Do migraine drugs work in kids?

About 6% of young children suffer from migraine headaches. After puberty, this number triples to 18% in girls and remains at 6% in boys. Several abortive drugs (drugs taken as needed), such as rizatriptan (Maxalt) and zolmitriptan (Zomig) are approved for migraines in children. Only topiramate (Topamax) is approved for children (over the age of 12) for the prevention of migraines. We do use preventive drugs approved for adults in children as well. These are divalproex sodium (Depakote), propranolol (Inderal), and botulinum toxin (Botox). Many other drugs, such as amitriptyline (Elavil), gabapentin (Neurontin), candesartan (Atacand) are used “off label”, meaning that they are not FDA-approved for migraines in adults or children. One of the reasons that more drugs are not approved specifically for children is the difficulty in conducting research in kids. Their are migraines are usually shorter in duration and often stop occurring for long periods of time without treatment.

A large multi-center 24-week study just published in the New England Journal of Medicine examined the efficacy of topiramate, amitriptyline and placebo in children between the ages of 8 and 17. It was a double-blind study with neither the children and their parents nor the doctors being aware of who was getting which drug or placebo. The study showed no statistically significant difference among the three groups. The main outcome measure was a 50% or higher reduction of headache days. Placebo achieved this result in 61% of children, while this number was 52% for those on amitriptyline and 55% on topiramate. Not surprisingly, side effects were much more common in children taking medications than placebo. Fatigue and dry mouth were the most common side effects from amitriptyline, while topiramate caused mostly tingling and weight loss. Serious side effects occurred in four – three kids on amitriptyline had a serious mood disorder and one on topiramate attempted suicide.

This study did not prove that amitriptyline and topiramate are ineffective since they did help half of the children they were given to, however the placebo worked at least as well. These findings are not surprising since placebo has a powerful effect, which is often more pronounced in children and because children’s migraines often stop on their own. Even in adults, placebo effect has often made clinical trials, particularly in migraines, very difficult. It took a couple of attempts to prove that Botox prevents migraines better than placebo, again not because Botox was ineffective, but because placebo also worked well.

The initial approach to treating migraines in children and adults should always involve looking for modifiable triggers, such as sleep schedule, regular meals with healthy food, elimination of caffeine and sugar, regular exercise, sleep hygiene, meditation or biofeedback, and so on. Our second step is trying supplements such as magnesium (which sometimes is given intravenously because of poor absorption of pills) and CoQ10, which have been proven to be effective both in children and adults. Other, less proven supplements, such as riboflavin, feverfew, and boswellia are also worth trying before starting a daily preventive medication. At the same time, since migraine often causes severe pain, we often prescribe abortive migraine medications, such as sumatriptan or rizatriptan, which are often more effective than ibuprofen and acetaminophen.

It is considered unethical for doctors to prescribe placebo, although we do sometimes prescribe very mild drugs in a small dose (cyproheptadine is one such drug), which is almost the same as prescribing a placebo.

An interesting study of placebo in patients with low back pain was just published in the journal Pain . One group was given the usual treatment and the other received the usual treatment as well as a placebo pill, but they were told that they are being given a placebo. The group that knowingly took placebo had a significant reduction in pain and disability. After three weeks of this trial, the first group was also given a placebo pill and they also had a significant drop in pain and disability. It is possible that the effect is just due to the act of taking a pill, which subconsciously sends a message to the brain that something is being done to fix the problem.