Study: Children Get No Benefit From Cough Meds

July 6, 2004 -- Parents: A coughing child keeping you up at night? Don't reach for a cough syrup, it won't help.

A new study finds that over-the-counter cough medications do not reduce nighttime coughing or improve children's sleep any more than non-medicated syrup in children with upper respiratory infections.

And OTC cough syrups also don't help parents of a coughing kid themselves rest any better, the research found.

"Over the counter cough medicines don't appear to provide any benefit for children with nighttime cough," says lead author of the study Ian Paul, a pediatrician at Penn State Children's Hospital, in Hershey, Pa. "And because of the potential for side effects, parents should think twice before giving them to their children."

Cough is the second most common reason for a child to visit a pediatrician. Paul says that one of the main reasons he conducted the study was so pediatricians could give parents advice on how to treat a child's cough based on real evidence.

"Parents always ask what they can give their kids with cough, and there is little information as to what they can use," says Paul.

The study, published in the issue of Pediatrics out today, included 100 children and adolescents between the ages of two and 18 with upper respiratory infections.

The 100 participating children all had symptoms for four days prior to the study. On the day of the study, parents were asked to evaluate the severity and frequency of their children's cough, as well as how the cough affected the parents' nighttime sleep.

The children were split into three groups and each assigned a different syrup to take 30 minutes before bedtime. One group took dextromethorphan, often abbreviated DM and the most common active ingredient in OTC cough medicines. Another took diphenhydramine, an OTC antihistamine that's available in many cold and allergy medications. And the third group took placebo, a non-medicated syrup.The following day, the parents were asked the same questions to evaluate their child's cough and the quality of their sleep.

"We found no difference in the change in symptoms when you compared the active medicines with the placebo, suggesting that the medicines were no better than placebo," says Paul.

The study examined also one aspect of nighttime cough in kids that has not been looked at before — how well do parents sleep if their kids are medicated?

"One of the reasons that parents bring their children in with colds is because they can't sleep at night," says Paul.

And the result? "Parents did not sleep better when children the active medicines as compared with placebo."

Pediatricians Not Surprised by Findings

Most experts agreed with the study's results.

"The study results do not at all surprise me," says Frederick Mandell, associate clinical professor of pediatrics at Harvard Medical School, and senior associate in Medicine at Children's Hospital, Boston. "I have found that the OTC cough medications are not very beneficial and I have told my patients the same … Some listen, others feel they need 'to do something' so they go to the OTC meds."

Notes Joseph Zanga, a professor of pediatrics at the Brody School of Medicine at East Carolina University in Greenville, N.C.: "We have mostly known for years that these medicines helped the mothers more than their children."

Added Ira S. Rubin, a pediatrician at Naperville Pediatrics in Illinois, "To my knowledge, there has never been strong evidence that "cough and cold" medicines are helpful for kids."

Earlier studies that compared OTC cough medicines to placebo syrup had similar results; cough medications don't really work. Previous studies also looked at how cough syrups improve daytime coughs in children and in adults, and the results are similar to his, says Paul. "They also found that OTC medications have doubtful effects for adults with acute cough."

Yet Paul and other pediatricians note that despite the lack of evidence, OTC medications are a billion-dollar industry. "Parents spend a good bit of money on these OTC 'cough' medicines in the aggregate," says Zanga.

For its part, Pfizer, manufacturer of Benadryl, says that although they did not have time to review the study, they still defend their products.

"We certainly stand by the products we manufacture and market, especially our pediacare and Benadryl products," says Erica Johnson in media relations for Pfizer's Consumer and Healthcare Division. "Our products have been thoroughly researched and tested and we stand by the claims that we make about the effectiveness of our products."

Pediatricians Weigh In

Many experts maintain cough medicines provide no benefit except to alleviate parents' worries and that the possible risks of cough syrups outweigh any perceived benefit.

"The benefit is really a false peace of mind with the parents that something is being done for their child," says David M. Krol, assistant professor of pediatrics at Columbia University in New York. "Fortunately and unfortunately the cough gets better and the association with the medicine is sometimes solidified."

Pediatricians also say that parents are less likely watch their child for changes or complications in their cold or cough if they have given them cough medicine.

"The risk is that a child who is treated may get a complication from the cold, like otitis or pneumonia, and the parent thinks that the child will be alright since the cold is 'treated' and the parent is not watching the child closely," says Rubin

Another expert adds: "The risk is that most coughs are … beneficial (keeping mucus/debris out of the lungs)." Says Joshua E. Petrikin, chair, Residency Recruitment Committee Division of Community Pediatric and Adolescent Medicine at the Mayo Clinic in Rochester, Minn. "This leaves few coughs that you would want to stop with OTC medication even if it worked," he said.

Not only do the OTC medications provide no benefit, but they also have many potential side effects.

Although the study does not address side effects, the authors note that children who took dextromethorphan were more likely to suffer insomnia on the night they took the medicine.

So what should parents do? Wait for the cough to get better on its own.

Andrea C. S. McCoy, medical director of Temple Pediatric Care in Philadelphia agrees with the study authors and says that upper respiratory infections are self-limited illnesses that improve with time.

But, she also says, "Those that last more than 10 to 14 days or are accompanied by fever for greater than 48 hours are concerning in that there may be secondary infections."

Concludes McCoy: "I really believe that many parents are not aware of the lack of benefit and potential side effects of [these] medications."