Monday, July 16, 2007

I’m Gonna Buy Me, One of Ben’s T-Shirts

This morning, I was reading the daily web news and generally minding my own business when I came across this little gem on that bastion of internet truth, MSN. I recognized this diet as it was was popular in the 70's and 80’s for hyperactivity and because I had the opportunity to be on it as a child.

This was perhaps a little surprising considering how much research shows the Feingold Diet doesn’t help ameliorate ADHD or hyperactivity and that most serious science in the field doesn’t give the Feingold Diet the time of day
anymore. But that can happen when the last piece of serious science on the subject was published over ten years ago.

Krummel et al., (1996) are pretty direct when they say:


“Numerous double-blind studies of the Feingold hypothesis have led to the rejection of the idea that this elimination diet has any benefit beyond the normal placebo effect. Although sugar is widely believed by the public to cause hyperactive behavior, this has not been scientifically substantiated. Twelve double-blind, placebo-controlled studies of sugar challenges failed to provide any evidence that sugar ingestion leads to untoward behavior in children with Attention-Deficit Hyperactivity Disorder or in normal children. Likewise, none of the studies testing candy or chocolate found any negative effect of these foods on behavior. For children with behavioral problems, diet-oriented treatment does not appear to be appropriate.”

Now, the role of Nutritionist is one I would like to have a lot of respect for; after all, who is against nutrition? However, it turns out that just about anyone can call themselves a
Nutritionist. It also seems that my general lack of respect for the title of “Nutritionist” isn’t limited to just me.

The Feingold Diet, for the uninitiated, was named after pediatrician and allergist Ben Feingold. It is a so called, elimination diet, where certain foods or additives are removed from a child’s diet. This leads to a theoretical improvement in a child’s behavior. Among the usual suspects are various food additives and dyes e.g. (red #40).


The Feingold Diet has never officially included sugar in its banned substances list. However, Feingold practitioners may advise the removal of sugar (of one sort or another) in addition to the complete Feingold Diet, if the diet by itself is not enough to reduce behavior problems. Dr. Feingold himself mentioned that cane sugar was suspect.

The diet does have some empirical support (Conners et al., 1976; and Rowe & Rowe, 1994). It looked fairly legitimate at one point in time. It also had its champions. At least one name should be familiar to those of us in the autism world. The late Bernard Rimland, who was better known in his latter years for his alternative theories; encouraging chelation for kids with autism; was an outspoken defender of the Feingold Diet.

Dr. Rimland raised a number of interesting
criticisms including the fact that the disproving studies couldn’t possibly have studied all 3,000 additives prohibited in the diet. Of Dr. Rimland didn’t explain how anyone could have accomplished this feat. He also mentions that the darn kids were sneaking “illicit food” during the study.

In a very interesting passage he writes:

“Who needs artificially colored and flavored food anyway? For millennia the human body - and mind - has evolved and thrived on real food. It is prudent to feed our children and ourselves real food, not the denatured, "refined," additive-laden artificial foods that emanate from factories. What is the cost to us, to our country, and to our civilization of allowing ourselves to be seduced into consuming the gaudy colors and deceptive flavors that are used to make non-nutritious food appear desirable?”

Anyone reading the above passage shoudl quickly note the logical fallacies present. Such fallacies inlcude the argument by rhetorical question. Argument from tradition. The fallacy of the false dilemma. Argument from adverse consequences. And another false dilemma. So, Dr. Rimland racks of 5 fallacies in 4 sentences.

But it isn’t just Dr. Rimland. There seems to be a fundamental logic problem in the whole nutritionist cum Feingold culture.I remember the first time I realized there might be something funny with Feingold Diet was in High School, when I read a pro-Feingold book that stated that even if what the Feingold Diet treated was not really an allergy, it was okay to call it such, because the problem was analogous to an allergy.

However, that book was written in the late 70’s and it was already 20+ years old when I read it. Different time….right? Different standard of proof.

In the early days the Feingold supporters had a very scientific looking way to help parents and caregivers navigate through which foods were a problem and which were not. The simply would add or take away a food item and over the course of a week see what would happen. And just like that, post hoc, ergo propter hoc, the answer would be made plain.

This represented a can do attitude on the part of Feingold and company. It involved the parents, it put the power and control in their hands. In today’s alternative medical circles some people would call them “health care freedom fighters” or some such title.

However, we have reason to be a bit cautious here. Hoover & Millch (1994) found that after giving supposedly sugar sensitive children artificial sweetener and telling their parents it was sugar, the parents rated the children’s behavior significantly worse than controls. This result seems to indicate that even the people who know a child the best, can still fall victim to the confirmation bias and other self-trickery. Post hoc logic, even when dressed up to look like science, still isn’t science.

Keeping the above fact in mind look
here. It is a bit disappointing to see the same pseudo-science being pushed 30 years after the fact to justify a diet that is largely negated by the research, and that hasn’t been seriously researched since 1994.

At one time the Feingold diet seemed like a plausible treatment. That day has come and gone, because the majority of the research didn't back it up. But the Feingold advocates are still promoting their theory which has seen little or no change since the last bit of science on the issue. Once again, the observation that the more science changes, the less woo does, is proved to be true.

References

Conners CK, Goyette CH, Southwick DA, Lees JM, Andrulonis PA. (August 1976). "Food additives and hyperkinesis: a controlled double-blind experiment.". Pediatrics 58(2): 154-66.

Hoover, D. W., Milich, R. (1994). Effects of sugar ingestion expectancies on mother-child interactions. Journal of Abnormal Psychology. 22(4), 501-15.

Krummel D. A., Seligson, F. H., Guthrie, H. A. (1996). Critical Reviews in Food Science and Nutrition. 36(1), 31-47.

Rowe KS, Rowe KJ (1994). "Synthetic food coloring and behavior: A dose response effect in a double-blind, placebo-controlled, repeated-measures study". Journal of Pediatrics 125: 691–698.

20 Comments:

Blogger Prometheus said...

The Hoover and Milich study should be required reading for parents who are involved in "alternative" autism therapies.

Parents believed that their children would react badly to sugar, were told that their children received sugar and then duly noted the expected results - even though their children hadn't gotten sugar at all.

Change that to:

Parents believe that their children's autism is due to mercury, are told that chelation will remove the mercury and lead to improvement and duly see improvement, even though the chelation wasn't actually doing anything.

The similarities are amazing (or appalling).


Prometheus

10:28 PM  
Blogger ResearchLibrarian said...

This comment has been removed by the author.

12:04 PM  
Blogger ResearchLibrarian said...

You write:

"Among the usual suspects are the dye, red 5 and refined sugar, which is practically Lord Voldermort incarnate."

(1) There is no red 5. It does not exist.

(2) The Feingold diet does not eliminate sugar. I will repeat that. The Feingold diet DOES NOT ELIMINATE SUGAR. Not sugar. Not corn syrup. Not honey. Our kids LOVE sugar. Sugar is not the problem.

(3) BTW, the Feingold Program also DOES NOT eliminate chocolate.

(4) The researchers were named Rowe and not Rowse.

(5) There are rather a lot of studies available; No, they no longer need to prove that the diet works. They already know it works, and are beginning (finally) to find out why.

(6) Ward (1997) in the UK has shown that kids with ADHD exposed to coloring lose zinc. Zinc is connected with behavior (surely you already know that?)

(7) Lau (2006) has shown that combinations of coloring plus other additives harms neurons far more than would be expected from studying each alone (as has always been done).

(8) The FDA (2003) has asked hospitals to stop the use of blue #1 coloring in tube feedings because in sick people the coloring goes through the intestinal walls. When these people die, they are not dying from their disease, but from the blue coloring, which the FDA itself says is a mitochondrial toxin.

(9) Bateman (2004) found that parents of 25% of several hundred toddlers could tell when they were given a mere 20 mg of coloring. These were normal kids, too.

(10) Harris (1998) and Alberti (1999) have shown that children with autism have low levels of the enzyme PST (phenol sulfotransferase-P) and that salicylate suppresses it further.

(11) The Feingold Program does not eliminate all additives. It does eliminate the worst of them. All the FD&C colorings have been shown to cause DNA changes in the gut within hours. The 3 preservatives BHA, BHT, and TBHQ are all considered tumor promoters by the NIH. The few artificial flavorings studied suppress liver enzymes; Most have never even been studied, and have never been proven safe. Anything can be called a "flavoring" and added to foods based on the "de minimis" principle (Kroes 2000, 2002, 2005). You are eating a "pig in a poke" ... or perhaps playing additive roulette - bon appetit if you wish it.

(12) Some (no, not all) salicylate-containing foods and medications are eliminated at the beginning of the diet (note #10 above) but after a few weeks, when the person is better, they can usually be reintroduced. They are added one at a time, testing for tolerance the same way you add foods to a baby's diet, and the same way all elimination diets work.

(13) Why not all salicylates? There are many kinds of salicylate chemical compounds. No studies have been done on relative toxicities, but it is reasonable to expect that ethyl salicylate and methyl salicylate are not the same. The list of those salicylate-containing foods to be eliminated was created clinically for salicylate-sensitive asthma patients in Germany in the 1930's (I think) and it has stood the test of time.

It might be a good idea to find out at least a few of the facts before you rant for paragraphs about a subject. I thought your misinformation was really funny, but others may be misled.

A good source for such facts would NOT be the Zimmerman article you started with (she can't even get our name right) but the actual Feingold Program web site at http://www.feingold.org

You can also see more studies, linked to their sources in MedLine and (where possible) to their full text, at diet-studies.com and you can see what the schools have been doing at school-lunch.org

No, the diet doesn't "cure" everybody. Nothing does. But it is worth trying. Yes, it helps over 70% of those who try it properly. And yes, just like any treatment you do have to do it properly. This diet helped my son to leave a special school for severe learning disability and behavioral disorder, and he is today a happily married professional engineer. It (plus a few other interventions such as Vitamin B, zinc, and eliminating corn) made it possible for my daughter to become a successful pharmacist. You can see other testimonials from real members on our web site.

Finally, with apologies for being so long-winded, you will find plenty of negative articles about the diet on the internet. Some are from ignorant people quoting other ignorant people; some are vicious, with conflicts of interest and connections to the pharmaceutical and food additive companies. It's too bad, because it is the children who suffer.

2:00 PM  
Blogger ResearchLibrarian said...

Just one more comment .... re the sugar studies .... all of them were testing TABLE SUGAR. So what is the problem with that? Well, they were testing kids whose parents thought that they were "sugar-sensitive." However, what the parents did not know is that most of the "sugar" in candy and soda is CORN SYRUP and not table sugar. As you guys know, you can't tell anything about "A" by testing "B" ... these sugars are not the same, so all those studies proved ..... well ... nothing. Except maybe that table sugar is not the problem (and we in the Feingold Association agree).

2:06 PM  
Blogger Interverbal said...

Hi Research Librarian,

Thank you for visiting my blog and reading this article. I would like to take a chance to quote you and to offer some replies.

“(1) There is no red 5. It does not exist.”

This should red #40. Thank you for the correction.

“2) The Feingold diet does not eliminate sugar. I will repeat that. The Feingold diet DOES NOT ELIMINATE SUGAR. Not sugar. Not corn syrup. Not honey. Our kids LOVE sugar. Sugar is not the problem.”

I have heard this assertion before. However, Dr. Feingold himself made it clear that table sugar and especially cane sugar were suspect. This attitude encouraged the exclusion of sugar and was written about very clearly in several late 1970’s publications.

“(3) BTW, the Feingold Program also DOES NOT eliminate chocolate.’

You are introducing a new point that was not mentioned in my post. However, for the record, chocolate that had additives was sometimes excluded.

“(4) The researchers were named Rowe and not Rowse.”

Thank you for the correction.

“There are rather a lot of studies available; No, they no longer need to prove that the diet works. They already know it works, and are beginning (finally) to find out why.’

I have taken the chance to review that site’s research listings. I note that there is no “Feingold section” but only a series of subsections relating to a wide variety of problems. I also note that some of these sections have absolutely nothing to do with the Feingold diet or diet based treatment. Some sections seem to have a great deal to do with other alternative beliefs in medicine, such as can be found in the autism section.

Further, only a portion of these listings are actual research. And of this portion only a minority are true experimental designs.

Now, I would have expected to see specific citations that proved the efficacy of the Feingold Diet. I had to attempt to sort through a variety of tangential issues. To find what was relevant to this specific issue, I reviewed the ADHD section is detail. Some of the articles were familiar others less so. Only a handful mentioned the Feingold Diet by name. Of these the best controlled one, was still flawed, and it failed to reject the null hypothesis. The other two in this class did not meet criteria for a true-experimental design. They were quasi-experimental designs and had questionable outcome measures.

If that is the extent of the research, I find no reason to agree that the diet is proven. The review of literature I conducted before writing suggests that the Feingold Diet is not substantiated by the research.

I also note that the Feingold Diet is still listed (please feel free to correct this) as an alternative or complementary treatment, the health authority powers that be, seem to think so to.

Also, I note that it has been quite a while since research was done specifically on the Feingold Diet. That seems very unusual.

“(9) Bateman (2004) found that parents of 25% of several hundred toddlers could tell when they were given a mere 20 mg of coloring. These were normal kids, too.”

How does this comapre to what could be predicted by chance?

“It might be a good idea to find out at least a few of the facts before you rant for paragraphs about a subject. I thought your misinformation was really funny, but others may be misled.”

You are able challenge the factual basis of this post. What is more, you are welcome to do so. You have very helpfully corrected mistakes in terms of the number of the red dye and the name of a pair of researchers.

However, I take issue with your attempted correction of the inclusion of cane sugar and chocolate in the Feingold Diet. Further, the researcher you have broadly alluded to, is not satisfactory. The researcher you specifically cite such as Lau (2006) does not prove the efficacy of the Feingold Diet. These merely set the groundwork for what might be a potential solution. Those results, must be born out in applied research. Such studies seem to be inadequate and no one seems to want to address it anymore. Again, you are welcome to correct that.

Also, I assure you, I was calm, clear, and collected when I wrote this post. This was not a rant. Although, it does accurately reflect my distaste and anger with many issues in the way the Feingold Diet is advertised and justified. I am glad you found my post to be funny. But, if I was presented with the type of strongly worded rebuttals of something I advocated for, such as appears in the formal medical journals and was cited in this post, I would probably be embarrassed. Again, it is good that you can take humor from this situation.

“No, the diet doesn't "cure" everybody. Nothing does. But it is worth trying.”

Is it? What makes it so?

“Yes, it helps over 70% of those who try it properly.”

Will you please reference the research that shows this?

“This diet helped my son to leave a special school for severe learning disability and behavioral disorder, and he is today a happily married professional engineer. It (plus a few other interventions such as Vitamin B, zinc, and eliminating corn) made it possible for my daughter to become a successful pharmacist.”

The plural of anecdote is not data. But, if we want to do anecdotes. I am graduate student. I was a hyperactive child. I also had the opportunity to be on the Feingold diet (complete with chocholate and sugar restrictions) as a child. So, if we use illogical post hoc, ergo propter hoc logic, then we might attribute my current position to the Feingold Diet. However, a friend of mine was also a hyperactive child, was placed on no treatment, and he is now working on his M.D. Another friend was also called hyperactive, was placed on Ritalin, he is now working on his Ph.D in history. Are our success artifacts of our (non) treatment by Feingold/Ritalin? If we are being logical or scientific, how do we know?

“Finally, with apologies for being so long-winded, you will find plenty of negative articles about the diet on the internet. Some are from ignorant people quoting other ignorant people; some are vicious, with conflicts of interest and connections to the pharmaceutical and food additive companies. It's too bad, because it is the children who suffer.”

You are welcome to be long winded, as long as you stick to the topic.

I found plenty of negative reviews of the diet, in the research literature and in metanalyses.

I am sure some are from ignorant people and some way well be from vicious (I am not quite sure what you mean?) people. Also, some may be from people with conflicts of interest. But conflict of interst is a tricky thing, are you willing to be fair and apply the same standard to those who wrote books or took money for advising others how to implement the Feingold Diet. The best intentions in the world, do not erase a conflict of interest after all.

However, what about negative reviews from people who are none of the above? How do such reviews or research fit into your schemata? Also, is arguing against the quality of a person, as opposed to the facts, a good way to prove a scientific point?

And do the children suffer? Again, where are your studies proving this diet you advocate for, works? And why haven’t recent studies specific to the diet been conducted?

10:10 PM  
Blogger Interverbal said...

Note:

This article has been edited to remove mistakes made in terms of sugar restrictions in the Feingold Diet, the number of a red dye, and the name of two researchers.

11:28 AM  
Anonymous Anonymous said...

Hi Interverbal -

Ran into this today and thought about your blog. It seems this kind of research is still being performed after all. Here is a link to a new study in The Lancet that would seem to vindicate some parents observations as not placebo based in regards to artificial additives.

http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=17825405&ordinalpos=1&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_RVDocSum

Go figure.

- pD

8:22 AM  
Blogger Interverbal said...

Hi PD,

Thanks for the link. This is a very interesting study; it is the first one looking at this issue, in a long time. It supports the idea that 2 specific factors may result in hyperactivity in children. This study doesn’t support the broader Feingold diet as a whole however.

I would like to discuss the strengths and weaknesses of the study, I will do so below.

The study uses a double-blinded, placebo-controlled, crossover trial, which is a very strong design when used correctly. It seems to have been well used in this case.

Areas of relative weakness in this study are the assessment and analysis however. Specifically, the 8-9 year old group used a computerized test of attention (more is not said in the abstract) that was not used in the 3 years old group. This may bias any comparisons between the groups in terms of conclusions.

Also, I found it curious that the 3 year old group who got the (b) mix of the artificial food color and additives didn’t achieve significantly worse results; but the 8-9 (b) group did when given the same mix. I wonder if this result is an artifact of the use of the computer program with the 8-9 group?

It seems to me that this study avoided comparing the two age groups which used slightly differing assessment methods, statistically (which would almost have certainly gotten some dissent from the peer reviewers). But did not avoid this, when verbally comparing the groups. I would argue that in a study like this both age groups should be statistically compared, especially in the presence of an odd finding like what was seen for the (b) group in the 3 year olds, but again that can’t happen in this study, because of the lack of the same assessments. This is a flaw.

I think that the methods are solid in this study, but I take issue with the assessment and lack of solid statistical analysis between groups.

5:18 PM  
Anonymous Anonymous said...

Hi Interverbal -

"This study doesn’t support the broader Feingold diet as a whole however. "

Sure. But kids on Feingold wouldn't get the additives in this study, and kids on 'standard' american diets would. Wouldn't one group have less hyperactivity, barring some as of yet undescribed mechanism by which the feingold diet could increase hyperactivity up and above the decrease we'd expect to see from less aditive?

"Specifically, the 8-9 year old group used a computerized test of attention (more is not said in the abstract) that was not used in the 3 years old group. "

It seems likely to me that this is an artifact of the problems with getting a three year old to use a computer program at all.

If the study only used 8-9 year olds, would you still have concerns over the assessment methods used? I guess I'm curious as to if you'd feel comfortable saying, at the least, that 8 - 9 year olds are affected by the additive based on this study. (?)

Take care!

- pD

6:59 AM  
Blogger Interverbal said...

Hi PD,

“Sure. But kids on Feingold wouldn't get the additives in this study, and kids on 'standard' american diets would. ”

That may or may not be true. A lot of kids come to school and go home to 100% fruit juice drinks; they are not on the Feingold diet.

“It seems likely to me that this is an artifact of the problems with getting a three year old to use a computer program at all.”

I am sure that is exactly right. But that doesn’t change the fact that the partial inclusion of one of the assessments, harms this study.

“If the study only used 8-9 year olds, would you still have concerns over the assessment methods used?”

No, I would have little ground to stand on if I was being critical.

“I guess I'm curious as to if you'd feel comfortable saying, at the least, that 8 - 9 year olds are affected by the additive based on this study.”

I am cautiously in favor of backing the authors conclusions for the (a) mix + S.B. for the 8-9 group. I would like to see this result replicated however, before I give strong support.

I am suspicious of the results of the (b) mix in the 8-9 group, because of the results of the 3 year old group.

I also think that research needs to flesh out whether it was the coloring or the S.B. (or both) that was a factor here. We can’t tell based on this research.

5:25 PM  
Blogger ResearchLibrarian said...

My answers after @@@@

"However, Dr. Feingold himself made it clear that table sugar and especially cane sugar were suspect. This attitude encouraged the exclusion of sugar and was written about very clearly in several late 1970’s publications."

@@@@ Can you please tell me from where you have this information? I have been a volunteer in the Feingold Association for well over 20 years, and I have many of Dr. Feingold's writings, as I am creating an archive of his work, but I do not have that one. As a matter of face, in his book "Why Your Child is Hyperactive" most of page 179 is taken up with suggestions for acceptable candy and chocolate treats for the children (back then not so many acceptable candies were commercially available as there are now).

“(3) BTW, the Feingold Program also DOES NOT eliminate chocolate.’
You are introducing a new point that was not mentioned in my post. However, for the record, chocolate that had additives was sometimes excluded."

@@@@ I did not introduce this point -- you mentioned chocolate in your extensive quote of Krummel. Of course chocolate with artificial flavoring was ALWAYS excluded - it was the additive that was the problem, not the chocolate. Not all chocolate has additives.

"I note that there is no “Feingold section” but only a series of subsections relating to a wide variety of problems.

@@@@ There is no Feingold Section because the entire website is devoted to research relating to the dietary effect on behavior, mood, learning and health -- all of which is part of the Feingold Program's purpose. Those problems are not separate, but inter-related. People with ADHD often have other symptoms as well; when the diet works for them, it often works for all the symptoms. Each symptom alone, however, has had its own share of research, which is why it is broken down like that in the web site.

"Some sections seem to have a great deal to do with other alternative beliefs in medicine, such as can be found in the autism section."

@@@@ Autism is not an alternative belief. Perhaps I am not understanding what you are trying to say here? Some researchers place autism today on the same continuum of attentional problems, now called ASD. Whatever the reason, however, parents of children with autism came to us and began to inform us that the diet helped their children - it is something we did not originally know, and when Dr. Feingold wrote his books autism was not the problem it is today. Because many of our members now include those with autism, we include other information about treatments that have been found helpful.

"Further, only a portion of these listings are actual research. And of this portion only a minority are true experimental designs. "

@@@@ Yes, some of the listings are reviews of research. However, almost 40 of them are double blind placebo control studies. Did you know that according to the NIH, it only takes 2 double blind studies on a drug to have it considered a Class A treatment for ADHD? So why is this treatment held to a different standard?

" I had to attempt to sort through a variety of tangential issues. "

@@@@ Perhaps you may mean the studies on animals such as rats? Many toxins make rats hyperactive. The point is that toxins DO cause hyperactivity ..... hyperactivity is a common response to a toxin the organism cannot tolerate.

@@@@ However, since all the studies are arranged in date order, this can be confusing and you have a point about that. I will be reorganizing it hopefully by the end of the year. You may prefer the organization of the research section of our new "bluebook" at http://diet-studies.com/PDFstudies/BLUE/research.pdf

To find what was relevant to this specific issue, I reviewed the ADHD section is detail. Some of the articles were familiar others less so. Only a handful mentioned the Feingold Diet by name. Of these the best controlled one, was still flawed, and it failed to reject the null hypothesis. The other two in this class did not meet criteria for a true-experimental design. They were quasi-experimental designs and had questionable outcome measures.

@@@@ You do not name the studies you are discussing, so I cannot comment on their "flaws."

@@@@ I suppose one of them is the Schoenthaler study of schools since it is a quasi-experimental design. On what grounds, however, do you conclude that his conclusion was questionable? Have you seen his discussion of all possible conclusions? You may see it at http://www.diet-studies.com/PDFstudies/Schoenthaler-schoolhyp.pdf

@@@@ As for flaws -- you know all studies have flaws. You did not appear to be unduly upset about Krummel's flaws while quoting him as your expert.

" If that is the extent of the research, I find no reason to agree that the diet is proven."

@@@@ And your problem with the Boris & Mandel, and Rowe & Rowe 1994 studies was .... what?

@@@@ Do you truly not get it? When there is a study like the Ward studies, where kids with ADHD lose zinc and deteriorate both behaviorally and physically upon exposure to artificial coloring -- this IS a test of the Feingold diet, whether they use the word or not.

@@@@ You seem to have had a problem with the studies that used the oligoantigenic diet rather than the Feingold diet. With a "few foods" diet, the researchers could get "more bang for their buck" by also picking up those children who had true allergies to milk etc. Nevertheless, their diets were simply an "extreme" Feingold-type diet and certainly their results proved that "diet" works -- whether ours or theirs makes little difference. Theirs is quite a good approach for diagnosis, but rarely necessary and unpleasant to live with. Ours is much easier to implement and accept, while having pretty much the same results. The difference is that when a child on our diet is also allergic to milk, they tend to find out later rather than earlier.

"I also note that the Feingold Diet is still listed (please feel free to correct this) as an alternative or complementary treatment, the health authority powers that be, seem to think so to. "

@@@@ So? Are you aware that doctors who used thermometers were once thought to be using quackery?

"However, I take issue with your attempted correction of the inclusion of cane sugar and chocolate in the Feingold Diet. "

@@@@ Are you saying that they are EXcluded? I have been teaching the diet for 20 years. I eat sugar and chocolate all the time -- actually I eat more of it at our annual Feingold conferences than any other time.

"Further, the researcher you have broadly alluded to, is not satisfactory. "

@@@@ Um, interesting. Who did I "broadly allude" to? I generally specifically cite everybody with links etc.

"The researcher you specifically cite such as Lau (2006) does not prove the efficacy of the Feingold Diet. "

@@@@ This study was not intended to prove anything about any diet. It was intended to study whether additives together are more toxic than when used separately.

@@@@ Studies intending to prove safety of additives have almost always studied them individually, but they are usually not eaten individually. Usually many additives are eaten together. The very few studies intended to show interactions -- like this one and the Thompson 1988 study showing that while BHA alone has no effect on the lung, adding a small amount of BHT makes it much more toxic so that lung weight is increased (by cell deaths) in a dose-dependent manner. In the real world, we eat additives together all the time. NO RESEARCH has been done to prove this a safe practice. It is akin to using any drugs you want with no consideration of interactions. Chemically, additives are similar to drugs and they do interact. Yet the kind of research required to prove safety of drugs and their interactions before giving them to patients is not required of additives given to the vast majority of our population with no controls whatsoever.

@@@@ You are obviously an educated person. This practice doesn't bother you?

"These merely set the groundwork for what might be a potential solution. Those results, must be born out in applied research. "

@@@@ I fully agree that more research is good. On the other hand, while I agree that an accused individual should be innocent until proven guilty, I believe that an accused additive should be considered guilty until proven innocent. While we fiddle around with years of research, toxic additives can wreak havoc with the lives of our most vulnerable population - our children.

"it does accurately reflect my distaste and anger with many issues in the way the Feingold Diet is advertised and justified. "

@@@@ We do not advertise. Our income is used to provide services and to provide materials for those who cannot afford the modest membership fee. Our website is our main outreach information effort, and I am the person who creates the website. If you would like to specify what you find distasteful in it, I will be attentive.

"Will you please reference the research that shows this [70%+ success rate of the diet]?"

@@@@@The percentages cited are for Feingold-type diets. Those researchers who used more restricted diets did get a higher percent of children responding.

Egger 1983 ..... 93%
Egger 1985 ..... 82%
Rowe 1988 ..... 73%
Egger 1989 ..... 80%
Carter 1993 .....76%
Boris 1994 ..... 73%
Rowe 1994 ...... 75%
Pelsser 2002 .... 81%

"I found plenty of negative reviews of the diet, in the research literature and in metanalyses. "

@@@@ Perhaps I did not mention it, but a problem with meta analyses is that they can only analyze the available studies. Many of the studies done before 1985 put the kids on a diet. When they improved -- and remember, it was necessary to the study that they used children who DID improve -- then they challenged them with a tiny amount of a single food additive. When nothing happened or when only the youngest children responded, the conclusion was drawn that the kids were not sensitive to the challenge and therefore the diet didn't work. The problem with this, however, is that the study did not prove anything about the diet. It simply proved that the CHALLENGE didn't work. I recall one study (Adam I think) in which they put yellow color in the cake frosting for the challenge .... but they put in so little color that the frosting was still white so that they could use the white frosting as the control. And another study (Levy 1978) tested the kids with ONE mg of coloring ... and the tests were done the day AFTER. He was certainly being careful ..... careful to make sure that none of the kids would react to the dye, don't you think? If he had done that same experiment with cocaine, he could have "proved" it safe enough to put that too in the kids' lunches.

"But conflict of interst is a tricky thing, are you willing to be fair and apply the same standard to those who wrote books or took money for advising others how to implement the Feingold Diet."

@@@@ The Feingold Association is a volunteer-run organization. Even the few people who actually get paid as staff are paid very little. If the diet didn't work, our volunteers would leave and the rest of us would go get a "real job. " Nobody ever got rich - not even Dr. Feingold - by promoting the Feingold diet. Where, then, is even a perceived conflict of interest?

1:17 AM  
Blogger ResearchLibrarian said...

Answering now your later post (my apologies for getting your posts out of order, but I am still new to this blogging thing):

I agree that it is regrettable that both age groups could not be given the same test, but unfortunately you can't usually give 3 year olds the computer test. Even the TOVA, which does not use the alphabet and which has a short version for younger kids just doesn't work for toddlers. Therefore, this is more like having done two separate studies at the same time; they really cannot be compared well.

"Also, I found it curious that the 3 year old group who got the (b) mix of the artificial food color and additives didn’t achieve significantly worse results; but the 8-9 (b) group did when given the same mix. I wonder if this result is an artifact of the use of the computer program with the 8-9 group?"

It was not the same mix. Mix A was given to the toddlers at a level of 20 mg .... this is about how much coloring is in a half teaspoon of brightly colored frosting. It is enough to color about 6 ounces of Koolaid. I don't know about kids in the UK, but the average American child would normally get rather more. I was surprised that they could even detect a difference in kids who - not being hyperactive - would not be expected to be overly sensitive to such coloring to begin with. The 8/9 year olds got about 24 mg of this Mix A and predictably (to me) had no reaction. This is a dose/size relationship. A half a baby aspirin might have an effect on pain in toddlers, too, but is not likely to do much for a 9-year old.

Consider now, what they did for Mix B. They used 30 mg for the toddlers, but more than DOUBLE that amount for the older group. NOW they could see a clear reaction in the older group. May I remind you that way back in 1977, the National Academy of Sciences determined that the average American was ingesting up to 327 mg coloring per day on AVERAGE. For reasons neither I nor my statistics prof could comprehend, they then took this amount and divided it by 5 to get an "average" of about 65 mg per day. Remember -- that was 1977, before blue oatmeal and fluorescent toothpaste and all. So, as you can see, even the larger amount given the older children was certainly not unreasonable. And they did have a clear reaction ... not a HUGE reaction of course -- remember these were not hyperactive kids;

But what about the younger ones? First, remember that they are using a very small amount of coloring and it is a different mixture. It is possible that kids on average are more sensitive to something in MixA than in MixB when in small doses. But look closer -- there are graphs in the study on pages 5 and 6. They reported AVERAGES, and then they did some statistical comparisons which probably you understand much better than I -- as they themselves claimed, it is not that the younger ones did not react to Mix B, but their reactions were so uneven that they cancelled each other out in the averages. If you look at the set of lines at left of each graph, you will see there is a clear difference even in the averages between Mix A and Placebo, and also between Mix B and placebo .... while at right these are statistical computations which formed the basis of the conclusion that the difference was unclear for the entire group.

Another possibility is that the contents of the two mixes were not equally reactive .... 20 mg of a mix with Yellow 5 may just happen to be more reactive than a mix with Yellow 10 of equal amount.

Another thing to think about ... if thalidomide had not done such dramatic damage to babies, but had instead simply made them more likely to suffer asthma, or lowered their IQ by 10% .... would we have noticed? More likely, we would still be using it, and wondering why kids seemed less smart today.

When it comes to the welfare of our babies, it makes sense to me to err on the side of caution -- in other words a suspected additive should definitely be considered guilty until proven innocent. But in the real world, studies of the colorings (Tanaka 1993, 1996, 2001, 2006)in rats show neurological changes - difficulty swimming, crawling uphill, developmental delays, etc - yet these results are ignored.

Unborn babies and young children are exposed daily to chemicals we cannot prevent. The artificial colorings, however, are not a requirement for nutrition and can be replaced easily enough.

A word about sodium benzoate. It would, of course, be nice to know how much of the kids' reaction was due to the preservative, but that was not the intent of the study. The results of the combination - how kids get this stuff in the real world - was the question. I am more surprised that they did not use BHA, BHT, and TBHQ, but I understand those preservatives are not used so much today in foods for kids in the UK. It would sure be nice if someone would replicate the study on American kids using the colorings and preservatives prevalent here.

8:30 AM  
Anonymous Anonymous said...

Hi Interverbal -

Something has been bothering me about this conversation, but it took me a while to figure out
what it was. I cannot for the life of me, see how you could blind participants as to if
they were actually on Feingold or not. It would seem, in order to measure a reduction (or lack of) in
hyperactivity you'd have to take children who ate plenty of additives, and then remove
them from their diet (at least for the test group). But we aren't talking about taking a pill with
active ingredient or taking a pill with filler; we are talking about drastic dietary changes.

Do you believe that you could blind an eight year old that has been eating Nacho 'Cheese' Doritos for five years that his diet has not been altered when his diet
suddenly becomes additive free?

Likewise, if you took children who have been on Feingold, and started giving them Doritos,and Kool Aid
they would know that their diet had been changed.

Perhaps I have misread you, and you don't feel that a true double blind, placebo trial is
necessary; but in previous postings you seem to have only wanted to give credence to the
'blind' GF/CF trial conducted in Gainseville. In much a similar fashion, I am absolutely positive that nobody who has ever eated a GF/CF 'pizza' could ever believe the consumers of the diet were blind to the change. GF can be substituted with some success, possibly, but the CF 'cheese' can not be mistaken for the real thing by anyone with more than 2 operational taste buds.

Your thoughts?

Take care!

- pD

11:26 AM  
Blogger Interverbal said...

PD and RL respectively:

Thank you for offering very interesting comments which I have only briefly looked over.

I am quite busy at the moment and can not offer a reply yet.

You can expect my responses somtime Saturday.

10:53 PM  
Blogger Interverbal said...

Hi PD,

I think you raise a valid concern. I believe it is solvable however. The solution would involve a general change in diet. So, the control wouldn’t be the child’s old “Doritos” diet vs. the cf pizza diet, but would be other alternatives for both.

Part of the excellence of the recent gf/cf trial, was that the researchers were able to do this. I also think that in double-blind research with children, the attempt is not so much to blind the children (who may or may not have given their informed consent or even be cognizant of their participation) from the conditions, but to blind their direct assessors i.e. parents/teachers/aids.

Thanks PD.

4:28 PM  
Blogger Interverbal said...

Hi Research Librarian,

@@@@ Can you please tell me from where you have this information?

*** According to Dr. Feingold, "One must be aware that not only refined cane sugar, but all the simple sugars which includes brown sugar, beet sugar, corn syrup, molasses and even honey may play a role in the behavior." http://findarticles.com/p/articles/mi_m0860/is_n8_v51/ai_7746127

“@@@@ I did not introduce this point -- you mentioned chocolate in your extensive quote of Krummel.”

***Now I see, point ceded.

@@@@ There is no Feingold Section because the entire website is devoted to research relating to the dietary effect on behavior, mood, learning and health -- all of which is part of the Feingold Program's purpose. Those problems are not separate, but inter-related. People with ADHD often have other symptoms as well; when the diet works for them, it often works for all the symptoms. Each symptom alone, however, has had its own share of research, which is why it is broken down like that in the web site.

***No argument there, but these many of these issues are tangential to topic of my post. The topic here is hyperactivity and the Feingold diet. I would prefer to stick to that topic, unless you have a specific issue you would like to tie this topic into to make your argument.

@@@@ Autism is not an alternative belief. Perhaps I am not understanding what you are trying to say here? Some researchers place autism today on the same continuum of attentional problems, now called ASD. Whatever the reason, however, parents of children with autism came to us and began to inform us that the diet helped their children - it is something we did not originally know, and when Dr. Feingold wrote his books autism was not the problem it is today. Because many of our members now include those with autism, we include other information about treatments that have been found helpful.

***I am not proposing that autism is an alternative belief. I am proposing that the information provided in the “Autism” Section in your organization’s website contains alternative beliefs about autism. I would like to reiterate that point. The Autism Section contains a link to the Mutter (2005) article and the DAN! website.

Further, the ASDs in the mainstream are still considered to be the five PDDs, they do not officially include attention based disorders. Also, will you explain how autism wasn’t a problem in the 70’s like it is today?

@@@@ Yes, some of the listings are reviews of research. However, almost 40 of them are double blind placebo control studies. Did you know that according to the NIH, it only takes 2 double blind studies on a drug to have it considered a Class A treatment for ADHD? So why is this treatment held to a different standard?

***Will you cite these 40? I don’t think it is enough to have 2 double blind placebo controlled study and have that alone determine a treatments worth. Particularly if the study is tangential. What determines a studies worth is how well the design was implemented and matches the researcher’s question. You could have a 100 such studies and if they are not well designed or properly implemented, they might not teach us a thing.

On the other hand if just 2 out of those 40 directly take on the Feingold hyperactivity hypothesis and they design and implement the study well, then I would be happy to agree with you. You are welcome to try and show that.

@@@@ Perhaps you may mean the studies on animals such as rats?

***Not per se. There seems to be a host of issues in whole site, that are tangential to this post which is about the Feingold diet and hyperactivity.

@@@@ However, since all the studies are arranged in date order, this can be confusing and you have a point about that. I will be reorganizing it hopefully by the end of the year.

***No, not to be a contrarian, but I had no problem with the current ordering.

@@@@ You do not name the studies you are discussing, so I cannot comment on their "flaws."

Fair criticism, I will correct that now:

The best controlled was Harley (1978) and as you helpfully noted there is some debate as to whether there was an order effect here.

Rowe & Rowe (1994) is quasi-experimental, more on that below.

Rose (1978) uses a double blind conditions embedded in a BAB single case design. BAB design (or treatment-baseline-treatment designs) are quasi-experimental. The sequence should have been carried on for at least another reversal or so, to demonstrate experimental control.

@@@@ I suppose one of them is the Schoenthaler study of schools since it is a quasi-experimental design. On what grounds, however, do you conclude that his conclusion was questionable?

***In any quasi-experimental design we are uncertain to what extent the independent variable influences the dependent variable. That is what I mean by a questionable outcome.

@@@@ As for flaws -- you know all studies have flaws. You did not appear to be unduly upset about Krummel's flaws while quoting him as your expert.

***The fact that all research has at least some flaws, doesn’t work as an excuse. I would be surprised to learn that such an excuse has ever convinced anyone on a dissertation committee or journal peer reviewer group. As to Krummel, if you see a flaw in what he wrote you are welcome to share it.

@@@@ And your problem with the Boris & Mandel, and Rowe & Rowe 1994 studies was .... what?

***Fair question:

Boris & Mandel: They excluded things like milk, wheat, corn, yeast, soy, citrus, egg, chocolate, and peanuts. Also atopic children with ADHD had a significantly higher response rate than the nonatopic group. So, maybe the real problem here was allergies.

Rowe & Rowe: The authors pre-selected from a “reactors” group identified during a pre-study. This creates a bias in terms of finding an association. You can’t do this and have a true-experimental design. We are left with the option of calling this design quasi-experimental or saying that it only applies to some subset of children defined by some unknown variable.

In addition, the statistical design is unusual with each child serving as their own control. The authors seem to be mixing single-case and group design logics. I am not sure the Wolcoxon matched pairs statistical analysis was appropriate here (I could be wrong). And the authors used different strength levels of their Independent variable effectively creating multiple independent variables. They should have used a MANOVA or similar design here. Although, they do seem to address this adequately using a detailed chi-square.

In addition they modified an objective behavior checklist in a way that may or may not have removed its reliability and validity.

@@@@ Do you truly not get it? When there is a study like the Ward studies, where kids with ADHD lose zinc and deteriorate both behaviorally and physically upon exposure to artificial coloring -- this IS a test of the Feingold diet, whether they use the word or not.
@@@@ So? Are you aware that doctors who used thermometers were once thought to be using quackery?

Yes, and Pasteur wasn’t believed at first and Semmelweis had a hard time of it. By why should I believe that because these disbelieved people were proved right in time, that you will also be?

***So, by only testing one aspect out of very many, you prove the whole thing? I guess I don’t get it. Please the logical process you used here? Also, while we are on Ward (1997) why the heavy metal testing using hair? Many advocates of the heavy metal theory of autism would be quick to tell you that hair based tests of heavy metals have lessened validity.

@@@@ Um, interesting. Who did I "broadly allude" to? I generally specifically cite everybody with links etc.

***I recognize it merely as a typo, it should be “research” not “researcher”.

@@@@ You are obviously an educated person. This practice doesn't bother you?

***I advocate testing of additives and I have no problem with caution, but I also don’t believe in assuming harm in the absence of science.

@@@@ I fully agree that more research is good. On the other hand, while I agree that an accused individual should be innocent until proven guilty, I believe that an accused additive should be considered guilty until proven innocent.

***Again, I believe it safety testing, but

@@@@ We do not advertise. Our income is used to provide services and to provide materials for those who cannot afford the modest membership fee.

***I did not accuse your organization of it. But others have advocated or advertised the Feingold diet. My least favorite aspect of it was the Feingold diet helping resolve “allergies” when the advocates knew they weren’t allergies.

@@@@@The percentages cited are for Feingold-type diets. Those researchers who used more restricted diets did get a higher percent of children responding.

***Thanks for citing these.

@@@@ Perhaps I did not mention it, but a problem with meta analyses is that they can only analyze the available studies.

***Yes that is a problem with meta-analyses, they only use controlled studies.

@@@@ The Feingold Association is a volunteer-run organization. Even the few people who actually get paid as staff are paid very little.

***Even if they do not get paid a lot, they still get paid. That still meets criteria for a conflict of interest.

@@@@If the diet didn't work, our volunteers would leave and the rest of us would go get a "real job."

****Would they, I am glad they possess such excellence and commitment to fair proof and the scientific method.

@@@@Nobody ever got rich - not even Dr. Feingold - by promoting the Feingold diet. Where, then, is even a perceived conflict of interest?

****You don’t have to get rich to have a conflict of interest.

11:38 PM  
Blogger Interverbal said...

Hi Research Librarian,

Part 2

“I agree that it is regrettable that both age groups could not be given the same test, but unfortunately you can't usually give 3 year olds the computer test. Even the TOVA, which does not use the alphabet and which has a short version for younger kids just doesn't work for toddlers. Therefore, this is more like having done two separate studies at the same time; they really cannot be compared well.”

I agree, but that is my point. The authors did verbally compare them.

“as they themselves claimed, it is not that the younger ones did not react to Mix B, but their reactions were so uneven that they cancelled each other out in the averages.

One of the points of group logic research is to wash out individual differences.

12:30 AM  
Anonymous Anonymous said...

Hi Interverbal -

I'm not so sure that blinding the parents will help all of the time. If I remember correctly,
in the Elder study, participants were up to sixteen years of age. I know when I was sixteen,
the first thing I did when I got to a friends house was try to get some food that I wasn't allowed
to have at my house (sugared cereal, mostly). Why? Because I was unsatisfied with the foods I had at my house; it seems probable that other sixteen year olds had similar desires. Elder did indeed
report that in 'several' instances parents reported that their children had obtained illegal foods
either from peers or siblings. Besides the obvious impact on the validity of the study (I found no
reference indicating these children were removed for group analysis), in these instances, it seems very possible the participants were not fooled. Why sneak real maccaroni and cheese if you are satisified with the
maccaroni and cheese provided by researchers? One thing I cannot imagine is the reverse, a child on a regular diet 'sneaking' GF/CF equivalents. LOL!

I did hear about a larger scale GF/CF study being undertaken that tries to solve this problem
by moving everyone to GF/CF, and then giving out either filler pills or gluten / caesin pills to be taken. This is a better solution than what I'd thought of, but still doesn't do much for the kid that wants a real piece of pizza and finds himself without supervision for 5 minutes in the lunchroom. There may also be differences in absorption if you take something via pill versus in the foods you eat; I believe this is one reason why multivitamins are good, but you cannot multivitamin your way to good health while eating french fries and milkshakes. But at least it is a start.

Take care!

- pD

8:11 AM  
Blogger Interverbal said...

Hi PD,

The biggest value of the Elder study was to show that we can do a gf/cf study where the parents are blinded. This had been in serious some contention before.

The researchers found that the parents in this study had no better than chance ability, to label what condition came first for their child.

The age range in this sudy was 2-16, with the median age being lower in this case.

You are right, that several chidlren did sneak food, but we do not know which condition this occured in. It is a threat however.

This is an imperfect study both because of the sneaking food, and due to of the smaple size being smaller than 30.

It is however, the best study to come out to date for several reasons:

1. Careful diagnosis before study.

2. Double-blind crossover design (quite strong).

3. Objective, 3rd party direct behavior assesment for dependent variable.

That last one in particular is a big deal.

9:07 PM  
Blogger Unknown said...

I have absolutely no scientific data to add to this, just my story as a mom. I just wanted to share my own personal experience. I have a 3 year old who was hyperactive and aggressive. Non stop running around the house, could not concentrate or look me in the eyes when asking him question or to complete simple tasks. He was also incredibly aggressive for no reason, and always very suddenly. Would hit me, my husband, our dog.. whoever was near him at the time. He would throw objects at us or at his door or walls... and he exhibited these behaviors every day. Only 2 weeks ago I found out about the Feingold diet and immediately started my son on it. Just to note, I made no other changes along with the diet... no parenting changes, etc. Within 2 days on the diet he is COMPLETELY rid of all of those behaviors. He is now acting like a normal 3 year old! He can finally sit still long enough to eat a meal, and he is no longer violently attacking us for no reason. We have yet to reintroduce the salicylates to see if any of them was the culprit, but I'm curious to see what reaction they will have on him. I've been truely amazed and blessed to have found this diet. All within a matter of 2 weeks I now have a boy who will listen to me when I'm talking to him, or sit through storytime (he could not do this before). Not to mention I'm not constantly worried that he's going to attack another child when we're out in public. Though I know nothing of the science behind the diet, or the research done on it, I know what worked for my son. I'd have to say that the Feingold diet truely did work for my child!

9:37 PM  

Post a Comment

<< Home