Am Fam Physician. 2009 Jul 15;80(2):120-121.
Each month, three presenters review an interesting journal article in a conversational manner. These articles involve “hot topics” that affect family physicians or “bust” commonly held medical myths. The presenters give their opinions about the clinical value of the individual study discussed. The opinions reflect the views of the presenters, not those of AFP or the AAFP.
This Month's Article
Paul IM, Beiler J, McMonagle A, Shaffer ML, Duda L, Berlin CM Jr. Effect of honey, dextromethorphan, and no treatment on nocturnal cough and sleep quality for coughing children and their parents. Arch Pediatr Adolesc Med. 2007;161(12):1140–1146.
Is honey an effective treatment for cough in children compared with dextromethorphan or no treatment?
Andrea: Based on a Cochrane review, we know that there are no over-the-counter (OTC) preparations that are effective for decreasing cough in children with acute cough.1 The American Academy of Pediatrics recommends against the use of codeine- or dextromethorphan-containing cough and cold medication in children,2 and the U.S. Food and Drug Administration recently opened an investigation regarding the effectiveness of children's OTC cough and cold medication because of lack of evidence of effectiveness, as well as an increased risk of adverse outcomes.3 The World Health Organization recommends the use of honey to soothe cough in kids older than one year.4 So, what do we do to help children and their parents when no one can sleep because of cough from an upper respiratory infection (URI)?
What does this article say?
Andrea: The authors of this study had previously demonstrated that there were no significant differences in the effectiveness of dextromethorphan, diphenhydramine (Benadryl), and placebo on nocturnal cough and sleep quality in children with cough.5 Here, they attempted to evaluate, using the same seven-point Likert scale, the effect of a single dose of buckwheat honey (volume equal to age-adjusted volume of dextromethorphan), honey-flavored dextromethorphan (dose adjusted for age), or no treatment (empty syringe) on the frequency, severity, and bothersomeness of nocturnal cough, as well as the quality of sleep for parent and child.
Overall, 130 children two to 18 years of age were eligible to be included in the study based on the presence of rhinorrhea and cough related to URI for less than seven days. Twenty-two of the children were excluded because their symptom score was too low; they had a history of asthma, reactive airway disease, or chronic lung disease; or they had taken cough medication or an antihistamine the night before study enrollment.
Parents completed a questionnaire that assessed cough frequency, severity, and bothersomeness on the previous night, as well as the impact of the cough on the child's and their own ability to sleep. Parents received a paper bag with a randomly assigned treatment (or an empty syringe) and administered the treatment that night. A follow-up survey with the same questions was administered via telephone the next day.
The authors found that there was at least a one-point improvement on all questions, regardless of treatment allocation. They also found that statistically, dextromethorphan performed equally to no treatment, whereas honey performed equally to dextromethorphan and better than no treatment. Based on this information, the study authors concluded that honey was effective for the treatment of cough and improvement of sleep quality for parent and child.
Should we believe this study?
Andrea: I think honey can be effective for soothing cough and sore throat based on personal experience, but I don't think the authors proved their case with this article. In essence, they are asking us to accept that honey is a good treatment for cough when “…direct comparison between honey and dextromethorphan yielded no statistically significant differences.” True––honey was statistically better than no treatment for several individual and combined scores, yet it was no different than dextromethorphan, and dextromethorphan was no better than no treatment.
Failure to provide any treatment at all (not even a placebo) to one third of the participants may have biased the response of the parents to the questionnaire (i.e., the child wasn't treated, so the cough was perceived to be the same or, perhaps, worse). If these families had been allowed to experience the true placebo effect, we might have seen that placebo performed better than honey or dextromethorphan.
Bob: I'm not sure that the questionnaire used really gives us a good idea about the magnitude of effect of these interventions on the symptoms. What is the difference between “somewhat” and “a lot” when defining a bothersome cough, poor sleep, or cough frequency? It brings us back to the concept of statistical versus clinical differences. On the seven-point Likert scale used in this study, honey decreased cough frequency by 1.89 points, whereas dextromethorphan and placebo decreased cough frequency by 1.39 and 0.92 points, respectively. Similar reductions in cough severity and improvements in sleep were noted. But what do these numbers mean? Does the 0.5-point difference between honey and dextromethorphan mean the child has noticeably less coughing with honey?
Mark: It might be better to ask parents questions like: “Would you administer this medication to your child again?” or “Did you miss work or did your child miss school because of symptoms?” I have a nagging sense that the positive conclusions supporting the use of honey may be another case of an attempt to please the sponsors of the study (in this case, the National Honey Board).
What should the family physician do?
Andrea: We have a large body of evidence that shows that dextromethorphan is ineffective for the treatment of cough in children with URIs, and good evidence that it can cause harm. Although this article suggests that honey is a safe and effective alternative, the actual study data fail to make a convincing case for effectiveness. I think we can still consider honey as an option because it is safe in children older than one year and it may reduce the inappropriate use of OTC cough and cold medication.
Bob: I agree. And most importantly, remember that all OTC cough and cold medications have risks associated with them. One recent survey estimated that more than 7,000 emergency department visits occurred annually because of adverse drug events associated with children's OTC cough and cold medication. One third of these were because the parents administered the wrong formulation or made an error in dosing.6
Mark: Remember to talk to parents about the risks of OTC cough and cold medications and discourage their use in children. Honey, as well as time, rest, and hydration, is safe and possibly effective for troublesome URI symptoms.
Dextromethorphan-containing cough and cold medications are neither safe nor effective in the treatment of URI symptoms in children.
Ensure that parents understand the risks and questionable benefits of children's OTC cough and cold medications. Consider providing a handout regarding these issues as part of routine anticipatory guidance.
Although this study failed to provide convincing evidence of effectiveness, honey may represent a safe alternative to soothe cough in children older than one year.
Failure to use a true placebo may jeopardize the validity of the results of a trial. In the case of this study, the parents who got an empty syringe knew their children were not getting treatment and may have been biased toward a more negative interpretation when they answered the follow-up questions regarding their child's cough and sleep quality.
Ensure that questionnaires used in a study ask the questions that are important to your patients, and report the answers in a meaningful and interpretable manner. This is particularly important when a broad age range in children is used, such as in this study. This can result in very different interpretations for a two-year-old versus a 15-year-old.
REFERENCESshow all references
1. Smith SM, Schroeder K, Fahey T. Over-the-counter medications for acute cough in children and adults in ambulatory settings. Cochrane Database Syst Rev. 2008;(1):CD001831....
2. American Academy of Pediatrics Committee on Drugs. Use of codeine-and dextromethorphan-containing cough remedies in children. Pediatrics. 1997;99(6):918–920.
3. U.S. Food and Drug Administration. Public health advisory. Non-prescription cough and cold medicine use in children. August 15, 2007. http://www.fda.gov/Drugs/DrugSafety/PublicHealthAdvisories/ucm051282.html. Accessed June 23, 2009.
4. World Health Organization. Cough and cold remedies for the treatment of acute respiratory infections in young children. Geneva, Switzerland: World Health Organization; 2001. http://whqlibdoc.who.int/hq/2001/WHO_FCH_CAH_01.02.pdf. Accessed June 23, 2009.
5. Paul IM, Yoder KE, Croswell KR, et al. Effect of dextromethorphan, diphenhydramine, and placebo on nocturnal cough and sleep quality for cough in children and their parents. Pediatrics. 2004;114(1):e85–e90.
6. Schaefer MK, Shehab N, Cohen AL, Budnitz DS. Adverse events from cough and cold medications in children. Pediatrics. 2008;121(4):783–787.
For more information on EBM terms, see the EBM Toolkit at http://www.aafp.org/afp/ebmtoolkit.
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