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, email@example.com.
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:
CPH faculty member Kelly Baker studies the cascade of health issues connected to water, sanitation, and hygiene.
Water has been a consistent theme running through Kelly Baker’s work, one that has led her from her home state of Oklahoma to California, Mexico, India, Ghana, and elsewhere around the globe.
“I’ve always been a bit of a vagrant,” says Baker, who joined the College of Public Health in 2014 as an assistant professor of occupational and environmental health. “Even before getting into global health work, I traveled a lot.”
After completing her undergraduate studies in biology and ecology, Baker moved to California intending to earn a PhD in oceanography.
“I wound up a bit disillusioned with the potential for career success in that field,” says Baker, who took time to rethink things. “I’d work then travel – typically into Mexico and Ecuador – and I settled on the concept of public health because it tied into a lot of the problems I observed in my travels.”
Baker then attended the University of Maryland-Baltimore, where she completed a PhD in microbiology and immunology.
“I started off studying bacterial pathogenesis and molecular diagnostics,” Baker says. “It was very bench-based work and I enjoyed it, but I realized it wasn’t where my interests were. I wanted to do fieldwork.”
After Baker graduated, she was offered a fellowship with the University of Maryland’s Global Enteric Multicenter Study (GEMS), one of the largest, most comprehensive studies of childhood diarrheal diseases ever conducted in developing country settings.
“My role was the environmental component of the study – understanding how water sanitation and hygiene affected a child’s odds of diarrhea,” Baker explains. “In Bangladesh, I designed questionnaires to understand the practices specifically related to water quality in the home or to hand washing. I collected environmental samples, and identified and measured how much contamination was in these samples. That was really my introduction to a lot of different disciplines, from field epidemiology to environmental microbiology to behavioral data collection methodologies.
“It resonated very strongly as the pathway I wanted to go in,” Baker continues. “In low-income countries, people are exposed over time to many different organisms. For me, improvements in fundamental environmental health offered a panacea against disease spread. You could prevent exposure to lots of different things over time, and, hopefully, prevent a child from ever getting to the point where they would have diarrhea or be malnourished from it.”
Baker’s next stop was Accra, Ghana, where she worked as an in-country investigator for the Emory University-based SaniPath study, an assessment of exposure to human waste in low-income urban environments. That experience in Ghana helped inform Baker’s current work in understanding the relationship between water and contamination.
“Water is a means by which we consume contamination, such as through drinking water or accidentally swallowing water while swimming,” Baker says. “But water is also is a mechanism by which contamination is introduced into the environment. For example, at an open defecation site, water can move beyond one centralized location and wind up contaminating a much broader area and exposing a broader population. It all leads back to containment of waste being a really important component of preventing the disease cycle from occurring again.”
Baker’s experience strengthens the College of Public Health in several areas, says Peter Thorne, CPH professor and head of occupational and environmental health.
“We’re pleased to have Kelly’s expertise in water quality, sanitation, and global public health,” says Thorne. “These are important areas of environmental health where we have needed more scholarship and student mentoring. While Kelly is doing great international work, we also look to her expertise to address problems with water quality in Iowa.”
Baker’s current research falls into three interconnected areas. “On the exposure side of things, my lab is developing a tool that simultaneously detects and quantifies over 20 known types of microorganisms that cause diarrheal disease,” Baker says. “We’re going to use this tool to better understand waterborne, watershed exposure risks in a low-income country.”
Worldwide, the lack of adequate sanitation facilities allows diarrheal pathogens to enter the environment, Baker explains.
“So the overall likelihood of being infected and experiencing illness is extremely high for those living in those areas,” she says. “We’re going to use this tool to identify the pathways by which groups of organisms spread in the environment and come into contact with people. We can use this information as a baseline for evaluating the impact of sanitation-related interventions on environmental safety and human health risks.”
The research team will be conducting projects this summer in Kenya and Iowa. “While Iowa may be relatively clean in terms of human waste, there’s zoonotic transmission through wildlife and livestock. Comparing the patterns we find in Iowa versus in Kenya will help us better understand what the inherent risks are in a place where there are good human sanitation systems versus a place where there are not.”
Maternal and Child Health
Another part of Baker’s work is exploring whether and how water and sanitation impact maternal and child health.
“We’re in the process of completing a project in India where we’re exploring what the patterns of sanitation use are for women across the life course, and how it impacts their health,” Baker says. “In India, for a number of reasons, open defecation is rampant even where public toilets are available. For women, fear of violence is an issue.”
Women’s struggles to access safe, private sanitation and obtain clean water create extremely stressful mental and physical environments, Baker explains. One finding from the project is that women with poor sanitation access are twice as likely to experience pre-term birth or give birth to a low-birth-weight infant.
“The next phase of our work is to understand why,” Baker says. “And not just why, but what are the downstream ramifications? Is the stress related to poor water and sanitation access something that is biologically linked to preterm birth? We want to understand what these pathways are so that we can design interventions that potentially can alleviate stressors for pregnant women.”
Baker emphasizes that the impact is not just on the woman, but also the child. “We hypothesize that how and when a child enters the world is a major predictor of whether that child, two years from now, will have a higher incidence of diarrheal disease, or is more likely to be stunted (low height for age) and wasted (low weight for height). We’re trying to understand that cascade — how is the disparity from poor water and sanitation access passed from mother to offspring, and what are the consequences?”
Baker’s third area of work is, as she puts it, “How do we identify effective interventions, and how do we understand whether those interventions work?”
Baker is collaborating with Safe Water Network, a non-governmental organization that partners with communities in Ghana and India to develop market-driven, financially sustainable, locally owned and managed water systems. Safe Water Network plans to conduct a heath-impact assessment, Baker explains, and her role is to help them understand when and how their programs are working.
“I have a lot of irons in the fire,” Baker admits, but the passion for her work is evident. “The three parallel tracks of my work are all really engaging, and none of them really stand alone. I’m a big picture person, and I really like projects where I have collaboration with and can learn from other people.”
This story originally appeared in the spring 2015 issue InSight magazine for alumni and friends of the UI College of Public Health.
CPH researchers are helping to unpack what works in a program that introduces kids to new foods.
For many parents, such a request would be nothing short of miraculous. But an Iowa-grown nutrition education program that is now in its second decade has spurred many kids to ask for healthier foods.
Pick a better snack™ was developed by the Iowa Nutrition Network in the Iowa Department of Public Health. With a proven track record, it is becoming a model for other states. Since all states receive funds from the Supplemental Nutrition Assistance Program (SNAP) to provide nutrition education for low-income children, it makes sense to replicate the most effective programs.
When the USDA did a large scale evaluation of the Iowa Pick a better snack™ (PABS) program in 2013, the results were clear: The program works.
“What was less clear,” says Doris Montgomery, state coordinator for the Iowa Nutrition Network, “was why it worked.”
Montgomery enlisted the help of Natoshia Askelson, CPH assistant professor of community and behavioral health. Along with a team of graduate students and recent alumni, Askelson is working to unpack which aspects of the PABS program are effective. And that’s not as easy as it might sound.
The program has a lot of moving parts. Understanding which ones are vital to producing positive results will help Montgomery and her peers across the nation to know where to put their funds.
Nutrition Rock Stars
Nutrition educators who visit schools once a month are the hallmark of the program. In addition to in-class time, kids take home bingo cards that encourage them to try different foods and physical activity throughout the month. Children who complete a bingo receive prizes like hacky sacks and Frisbees. Parents receive a newsletter with cooking and shopping tips. The program also has signage in local grocery stores and advertising on billboards.
It’s that class time that the kids remember. Montgomery calls the nutrition educators “rock stars” and says that kids will try things for them that they won’t for their parents or regular teachers.
One of those stars is Judith Dittmar, who leads the program in the seven Council Bluffs elementary schools that are eligible. The curriculum is focused on younger grades, so each month Dittmar visits kindergarten through third-grade classrooms, bringing with her a healthy snack that features a different fruit or vegetable. Recent offerings have included jicama, cranberries, and cauliflower.
Kids are encouraged to touch the food, smell it, and then – hopefully – taste it. The idea is that the more curiosity kids can bring to the experience, the more likely they are to take the final step and eat something new.
“We use positive peer pressure,” says Dittmar, noting that sometimes kids will be cheering for each other to try a food that’s either unfamiliar to them or believed to be “bad.” During her ten years in the position, she has watched a lot of kids overcome preconceived notions about different foods. Blueberries may not be such a hard sell, but spinach and asparagus are tougher.
There are eleven participating sites in the state. These are places where more than 60 percent of a school is eligible for free and reduced lunch. In each location, a school district or county extension office receives funding from the Iowa Nutrition Network School Grant Program to provide nutrition education to schools. Montgomery notes that many schools around the state that are not eligible find alternative funding to cover the program’s expenses and maintain participation because they find the program so valuable.
Iowa has an increasing poverty rate and low national ranking in consumption of fruits and vegetables, meaning kids often lack access to fresh food at home. Which is where Askelson’s research comes into play. The success of PABS lies, she says, in “pester power” – that age-old talent kids have for getting what they want. In this case, it’s being used to ask for healthier food options.
“We want to be sure they are learning how to be better askers,” Askelson says. After the kids learn about a new food, it’s important that they have the skills to help make that food appear on the family dinner table.
Last summer, two College of Public Health graduate students called parents of children who had participated in the program. One of the interviewers, Julia Friberg, a second year Master of Public Health student from Rockford, Ill., explains, “The questions focused on how children ask for food, grocery shopping habits, and strategizing for food budgets.”
Friberg, whose own interests include community-based participatory research and health disparities, said the experience helped her to hone skills while also gaining a better idea of the current landscape of nutrition and food access issues.
Montgomery says that having an independent evaluator provides more credence to the results. She also appreciates that Askelson has added her own experience in health promotion and community-based initiatives to the table.
The results of Askelson’s research from last summer were used to revise the classroom lessons. Following this summer’s research, another round of revisions will be made with the aim of making PABS as effective as possible.
Maine has already adopted PABS, and Montgomery believes other states will follow suit. With child hunger an ever-growing problem – more than twice as many K-12 students are eligible for free and reduced lunch nationwide as compared to 1980 – finding programs that really help to connect children and families with healthy food is essential. PABS is just one small piece to a larger problem, but it provides kids with knowledge and a hunger for better foods.
This story originally appeared in the spring 2015 issue InSight magazine for alumni and friends of the UI College of Public Health.
Photos by Tom Langdon