The Gluten Intervention: A Randomized Trial
Modern medicine has built a temple to the double-blind, randomized, placebo-controlled clinical trial. Termed interventional trials, these experiments are thought to best elucidate the effects of a given treatment. This approach can be a limited one, however for contemporary science. We are putting together groups of people who are bringing very different things to the table with regard to genetics and epigenetics, including stress response and environmental exposures. The effect of food, and food products on symptoms is dependent on a number of these variables.
It is all the more compelling, then, to see the clear results of the latest in a growing literature implicating gluten exposure in poor health. Titled, Small Amounts of Gluten in Subjects with Suspected Nonceliac Gluten Sensitivity: a Randomized, Double-Blind, Placebo-Controlled, Cross-Over Trial, this paper speaks to the personal and clinical observations of so many patients who found health freedom through gluten elimination.
Not defined by antibody-driven damage of the small intestine and predicted by genetic markers, nonceliac gluten sensitivity captures an inflammatory response that may actually be occurring in all individuals, and particularly in those manifesting neurologic symptoms in the absence of gastrointestinal complaints.
The authors state:
We enrolled 61 adults without celiac disease or wheat allergy who believe ingestion of gluten-containing food to be the cause of their intestinal and extra-intestinal symptoms. Participants were randomly assigned to groups given either 4.375 g/day gluten or rice starch (placebo) for 1 week, each via gastro-soluble capsules. After a 1 week of gluten-free diet, participants crossed over to the other group.
They concluded that:
…intake of gluten significantly increased overall symptoms compared with placebo (P=.034). Abdominal bloating (P=.040) and pain (P=.047), among the intestinal symptoms, and foggy mind (P=.019), depression (P=.020), and aphthous stomatitis (P=.025), among the extra-intestinal symptoms, were significantly more severe when subjects received gluten than placebo.
This data contributes to research implicating gluten in psychiatric symptoms as well as the relevance of an elimination provocation trial for any patient since there is not a test available for non-celiac gluten sensitivity. The use of a true placebo may have further amplified the results, but this experiment makes a compelling argument for the relevance of a gluten free trial for any patient with enduring cognitive and mood complaints.
Image Copyright: nmcandre / 123RF Stock Photo
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