful.

Or maybe there is something beneficial in having needles put into the forehead muscles that helps to cut down on the number of headaches. This may be why all the studies that involve some type of needle to the forehead muscles have similar results. I think it doesn’t matter if you inject anything at all, its the needle that matters.

A good study would be to look at the effect of Topiramate versus injections with salt water or just using acupuncture needles at trigger points on the head. I don’t think there will be much difference. If true this could greatly simplify the treatment of headaches. It’s much cheaper and safer to use acupuncture needles once a month than to take Topiramate every day. Don’t worry acupuncture needles are very small and not really painful.

So Where Do I Go from Here?

Now you know a little about the effectiveness of these medications. Hopefully you can use this to help you decide how you’d like your treatment to proceed. Maybe you can see why I am such a big proponent of lifestyle change. While most lifestyle changes such as diet, relaxation training, or sleep hygiene instruction, have not been studied as rigorously as these medications and procedures, they certainly have none of the negative side effects. In fact, you’ll find that life style changes have only positive side effects. For instance, if you change you diet, lose a few pounds, and unfortunately your headaches don’t improve, at least you’ve gotten something good out of the deal.

Take a headache medication for three months and you’re about 50% likely to see no benefit, except a lighter wallet. Though, if you do take the preventative medication, remember that it may take one to three months before you realize any benefits. If you want the benefits, you’ll have to take it consistently. I use these medications frequently and I think they work for many people. However, I’ve found that having correct expectations and making a commitment to a proper trial for three months are important factors in predicting a successful outcome.

References:

Bandolier, http://www.jr2.ox.ac.uk/bandolier/booth/booths/migraine.html. Data found in Table 1 on Topirimate, Depakote, Carbamezapine, Gabapentin, Propanolol.

Neurology, 2005 Feb 22; 64(4):713-5. Efficacy of coenzyme Q10 in migraine prophylaxis: a randomized controlled trial.

Neurology, 1998 Feb; 50(2):466-70. Effectiveness of high-dose riboflavin in migraine prophylaxis: a randomized controlled trial.

Headache, 2004 Oct; 44(9):885-90. A combination of riboflavin, magnesium, and feverfew for migraine prophylaxis: a randomized trial.

Headache, 2007 Nov 28, “Botulinum Toxin Type A as Migraine Preventive Treatment in Patients Previously Failing Oral Prophylactic Treatment Due To Compliance Issues.”

Mayo Clinic Proceedings, 2005 Sep; 80(9):1126-37. Botulinum toxin type A for the prophylactic treatment of chronic daily headache: a randomized, double-blind, placebo-controlled trial.

Lancet Neurology, 2006 Apr; 5(4):310-6. Efficacy of acupuncture for the prophylaxis of migraine: a multicentre randomized controlled clinical trial.

Cephalagia, 2007 Jul; 27(7):814-23.Topiramate reduces headache days in chronic migraine: a randomized, double-blind, placebo-controlled study.

Arch Neurology, 1979 Nov; 36(11):695-9. Amitriptyline in migraine prophylaxis.

Clin J Pain, 2008 Feb; 24(2):98-105. Acupuncture in migraine prevention: a randomized sham controlled study with 6-months post-treatment follow-up.

Return to Headaches