More Doubts About the GFCF Diet

As I explain in The Politics of Autism: Navigating the Contested Spectrum, questionable approaches such as the gluten-free/casein free diet and chelation fill the vacuum caused by the basic uncertainty surrounding the issue.

At The Journal of Autism and Developmental Disorders, Susan L. Hyman and colleagues have an article titled, "The Gluten-Free/Casein-Free Diet: A Double-Blind Challenge Trial in Children with Autism." The abstract:

To obtain information on the safety and efficacy of the gluten-free/casein-free (GFCF) diet, we placed 14 children with autism, age 3–5 years, on the diet for 4–6 weeks and then conducted a double-blind, placebo-controlled challenge study for 12 weeks while continuing the diet, with a 12-week follow-up. Dietary challenges were delivered via weekly snacks that contained gluten, casein, gluten and casein, or placebo. With nutritional counseling, the diet was safe and well-tolerated. However, dietary challenges did not have statistically significant effects on measures of physiologic functioning, behavior problems, or autism symptoms. Although these findings must be interpreted with caution because of the small sample size, the study does not provide evidence to support general use of the GFCF diet.

National Advertising Division Questions Claims for a Company's Dietary Supplements

Many posts have discussed "alternative" treatments. The Advertising Self-Regulatory Council reports:= (h/t HBE):

The National Advertising Division has recommended that Pursuit of Research, LLC, discontinue all challenged claims for the company’s Nutriiveda dietary supplements, which are marketed as “cures” for conditions that include attention deficit disorder, apraxia, autism, diabetes, dyspraxia, seizures, traumatic brain injury and stroke. The advertiser said it will appeal NAD’s decision to the National Advertising Review Board (NARB.)

The claims at issue were challenged by Nourishlife, LLC, manufacturer of a competing product, Speech Nutrients.

NAD is an investigative unit of the advertising industry’s system of self-regulation. It is administered by the Council of Better Business Bureaus.

NAD noted in its decision that the advertiser sells Nutriiveda Original on its Pursuit of Research website. The advertiser also is the founder of the Cherab Foundation, “a world-wide nonprofit organization working to improve the communication skills and education of all children with speech and language delays and disorders.

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The advertiser explained that Nutriiveda Original is an all natural gluten-free and casein-free food product that provides essential amino acids, vitamins, minerals and soluble fiber. The advertiser posited that protein and essential amino acid deficiencies and changes to gut bacteria through diet are linked to autism, apraxia and other neurological disorders.

The advertiser has not conducted any clinical trials on the efficacy of Nutriiveda Original, but maintained that the essential amino acids and whey protein in Nutriiveda are responsible for the claimed health benefits. The advertiser offered as support a number of research articles on amino acids and testimonials from its website.

NAD determined that none of the articles submitted by the advertiser described studies that constituted competent and reliable evidence sufficient for claim support.

FDA Defines "Gluten-Free"

The Los Angeles Times reports:

With one-third of Americans trying to avoid the protein, the "gluten free" label holds increasing cachet. On Friday, the federal government issued an official definition of that claim, bringing a measure of uniformity to a burgeoning industry.

According to the Food and Drug Administration, a food or other substance can be labeled "gluten free," "no gluten," "without gluten" or "free of gluten" if contains less than 20 parts per million of it. Manufacturers have until Aug. 5, 2014, to comply with the new definition.

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Some parents believe their children's autism symptoms improved when they stopped eating gluten and casein (a protein found in milk products), though there's no scientific evidence to support their observations.

See the FDA release. 

Treatments Without Evidence

In Research on Autism Spectrum Disorders, Johnny Matson and colleagues ask: "Why are there so many unsubstantiated treatments in autism?"  The abstract:

The number of interventions used in the field of autism is astronomical. Unfortunately, while there are effective and well-researched methods, many of the techniques that parents use have no empirical support. These interventions are expensive, take up valuable time, and in some cases are dangerous. How bad is this problem, how did the field get here, and what are potential solutions? This review covers this important but infrequently discussed topic.

Highlights

► Large numbers of treatments in widespread use have little or no research support.
► There are a number of factors that appear to be driving this very disturbing trend.
► The gap between the evidence base and the use of unsubstantiated treatments appears to be growing.
► More emphasis on establishing guidelines, enforcing professional standards, and disseminating information is needed.

What are some unsubstantiated treatments?

 Parents gain information from many sources. Testimonials, parent groups and acquaintances, and especially the Internet are rich sources of misinformation. Often an impetus to seek these alternative methods is the lack of satisfaction and/or ineffectiveness of treatment. One common method is complementary and alternative medicines such as special diets, special vitamins, animal therapy (e.g., petting dogs, riding horses, etc.), chelation therapy, craniosacral therapy, music therapy, and  secretin. Estimates are that 32–92% of parents use one or more of these methods for their children with ASD. Additionally, it has been reported that 62% of parents shared their use of one or more of these methods with their child’s primary care doctor (Wong & Smith, 2006). These treatments are expensive, require a great deal of time and effort, are often dangerous, and they have not been proven to be effective. Davis and colleagues (2013) reviewed the available research on chelation therapy, for example, and concluded that the evidence supporting its effectiveness is extremely weak. Likewise, Lang and colleagues (2012) reviewed the studies published on sensory integration therapy and concluded that agencies that use research or scientific methods should not use this treatment. Similarly disappointing results have been noted for gluten-free and casein free diets (Mulloy et al., 2010).

Alternative and Psychotropic Treatments

Sooner or later, the Food and Drug Administration will be assuming a higher profile in the issue.

WebMD reports:

Many families are turning toward to special diets and/or psychotropic medications to help better manage autism spectrum disorder and its symptoms in their children, two new studies show.

The CDC estimates that about one in 110 children in the U.S. have an autism spectrum disorder, the umbrella name given to a group of disorders that can range from the mild to the severe that often affect social and communication abilities.

One study shows that 21% of children with autism spectrum disorder are using complementary and alternative medical therapies. Of these, 17% were on special diets, most commonly a gluten-free or casein-fee diet.

Another study shows that more than one-quarter of children with autism spectrum disorder receive at least one psychotropic medication to treat some of their behavioral symptoms such as hyperactivity or irritability.

A new study, however, finds no support for GFCF diets:

This paper systematically reviews research on the effects of gluten-free and/or casein-free (GFCF) diets in the treatment of ASD. Database, hand, and ancestry searches identified 15 articles for review. Each study was analyzed and summarized in terms of (a) participants, (b) specifics of the intervention, (c) dependent variables, (d) results, and (e) certainty of evidence. Critical analysis of each study’s methodological rigor and results reveal that the current corpus of research does not support the use of GFCF diets in the treatment of ASD. Given the lack of empirical support, and the adverse consequences often associated with GFCF diets (e.g., stigmatization, diversion of treatment resources, reduced bone cortical thickness), such diets should only be implemented in the event a child with ASD experiences acute behavioral changes, seemingly associated with changes in diet, and/or medical professionals confirm through testing the child has allergies or food intolerances to gluten and/or casein.