I met Dr. Mike Ginsberg via interweb first when we were both ranting about… the usual, the anti-science movement and the effect it has on his job. He was well spoken, passionate, and about as mad as I was about the fact that we had an outbreak of a disease that we thought we got rid of thirty years ago.
So when I was in San Francisco a few weeks ago, I caught up with Dr. Ginsberg over pizza and a diet coke or three.
Along with him being a great guy, speaking with someone who’s so knowledgeable about their field was wonderful. As much as I can answer questions about what is (and what isn’t) good science, it’s important to defer to experts like him on questions about medications for children. I’m not an expert in that field and I want people to get information from the right source. He started telling me (1) that a lot of medications are not recommended for children under a certain age and (2) about the research on the available medications in treating cough for infants… and the research indicates that placebos work as well as the stuff on the shelves.
And he’s not having it.
I asked him if he could write up his explanation, and here the good doc is in his own words.
Placebo for treating cough in children: why I won’t do it.
Mike Ginsberg, M.D., M.S., FAAP
An acute cough is defined as a cough lasting less than 15 days. Cough is the third-most common reason that patients see a doctor and the most common acute complaint to primary care physician’s offices.(1) As a practicing pediatrician, I’d estimate that visits for acute cough probably consume roughly a quarter of my average daily schedule between the months of December and March. The vast majority of acute cough in children is caused by self-limited viral upper respiratory infections (URI).(2) While some otherwise healthy children may have as many as 15 URIs in a year, the average child has a URI 5-6 times per year, which means that normal children between 6mo and 2yo will be sick at least once per month during the winter.(3)
Cough makes parents worry, it fills my schedule, and it makes me feel like a broken record. I walk into the room to see a smiling, drooling, happy baby with a light cough and a mother who has terror in her eyes worrying that “my mother said he might have pneumonia.” True pneumonia is vastly overdiagnosed by emergency rooms, urgent care centers, and primary care physicians. It actually only affects 5% of children in industrialized nations per year.(4) Of course, it’s our job as clinicians to recognize those rare cases of cough that are “more than just a cough.” But for acute cough, our job is to provide peace of mind. Peace of mind doesn’t need to take the form of a teaspoon of medicine. That’s why machines will never replace us and that’s what makes me get out of bed and go to work every morning.
Parents often reach for cough suppressants and decongestants but these medicines cause more harm than good in children under 5; they do not relieve symptoms, yet side-effects from overdoses are common.(5,6,7,8) One trial showed that “VapoRub” and that parents thought it was more effective than fragrance-free patrolatum or no treatment, but it will be hard to convince me that “VapoRub” is effective given that there’s no good way to make a placebo.(9) At least two randomized placebo-controlled trials found that a teaspoon of honey may be effective for relieving acute cough in children over 12 months although they don’t alter the outcome of the illness, and this is certainly a safe option that I confidently recommend to my patients.(10,11) Another study (partially funded by the Israeli Honey Board, but with sound methodology) found that three different types of honey all were equally effective for acute cough and more effective than a date nectar placebo.(12) This is fine for children over 12 months, **but in children under 12 months, honey is a risk for botulism poisoning and it is not safe to use.**(13)
As a pediatrician, that leaves me in a bit of a bind. Cough is a common and bothersome complaint in children under 12 months and I understand how desperate parents can be for something, anything to make it better. Furthermore, I worry that parents might ignore my advice to “just wait it out” and reach for these medications, anyway.
Enter Dr. Ian Paul ,Ms. Jessica Beiler, MPH, and friends (I’ve already cited two other papers of theirs here) with an article published in JAMA Pediatrics from November 2014 suggesting that placebo is effective in improving cough in children.(14)
Actually, this is no big shock at all if you do what I do for a living. In their study, they took children 2-47 months old presenting to the office with a complaint of acute cough and randomized them into three groups. In one group, parents were educated that there was nothing that they could do and sent home. In the next group, parents were given a placebo of artificially-sweetened grape-flavored water. In the third group they were given agave nectar. The two groups that were given a product were told give a dose to their children that night and then were assessed for their perception of improvement.
Not surprisingly, parents of children who were given either placebo or agave nectar reported a significant improvement in the child’s symptoms and in the child’s and parents’ quality of sleep. Well, no duh. Placebo is commonly known to be very effective for all sorts of physical complaints, which is exactly why any well-done study has a placebo control! The act of giving a child medicine is comforting for parents (and probably for the child) and makes them feel like they are doing something about it and thus, they report improvement in the cough.
The authors concluded: “In a comparison of agave nectar, placebo, and no treatment, a placebo effect was demonstrated, with no additional benefit offered by agave nectar. Health care professionals should consider the potential benefits and costs when recommending a treatment with only a placebo effect for infants and toddlers with nonspecific acute cough.”
Now, some colleagues who I respect a lot have started recommending agave nectar to parents of children 2-12 months with acute cough based on this data. Their reasoning is that it might stop parents from reaching for dangerous stuff like dextromethorphan or codeine and that it at least “helps” by allowing the parents to sleep soundly in the knowledge that they “did something to help the baby feel better.” The authors of this study are good researchers who have a knack for robust study design and they draw substantiated conclusions from their studies. They like the idea of offering a placebo, but I respectfully disagree.
I can’t bring myself to recommend it. Here’s why:
First of all, the folks at Zarbee’s are all over it, bless their hearts, selling 60mL (2 fl oz.) of grape-flavored dilute “all natural” agave nectar “cough syrup” for $7 on Amazon and I’ve seen $10+ in retail pharmacies. Many of my patients are poor. Zarbee’s frequently succeeds in getting them to spend that kind of money for some sugar water. I think it’s outrageous and I’m not playing along. Zarbee’s also sells a honey product that consists of diluted dark honey with some ivy leaf extract and a few other harmless things for the same price for 4oz for children 12mo and up. But as far as I know, nobody has ever done a double-blinded trial on it and there’s no evidence that it’s any better than straight honey, which is way cheaper.
Perhaps the strength of the placebo effect is improved the more you overcharge for it.(15)
Second, even for my well-to-do, six-figure income families, I still can’t bring myself to do it. Prescribing a placebo and even implying that it might actually help would involve misleading my patients and that’s not a line I’m willing to cross, even as innocuously as this one.
Third, while I’m willing to recommend honey for children over 12 months because it’s actually demonstrated to be more effective than placebo, remember that we have already established that acute cough is incredibly common in young children. Given that a typical acute cough can last up to two weeks (by definition), some otherwise healthy children may have acute cough for more days during a given winter than not. So much so that personally, I think of acute URI/cough as a variation of the normal physiologic state in children under 5 during winter. To me, in recommending a placebo for a baby with an acute cough that might hit as often as every two weeks, I am simply reinforcing the idea that this normal physiological state of affairs requires medication when it absolutely does not. I am a medical minimalist; I like to keep children away from “medications” –whether proven effective or not, whether “natural” or synthetic– unless absolutely necessary.
Finally, there are 3-6 grams of sugar in a “dose” of agave nectar,(16) and as we established, some kids may actually have acute cough for >50% of the days during a given winter, so that adds up to an awful lot of sugar. I’m not going to post references here (that’s a whole separate article) but trust me when I say that concentrated sugar is not good for us. Primum non nocere. “First, do no harm.”
For acute cough in infants aged 60 days to their first birthday, the best and most “natural” thing to do is nothing. I can’t recommend “VapoRub” without better evidence that it’s effective (although at least I can tell parents that it’s not unsafe to use). I can’t recommend agave nectar even leaving aside the outrageous price. The safest, most effective, and natural thing you can do for acute cough in an infant is to reassure yourself that this, too, shall pass and treat it with what we in the business call “tincture of time.”
-MLG June 2015
DISCLOSURE: The opinions expressed in this work are mine alone and not those of my employer or any other individual and organizations. I have no relationships, personal or financial, with any individual or organization referenced in this work.
So there’s the good doc’s word on cough medications. I’ll definitely trust the doctor who seeks evidence before prescribing and isn’t trying to make you spend money on unnecessary meds. Please stick to medications that are proven to help your children.
(2)McCormick A, Fleming D, Charlton J. Morbidity statistics from general practice—fourth National Morbidity Survey, 1991–92. London, UK: HMSO, Office for National Statistics; 1995.
(3)Chonmaitree T, Revai K, et. al. Viral Upper Respiratory Tract Infection and Otitis Media Complication in Young Children. Infect Dis. 2008; 46(6):815-823.
(4) Rudan I, Boschi-Pinto C. Epidemiology and etiology of childhood pneumonia. Bull World Health Organ. May. 2008; 85(5) Abstract.
(5)Hutton N, Wilson NH, et al. Effectiveness of an Antihistamine-Decongestant for Young Children With the Common Cold: A Randomized Controlled Clinical Trial. J. Pediatrics 1991;118:125-130
(6)Taylor JA, Novak AH, et al. Efficacy of Cough Suppressants In Treating Nighttime Cough in Children. AJDC 1991; 145-389. Abstract.
(7)Gadomski A, Horton L, et al. The Need for Rational Therapeutics in the Use of Cough and Cold Medicine in Infants. Pediatrics 1992; 89(4)774 -776
(8)Infant deaths associated with cough and cold medications–two states, 2005. MMWR Morb Mortal Wkly Rep. 2007 Jan 12;56(1):1-4.
(9)Paul IM, Bieler JS, Vapor Rub, Petrolatum, and No Treatment for Children With Nocturnal Cough and Cold Symptoms. Pediatrics 2010;126:6
(10)Paul IM, Beiler J, et al. Effect of Honey, Dextromethorphan, and NoTtreatment on Nocturnal Cough and Sleep Quality for Coughing Children and Their Parents. Arch Pediatr Adolesc Med. 2007;161(12):1140–6.
(11)Olabisi O, Meremikwu MM, Honey for acute cough in children. Cochrane Acute Respiratory Infections Group. Published Online: 23 DEC 2014. Abstract
(12)Cohen HA, Rosen J, et al. Effect of Honey on Nocturnal Cough and Sleep Quality: A Double-blind, Randomized, Placebo-Controlled Study. Pediatrics 2012; 130(3)
(13)Cox N., Hinkle R. Infant Botulism. Am Fam Physician. 2002 Apr1; 65(7): 1388-1393. Review.
(14)Paul IM, Bieler JS. et al. Placebo Effect in the Treatment of Acute Cough in Infants and Toddlers: A Randomized Clinical Trial. JAMA Pediatr. 2014;168(12):1107-1113.
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