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Some Positive Takeaways from Some Negative Studies

December 7, 2021

Journals often prefer to publish studies that have a clinically meaningful and statistically significant finding. Those are the ones that generally change practice.  But a well-done negative study can inform us about associations that do not seem to exist or treatments that do not work. That is the case with two studies in Pediatrics that are well worth your attention.

The study by Glanz et al (10.1542/peds.2021-051910) looks at whether there is an association between the childhood vaccination schedule and type 1 diabetes. The authors analyzed data from a retrospective cohort study of 584,171 children born between 2004 and 2014 in 8 US health care organizations that participate in the Vaccine Safety Datalink registry. In the whole cohort there were 1132 cases of type 1 diabetes. The bottom line is that there was no association between routine vaccination and type 1 diabetes. 

The study by Muniz et al (10.1542/peds.2021-051703) focused on whether intranasal surfactant could be used to treat acute otitis media. Given that most otitis is viral in etiology, and that viral pathogens stimulate mucus production in the nasopharynx that can obstruct the eustachian tube, the hypothesis was that intranasal surfactant could reduce the surface tension of the thick mucus and restore function relieving the discomfort of otitis. The authors performed a single center double-blind randomized placebo-controlled clinical trial to assess the safety, tolerability, and efficacy of an intranasal surfactant product as adjunct therapy to oral antibiotics in young children. Overall, 103 children ages 6 to 24 months were randomized to receive amoxicillin clavulanate plus or minus the surfactant and after 20 days of treatment were followed up to 1 month. The primary outcome was resolution of the bulging eardrum at 4-6 days of treatment and of an resolution of effusion by 12-14 days.  The secondary endpoints included: (1) absence of bulging of the tympanic membrane at visits on Days 12  and 28; (2) absence of middle-ear effusion at visits on Days 4 and 28 ; (3) normal tympanogram at visits on Days 4, 12, and 28; (4) complete or near complete resolution of symptoms assessed at subsequent visits; (5) ≥50% reduction from baseline in the acute otitis media severity of symptoms (AOM-SOS) score assessed at visits on Days 4, 12, and 28; (6) change from baseline in AOM-SOS score over the 10-day treatment period by parent/caregiver diary data; (7) clinical treatment failure at Day 12; 152 and (8) recurrence of AOM. The authors found no meaningful difference clinically in the two treatment groups for either the primary or secondary endpoints and no safety concerns.  Unfortunately, this does not seem like a strategy that would help our patients.

We share both these negative studies with you to highlight how results need not always be positive to warrant your attention.  The first study should help you convince families worried about autoimmune complications of vaccines that their concerns are still not scientifically valid and the second introduces you to a novel therapy that unfortunately does not seem helpful.

We’re positive you’ll find reading these two negative studies well worth your time so link to them and see what we mean.

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