Coughing Child, Weary Parents: Is Placebo the Right Call?
Coughing Child, Weary Parents: Is Placebo the Right Call?
Paul IM, Beiler JS, Vallati JR, Duda LM, King TS
JAMA Pediatr. 2014;168:1107-1113
Parents and providers face a dilemma in wanting to help children with cough but also recognizing that over-the-counter medications have limited clinically proven benefit and real safety concerns when administered to young children. Because recent studies have demonstrated the potential benefit of honey, Paul and colleagues sought to test agave nectar, a similar substance, to determine whether it could also be effective in controlling cough symptoms. They used a pasteurized agave nectar preparation in a randomized, placebo-controlled trial to assess whether it improved nocturnal cough and sleep.
The children were enrolled in 2013 and 2014 from two outpatient clinics. Children were 2-47 months old with a cough history of less than 1 week. Children with chronic respiratory diseases or severe respiratory diseases (such as pneumonia) were excluded. Children were randomly assigned to one of three groups. The treatment group received pasteurized agave nectar with grape flavoring, the placebo group received grape-flavored water with artificial coloration, and a third group received no treatment. Children were asked to avoid other medications and caffeine for the one night of the study. Children were enrolled on the basis of parental answers to a seven-item survey that assessed nocturnal respiratory symptoms. Only children with "moderate" or greater symptom severity were enrolled in the trial.
On the morning after a single bedtime dose of the child's assigned preparation administered by the parents, the parents completed the same seven-item survey to assess nocturnal symptoms, including cough, congestion, and rhinitis, from the previous night. The instrument also assessed the sleep of the child and the parent. Parents were asked to complete the follow-up survey within 30 minutes of awakening the morning after administering the study preparation.
The mean age of children was 22.9 months. The sample was 50% girls, and 86.6% were white, non-Hispanic. The active preparation group had 39 children; there were 40 children in each of the other groups. There were no differences among the groups at baseline on either demographic factors or severity of illness. Of interest, each group experienced improvement in symptoms scores on the second day. For all seven question items, plus a combination score, the differences in improvement between the agave nectar group and the no treatment group were statistically significant, and for many of the measures there was also a significant difference between the placebo group (grape-flavored water) and the no treatment group. However, for all measures, the agave group and placebo group experienced no significant differences in symptom improvement (both improved equally).
In secondary outcomes, it was evident that the parents did not sleep well and checked on their child approximately four times per night. Neither duration of illness nor the use of other therapies prior to enrollment had any effect on the outcomes. Parents in both the nectar group and the placebo group were generally able to guess which preparation their child had received. The investigators concluded that there is a significant placebo effect when treating the nocturnal cough symptoms of young children and that watchful waiting with no treatment may not be the best approach.
This study is very interesting in that it had both a placebo and a "no treatment" group. The significant response experienced by the placebo group is the primary basis for the researchers' conclusions. In an accompanying editorial, Taylor and Opel commented that placebo effects can be powerful and in this case may actually be beneficial. The parents reported overnight sleep quality, but the recall nature of the survey means that the clinician cannot be sure whether improved sleep actually occurred. However, an approach that uses a placebo hopefully, at a minimum, meets the "do no harm" precept to which clinicians aspire while providing some meaningful benefit to the parents, as in this case.
Placebo Effect in the Treatment of Acute Cough in Infants and Toddlers: A Randomized Clinical Trial
Paul IM, Beiler JS, Vallati JR, Duda LM, King TS
JAMA Pediatr. 2014;168:1107-1113
Study Summary
Parents and providers face a dilemma in wanting to help children with cough but also recognizing that over-the-counter medications have limited clinically proven benefit and real safety concerns when administered to young children. Because recent studies have demonstrated the potential benefit of honey, Paul and colleagues sought to test agave nectar, a similar substance, to determine whether it could also be effective in controlling cough symptoms. They used a pasteurized agave nectar preparation in a randomized, placebo-controlled trial to assess whether it improved nocturnal cough and sleep.
The children were enrolled in 2013 and 2014 from two outpatient clinics. Children were 2-47 months old with a cough history of less than 1 week. Children with chronic respiratory diseases or severe respiratory diseases (such as pneumonia) were excluded. Children were randomly assigned to one of three groups. The treatment group received pasteurized agave nectar with grape flavoring, the placebo group received grape-flavored water with artificial coloration, and a third group received no treatment. Children were asked to avoid other medications and caffeine for the one night of the study. Children were enrolled on the basis of parental answers to a seven-item survey that assessed nocturnal respiratory symptoms. Only children with "moderate" or greater symptom severity were enrolled in the trial.
On the morning after a single bedtime dose of the child's assigned preparation administered by the parents, the parents completed the same seven-item survey to assess nocturnal symptoms, including cough, congestion, and rhinitis, from the previous night. The instrument also assessed the sleep of the child and the parent. Parents were asked to complete the follow-up survey within 30 minutes of awakening the morning after administering the study preparation.
Study Findings
The mean age of children was 22.9 months. The sample was 50% girls, and 86.6% were white, non-Hispanic. The active preparation group had 39 children; there were 40 children in each of the other groups. There were no differences among the groups at baseline on either demographic factors or severity of illness. Of interest, each group experienced improvement in symptoms scores on the second day. For all seven question items, plus a combination score, the differences in improvement between the agave nectar group and the no treatment group were statistically significant, and for many of the measures there was also a significant difference between the placebo group (grape-flavored water) and the no treatment group. However, for all measures, the agave group and placebo group experienced no significant differences in symptom improvement (both improved equally).
In secondary outcomes, it was evident that the parents did not sleep well and checked on their child approximately four times per night. Neither duration of illness nor the use of other therapies prior to enrollment had any effect on the outcomes. Parents in both the nectar group and the placebo group were generally able to guess which preparation their child had received. The investigators concluded that there is a significant placebo effect when treating the nocturnal cough symptoms of young children and that watchful waiting with no treatment may not be the best approach.
Viewpoint
This study is very interesting in that it had both a placebo and a "no treatment" group. The significant response experienced by the placebo group is the primary basis for the researchers' conclusions. In an accompanying editorial, Taylor and Opel commented that placebo effects can be powerful and in this case may actually be beneficial. The parents reported overnight sleep quality, but the recall nature of the survey means that the clinician cannot be sure whether improved sleep actually occurred. However, an approach that uses a placebo hopefully, at a minimum, meets the "do no harm" precept to which clinicians aspire while providing some meaningful benefit to the parents, as in this case.
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