Looking at Conventional Medical Treatment and Advice for Common Pediatric Problems: Do They Work?

Daniel Jon Merenstein, MD, explored this issue as an RWJF Clinical Scholar.

The Problem: Research dollars are largely earmarked for fighting primary diseases like cancer, heart disease, AIDS, obesity and diabetes. But should research also look carefully at conventional medical advice and everyday responses for common problems?

Grantee Background: Daniel Jon Merenstein, MD, originally planned to study pediatrics, but at the last minute switched to the same field as his father, who practiced family medicine outside of Pittsburgh. After graduating in 1992 from Brandeis University in Waltham, Mass., Merenstein attended Thomas Jefferson Medical College in Philadelphia. He then completed his residency at Fairfax Family Practice, Fairfax, Va., and began his medical career with the Georgetown Family Practice in Ballston, Va.

In 2000, while practicing family medicine, Merenstein began conducting research on the side. "I always liked to question things," he recalls. "Even when in private practice, I did a study on how we use antibiotics for sinusitis. I looked at, 'Where is the data to support this level of use?' and 'Does a clinical trial exist?' We used a small grant from the American Academy of Family Physicians Foundation for that study."

Merenstein's early experience convinced him that, to continue in research, he needed a better understanding of statistics and more sophisticated research techniques. He investigated several fellowship programs, and was accepted into the Robert Wood Johnson Foundation Clinical Scholars program at Johns Hopkins School of Medicine in Baltimore for 2003–2005.

Grantee Perspective: Most of Merenstein's research is focused on the everyday practices and advice embraced in medicine. "When it comes to having children, we tell parents so many different things. We tell them, 'Don't give your baby food until a certain age.' We talk about all the different sleep strategies in order to get babies to sleep through the night. We tell them to let them cry. We tell them many things, but there's just so little evidence for what we say."

As a Clinical Scholar, Merenstein put many assumptions about primary care under a microscope. He conducted several research projects on such topics as: Do children receive better routine care in children's hospitals? Should physicians rate screening tests given during preventive health exams? How should physicians share information about giving antibiotics for ear infections? And in a study that attracted national attention, Merenstein wanted to know why 50 percent of pediatricians tell patients that the drug diphenhydramine (commonly known as the over-the-counter medicine Benadryl) will help children sleep through the night, when there was no supportive evidence other than anecdotal reports?

Results: Merenstein's research project on Benadryl, or diphenhydramine, is called the TIRED study: the Trial of Infant REsponse to Diphenhydramine. Conducted with several colleagues (including fellow former Clinical Scholar Haya Rubin, MD, PhD, and director of the Hopkins program Marie Diener-West, PhD), the objective of the study was to determine if infants aged six to 15 months with frequent parent-reported nighttime awakenings slept better after being given Benadryl or a placebo. In this clinical trial, 44 infants received a placebo or diphenhydramine 30 minutes before bedtime. The result? "Diphenhydramine was no more effective than a placebo in reducing nighttime awakening or improving overall parental happiness with sleep for infants," says Merenstein.

"Many in the medical and lay community accept diphenhydramine as effective treatment for sleep problems," Merenstein wrote in a paper published in the July 2006 Archives of Pediatrics and Adolescent Medicine. "Unfortunately, this attitude is based on anecdote and studies of adult physiological interactions. However, the TIRED study results demonstrated that at the most commonly used dose, diphenhydramine may play no role in treating infant sleep problems."

The study results reinforce the need for rigorous studies of common primary care interventions and they illustrate that such studies are feasible, says Merenstein. "We have shown that it is possible to conduct quality patient-oriented primary care research in young children to provide parents and physicians with evidence to help them make their decisions," he says.

Merenstein's article received the "Article of the Year" award from the Society of Teachers of Family Medicine in May 2008. As the parent of three young sons, Merenstein believes more than ever in the importance of research on daily medical decisions and advice. "We should do studies before we give our kids medicine," he says. Today, Merenstein devotes 70 percent of his time to research at Georgetown University, where he is director of research programs and associate professor of family medicine. The rest of his professional time is devoted to family practice and seeing patients at a Kaiser Permanente clinic in the District of Columbia.

The Clinical Scholars program provided a great environment for research, says Merenstein. "I have nothing but positive things to say," he says. "Everyone around you is a superstar and everyone wants to help. With the Clinical Scholars name behind you, everyone is easy to talk to. It's easier to pick up the phone and make the call."

RWJF Strategy: Originally authorized in 1972, the Robert Wood Johnson Foundation Clinical Scholars program is the oldest national program at RWJF. The program fosters the development of physicians who will lead the transformation of American health care. Former Clinical Scholars have become directors of federal, state and local health agencies and departments. Senior Program Officer J. A. Grisso, MD, MSc, who managed the program at RWJF, summed up the ideal Clinical Scholars candidate this way: "Someone with the passion to make a difference in health and health care, and the promise of being able to do it."

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