Prescribed medications are no more effective than a sugar pill when used to prevent migraines in children and teens.
A study published Oct. 27 in The New England Journal of Medicine shows no significant differences among amitriptyline, topiramate, and placebo in reducing headache days or related disability.
“The study was intended to demonstrate which of the commonly used preventive medications in migraine was the most effective. What we found is that we could prevent these headaches with either a medication or a placebo,” says Andrew Hershey, MD, PhD, co-director of the Cincinnati Children’s Headache Center and senior author of the study. “This study suggests that a multi-disciplinary approach and the expectation of response is the most important, not necessarily the prescription provided.”
Researchers conducted the Childhood and Adolescent Migraine Prevention (CHAMP) study at 31 sites in the United States.
Cincinnati Children’s served as the Clinical Coordinating Center (CCC) for the study, and was responsible for all clinical oversight activities. The Clinical Trials Statistical and Data Management Center (CTSDMC) at the University of Iowa served as the Data Coordinating Center for the study. It had primary responsibility for data management, implementing the electronic data capture system, and all statistical aspects of the study.
Interpreting the Results
“The interpretation of these results is very challenging. In most situations, trials that fail to show benefit of an intervention do so because study participants do not improve. That was not the situation here. A majority of all study participants improved, regardless of their assigned treatment group,” says Chris Coffey, PhD, director of the CTSDMC and professor of biostatistics in the University of Iowa’s College of Public Health, and lead statistician for the study. “Further research is needed to better understand the results and to determine what future strategies might optimize the treatment of headaches in these childhood and adolescent populations.”
The 24-week clinical trial included 328 eligible patients. The trial used a clinically meaningful endpoint of a 50 percent or greater reduction in headache days from the 28 days prior to randomization to the final four weeks of the 24-week study. Sixty-one percent of those on a placebo saw the days they had a headache reduced by 50 percent or more.
For the two medication groups, 52 percent of those taking amitriptyline and 55 percent of those taking topiramate had this level of reduced headache days. The responder rates were not statistically different between the three groups.
Compared to placebo, those on the two active drugs had a significantly higher rate of side effects, including fatigue, dry mouth and, in three cases, mood alteration. Thirty-one percent of those on topiramate had paresthesia – a “pins and needles” tingling in the hands, arms, legs or feet.
The results raise questions about the best way to prevent migraines, particularly given that it’s unethical to prescribe a placebo without the patient’s knowledge, according to the authors. They add it’s likely the expectation of responding to a medication may override the actual biochemical and pharmacological changes that are thought to occur with pharmacotherapy.
Major pediatric headache centers, such as Cincinnati Children’s, incorporate a multi-disciplinary approach that includes acute therapy, preventive therapy and behavioral treatment in a systematic approach, says Hershey. The CHAMP study incorporated this approach across all 31 study sites to ensure uniformity.
“Our national team was hoping to develop evidence to drive the choice by medical providers of the first line prevention medication for helping youth with migraine, but the data showed otherwise, says Scott Powers, PhD, pediatric psychologist, co-director of the headache center at Cincinnati Children’s, and first author of the paper. “We see this as an important opportunity for health care providers, scientists, children, and families because our findings suggest a paradigm shift. First line prevention treatment will involve a multidisciplinary team approach and focus on non-pharmacological aspects of care. The good news is we can help children with migraines get better.”
Powers says the study also underscores the importance of conducting more research with a developmental focus on children and young adults. This will allow innovations that can be applied directly to a chronic illness of childhood.
The study was supported by the National Institute of Neurological Disorders and Stroke and the Eunice Kennedy Shriver National Institute of Child Health and Human Development of the National Institutes of Health through grants U01NS076788 and U01NS077108.
Author and journalist Roger Thurow will be a guest of the Office of the Provost and College of Public Health on Tuesday, October 11. His visit is by special arrangement with the World Food Prize Organization in Des Moines.
There will be a public lecture at 5:00 pm in the Callahan Auditorium of the College of Public Health Building (CPHB), followed by a reception. The title of his lecture will be “1,000 Days to Change the World: Stories from the Fight to End Early Childhood Malnutrition.”
Thurow, an alumnus of the University of Iowa, joined The Chicago Council on Global Affairs as senior fellow for global food and agricultural in January 2010 after three decades at The Wall Street Journal. For 20 years, he served as a Journal foreign correspondent, based in Europe and Africa. His coverage of global affairs spanned the Cold War, the reunification of Germany, the release of Nelson Mandela, the end of apartheid, the wars in the former Yugoslavia and the humanitarian crises of the first decade of this century – along with 10 Olympic Games.
In 2003, Thurow and Journal colleague Scott Kilman wrote a series of stories on famine in Africa that was a finalist for the Pulitzer Prize in International Reporting. Thurow and Kilman are authors of the book, ENOUGH: Why the World’s Poorest Starve in an Age of Plenty. In 2009, they were awarded Action Against Hunger’s Humanitarian Award.
In May 2012, Thurow published his second book, The Last Hunger Season: A Year in an African Farm Community on the Brink of Change. His new book, The First 1,000 Days: A Crucial Time for Mothers and Children—And the World, was published in May this year.
He will also speak that evening at 7:00 pm at the Prairie Lights bookstore.
For further information or requests for special accommodation, please contact Dan McMillan, Strategic Communications Director, College of Public Health, (319) 335-6835, firstname.lastname@example.org.
Natoshia Askelson, assistant professor of community and behavioral health, recently took part in the UI’s Communicating Ideas workshop. Participants gain practical tips for crafting and honing their messages and have an opportunity to record a brief video clip about their research. Askelson discussed how to support children in making fast, easy, and healthy food choices, especially in the lunch room.
Sharing a sanitation facility between households can be linked to increased risk of moderate-to-severe diarrhea (MSD) in children under 5 years of age at some sites, according to Global Enteric Multicenter Study (GEMS) study findings published this week in PLOS Medicine. The study, conducted by Kelly Baker, assistant professor of occupational and environmental health at the University of Iowa College of Public Health, and colleagues, suggests that access to private sanitation facilities should remain a global health priority.
Diarrhea kills about three-quarters of a million young children every year. Interventions to improve sanitation and hygiene may benefit the roughly 2.5 billion people who do not use improved sanitation, including the 1 billion who defecate in the open. GEMS is a case-control study of pediatric diarrhea in children under 5 years of age at seven sites in Africa and South Asia. This study compared 8,592 children under 5 y with clinically and laboratory confirmed MSD matched to 12,390 asymptomatic children to uncover associations between household sanitation and incidence of diarrhea.
Compared to having a private household sanitation facility, sharing a facility with one or two households was found to be associated with an increased risk of diarrhea in young children at the study sites in Nyanza Province, Kenya (adjusted matched odds ratio 1.41 [95% confidence interval 1.11-1.79]), Bamako, Mali (1.23 [1.02-1.48]), and Karachi, Pakistan 1.58 [1.19-2.09]). Sharing a facility with three or more households was associated with further increased MSD risk. Sharing a sanitation facility was not found to be associated with increased MSD risk at the sites in Basse, The Gambia (1.69 [0.96-2.97]), Mirzapur, Bangladesh (0.83 [0.70-0.99]), or Kolkata, India (1.04 [0.78-1.39]).
As the study is observational, confounding by related characteristics such as hand washing may limit interpretation of results. In a linked Perspective, Jonny Crocker and Jamie Bartram of University of North Carolina at Chapel Hill, United States, discuss study limitations but argue that “Baker and colleagues present the best dataset yet on diarrheal disease associated with sanitation and hygiene. They provide compelling evidence on sanitation and hygiene risk factors for MSD and variability in that risk.” (originally published on EurekAlert!)
Two recent related studies co-authored by Baker: