There may be a sweet alternative to OTC cough preparations

January 2008

There has been much to-do recently about over-the-counter medications for infants and children, which makes for disturbing nighttime reading.

A summary of some of the FDA hearings on this issue can be found at www.fda.gov and although it is quite long, one may simply want to read the AAP submission.

The essence of the argument is that there is either no evidence of efficacy for these preparations in this age group or there is no efficacy in the case of pseudoephedrine. On the other hand, there are hundreds of thousands of calls to poison centers, tens of thousands of ER visits and some deaths from these preparations. The good news is that there is a “sweet alternative” for which there is some evidence of efficacy. The alternative appears to be safer and more pleasant (Arch Ped Adol Med. 2007;161:1140.). More on that later.

The lead article in The New England Journal of Medicine summarizes the issue quite well. The current regulations call for the OTC preparations labels to contain directions. Many of these preparations contain the information to “consult your physician.” This essentially shifts the responsibility from the manufacturer to the physician who is expected to provide guidance on the basis of nonexistent evidence of safety and efficacy. The manufacturer’s response has been to withdraw medications for coughs and colds for children aged younger than 2 years and would add the words “do not use to sedate” for antihistamines.

The advertising of OTC preparations is another issue. Advertising is monitored by the FTC, which does not have the expertise of FDA, which may account for some of the claims made in these ads. A review by an FDA panel in 1976 recommended against marketing these preparations for children aged younger than 2 years but endorsed extrapolation of doses for older children from adult doses. The labeled dosage by age, (eg, 7.5 mg per dose of dextromethopan for 2- to 5-year-olds, 7.5 for 6- to 11-year-olds), results in a per kg dose ranging from 0.35 mg/kg per dose to 0.94 mg/kg per dose, a 2.5-fold difference on a mg/kg basis (Clin Ther. 2004;26:1508.).

An alternative

It always gives me pleasure to learn that a “bobbe myseh” or grandmother’s tale (Joys of Yiddish, Leo Rosten), may have some validity.

The bobbe myseh has to do with the curative benefits of honey. In a study comparing the effect of a nocturnal dose of buckwheat honey, honey-flavored dextromethopan product and no treatment at all (Arch Ped Adol Med. 2007;161:1140), honey’s benefits exceeded no treatment and dextromethopan did not. The most common adverse event was hyperactivity in about 15% of participants, which some may have predicted if one believes that sugar at bed time is not conducive to sleep.

In the article, the researchers discuss some of the reasons that honey might work. They cite an entertaining and informative reference titled, “Mechanisms of the Placebo Effect of Sweet Cough Syrups” (Resp Phys Neurobiol. 2006;152:340). In the interests of being politically correct, I will quote the author’s origin of the term placebo, which he states is from the Catholic vespers for the dead and means, “I shall please.”

The effectiveness of cough medications parsed to several causes. Placebo undoubtedly is a major factor. In the case of infants, the parents also derive the benefit of “doing something” and the belief that it must be doing some good. It was noted that the opioids do have an effect on the opioid receptors in the cough control center of the brain stem. In a study on dextromethopan, it was shown that lower doses based on mg per age on the labeling of OTC products do not have a cough suppressive effect but that those in the upper range might (Clin Ther. 2004;26:1508.). Thus it is conceivable that trials based on mg/kg might be effective in contrast to the present OTC labeling by age.

It is postulated that sensory stimuli, eg, sweetness, may increase secretions and ciliary activity by reflex action analogous to gustatory rhinorrhea after eating spicy foods. In addition, it is believed that sweet syrups may generate the secretion of endogenous opioid as may occur when sedating newborns with sucrose. This is supported by the observation in animals that the analgesic effect can be vitiated by morphine antagonists (Brain Res Bul. 2004;64:319.).

In summary, one can recommend honey for relief of cough with some, although modest, evidence to support its efficacy. One should not feed honey to infants younger than 1 year of age as infantile botulism could be a serious adverse effect. The AAP has recommended that all OTC medications for the pediatric age group undergo efficacy trials and that the old practice of extrapolating from adult data, most of which are negative for efficacy, be abandoned.

I was a great student of my grandmother’s lore. She was a midwife and a real Mary Poppins. I used honey frequently for my own children with equal parts of some sweet Manichevitz wine, 11% alcohol, when they had croup. This now would probably be considered child abuse.

Parenthetically, none of my children will so much as touch a beer. Perhaps they were immunized against alcohol.

Alcohol is a respiratory stimulant in small amounts and might be beneficial in croup.

For my patients with cough, I would recommend lollypops, which also have a demulcent action. Wasn’t it Mary Poppins who said “a spoonful of sugar helps the medicine go down?”

It is unlikely that both Mary Poppins and my grandmother both could be wrong.