News Author: Laurie Barclay, MD
CME Author: Laurie Barclay, MD
Release Date: December 3, 2007; Valid for credit through December 3, 2008
COPY FOR EDUCATIONAL PURPOSES/COPIA CON FINES DOCENTES
December 3, 2007 — Honey may be a viable option for treating cough associated with upper respiratory tract infections (URIs) in children, according to the results of a randomized study reported in the December 3 issue of the Archives of Pediatrics & Adolescent Medicine.
“Parents of children over age 1 year seeking to relieve the cough and sleep difficulty associated with colds should consider trying honey,” lead author Ian M. Paul, MD, MSc, an associate professor of pediatrics and public health sciences at the College of Medicine, Pennsylvania State University, Hershey, tells Medscape Pediatrics. “Honey has been cited by the World Health Organization as a treatment for cough and cold symptoms in children, and it is used for symptomatic relief for these illnesses by cultures all over the world. Because none of the currently available over-the-counter therapies have been shown to be effective for cough and cold symptoms in children, honey was a logical choice to study given that it is safe for children over age 1, cheap, and widely used.”
The goal of this partially double-blinded, randomized study was to compare parental satisfaction with the effects of a single nocturnal dose of buckwheat honey, honey-flavored dextromethorphan (DM), or no treatment on nocturnal cough and sleep difficulty in children with URIs.
“Dr. Paul’s study represents a welcome addition to the literature on cough medications in children,” Michael Dale Warren, MD, from Vanderbilt University in Nashville, Tennessee, told Medscape Pediatrics when asked for independent comment. “During the cough and cold season, pediatricians are bombarded with questions from parents who want to know what they can to do to relieve symptoms in their child who has a cold. Supportive care (nasal saline sprays/drops, bulb suctioning, cool mist humidifiers, fever-reducing medications, fluids, and rest) is the mainstay of therapy for children with URI symptoms.”
Dr. Warren, who was not directly involved in this study but was lead author of an accompanying review, is a clinical fellow, Division of General Pediatrics, and instructor in clinical pediatrics at Monroe Carell, Jr. Children’s Hospital at Vanderbilt.
“Dr. Paul’s study has now shown that honey may be effective in reducing cough symptoms in children with URIs,” Dr. Warren said. “Pediatricians who choose to offer therapy to children with cough now have another tool in their arsenal for treating cough symptoms associated with URIs in children.”
At a single outpatient, general pediatric practice, 105 children with URIs were randomized to receive a single dose of honey, honey-flavored DM, or no treatment 30 minutes before bedtime. Inclusion criteria were age 2 to 18 years with URI, nocturnal symptoms, and duration of illness of 7 days or less.
Parents completed a survey on 2 consecutive days, first on the day that the child was first seen, when no medication had been given the evening before, and again on the following day after receipt of honey, honey-flavored DM, or no treatment before bedtime. The main endpoints were frequency and severity of cough, bothersome nature of cough, and quality of sleep for child and parent.
“This is a well-designed, randomized controlled clinical trial,” Dr. Warren said. “Dr. Paul’s study provides valuable information on a topic for which data is lacking — efficacy of cough medicine in children. The authors were diligent in their equal treatment of study groups and in their attempts to maintain blinding between the dextromethorphan and honey groups.”
Symptom improvement was significantly different between treatment groups, being consistently scored the best for honey and scored the worst for no treatment. Paired comparisons revealed that honey was significantly better than no treatment for cough frequency and for the combined score, that DM was not better than no treatment for any outcome, and that outcomes for honey and DM were not significantly different.
“The study answers an important question for pediatric providers and for parents — what else can be done to alleviate cough symptoms in children with URIs?” Dr. Warren said. “There is a lack of data supporting many commonly used cough medications in children, yet there is data showing the potential for harm associated with these medications. This question is even more timely given the recent FDA [Food and Drug Administration] panel recommendations that over-the-counter cough and cold medications not be used in children under the age of 6.”
Based on this comparison of honey, DM, and no treatment, the study authors concluded that parents rated honey most favorably for symptomatic relief of their child’s nocturnal cough and sleep difficulty from URI, suggesting that honey may be the preferred treatment option for the cough and sleep difficulty associated with URI in children. While awaiting additional studies to confirm these findings, they recommend that each clinician consider the positive findings with honey, the absence of such published findings for DM, and the risk for adverse effects and cumulative costs associated with the use of DM.
“The study results are widely applicable to many patients that we see regularly; visits for URIs account for 11% of visits in children ages 1-12, according to the 2005 National Ambulatory Medical Care Survey,” Dr. Warren said. “Honey is a reasonable option for treating cough associated with URIs, given its low cost, relatively low adverse effect profile, and potential benefit.”
Limitations of the study that the authors acknowledged include the fact that each child had a clinician visit between the 2 nights of the study, which could account for some of the symptomatic relief in all of the groups; some of that relief attributed to the natural history of URIs; use of a subjective survey; and inability to guarantee compliance with medication administration. Dr. Warren also notes that it would be helpful to have more information about the cough scale used for assessing symptoms in this study, and its validation in a full publication.
“It is unclear whether the benefits of honey are variety specific,” Dr. Warren continued. “This study used buckwheat honey; the authors note that darker honeys, such as buckwheat honey, consist of more phenolic compounds than other varieties and that the associated antioxidant effect might have contributed to the improvement seen in those children treated with this kind of honey. If the effect is variety specific, then local availability of particular varieties of honey or cost to consumers may limit the applicability of the results.”
Dr. Paul told Medscape Pediatrics that additional research should include confirmatory trials of these findings, trials with different types of honey, and determination of the effects of repeated doses. Dr. Warren recommended further studies to develop more pediatric-specific cough symptom questionnaires, to evaluate whether the observed symptomatic relief is specific to particular varieties of honey, and to explore whether similar relief is seen for symptoms other than cough and whether the effects carry over to adults.
“Dr. Paul’s work specifically looks at the impact of honey on cough in children,” Dr. Warren said. “More research would be needed to determine whether honey is effective in reducing other URI symptoms in children and adults.”
However, Dr. Paul believes that the use of honey might be a reasonable therapeutic option beyond the confines of this study.
“I believe the findings would be applicable to adults,” Dr. Paul concluded. “As for other symptoms, I suspect honey would also provide relief for throat discomfort.”
The National Honey Board, an industry-funded agency of the US Department of Agriculture, supported this study. Dr. Paul has been a consultant to the Consumer Healthcare Products Association and McNeil Consumer Healthcare and has obtained funding. The other study authors have disclosed no relevant financial relationships. Dr. Warren and coauthors have disclosed no relevant financial relationships.
Arch Pediatr Adolesc Med. 2007;161:1140-1146, 1149-1153.
In the United States, cough, typically accompanying a URI, accounts for nearly 3% of all outpatient visits. Nocturnal cough frequently disrupts sleep. Despite the widespread use of DM for treatment of cough in children, the American Academy of Pediatrics and the American College of Chest Physicians do not endorse this practice.
Earlier studies have shown that DM was not better vs placebo for relief of cough and sleep disruption. Unlike DM, which has potential adverse effects, honey is thought to be safe for children older than 1 year of age and has been recognized by the World Health Organization as a potential treatment. No previous studies have proven efficacy, but potential mechanisms of action of honey may include its demulcent effect, which may soothe the throat; improved mucociliary clearance in the airway; reflex salivation and endogenous opioid production caused by sweet substances; antioxidant properties; and promotion of cytokine release, which may underlie its antimicrobial effects.
- The objective of this randomized study was to compare parental satisfaction with the effects of a single bedtime dose of buckwheat honey, honey-flavored DM, or no treatment on nocturnal cough and sleep difficulty in children with URI.
- From September 2005 through March 2006, at a single outpatient, general pediatric practice, 105 children aged 2 to 18 years with URI, nocturnal symptoms and illness duration of 7 days or less were randomized to receive 1 dose of honey, honey-flavored DM, or no treatment 30 minutes before bedtime. Randomization was stratified for age (2 – 5, 6 – 11, and 12 – 18 years).
- Exclusion criteria were signs or symptoms of asthma, pneumonia, laryngotracheobronchitis, sinusitis, or allergic rhinitis; history of reactive airways disease, asthma, or chronic lung disease; use of a drug known to inhibit DM metabolism; or use of antihistamine or DM hydrobromide within 6 hours of bedtime or DM polistirex within 12 hours of bedtime the evening before or on the day of enrollment.
- Of 130 children enrolled, 105 (81%) completed the single-night study. Treatment groups were similar in baseline characteristics. Median age was 5.22 years (range, 2.22 – 16.92 years), 53% were girls, and mean duration of illness was 4.64 ± 1.68 days.
- Parents completed a survey on the day that the child was first seen; when no medication had been given the evening before; and again on the following day after receipt of honey, honey-flavored DM, or no treatment before bedtime.
- The main endpoints were frequency and severity of cough, bothersome nature of cough, and quality of sleep for child and parent.
- Relief of symptoms was significantly different between treatment groups. Scores were consistently best for honey and worst for no treatment in cough frequency and severity, bothersome nature of cough, children’s sleep quality, parental sleep quality, and combined score.
- In paired comparisons, honey was significantly better vs no treatment for cough frequency and for the combined score, DM was not better vs no treatment for any outcome, and outcomes for honey vs DM were not significantly different.
- Based on this comparison of honey, DM, and no treatment, the study authors concluded that parents rated honey most favorably for symptomatic relief of their child’s nocturnal cough and sleep difficulty from URI, suggesting that honey may be the preferred treatment option.
- Additional research is needed to confirm these findings. In the interim, each clinician should consider the positive findings with honey, the absence of such published findings for DM, and the risk of adverse effects and costs of DM.
- DM was generally well tolerated, but the authors cite serious adverse events reported in the literature (eg, dystonia, anaphylaxis, bullous mastocytosis, dependence, psychosis, ataxia, somnolence, insulin-dependent diabetes, peripheral neuropathy, cerebellar degeneration, megaloblastic anemia, and even death) with higher doses.
- Mild adverse effects of hyperactivity, nervousness, and insomnia were significantly more common in those treated with honey (n = 5). The study authors also note that, in honey, there is a rare risk for grayanotoxin-mediated syndrome reported in the literature.
- Limitations of the study include the fact that each child had a clinician visit between the 2 nights of the study, which could account for some of the symptomatic relief in all of the groups; some of that relief attributed to the natural history of URIs; use of a subjective survey; inability to guarantee compliance with medication administration; lack of validation of the cough scale used; and lack of generalizability to varieties of honey other than buckwheat.
Pearls for Practice
- In this study of children with URI, parent-rated scores for symptomatic relief were consistently best for honey and worst for no treatment in frequency and severity of cough, bothersome nature of cough, children’s sleep quality, parental sleep quality, and combined score. In paired comparisons, honey was significantly better vs no treatment for cough frequency and for the combined score, and outcomes for honey vs DM were not significantly different.
- Compared with no treatment, DM was not better for any outcome. Honey, which is also considered to be safer than DM, may therefore be the preferred treatment option.