I love to read a well-designed and reported study, and an even bigger treat is if I learn something new about disease pathophysiology and some general trivia to boot. Here's an article that fulfills this trifecta for me.
Source: Lionetti E, Gatti S, Galeazzi T. et al. Safety of Oats in Children with Celiac Disease: A Double-Blind, Randomized, Placebo-Controlled Trial. J Pediatr. 2018;194:116-122.e2; doi:10.1016/j.jpeds.2017.10.062. See AAP Grand Rounds commentary by Dr. Philip Rosenthal(subscription required).
This was a randomized, placebo-controlled, double-blind noninferiority crossover study of oats in children with typical celiac disease, suggesting that oat ingestion does not cause an increase in intestinal symptoms in this patient population.
Look at the adjectives in the first part of that sentence. It has 5 important concepts in study design. First, it was randomized, and in fact, the individuals generating the randomization sequence had no other role in the study, helping to ensure blinding of those directly involved with the study subjects. Second, it was placebo-controlled, meaning 1 group received oats and the other a placebo. (Actually, both groups received both oats and placebo, that's the fifth point below.)
The third important feature is the double-blinding; neither investigators nor patients and family knew which treatment arm they had been assigned to. Beyond just concealing the randomization scheme, the oats and placebo had to be indistinguishable from one another, e.g. children should be unable to determine when they were eating oats just by taste or other feature of the meal. This apparently was the case. Fourth, this was a noninferiority trial, which I've discussed on a few occasions in the past. It's a method that allows for a smaller study size and, while not achieving a large enough sample to detect a statistically significant difference in treatments, if such exists, it does assure that enough patients are enrolled to state that, if a difference exists, it is too small to be noteworthy. Thus, a particular treatment is "noninferior" to another, at least within a predetermined range.
The fifth element, crossover design, also has been mentioned before. This is a very useful study design technique when studying treatments of chronic diseases that do not progress (or regress) quickly over time. Here, 1 treatment group received a gluten-free diet plus oats added in for 6 months, then underwent a "washout" period of 3 months on a gluten-free diet followed by a crossover to a gluten-free diet without oats (the placebo arm) for another 6 months. Everyone was blinded to the type of diet being administered, except during the washout period. The other treatment group did the reverse: first gluten-free diet without oats (placebo), then washout, then gluten-free diet plus oats.
Bottom line: based on measurement of clinical symptoms, serologic data, and a noninvasive test of mucosal integrity (it was considered unethical to perform repeated intestinal biopsies of children for research purposes), the investigators found that ingestion of oats combined with a gluten-free diet was "noninferior" to a gluten-free diet with no oats. However, it could be problematic implementing the addition of oats to diets of celiac disease patients, because it's hard to be sure that oat products aren't contaminated with other grains during processing.
The trifecta I mentioned came with the Discussion section of the article, where I learned a great deal about differences in gluten based on the taxonomic classification of cereals and the structure of different grain structural proteins. It provided a biologic basis for why oat ingestion might be safe for celiac disease patients to ingest, as well as some new trivia tidbits to bring up at the next neighborhood cookout I attend.
Also, please pardon my Mairzy Doats reference in the title, I think I'm going overboard in my new grandfather role.
