Migraines in Kids

From here – http://blog.cincinnatichildrens.org/healthy-living/preventing-kids-migraines/

Migraines in Kids: How Can We Best Prevent Them?

OCTOBER 28, 2016

Migraines in kids. How can we best prevent them? That is a question we hoped to answer when began a study that was published in the New England Journal of Medicine this week.

In particular, we wanted to know which preventive medications are the most effective at preventing migraines in kids. With 10% of children under the age of 12 and up to 25% of girls by the time they turn 18 getting migraines, we think it is important information to have.

THE STUDY’S RESULTS

Surprisingly, our study results found that the commonly prescribed preventive medications for migraines in kids – amitriptyline and topiramate – were just as effective as a sugar pill, or placebo.

I am certain that this is going to raise many questions with both parents and physicians alike. The good news is that we know that kids’ migraines can get better with the multidisciplinary therapies applied in this study and the expectation of response (read more about that below) – in addition to the medications. In fact, our study found that those receiving:

  • A sugar pill had a 61% reduction in migraines
  • Amitriptyline had a 52% percent reduction in migraines
  • Topiramate had a 55% reduction in migraines

Neither the two medications nor the sugar pill’s results were statistically different from each other. We got kids with migraines better, but it doesn’t necessarily mean they need to take a medication for that to happen.

WHAT’S INTERESTING ABOUT THE RESULTS

These two aspects – not necessarily medications – appear to have played a more important role in getting kids better:

  • The expectation of a response
  • Non-pharmacologic (drug) therapies

The placebo effect, or the expectation of a response after receiving a sugar pill, was 61% effective at reducing migraines. Patients thought that they would get better, so they did. This study tells us that we need to look further into how we can help kids achieve this without giving them medications (or thinking that they’re being given medications).

THE ROLE OF NON-PHARMACOLOGIC (DRUG) THERAPIES

The other interesting aspect was the non-pharmacologic therapies utilized with all 328 patients across 31 sites nationally. Every patient received acute therapy, healthy habit discussions and help with adherence. Because medications and placebo were equally effective, these other therapies probably played a large role in getting kids’ migraines better.

When we embarked upon this study, we hoped to find a clearer picture for preventing migraines in kids. What we found is that it might not be as simple as prescribing a medication. Our research shows that a more holistic approach incorporating multiple therapies may be the best at preventing them.

So to answer the question, how can we best prevent migraines in kids? With this research, we now know that it’s not a simple answer of which medication to use. It’s more complex of an answer and we plan to study this further to determine which therapies work the best to prevent migraines in kids.

Editor’s note: Andrew Hershey, MD, PhD, pediatric neurologist and co-director of the Headache Center at Cincinnati Children’s, was a co-author of this study.

 

From here – http://blog.cincinnatichildrens.org/healthy-living/preventing-kids-migraines/

 

From here – http://www.nejm.org/doi/full/10.1056/NEJMoa1610384

Trial of Amitriptyline, Topiramate, and Placebo for Pediatric Migraine

Scott W. Powers, Ph.D., Christopher S. Coffey, Ph.D., Leigh A. Chamberlin, R.D., M.Ed., Dixie J. Ecklund, R.N., M.S.N., Elizabeth A. Klingner, M.S., Jon W. Yankey, M.S., Leslie L. Korbee, B.S., Linda L. Porter, Ph.D., and Andrew D. Hershey, M.D., Ph.D., for the CHAMP Investigators*

N Engl J Med 2017; 376:115-124January 12, 2017DOI: 10.1056/NEJMoa1610384

BACKGROUND

Which medication, if any, to use to prevent the headache of pediatric migraine has not been established.

METHODS

We conducted a randomized, double-blind, placebo-controlled trial of amitriptyline (1 mg per kilogram of body weight per day), topiramate (2 mg per kilogram per day), and placebo in children and adolescents 8 to 17 years of age with migraine. Patients were randomly assigned in a 2:2:1 ratio to receive one of the medications or placebo. The primary outcome was a relative reduction of 50% or more in the number of headache days in the comparison of the 28-day baseline period with the last 28 days of a 24-week trial. Secondary outcomes were headache-related disability, headache days, number of trial completers, and serious adverse events that emerged during treatment.

RESULTS

A total of 361 patients underwent randomization, and 328 were included in the primary efficacy analysis (132 in the amitriptyline group, 130 in the topiramate group, and 66 in the placebo group). The trial was concluded early for futility after a planned interim analysis. There were no significant between-group differences in the primary outcome, which occurred in 52% of the patients in the amitriptyline group, 55% of those in the topiramate group, and 61% of those in the placebo group (amitriptyline vs. placebo, P=0.26; topiramate vs. placebo, P=0.48; amitriptyline vs. topiramate, P=0.49). There were also no significant between-group differences in headache-related disability, headache days, or the percentage of patients who completed the 24-week treatment period. Patients who received amitriptyline or topiramate had higher rates of several adverse events than those receiving placebo, including fatigue (30% vs. 14%) and dry mouth (25% vs. 12%) in the amitriptyline group and paresthesia (31% vs. 8%) and weight loss (8% vs. 0%) in the topiramate group. Three patients in the amitriptyline group had serious adverse events of altered mood, and one patient in the topiramate group had a suicide attempt.

CONCLUSIONS

There were no significant differences in reduction in headache frequency or headache-related disability in childhood and adolescent migraine with amitriptyline, topiramate, or placebo over a period of 24 weeks. The active drugs were associated with higher rates of adverse events. (Funded by the National Institutes of Health; CHAMP ClinicalTrials.gov number, NCT01581281).

 

From here – http://www.nejm.org/doi/full/10.1056/NEJMoa1610384

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