A study using a ‘placebo’ that really isn’t deserves to be dismissed

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August 28, 2014




In her book, The Man Who Sued the FDA, which I reviewed at this site back in July of last year, Adrienne Samuels describes how, in the course of the decades-long investigation she and her late husband Jack conducted on the effects of MSG (monosodium glutamate and other flavor enhancers containing free glutamic acid), they came upon a shocking bit of information.

It had been reported that in double-blind studies of MSG conducted by the International Glutamate Technical Committee, or IGTC, there were just as many adverse reactions reported to placebos as there were to MSG. But then in 1991 the couple discovered what was really in those “placebos” – the artificial sweetener aspartame, which the IGTC chairman admitted to its having used as a replacement for sucrose starting in 1978.

As Samuels pointed out, the aspartic acid contained in aspartame “causes brain lesions, endocrine disorders, migraine headaches, depression, and all the other adverse reactions that can be caused by the free glutamic acid found in monosodium glutamate, hydrolyzed protein products, autolyzed yeast, etc.

“Today, we know that all of the industry-sponsored studies were of similar design … that all failed to meet the requirements of the statistical models on which their conclusions were based; and all used aspartame in placebos – leading us to conclude that taken as a whole, the glutamate industry studies bordered on, and were flawed to the point of being fraudulent,” she added.

I couldn’t help being reminded of that revelation when a Facebook friend who has trouble with the idea that processed foods could have so many harmful ingredients sent me a link to an article featured at the site Business Insider under the headline, “Researchers Who Provided Key Evidence For Gluten Sensitivity Have Now Thoroughly Shown That It Doesn’t Exist.”

Now admittedly, gluten in processed food products has not been a big concern of ours here at Food Identity Theft. And that’s not just because it affects only a relatively small group of people – about three million Americans (one percent of the population) who suffer from celiac disease, plus an estimated 18 million or so who claim to have non-celiac gluten sensitivity. It’s also because if there’s anything the food industry has gone out of its way to eliminate from products, it’s gluten.

The fact is that gluten-free labels are everywhere – often serving to disguise the presence of a variety of harmful ingredients that help promote other, far more pervasive health problems, such as obesity, diabetes and heart disease.

Still, this article was one whose apparent purpose was to debunk the validity of non-celiac gluten sensitivity (NCGS), or gluten intolerance, in order to serve as an example of how, in the industry’s opinion, adverse reactions to additives are largely inventions. And, according to the article, the study involved, which was conducted by Peter Gibson, the Australian professor of gastroenterology whose previous research was strongly supportive of the existence of NCGS (and gave rise to the “gluten-free” diet craze) succeeded in doing just that.

That is, except for one little detail – a basic flaw in the methodology that renders the results effectively null and void. Not that this was evident from the Business Insider article. To discover it, I had to go to a more detailed account provided at the website Real Clear Science under the somewhat less sensational headline “Non-Celiac Gluten Sensitivity May Not Exist.”

Sixteen grams of what?

Gibson, the article noted, “resolved to repeat the trial with a level of rigor lacking in most nutritional research. Subjects would be provided with every single meal for the duration of the trial. Any and all potential dietary triggers for gastrointestinal symptoms would be removed, including lactose (from milk products), certain preservatives like benzoates, propionate, sulfites, and nitrites, and fermentable, poorly absorbed short-chain carbohydrates, also known as FODMAPs.”

Now, all 37 of these subjects, mind you, were confirmed not to have celiac disease, but claimed their symptoms were alleviated by a gluten-free diet. When he analyzed the data from his new study, however, “Gibson found that each treatment diet, whether it included gluten or not, prompted subjects to report a worsening of gastrointestinal symptoms to similar degrees. Reported pain, bloating, nausea, and gas all increased over the baseline low-FODMAP diet.” And even in a second experiment, “when the placebo diet was identical to the baseline diet, subjects reported a worsening of symptoms!”

The one thing that Gibson apparently failed to take into account, however, was the nature of that “placebo diet” many of the subjects were given. But it’s right there in the Real Clear Science article – 16 grams per day of whey protein isolate to substitute for the 16 grams of gluten other subjects were being fed  — along with 14 grams of whey protein isolate and two grams of gluten given to a third group to serve as a “low gluten” control diet.

After reading this, I contacted Samuels and asked her what she thought of the study. “Whey protein isolate contains neurotoxic glutamic acid, aspartic acid and L-cystein,” she replied.  “Those amino acids are known to cause the same reactions as were reported by the participants in this study.” In fact, she pointed out that all these symptoms are also among those listed as adverse reactions to processed free glutamic acid (MSG) and aspartame in the Food and Drug Administration’s Adverse Reaction Monitoring System.

So next time you read about a study that purports to show a certain food-related condition or problem really “doesn’t exist,” take a look at what the researchers involved are using as a “placebo.” And if it’s something to which a lot of people have reported adverse reactions, rather than the “innocuous or inert” substance that a placebo is supposed to be, the only thing it should tell you is that study involved was fatally flawed from the get-go.