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Kudos to Boston Children’s Hospital for release on acetaminophen and asthma study

Acetaminophen does not aggravate children's asthma

Our Review Summary

sick childThis news release by Boston Children’s Hospital is based on a study published in the New England Journal of Medicine on 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.

The news release provides detailed, clear information on almost all of our criteria. It explains early in the text the significance of the study and gives appropriate figures in easy-to-read bullet points to support the finding that there is “absolutely no difference between Tylenol and Motrin.” (Although these two brands do contain acetaminophen and ibuprofen, respectively, we noticed that researchers actually gave Little Fevers by Little Remedies and Children’s Advil to participants.)

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).

One drawback the release shared with another release we reviewed on the same study (by University Hospitals Case Medical Center) was the omission of financial ties between several study authors and the makers of branded versions of acetaminophen and ibuprofen.

 

Why This Matters

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. Parents of young children can take comfort in the fact that acetaminophen use will not worsen asthma symptoms.

Criteria

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

Not Satisfactory

Costs are not addressed in the Boston Children’s Hospital news release. The acetaminophen medication used in the study, Little Remedies, costs about 50 percent more than Children’s Advil – $8.86 versus $4.96, respectively – at Walmart. It would have been helpful to readers to include the less costly generic versions of these drugs.

Since costs are not mentioned in the news release, we give it an Unsatisfactory rating here.

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

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. This release does a laudable job laying out the figures for the number of asthma exacerbations for each group. It also includes quantitative data for the percentage of days with full asthma control, use of “rescue medication” and unscheduled healthcare visits. It also used the term “significant” correctly, stating that there “were no statistically significant differences between groups” (a common mistake we’ve seen in other releases).

Due to all these factors, we give the news release a Satisfactory rating here.

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

Satisfactory

Another major study question was whether frequent acetaminophen use in children with mild persistent asthma worsens symptoms. This was measured by the number of asthma exacerbations, percentage of days with full asthma control, use of “rescue” medication and unscheduled healthcare visits for asthma. As mentioned in the “Quantify Benefits” section, this release includes quantitative data from the original study in easy-to-read bullet form. Furthermore, the headline and quotations used in the news release reinforce the study’s findings, making it clear that acetaminophen does not worsen asthma symptoms in children.

For these reasons, we give the news release a Satisfactory rating.

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

Satisfactory

Boston Children’s Hospital does a thorough job outlining the study design — including information on study criteria, dosage and follow-up. In addition, it gives exact numbers on how many people enrolled in and completed the study.

The news release also points out the study’s limitations. For example, authors chose to include young children with mild persistent asthma receiving asthma controller therapy. Therefore, the news release notes, “Findings may not apply to other age groups or children with more severe asthma.”

It would have been helpful to mention that the study did not include a placebo group, since researchers deemed this to be unethical. However, this means that the trial cannot answer the question of whether the use of acetaminophen or ibuprofen itself worsens asthma, compared with no drug interventions.

Despite this omission, we feel the news release merits a Satisfactory rating here for describing the study’s design and limitations.

Does the news release commit disease-mongering?

Satisfactory

There is no disease mongering in this news release.

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

Not Satisfactory

Boston Children’s Hospital discloses the fact that the National Institutes of Health and the National Heart, Lung and Blood Institute’s Asthma Network (AsthmaNet) funded the study.

However, no mention is made of the ties several of the researchers have to Pfizer, the maker of Children’s Advil, and to McNeil Consumer Healthcare and Johnson & Johnson, makers of Tylenol.

Not providing the potential conflicts of interest earns the release a Not Satisfactory rating here.

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

Boston Children’s Hospital was clear in explaining how this study contributes to the existing body of literature. In other words, what’s “new” about this study is that it “is the only blinded, randomized, controlled trial to date to prospectively compare acetaminophen head-to-head with ibuprofen (Motrin, etc.) in children with asthma.” The news release adds that it should settle the debate on whether taking acetaminophen for pain and fever worsens asthma symptoms in children.

We applaud this clarification and give the news release a Satisfactory rating here.

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

Satisfactory

The news release from Boston Children’s Hospital does not use unjustifiable, sensational language.

Total Score: 6 of 8 Satisfactory

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