Tag Archives: science

So, did I get into the Celiaction study?!

Sorry, guys. I didn’t mean to hold out on you, but you know how summer gets. You’re busy with your NEW projects, like relearning to play the guitar or jab-cross-hooking at the local kickboxing studio, all while trying to soak up as much sunlight as you can on those glorious long weekend days. The computer is the last place you want to be (especially if—cue the whining—you’re still trying to avoid screens in an effort to kill your sleep problems).

As I’ve mentioned, before officially enrolling in the Celiaction study I had to undergo an endoscopy (with multiple biopsies) to prove I still have intestinal damage and can therefore reasonably blame my ongoing symptoms on celiac disease, rather than a mystery ailment, hypochondria, or “somatization disorder.”

The endoscopy went down last week and was about as much fun as it always is to eat and drink nothing for twelve-plus hours, don an IV bag and a precariously fastened tent of a hospital gown, and get a camera stuck down your throat and into your intestines. (Getting paid for it, I admit, was pretty fun.)

no gluten hospital bracelet

My hospital ID and “allergy” bracelets. I also had a big “NO GLUTEN” sign on my bed in case someone gave me crackers while I was too drugged to resist.

For extra enjoyment, I woke up in the middle of the procedure. I was certain I was going to throw up and suffocate myself, but I stayed still, expressing my panic only through my now-wide-open eyes. I distinctly remember my doctor saying, after she noticed I was awake and before they put me under again, that I was being “such a good patient.” (That may be an anesthesia-induced hallucination, but I’m proud of it nonetheless.)

Celiaction study coordinator with my biopsy samples!

Shipping my intestines off for inspection

The study coordinator kindly consented to be photographed with the package of samples taken from the intestinal lining of yours truly, en route to the lab. I went home to sleep it off, and then—like all of you have been doing, I’m sure—I waited.

Are my guts damaged enough?, I wondered. Oh, please, let my guts be damaged enough.

Well, the verdict is in . . . and so am I! I’m not sure yet of the exact Marsh score, but the biopsies showed mild damage—an improvement over the “diffuse subtotal to total villous atrophy” I used to have, but not a full recovery. So, yay! I’m in the study! I’ll keep making my phone calls and soon I’ll start taking either ALV003 or a placebo.

No one will know which I receive—not me, not the researchers. Many other things are equally uncertain. Will I feel better? If I do, will it be due to the drug? The placebo effect? The kickboxing? Or just time, steadily continuing to do its work?

Because it’ll be so uncertain why I’m feeling however I’m feeling in a few weeks or months, the study coordinators have asked me to refrain from publicly sharing my health progress during the trial. Out of context, my symptoms or lack thereof won’t reveal anything about the medicine’s effect, but my reports still might unduly influence someone else in the study who happened across this blog. In the name of Science, I’m happy to oblige the request (and was flattered to receive it!).

So, this is the last you’ll hear from me for now on how I’m doing (middlingly). I’ll still likely write about the study, just not my symptoms. If you find yourself dying to know how I am, and you aren’t in the study yourself, I welcome any and all questions, however personal, by email. Otherwise—assuming my summertime laziness subsides—I’m sure we’ll find plenty of other stuff to talk about!

What are your summer projects? How was your endoscopy experience?

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Is gluten sensitivity fake? Maybe. I’ll wait while you read the study.

Recently, if everyone you know is anything like everyone I know, they’ve been sending you articles with headlines like:

And, if you’re anything like me, you’re pretty annoyed about it.

The study itself focuses on non-celiac gluten sensitivity (NCGS). Peter Gibson and the other authors of a milestone 2011 study providing evidence for NCGS decided to check their results. They’d found no reason why gluten would cause digestive symptoms for non-celiac people, so they wondered if something went wrong in their first study—if there were confounding variables.

In their new study, they strove to control for those variables and wound up finding “no evidence of specific or dose-dependent effects of gluten in patients with NCGS placed diets low in FODMAPs.” 

Unfortunately, no one is actually reading the study.

Most of the above “articles” don’t link directly to the study (which can be found here and, by the way, came out many months ago). Instead, they link to a write-up at Real Clear Science, suggesting that’s all they read. Real, clear, and scientific though that write-up may be, it is not enough to get the whole picture, especially if one reads it selectively.

Had writers taken time to learn something before jumping on the trending topic, the headlines may have been different. Or maybe not. After all, we clicked on them, didn’t we, and isn’t that the point?

The articles feature scant information, laughable errors, and a hearty, triumphant whiff of “I TOLD you nothing was wrong with you”—missing what the researchers take as a given: something is wrong. It just might not be gluten.

Now, one study does not overturn all the other research that’s been done on NCGS. Rather, it introduces doubt—and an opportunity to provide people with better treatments for the pain and discomfort they do indeed experience.

Since no one is bothering to read the study, here are some key points:

The 37 participants:

  • did not have celiac disease or other gastrointestinal diseases
  • did have symptoms of IBS fulfilling Rome III criteria
  • felt their symptoms improved with a gluten-free diet (though for some, the diet hadn’t helped 100%)
  • were not asked about extra-intestinal symptoms (other than fatigue and sleep)

Like Jenny Craig, the researchers provided three meals a day, which were:

  • low-FODMAP (that’s an acronym for fermentable oligosaccharides, disaccharides, monosaccharides, and polyols—carbs that can cause digestive distress, and are found in wheat/rye/barley, among other foods)
  • dairy-free (you got this one)
  • low in “food chemicals”
  • keyed to caloric needs but otherwise identical
  • probably not that tasty

After establishing a baseline, the researchers mixed a little glutena lot of gluten, or a placebo into the meals. The trial was double-blind (so no one, including the researchers, knew who was getting what when) and cross-over (so participants spent some time eating each of the three kinds of meal).

The placebo was:

  • lactose-free whey protein
  • indistinguishable from the gluten in taste and texture

The results:

  • Participants all felt better on the baseline low-FODMAP diet (compared to their previous GF diet).
  • Some participants felt worse on the gluten-containing diets . . .
  • But a similar number also felt worse, to a similar degree, on the placebo-containing diet, pointing to a “nocebo” (negative placebo) effect.

The researchers’ conclusions:

  • “NCGS, as currently defined, might not be a discrete entity.”
  • FODMAPs may be the primary issue, or gluten might cause symptoms only in the presence of moderate FODMAPs.
  • The gluten in this study might have been different from the gluten in the first study and thus had different effects.
  • NCGS may cause mostly neurological, mood-related, and other non-digestive symptoms.
  • More research is needed!

Of course, the click-me-click-me articles don’t get far beyond bullet point #1. As such, they aren’t worth getting worked up over, though that hasn’t stopped me from practically combusting every time a friend broaches the topic. People are finally paying attention, and in all the wrong ways. It drives me bonkers.

The comments are, if possible, worse.

Many of them seem impervious to new ideas and scientific developments. “Of course gluten sensitivity is real,” they bristle, “and I’m proof.” They reel off symptoms they once felt, spinning miraculous recovery tales. Though I’m glad they feel better, by dismissing scientific inquiry, they reinforce stereotypes of the gluten-free community as irrational and dogmatic.

It’s understandable folks feel attacked. No likes to be told they’re wrong, especially in the bald, provocative terms of these headlines. In particular, no one likes to be told our symptoms are psychosomatic. We don’t appreciate the idea that we aren’t in perfect rational control. It sounds like an implication of stupidity, attention-mongering, or craziness. I get it: I’ve been through the “you must be stressed” talk. I’ve been prescribed anxiety medication. I’ve left in a huff.

But the placebo/nocebo effect is well documented. It may make us uncomfortable, but writing it off won’t get us anywhere. Psychosomatic symptoms aren’t “all in your head”—that’s the point. They start in your head, but they affect your body, too, in very real ways. (Of course, when other illnesses are misdiagnosed as anxiety or depression and therefore mistreated, that is no good.)

Sometimes, people expect to feel glutened, and so they do feel glutened—gluten or no gluten—whether or not they have a gluten-related disorder. In this study, it happened. That’s not all there is to know about NCGS, but it demands recognition.

female scientist with two test tubes

Just a screenful of Legos to help the placebo talk go down
Photo © Maia Weinstock | Flickr

Other commenters rail against the study’s authors’ “obvious bias” or claim it was “funded by the wheat industry,” coming off as paranoid and histrionic. Yes, the study authors are closely involved with researching the low-FODMAP diet, which introduces some bias—but it also means they’re passionate and educated about the topic and, therefore, well suited to research it.

Disclaimer time

I too have a horse in this race. I edited Sue Shepherd and Peter Gibson’s books, The Complete Low-FODMAP Diet and The Low-FODMAP Diet Cookbook (the latter of which you’ll see on shelves very soon!). So, increased attention to FODMAPs benefits me, at least indirectly.

9781615191918That said, I was a believer before the books ever crossed my desk and before I worked at The Experiment. Working on the books, learning the science behind them, and reading positive reviews by those who have tried the diet have only deepened that belief. I wish that articles would focus more on promoting this revolutionary treatment (to my knowledge, the only evidence-supported diet for IBS) and less on dissing another.

The low-FODMAP diet doesn’t work for everyone (its success rate is about 75%), just as a gluten-free diet doesn’t work for everyone. It may be the GFD works for even fewer people than we previously suspected—and if that’s the case, shouldn’t those who currently consider themselves gluten sensitive want to know, so they can feel even better?

My guess? There’s room for both diets. And there’s plenty of room for more research.

What’s your take on all the hullabaloo? Have you turned up any really good reporting on these issues? Would you be interested in more posts about FODMAPs down the line?

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Is a gluten-free diet good enough?

Last week, I had the pleasure of attending Columbia University’s Development of Therapies for Celiac Disease Symposium. Doctors and researchers from around the world gathered to present fascinating talks and Powerpoints full of text almost all too small to read.

Also attending were patients, like myself, and some folks doing fantastic work on behalf of the gluten-free community. Hearing their stories was my second favorite part of the conference. Glimpsing the most cutting edge of celiac science was my third.

First, of course, was the food. Everything served was gluten-free; and, it seemed, everything was served. Bread baskets overflowed, and entrees and sides kept even us vegetarians happy (saag paneer—yum). There was dessert after every meal, even breakfast—which was itself essentially dessert, consisting primarily of muffins, donuts, fruit, yogurt, and “coffee” cake.

In two days I ate more desserts than anyone should eat in a month. I can’t tell you how many exactly, because a) it would be embarrassing and b) I lost count, but brownies, crème brûlée, polenta cake, kheer (Indian rice pudding), and pound cake were not excluded. Some treats were from Pink Poppy, others from By the Way Bakery. So. Much. Sugar.

gluten-free muffins, donuts, and bagels at conference

The lighting doesn’t do them justice, but trust me: delicious unfrosted cupcakes muffins.

As if all that weren’t enough, we were also encouraged to take samples, and take them I did: The Simply Bars, Crunchmaster multi-grain crackers, NoGii paleo bars, Schar multigrain ciabatta rolls, and Le Veneziene chocolate hazelnut cookies. The cookies expire in a month, so we’ll have to eat them fast.

Okay, okay, I admit: the point of the conference was not the food. The point was to learn about gluten-related disorders. And I’m evading that point because the conference’s unofficial motto was “Good question! We can’t answer it.”

Much about celiac disease and gluten sensitivity remains uncertain, due to conflicting study results, lack of longitudinal and prospective data (meaning, collected over a period of time as events unfold, unhampered by subjects’ flawed memories), lack of appropriate controls, or the fact that serious research attention hasn’t been paid to this field until recently.

Celiac disease is not a simple disease. You know that, I know that, scientists know that, and (some) doctors know that. Unfortunately, that’s about all we know.

Still, because I did learn a lot about what we don’t know, this will be my first in a series of posts about the questions the conference raised, and the answers that may someday prove to be true—at least in part. I call it “Sprue/False.”

We start with a big one:

This question was at the symposium’s heart. If “go gluten-free” were all we needed, no one would be developing therapies (other than snake oil peddlers). “Go gluten-free and wait” is another option. Multiple presenters affirmed it can take years for adults to heal. But is that the best we can do?

Unsurprisingly, the drug developers say no. Glutenase (a.k.a. ALV003, and importantly distinct from “Glutenease”) researchers had a pool of about 200 gluten-free celiac patients keep a seven-day symptom diary. Over 90% had at least one day of symptoms, and 44% reported five to ten symptoms. Three quarters called their symptoms “moderate,” “severe,” or “very severe,” and 20% missed social events or called in to work.

Also potentially significant is the fact (stated in another presentation) that even on the gluten-free diet, adults’ villi may never rebound to “normal” length—meaning, possibly, we don’t regain the ability to absorb nutrients as well as we should. Yet another presenter suggested we may be wrong to assume that all is peachy—from a health perspective—for diagnosed kids.

We see an unmet medical need,” said Daniel Adelman, of Glutenase. “The gluten-free diet is all we’ve got, and it’s not enough.

But doctors aren’t so sure. Dr. Julio Bai’s comment that his patients did not make such complaints met with widespread head-nodding from clinicians. More than one expert scolded the drug developers for not surveying a control group. “For all we know,” their argument went, “everyone would report weekly gut symptoms if given the opportunity.”

I’m disappointed they didn’t include controls, but otherwise, I’m with the druggists. I’ve been scrupulously gluten-free for well over a year and still don’t feel well. And faulty memory, schmaulty memory, I know it wasn’t like this before. There has to be something more I can do. The question is, what?

Patients can help answer that. Both Larazotide and Glutenase—drugs being developed as adjuncts, not replacements, to the GFD—are in clinical trials. Neither trial is currently requiring participants to deviate from their usual diet, and both have been through extensive safety testing.

I’m investigating Glutenase’s CeliAction Study, myself. Celiac changed my life and so far the GFD hasn’t changed it back. I’m ready to try something new. Worst case scenario, I get a placebo or the drug doesn’t work. Best case? My life returns to really, truly good enough.
gluten-free Fridays Vegetarian Mamma
Over the next few weeks I’ll explore more unanswerable questions about gluten-related disorders, with less preamble about brownies. In the meantime, tell me: In your experience, is the gluten-free diet enough? Would you ever participate in a clinical trial? Have you already?

Post #2 on the conference is up: check out “More on Drugs” and share your thoughts!

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Scientists say: schedule gluten, save babies.

Hey new moms and moms-to-be, great news! Scientists have pinpointed the precise moment in your baby’s life when it’s acceptable to introduce gluten to his or her diet.

As long as you administer just the right dose of gluten no earlier or later than 3:42:18 a.m. exactly 126 days after your baby is born, he/she can’t possibly get celiac disease. (We don’t know yet about gluten sensitivity, sorry.) On the other hand, if you jump the gun or miss your cue, Baby is almost guaranteed to develop an autoimmune response to gluten, so get it right.

Don't mess up, now. Photo © Donnie Ray Jones | Flickr

Don’t mess up, now.
Photo © Donnie Ray Jones | Flickr

Sure, feeding gluten at that time goes against the World Health Organization (WHO)’s suggestion to breastfeed exclusively for six months to protect against gastrointestinal infections, decrease your baby’s chances of becoming obese, increase your baby’s likelihood of school success, and reduce your own risk of ovarian and breast cancer. But WHO are they to tell you what to do? You need to look at the big picture, and introduce gluten while you still can!

Oh, and should you follow the WHO’s other recommendation to continue to breastfeed for up to two years, then you’ll really seal the deal: the study demonstrates that babies who still latch on at age one may also be more likely to come down with a case of the celiac. Bummer!

The point I’m making, ladies, is that it’s up to you to prevent the spread of this celiac epidemic. So whatever you do, don’t focus on what seems right for your child’s and your own individual well-being. Your son wants to gum on a crust before the precise moment when it’s acceptable for him to do so? Tell him no! It’s how kids learn. Your eleven-month-old daughter still thinks breast is best? Wean her fast! Keep in mind that mother knows best, except when science does.

It’s too late to avoid passing your child the celiac genes. But you can make it right by timing it right. When it comes to introducing gluten, you must delay, delay, delay, and then ACT FAST. Keep that bread box stocked, and don’t be caught sleeping at the appointed time. In fact, set your alarm now.

Don't let Baby be caught sleeping, either. Photo © Yoshihide Nomura | Flickr

Don’t let Baby be caught sleeping, either.
Photo © Yoshihide Nomura | Flickr

The fate of your child is in your hands (and breasts). Celiac disease prevalence is increasing, and it seems mothers are to blame. Don’t become part of the problem.

If today marks day 127 of Baby’s life, then sorry, you’ve already flubbed it. You can always try again on your next child; science is all about learning from mistakes. Then again, having a sib with celiac disease will pretty much doom any future offspring, too, so you’d better not worry about it too much. After all, when it comes to ruining Baby’s life, getting stressed out is another surefire way.

For more totally-not-overstated headlines about the latest too-small-sample-sized study of a possible celiac risk factor by not-even-completely-convinced-themselves researchers, check out:

I’m glad research on causes of celiac disease continues. Still, I think sometimes we get so excited that science is paying attention to us that we give studies more weight than they deserve (even more than the researchers tell us to give them).

Confusing, isn't it? Photo © Alpha | Flickr

Confusing, isn’t it?
Photo © Alpha | Flickr

This was the latest in a patchwork of conflicting, insufficient studies on celiac disease triggers (and on breastfeeding). Most of the articles do include cautions about study limitations and conflicting existing research. But the headlines are pure mommy (sorry, “parent”) guilt.

Don’t you just love journalism?

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