NEW YORK NURSE: January/February 2009
by Priscilla Sandford Worral, PhD, RN, Coordinator of Nursing Research, University Hospital, SUNY Upstate Medical Center, Syracuse; Foundation of New York State Nurses Center for Nursing Research Planning Committee
Ever since the establishment of the National Center for Complementary and Alternative Medicine (NCCAM) in 1998, the Federal government has supported studies to test the effectiveness of such therapies as acupuncture, massage, and a number of herbal remedies. In 2008, more than $250 million dollars were allocated for NCCAM-sponsored studies. When studies demonstrate the advantage of a therapy that does not require a prescription and costly co-pay, patients benefit in terms of both their health and their budget.
Research conducted by Paul and colleagues (2007) serves as a good example of an interventional study testing the effectiveness of a home remedy versus a pharmaceutical. Use of honey, dextromethorphan, or no treatment were compared for their relative effect on cough frequency, cough severity, and sleep quality of boys and girls ages 2-18 years with upper respiratory infections (URIs) and their parents.
Of the 130 children enrolled in the study, 105 met study criteria, were randomized to one of the three treatment groups, and followed to study completion. Children in the three groups were similar in illness duration and symptoms at the start of the study, with the honey group tending to be more acutely ill. To minimize bias, researchers were blinded to patient assignment and did not know which children received which treatment. Also to minimize bias, children and parents randomized to the honey or dextromethorphan groups did not know which group they were in – the two treatments looked and tasted the same and were dispensed in the same way. Data were collected using surveys completed by parents.
The researchers found a 47.3% reduction in the mean score for cough frequency for the honey group, a 34.8% reduction for the dextromethorphan group, and a 24.7% reduction for the no treatment group. This difference between groups was both clinically relevant and statistically significant (p<.001). Buckwheat honey was found to be more effective than the other two treatments for every outcome measured.
What do the results mean for nursing practice? First, we need to ask how similar our patients are to those included in the study. As a general rule, practice should not be changed based on the results of a single study, even one that is well designed and conducted. These results are not relevant for children under two years of age (see below.) The researchers also note that although the treatment effect was statistically strong (p<.001 is very significant), use of a subjective survey completed by parents is less precise than would be use of a carefully calibrated device, should such a device exist. Finally, we need to remember that improvements found with the buckwheat honey used in this study might not be found with other varieties of honey.
Any change in practice requires that the evidence be strong enough to support that change. The take-home message from this study is treating 2- to 18-year-old children who have a URI-related nighttime cough with buckwheat honey may be a reasonable option given its possible benefit, low cost, and generally low risk profile. A more general message is that we can look forward to an increasing number of funded clinical trials that test complementary therapies head-to-head with drugs and devices that may be “high-tech” but also are likely to be high-cost.
The use of honey for children under 12 months old should be avoided, due to rare cases of infant botulism from spores. Regarding OTC cough products for children, in October 2008 the U.S. Food and Drug Administration (FDA) updated a Public Health Advisory, “FDA Recommends that Over-the-Counter (OTC) Cough and Cold Products not be used for Infants and Children under 2 Years of Age” (www.fda.gov/cder/drug/advisory/cough_cold_2008.htm).
Paul, I. M., Beiler, J., McMonagle, A., Shaffer, M. L., Duda, L., & Berlin, C. M. (2007). Effect of honey, dextromethorphan, and no treatment on nocturnal cough and sleep quality for coughing children and their parents. Archives of Pediatric & Adolescent Medicine, 161(12), 1140-1146.
For an evidence-based review of this study, see also: Warren, M. D., Point, S. J., Barkin, S. L., Callahan, S. T.,
Caples, T. L., Carroll, K. N., Plemmons, G. S., Swan, R. R. & Cooper, W. O. (2007). The effect of honey on nocturnal cough and sleep quality of children and their parents. Archives of Pediatric & Adolescent Medicine, 161(12), 1149-1153.