The New England Journal of Medicine published a study on October 27, comparing the effectiveness of topiramate, amitriptyline and placebo for the reduction of migraine days. Dr Andrew Hershey, MD, PhD, was the study’s senior author – Childhood and Adolescent Migraine Prevention (CHAMP) – which was conducted in 31 different sites in USA. The study found that placebos are just as effective in reducing migraine and related ailments as prescribed drugs amongst children and teens.
How the Study was conducted
The study is based on a clinical trial of 24 weeks, involving 328 eligible patients suffering from headache days. Cincinnati Children’s served as clinical coordinator while the University of Iowa provided their services as their data coordinator. Just as Cincinnati Children’s provided their expertise and oversight in clinical matters, University of Iowa was responsible for the management of data and the statistical analysis.
In order to come to a conclusive result the researchers compared the effects of the placebo and medications over 24 weeks. The study started 28 days before the medication and compared reduction of head ache days to the last 4 weeks of this study. The end point was determined to be 50% or more reduction in migraine days.
The trial shows that 55% on topiramate and 52% on amitriptyline experienced 50% or more reduced days of headache. While 61% on placebo too experienced the same result.
However, the thing to note here is that the active drugs have a much higher probabilities of negative or side effects. Dry mouth, fatigue etc being some of the most common side effects while few reported to have mood swings. Patients on topiramate reported to have tingling sensation such as pin and needles or paresthesia along the limbs.
This leads to the question about which is the most viable option to reduce pediatric migraine. While placebo definitely leads to lesser side effects, it is not ethical to prescribe placebo without letting the patient know about it. The study primarily suggests that expectation of response to medicine is more effective than the biochemical changes brought by the prescribed drug itself.
Many a centers who deal with pediatric migraine employ multi-disciplinary methods which include behavioral treatment, therapy for prevention and acute therapy. The same was incorporated in this study across all its 31 sites in order to maintain consistency. Even though placebos are not considered multi-disciplinary approach, the researchers are striving to conduct more trials to find out alternate ways to zero in on the optimized method of the helping the youth suffering from migraine.
Presently, the first line of preventive treatment for pediatric migraine is medication. The researchers aim to provide an alternate first line treatment which might optimise the benefits without causing much side effect. They focus on the necessity of more such studies. According to them, most studies fail because the methods tried do not yield any result. However, in this case, all the three groups yielded similar results. The researchers, hence, emphasize that this study alone is not enough but it provides grounds for conducting more and more research for better understanding of the results to come up with the most innovative and effective multi-disciplinary treatment to help the children and teen sufferers.