When a mother says something works...

[Update: A revised version of this post has been published at The Thinking Person's Guide to Autism, July 2010.]

One side effect of Joy's ongoing love of Baby Einstein videos is that I've practically got them memorized, including the self-promotion stuff that comes at the end of the VHS tapes. Baby Einstein's creator, Julie Aigner-Clark, touts the benefits of her series with testimonials from various Baby Einstein devotees. Somewhere in the middle of the promotion, she herself says enthusiastically,

When a mother says something works, you automatically try it!

She wasn't talking about alternative therapies for autism. But perhaps she might as well have been.

Two things today are making this connection for me. One was the second half of the alternative-therapies presentations by trainees in my LEND seminar.

The other was coming home to find Jenny McCarthy highlighted in the pages of the Time magazine that just arrived today. Jenny McCarthy, the celebrity face of the unproven-therapies-for-autism movement.

'Try everything,' says McCarthy. 'Hope is the only thing that will get us up in the morning.'

Karl Taro Greenfield, author of the article (and also brother to 42-year-old Noah who swims in the deep waters of the autism pool), somewhat wryly states, "it is hard to find a controversial, novel, or alternative treatment that McCarthy doesn't say has some merit."

One of the many alternative interventions that McCarthy has tried on her son and touted along the way is the gluten-free, casein-free (GFCF) diet for autism. That also happens to be the intervention about which I and two classmates presented yesterday afternoon. And I mentioned her in my portion of the presentation...

So here's some of what I and my co-presenters talked about! The gluten-free, casein-free diet is an elimination diet. To be eliminated are gluten, a protein found in grains (wheat, barley, rye, and some oats) and casein, a protein found in animal milk. Elimination diets have been around for a long time, and in general they rest on a very sound premise: if you are sensitive or allergic to something in your diet, stop eating it! The gluten-free diet is pretty much the only answer for celiac disease; if you have a demonstrated sensitivity or allergy to milk, dairy-free is the way to go. It's not an easy regimen to follow, but in those situations, it's known to be effective.

The "alternative" part of this therapy is the claim that GFCF can cure or ameliorate autism spectrum disorder -- in up to 90% of cases, according to Talk About Curing Autism (TACA). The underlying theory is this: People with ASDs are said have a predisposition to a gastrointestinal condition known as "leaky gut" or "autistic enterocolitis". The condition is supposedly triggered by an environmental insult -- vaccines, toxins, something perhaps as yet unidentified. When the condition is triggered, the hypothesis goes, you wind up with an incomplete breakdown of gluten and casein which escape through the leaky gut. The protein molecules/polypeptides travel through the bloodstream and attach to opiate receptors in the brain, leading to autism or magnifying the symptoms of autism.

According to this scenario, if you remove the gluten and the casein from the diet, the gut will heal, the opiate reaction is halted, and the autistic symptoms are alleviated -- generally in a couple of months of strict adherence to the diet, sometimes taking up to a year.

This is not an easy diet to follow, especially for someone who may already have a very restricted range of foods to begin with. It requires constant vigilance on the part of the parents, careful ingredient checking and diet balancing and making sure that gluten & casein don't slip in from unexpected sources (a playmate's cracker snagged from the floor, a bit of standard play-doh, etc.) Pre-fab GFCF foods can be very expensive. If you want to do the diet less expensively, you'll spend a lot of time in preparing foods from scratch. Recipe-sharing online can ease that burden; there's even a webpage from TACA that outlines how to do the GFCF diet on food-stamps!

The questions we were to answer for our presentation included an overview of the relevant research. There have been studies from a number of angles: measuring opioid peptides in the urine, measuring intestinal permeability, studying the outcomes of people with ASD who actually go on the diet. In all of those areas, research is a bit thin on the ground, and the results are not definitive. We don't even know for sure if people with ASDs have more GI issues in general than people without, though we do know that GI issues that occur in typically-developing folks do occur in folks with ASDs as well.

In a happy circumstance for our presentation, a consensus paper came out just a month ago in Pediatrics (a high-profile, peer-reviewed journal.) A whole slew of GI experts got together, weighed existing evidence, made consensus statements regarding GI issues and ASDs, and recommended a lot of new research. Here's a the citation to the paper and some of the statements:
Buie et al., Evaluation, Diagnosis, and Treatment of Gastrointestinal Disorders in Individuals With ASDs: A Consensus Report, Pediatrics 2010;125;S1-S18

• Individuals with ASDs who present with gastrointestinal symptoms warrant a thorough evaluation, as would be undertaken for individuals without ASDs...
  
  
• The prevalence of gastrointestinal abnormalities in individuals with ASDs is incompletely understood.
  
  
• The existence of a gastrointestinal disturbance specific to persons with ASDs (eg, “autistic enterocolitis”) has not been established.
  
  
• Available research data do not support the use of a casein-free diet, a gluten-free diet, or combined gluten-free, casein-free (GFCF) diet as a primary treatment for individuals with ASDs.

Interestingly, this consensus paper received some acclaim from both skeptics and proponents of the GFCF diet as a treatment for autism. Skeptics said, "Look, here it is in black and white -- current research data do not recommend this treatment!" Proponents said, "Look at all this research they're recommending -- we're finally being taken seriously!" (OK, those were both big-time paraphrase-summaries, but I think I've caught the flavor of it).

As it happens, there are already a couple of substantial studies of the diet itself in the works. I'll be particularly interested to see the results on one coming out of the University of Rochester: the data-collection was done a while ago, and as far as I know the analysis has been marching forward. This is a double-blind, placebo-controlled study where all the participants are on the GFCF diet but at certain points one group got GFCF snacks where another group got non-GFCF "challenge" snacks. [Update 5/21/10 - that study is now complete, and did not find any significant differences between the treatment and the control group. In other words, the GFCF diet did not help.]

A previous pilot study (Elder et al, 2006) took a slightly different approach, putting only half the participants on "the diet" but providing ALL foods for both groups, such that the participants and parents did not know whether or not they were GFCF. The study did not find any significant effects on either behavior or urinary peptide levels. However -- and here's the really interesting bit -- the parental reports and the researcher reports differed markedly. Parents thought they were seeing improvements that the researchers could not document. And nine of the families decided to keep going with the GFCF diet even when they were told that the researchers' observations didn't support it.

To me, this screams "placebo effect." People see what they want to see. No wonder the claims of efficacy are so high. To others, this may scream "only parents are the trustworthy observers; researchers can't see what's right under their noses!"

I do think that the GFCF diet is a different situation than secretin, which has been quite thoroughly debunked as an autism treatment (yet at one time had claims of helping 80% of ASD patients).

The thing is, some people with ASDs do have dietary sensitivities. Just like their typically-developing counterparts. When you address those sensitivities, people feel better. When people feel better, they behave better. And learn better. And interact better.

I'm open to the thought that there are more food sensitivities out there than we're aware of. But I'm not particularly convinced at this point that such sensitivities have any special causal effect as far as autism goes. My guess is that the evidence against the leaky-gut / autistic enterocolitis hypothesis is going to start to pile up. Autistic enterocolitis as a mechanism is under a certain shadow at the moment, in that the originator of the term (Andrew Wakefield) has been recently censured by the U.K. General Medical Council and his 1998 paper that fueled much of the speculation has been retracted by the Lancet.

We have not tried the GFCF diet with Joy, because we have not seen anything that would make us suspect a dietary sensitivity if she weren't on the spectrum.

Many, many families are trying it, however. This therapy seems extremely attractive to parents, and I think there are a number of reasons why. There are powerful testimonies out there, and high-profile proponents (from Temple Grandin to Jenny McCarthy). The diet has a reputation of harmlessness, though it can be nutritionally risky if not done carefully, especially for people whose diet is self-limited to only a few foods in the first place. There's definitely a "why not try it, what can it hurt?" vibe out there -- quite a bit of peer pressure, which can be hard to withstand when coupled with the 90% success rate claims. Besides all that, dietary changes are a familiar kind of intervention. Who hasn't "gone on a diet" at some point or another? Plus it's something that people can attempt without a prescription. There's plenty of DIY advice out there, on the web and in books and in support groups.

There is value in hope. There is value in parents feeling empowered and feeling that they are helping their child, even (I would argue) for those families in the Elder study who wanted to keep going even when the researchers weren't able to document improvements. And, as I said before, the GFCF diet demonstrably does help some people with autism -- as it demonstrably does help some people without autism.

I'm afraid, however, that the pendulum has swung too far with GFCF. Ideally people would be able to choose not to do "the diet" without being made to feel guilty, or to quit the diet in the absence of observed improvement without being told that they didn't try long enough (a YEAR?!) or that they must not have been doing it right. The counterpoint stories aren't as easy to find as the primary pro-GFCF narrative, but we do exist out here!

When a mother (Jenny McCarthy or otherwise) says something works, that can carry a big emotional pull. But that alone is far from sufficient to sort out the snake oil from the truly useful, or to decide what is really worth trying.

It looks like I'll be doing at least one more post about the rest of the alternative interventions presented yesterday: hippotherapy, hyperbaric oxygen therapy, vitamin therapy for Down syndrome, auditory integration therapy. Stay tuned.