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Data nearly absent in release claiming safety of acetaminophen in children with asthma

Study shows acetaminophen can be tolerated by children with mild, persistent asthma

Our Review Summary

AsthmaThis study published in the New England Journal of Medicine (NEJM) is the first randomized, double-blind, controlled trial comparing acetaminophen to ibuprofen to treat pain and fever in children with asthma. No statistically significant differences were found between the two treatment arms. Previous observational studies had suggested that acetaminophen could exacerbate asthma symptoms in young children.

This University Hospitals Case Medical Center news release does a good job summing up much of the relevant information, but more elaboration with data backing up the claims would have been helpful for busy reporters covering this important topic. Compared to a news release by Boston Children’s Hospital, which we also reviewed, this release omitted quantitative data needed to back up its statements, especially those addressing benefits and harms such as no “significant differences in safety [found] between the two drugs.” As we had noted in previous news releases, the word “significant” here is supposed to mean “statistically significant” – a fact that’s often not clear. The University Hospitals news release also could have been more explicit in explaining the importance of the study, given its context. Finally, although the news release correctly points out that caregivers used either acetaminophen or ibuprofen, it suggests the brand names Tylenol and Advil/Motrin were given to participants, when researchers actually administered Little Fevers by Little Remedies and Children’s Advil.

A short discussion of costs would have been beneficial in the news release, since acetaminophen (Little Remedies) generally tends to be more expensive than ibuprofen (Children’s Advil).

 

Why This Matters

It’s important context — but it was not discussed in this news release — that there has been concern among some pediatricians that acetaminophen should not be used in kids with asthma. This study set out to study the equivalence of acetaminophen and ibuprofen.

Acetaminophen is the most commonly used pediatric medication in the United States. Previous observational studies found a correlation between acetaminophen and increased asthma symptoms, as well as decreased lung function. Other analyses found that acetaminophen use resulted in more unscheduled medical visits for asthma than ibuprofen use. These findings have even led to alarm, as some physicians called for recommendations that acetaminophen should be avoided until more safety data become available.

But observational data carry limitations – namely, confounding by indication. That’s to say, people who use a drug more frequently differ in health and other features from those who use the drug less frequently or who do not take the drug at all. This was the first appropriately designed and randomized clinical trial in a well-characterized cohort to settle the debate of causation. The study’s message to parents and caregivers of young children is that acetaminophen use will not worsen asthma symptoms.

Criteria

Does the news release adequately discuss the costs of the intervention?

Not Satisfactory

Like the Boston Children’s Hospital news release, the University Hospitals Case Medical Center news release does not address costs. The acetaminophen medication used in the study, Little Remedies, costs about 50 percent more than Children’s Advil — $8.86 for 4 fluid ounces versus $4.96, respectively — at Walmart. It would have been helpful to include the costs of the generic versions of these drugs which could be significantly lower than brand name drugs.

Since costs are not mentioned in the news release, we give it a Not Satisfactory rating here.

Does the news release adequately quantify the benefits of the treatment/test/product/procedure?

Not Satisfactory

One of the questions the study attempted to answer was whether ibuprofen is a safer drug than acetaminophen in children with mild persistent asthma. Although the Boston Children’s Hospital news release details the numbers, this news release does not include any quantitative data. It only states that researchers “did not find any significant differences in safety between the two drugs.” The quantitative data are helpful because they show just how closely the two groups were matched and because they back up the claim to equivalent safety. As seen in many other news releases, the use of the word “significant” here is ambiguous, since it is meant as being “statistically significant,” instead of the colloquial use of the term.

As a result, we give the news release a Not Satisfactory rating here.

Does the news release adequately explain/quantify the harms of the intervention?

Not Satisfactory

Another major study question was whether frequent acetaminophen use in children with mild persistent asthma worsens symptoms. This was measured by asthma exacerbation rate, number of days of asthma control, need for “rescue” medication and unscheduled medical visits for asthma, as the news release points out. As mentioned above in the “Quantify Benefits” section, this release does not lay out any supporting quantitative data for these benchmarks. It only states, “The study did not detect any worsening of asthma in the children treated with acetaminophen compared with those receiving ibuprofen.”

For these reasons, we give the news release a Not Satisfactory rating here.

Does the news release seem to grasp the quality of the evidence?

Not Satisfactory

Unlike the news release from Boston Children’s Hospital, which does a thorough job outlining the study design, University Hospitals Case Medical Center only gives the bare bones of the study, including information only on the number of enrollment and criteria. Other pieces of information are not given, including medication dosage and follow-up time.

There is also no mention of the study’s limitations, such as a lack of a placebo group and the narrow inclusion criteria.

Due to these factors, we give the news release a Not Satisfactory rating here.

Does the news release commit disease-mongering?

Satisfactory

The news release does not engage in disease mongering.

Does the news release identify funding sources & disclose conflicts of interest?

Not Satisfactory

University Hospitals Case Medical Center discloses in its first paragraph the fact that the National Institutes of Health and the National Heart, Lung and Blood Institute’s Asthma Network (AsthmaNet) funded the study.

However, according to the published study, several of the researchers have ties to Pfizer, the maker of Children’s Advil, and to McNeil Consumer Healthcare and Johnson & Johnson, makers of Tylenol. These are important ties to mention in a news release.

Does the news release compare the new approach with existing alternatives?

Not Applicable

The study was designed to compare the safety of two drugs – acetaminophen and ibuprofen – in children with mild, persistent asthma, since previous observational studies had correlated acetaminophen with increased asthma symptoms.

Since the drugs themselves are already alternatives in treating pain and fever, we rate this one Not Applicable.

Does the news release establish the availability of the treatment/test/product/procedure?

Not Applicable

The availability of acetaminophen and ibuprofen is not in question, since these are well-known, over-the-counter drugs. We rate this one Not Applicable.

Does the news release establish the true novelty of the approach?

Satisfactory

This release was not explicit in describing what this study brings to the existing body of knowledge. Instead, it hints the new study’s findings go against previous observational studies in the long comment from the study’s co-author, but the reader doesn’t have a clear idea what makes this study so important and newsworthy, especially when this topic has been looked at before. It would have been helpful to mention that this study really was the first trial that was blinded, randomized and controlled in comparing acetaminophen and ibuprofen in young children with mild asthma.

Despite the ambiguity, we think the news release gave just enough information for a Satisfactory rating here.

Does the news release include unjustifiable, sensational language, including in the quotes of researchers?

Satisfactory

The news release from University Hospitals Case Medical Center does not use unjustifiable, sensational language.

Total Score: 3 of 8 Satisfactory

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