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The Appeal of Vaccine Treatments for Celiac Disease
Scott Adams posted an article in Diagnosis, Testing & Treatment
Celiac.com 12/21/2020 - Recent leaps in understanding the development of celiac disease have led efforts toward a new, non-dietary, vaccine therapy. A lifelong gluten-free diet remains the only treatment for celiac disease, but research shows that even the most diligent gluten-free dieters are likely to be exposed to gluten on a regular basis. This is part of the appeal of safe, effective non-dietary treatments for celiac disease. And adjunctive and/or vaccine therapy is one of those approaches. New therapies might focus on immune regulation by IL-10, as in vitro models of treated celiac patients show that external IL-10 can overwhelm the gliadin driven IFN-γ response in intestinal biopsies. But, even though people with active celiac disease show high levels of anti-inflammatory IL-10 it's not enough to suppress the overwhelming Th1-mediated response. However, vaccination with gluten might trigger the extension of regulatory T cells, which could restore oral tolerance to gluten. It remains to be seen whether these approaches can strongly decrease the inflammatory intestinal response in celiac disease. A few experimental clinical trial studies have been run, though only one trial has used concurrent gliadin-based immunotherapy; that study is numbered NCT00879749 using the ClinicalTrials.gov Identifier. One recent study indicated a safety evaluation and estimates an inducible immune response by intradermal injections of Nexvax2 in treated celiac patients, which is specific to HLA-DQ2 patients. That vaccine contains three gluten peptides established by ImmunsanT for the treatment of celiac disease. These epitopes are responsible for the various immune responses by isolated T cells. A phase I in 40 HLA-DQ2+ celiac disease patients, using subcutaneous doses, showed no clinically applicable harmful effects. So far, however, few experimental therapies have been emerged as new targets for celiac disease in phase I–II trials and larger randomized controlled trials. Any suitable unique therapy needs to be harmless, operative and inexpensive. This invites further examination into the development of a new non-dietary treatment for celiac disease patients. Read the full paper by Mohammad Rostami Nejad of the Celiac Disease Department, Gastroenterology and Liver Diseases Research Center at Shahid Beheshti University of Medical Sciences in Tehran, Iran in the International Journal of Celiac Disease, 2015, Vol. 3, No. 4, 115-117.- 4 comments
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A team of researchers recently took a look at how well the hepatitis B vaccine protected people with celiac disease over time. Specifically, they evaluated what is called long-term antibody persistence and immune memory to hepatitis B virus in adult celiac patients vaccinated as adolescents. The research team included F. Zingone, F. Morisco, A. Zanetti, L. Romanò, G. Portella, P. Capone, P. Andreozzi, R. Tortora, and C.Ciacci. They are affiliated with the Department of Clinical and Experimental Medicine of Federico II University of Naples in Italy. They set out to investigate the anti-HBs antibody persistence and immune memory to hepatitis B virus in adult celiacs vaccinated as adolescents, along with the effects of a booster administration in non-protected individuals. They found that, eleven years after receiving the initial vaccine dose, the percentage of vaccinees with blood levels ≥ 10 mIU/ml and antibody geometric mean concentrations (GMCs) were lower among celiac patients than among control subjects (68.6% vs 91.7%, p Patients with anti-HBs below 10 mIU/ml received a booster dose and were retested after two weeks to measure response levels. Post-booster anti-HBs levels were still The study shows that, compared with healthy control subjects, people with celiac disease have lower seroprotective levels of anti-HBs eleven years after main vaccination, in addition to having a substantially lower response rate to a booster dose of the hepatitis B vaccine. Do you have celiac disease? Have you had a hepatitis B vaccine? Have you had trouble getting proper immunity levels with the hepatitis B vaccine? Is this news to you? Share your comments below. Source: Vaccine. 2011 Jan 29;29(5):1005-8. doi: 10.1016/j.vaccine.2010.11.060.
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Celiac.com 08/25/2011 - This is a controversial topic. Elizabeth Hasselbeck’s book, The gluten-free Diet (1), has been attacked because it suggests that a gluten free diet can help some people lose weight. One celiac support group has condemned this book as misleading (2). However, I thought it was a pretty good book, and I’m grateful for the public attention that Hasselbeck has drawn to celiac disease and non-celiac gluten sensitivity. There are at least two sides to the question of whether a gluten free diet is useful for weight loss. As with much other dietary advice, each of these conflicting views is sometimes presented in very strident voices. On one side there are numerous websites and newspaper articles, with an array of “experts” weighing in on this issue, decrying the use of a gluten free diet for weight loss. I even saw a segment of a television show called “Dr. Oz” where the gluten free diet was asserted to cause only weight gain. On the same show the diet was referred to as a “fraud” with respect to weight loss. Similarly, one group of researchers claim that an important side effect of the gluten free diet is weight gain. Even some very popular advocates of the gluten free diet insist that it is inappropriate for weight loss. Yet there are some individuals who advocate this diet as an effective weight loss tool and there is some evidence to back them up. There are even a couple of research reports of weight loss on a gluten free diet. In fact there is at least one study that provides some support for each paradigm. So who are we to believe? What information supports each side of the argument? And how can we evaluate that information? Before we get to the evidence, however, I’d like to say that I have listened to Ms. Hasselbeck express some of her political and economic opinions. I am now of the firm belief that she is one of the five people on this continent who may know even less about these issues than I do. So let’s leave out the politics and confine our discussion to the issue of the gluten free diet and whether it is suitable for weight loss. The first and most compelling piece of evidence (for me) is a personal observation. I watched my mom try to lose weight, starting when I was in elementary school. She tried just about every diet out there, from radical fringe to mainstream. She drank protein powders mixed with water instead of eating meals. She tried eating these “rye” crackers that I thought tasted like cardboard.... very crunchy cardboard. She tried a low sodium diet, then a low fat diet, then a sugar free diet, an all fruit diet, a raw food diet, or maybe that was just a single diet of raw fruit. I’m not sure. She probably tried a host of other diets that I don’t remember, but I think you get the idea. She sometimes lost weight only to gain it back as soon as she stopped the diet. More often, she gave up because she got tired of being hungry all the time. She eventually gave up on dieting altogether and accepted being overweight. Then, about fifteen years ago, in her early-mid 70s, she started a gluten free diet. It wasn’t aimed at weight loss. She was trying to reduce the pain caused by her arthritis. In the first year and a half or two years, she lost 66 pounds. From that time onward, her weight continued to gradually diminish to the point where she had lost about 100 pounds over about ten years of eating gluten free. She was not trying to lose weight. She had long since given up on that objective. Yet the excess pounds just melted away. If only because of its weight loss benefits, I suspect that the gluten free diet has extended her life substantially. At about 85 years of age, she started eating gluten occasionally. Part of her gluten consumption is wilful. She sees something that she thinks she might enjoy eating, and she requests a serving. Perhaps because of mom’s lapses into gluten, the staff at the home where she now lives have also become quite cavalier about her gluten free diet. They frequently serve her dishes that contain gluten. Still, her weight has remained fairly stable. My mom is not the only example of weight loss on a gluten free diet. There are other stories on the Internet. Just Google “gluten free weight loss diet” and you will see what I mean. But I can’t vouch for those stories. I didn’t observe their weight loss. All I saw was my mom’s. Currently, there are only a few formal studies that have explored body mass changes on a gluten free diet. One conducted in Ireland reveals that there are eight times as many overweight celiacs as underweight celiacs (Dickey & Kearney). That is quite surprising in light of the common perspective that celiac disease is one of under-nutrition, suggesting that underweight should be a more likely sign of celiac disease. For a long time, that was the dominant belief, but there is clearly a flaw in this paradigm. Suspecting celiac disease only in underweight patients is not the only complication of this issue. Dickey and Kearney also report that after two years of dietary compliance, eighty two percent of their 143 overweight and obese patients with celiac disease had gained yet more weight on a gluten free diet. This would seem to suggest that the gluten free diet is not a good bet as a weight loss tool. However, these results do not seem to have been replicated by other investigators. Another follow-up study, conducted in New Rochelle, NY, reports that ’’ 66% of those who were underweight gained weight, whereas 54% of overweight and 47% of obese patients lost weight’’ on a gluten free diet (Cheng et al ). Thus, on this side of the Atlantic, of the eighty one overweight and obese celiac subjects, about half lost weight following a gluten free diet. That is quite different from the findings in Ireland. Another, much smaller study of childhood celiac disease revealed that about half of the eight overweight children they studied also experienced weight loss (Venkatasubramani et al ). This research was conducted in Milwaukee and is congruent with the findings from New Rochelle. So, on this side of the Atlantic, about half of the overweight celiac patients studied experienced weight loss on a gluten free diet. Perhaps these differences are the result of variations between the versions of the gluten free diet in North America, as compared with the diet in the United Kingdom. The primary difference I am aware of is that gluten free in the UK includes wheat starch whereas most American organizations do not accept wheat starch as gluten free. However, the gluten free diet that includes wheat starch has been shown to reduce cancer risk and many other celiac-associated risk factors, and has therefore been deemed safe. Nonetheless, that same wheat starch may be a factor in the different body mass findings between Ireland and the USA. Or maybe the difference lies in variations in research methods. Without further research, it is difficult to guess.... and that is exactly what we would be doing. Without solid evidence, our beliefs are no more than just guesses. For instance, my mom’s weight loss could have been the result of some factor other than her gluten free diet. Perhaps the beginning of her weight loss just happened to coincide with when she started the gluten-free diet. I’m convinced by my observations of her experience, but that doesn’t mean that you should be. After all, I could be kidding myself. Or her weight loss could have been caused by some other factor that I’m not even aware of or recognizing. That is why many of us contribute our hard-earned dollars to research. We need something more than stories about my mom’s experiences. We need solid, peer reviewed research such as what is found in medical journals. However, even there we need to be cautious about reported findings. One good indicator that researchers are on the right track is when we see a convergence of results from very different studies. When one study produces a given result, and another study produces a similar result despite very different study designs and objectives, the results of the first study are said to have been replicated by the second study. The advantage, in the case of celiac patients experiencing weight loss following institution of a gluten free diet clearly goes to the two studies conducted in the USA. The studies looked at two different sub-populations of celiac patients yet produced approximately the same results. But both studies still have a problem with selection bias. One of the greatest difficulties in assessing research findings is that we are really just assuming that what we see in one or two small groups will be reflected in the general population. This is why, where possible, study subjects are picked randomly from the general population. However, this cannot happen in studies of celiac patients. They are a select group. This is partly because these subjects have celiac disease and partly because they have a diagnosis of celiac disease. I’m really not splitting hairs here. Please bear with me for a moment as I try to explain this important distinction. Unlike more than 95% of Americans with celiac disease, these study subjects have a diagnosis. And don’t be fooled. Clinicians are missing almost as many cases of celiac disease in Europe as they are in the USA. Thus, all three of these studies are looking at a sub-group (diagnosed with celiac disease) of a select group (celiac disease). And the lengthy delays to diagnosis, somewhere between five and eleven years, also occur in Europe and Canada, so the difference is probably not dependent on whether there is a socialist medical system in place, as some have suggested. The select group is formed by people with celiac disease. The sub-group is people drawn from the three to five percent of those who have been diagnosed with celiac disease. We know some of the ways that those with celiac disease differ from the general population. But we don’t know any of the ways, beyond the diagnostic criteria, that people with undiagnosed celiac disease differ from the general population or from the population of people whose celiac disease has been diagnosed. Studying a small sub-group of celiac patients who have a diagnosis, then assuming that the features observed will be present in all those with celiac disease, whether they have a diagnosis or not, is a flawed approach. Statisticians call this mistake ‘selection bias’. It is a well recognized type of statistical error. For instance, if you wanted to predict the buying habits of people living in Pennsylvania, you would not just observe members of the Amish community. Doing so would not only induce a selection bias, it would lead to very misleading information about the general population of Pennsylvania. While many Amish live in Pennsylvania, their buying habits probably do not reflect the buying habits of most people in Pennsylvania. Similarly, the selection bias driven by extrapolating from observations of sub-groups of people with diagnosed celiac disease and applying those principles to undiagnosed celiacs, leading us to either assume that weight loss will or will not occur on a gluten free diet is mistaken and likely to produce misleading information. In addition to selection bias, sample size is another important factor in predicting features of a larger population based on observations of a sub-population. The smaller the group, the less likely it is to reflect the variations present in the larger population of those with celiac disease. For instance, if the US population is currently about 311 million, and the rate of celiac disease is about one in every 133 people, then there should be about 2.3 million Americans with celiac disease. Only three to five percent of Americans with celiac disease are thought to be diagnosed with celiac disease. And the studies of overweight celiacs who gained or lost weight on a gluten free diet include about 89 Americans and 143 Irish people. Is it credible to imagine that we can predict the responses of 2.3 million Americans based on observations of a sub-group of 89 of their compatriots and 143 Europeans? I think that most readers will agree that leaping to such conclusions is unreasonable. Yet that is what we do if we insist on the exclusive correctness of either side of the question of whether the gluten free diet is an effective weight loss tool. I am convinced, both by my observations of my mom, and by the results of these two small studies, that some celiacs will lose weight on a gluten free diet. However, I would not presume to insist that it is the best, or even a good tool for all overweight celiacs. Neither would I insist it was a good weight loss tool for all diagnosed overweight celiacs. Given the US studies, that is clearly not the case. Equally, denial of anecdotal reports or the two US studies claiming that the gluten free diet is not an effective weight loss tool for anyone is also unreasonable. We can only say, with confidence, that these study results may apply to those who are diagnosed with celiac disease. Yet we have a fairly even split, with American researchers showing that about half of overweight celiacs lose weight on a gluten free diet, and Irish researchers asserting that eighty two diagnosed overweight celiacs gained even more weight on a gluten free diet. Yet these statistical problems are not insurmountable. If a group of researchers conducted random screening blood tests for celiac disease in a variety of settings and circumstances, confirmed the celiac diagnosis in a large group of these individuals, and followed up with those who were overweight and undertook the gluten free diet, then their observations might reasonably be applied to the celiac population in general, whether diagnosed or undiagnosed. There would still be a relatively minor statistical error induced by cases of sero-negative celiac disease, but the statistical problems would not be anywhere near as problematic as asserting that any or all of these three studies tell us much about weight loss on a gluten free diet, except that it sometimes happens in small sub-groups of diagnosed celiac patients. Since such research has not been conducted, it behooves all of us to take a moderate stance on either side of this debate. That does not mean that we can’t or shouldn’t make use of the available information. Each of us can draw our own conclusions based on our interpretations of the available data. If you believe that, in North America, a gluten free diet can induce weight loss in about half of overweight, newly diagnosed celiac patients, it does seem reasonable to suggest that the gluten free diet may be all that is needed for some diagnosed celiacs to lose weight. However, since we are missing more than 95% of cases of celiac disease, it is difficult to say whether it will help those undiagnosed, overweight celiacs to lose weight. Nonetheless, it is possible. Thus, if it will help some, perhaps about half of them to lose weight, those individuals might well consider this information, limited though it may be, very valuable. Anecdotal reports, such as my mother’s story, might also be considered very valuable by those who can lose weight on a gluten free diet. For those who do not lose weight on this diet, I suspect that many of them have walked the path my mother did, and it won’t be the first time that a diet failed to work for them. This, of course, raises the question of why some individuals and organizations have vigorously opposed and decried anecdotal claims that a gluten free diet may help some people lose weight. Clearly, there is hard scientific evidence to support this claim. The reverse is not the case. Nobody has, or can, prove that the gluten free diet is always ineffective at helping people lose weight. Meanwhile, we can hope for more research that will answer some of the many questions that arise from this relatively new information that there may be many more overweight people with celiac disease than there are underweight people with celiac disease. Several of the questions that remain include: What causes overweight and obesity in patients with celiac disease? It is, after all, a disease that is characterized by inadequate absorption of nutrients from the food that passes through the gastrointestinal tract. I have previously suggested that specific nutrient deficiencies may induce food cravings that cause some to continue to eat despite feeling ’’full’’ because their bodies continue to demand these missing nutrients. The new field of metabonomic research may soon shed more light on this area. It has already demonstrated that subjects diagnosed with celiac disease are not as efficient at metabolizing glucose (usually derived from carbohydrates) as those without celiac disease. Does wheat starch have any impact on nutrient absorption or appetite? If even small amounts of opioid peptides survive in wheat starch and are allowed access to the bloodstream and brain, they may well have an impact on appetite. Opioids or some other component of wheat starch might also alter ghrelin (a hormone that incites appetite) and/or leptin (a hormone that suppresses appetite). We just don’t know. Are there other dietary differences between Ireland and the USA? We are aware of the difference in wheat starch, but what other factors might contribute to these divergent research results? How does wheat starch compare with the 20 parts per million currently being put forward as the labelling standard for American legislation in the offing? Does wheat starch contain 20 ppm? Will the legislation in question change conditions for celiac patients? Just how much contamination from gluten grains is present in commercial oats? Even in the absence of contamination, how many people with diagnosed celiac disease experience cross-reactions with oats? This is where the selective antibodies are sensitized to protein segments found in oats as well as in gluten grains. What other differences between Ireland and the USA might explain these variations in research findings? Could variations in sunlight, or water-borne minerals, or even genetics contribute to the difference in findings? How representative are these groups of other groups of celiac patients? Do they reflect what is going on among all the other diagnosed celiacs in their region? And how do these findings apply to the undiagnosed celiacs? Is region a genuine factor in all of this? I remember when many researchers were quite willing to believe that there was some difference that had Italy showing a rate of celiac disease of one in 250 while in the USA and Canada it was thought to afflict about one in twelve thousand. We now know that was silly, but at the time, there were a lot of apparently intelligent people who were vigorously asserting the accuracy of those variations and postulating many creative explanations for them. I remember one, now prominent celiac researcher, admonishing me not to take the Italian findings too seriously. He was very confident that they represented a large overestimation of the true incidence of celiac disease in Italy and could not reasonably be suggested as reflecting anything about Canada or the USA. Now here is a really startling thought. Some of the overweight people with non-celiac gluten sensitivity might also be able to lose weight on a gluten free diet. If so, this could produce as much as a ten-fold increase in the number of people who might lose weight on our diet. Has anyone tested obese and overweight people for anti-gliadin antibodies? Could gliadin be a factor in some peoples’ weight problems? I wonder how many people might be helped to lose weight if pre-conceived notions about the gluten free diet could be relinquished in favour of a more open minded view.... one that recognizes that there is some evidence that some people can and do lose weight on a gluten free diet? The dogmatic certitude that abounds on the question of weight loss through the gluten free diet is profound and disturbing. As is pointed out by nutritionist, Brian Dean, in his article on gluten and heart disease in this issue of The Journal of Gluten Sensitivity, one long-standing dietary sacred cow has been killed. We now know that eating saturated fats is not a causal factor in heart disease. Equally, the emerging sacred cow that a gluten-free diet is not appropriate for weight loss is, as yet, supported only by flimsy evidence, all of which is contradicted by other research. So let’s avoid making rigid pronouncements about the gluten free diet until we have a better understanding of the complex and perplexing causes of obesity and overweight in the context of untreated celiac disease. And please, let’s remember that some people can and do lose weight on a gluten-free diet alone. My mother is an excellent but by no means unique example. Others have similar stories. My own experience on the diet was weight gain, and now I have to work at keeping from gaining any more. Only those who know all there is to know should speak in absolutes. The rest of us should constrain ourselves to offering opinions and perspectives. Sources: Hasselbeck E, The Gluten-Free Diet: A Gluten-Free Survival Guide. Center Street- Hatchette Book Group, NY, 2009. http://glutenfreegoddess.blogspot.com/2009/05/gluten-free-diet-opinion-from-elaine-monarch.html Dickey W, Kearney N. Overweight in celiac disease: prevalence, clinical characteristics, and effect of a gluten-free diet. Am J Gastroenterol. 2006 Oct;101(10):2356-9. Cheng J, Brar PS, Lee AR, Green PH. Body mass index in celiac disease: beneficial effect of a gluten-free diet. J Clin Gastroenterol. 2010 Apr;44(4):267-71. Venkatasubramani N, Telega G, Werlin SL. Obesity in pediatric celiac disease. J Pediatr Gastroenterol Nutr. 2010 Sep;51(3):295-7.
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Celiac.com 12/13/2010 - Driven by the high prevalence of celiac disease, a team of researchers based in Italy to assess a new, noninvasive disease screening strategy that would allow them to make an early diagnosis of celiac disease in 6- to 8-year-old children. Timely diagnosis will help doctors to initiate a gluten-free diet in willing patients, achieve growth targets, and prevent celiac disease complications. For the study, the research team recruited 5000 subjects, and ultimately tested 4048 saliva samples for anti-tissue transglutaminase (tTG) and immunoglobulin (Ig)A using fluid-phase radioimmunoprecipitation. For children with positive samples, the team arranged follow-up screening by serum radioimmunoassay tTG IgA, enzyme-linked immunosorbent assay tTG IgA, and anti-endomysium IgA. Children with positive serum assays underwent endoscopy with duodenal biopsies, and researchers advised those diagnosed with celiac disease to start a gluten-free diet. The team gained screening consent from 4242 parents (84.8%), and obtained usable saliva samples from a total of 4048 children (95.4%). Thirty-two children showed positive salivary tTG IgA, with another nine showing borderline autoantibody results. Thirty-one of the 32 tTG IgA-positive subjects, and three of the nine borderline subjects also had positive blood screens. Intestinal biopsy showed twenty-eight children with villous atrophy, while one child showed Marsh 1 lesions. The research team recommended a gluten-free diet to three children without performing endoscopy. This makes for a celiac disease rate of 1.16% in the study population, including 19 known cases of celiac disease. The results show that screening detected three cases of celiac disease for every two cases diagnosed before screening was 3:2. The ratio between symptomatic and asymptomatic patients was 1:1.6. The study shows that saliva screens for celiac disease can be effective in identifying celiac disease early in childhood. Also, for this study at least, the data shows full compliance with gluten-free diet in the children diagnosed with celiac disease. Source: Journal of Pediatric Gastroenterology & Nutrition 3 November 2010. doi: 10.1097/MPG.0b013e3181e6f2d0
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Celiac.com 04/11/2012 - Studies on the gluten-free and/or casein-free (Gluten-free Casein-free) dietary intervention for children with autism spectrum disorders (ASDs) suggest that some children may positively respond to implementation of the dietary intervention. Other studies support the idea of using various factors, including gastrointestinal (GI) abnormalities and immune function to classify children diagnosed with ASDs Medical researchers Christine M. Pennesi, and Laura Cousino recently examined the effectiveness of the gluten-free, casein-free diet for children diagnosed with autism spectrum disorder. They are affiliated with the Department of Biobehavioral Health at the Pennsylvania State University in Pennsylvania, USA. For their study, Pennesi and Cousino presented a 90-question online survey to parents or primary caregivers of children diagnosed with ASD. The survey asked about the efficacy of the Gluten-free Casein-free diet. The survey included questions about the children's GI symptoms, food allergy diagnoses, and suspected food sensitivities, as well as the degree and length of their dietary regime. In all, they received 387 responses. Parents who reported GI symptoms, food allergy diagnoses, and suspected food sensitivities also reported greater improvement in ASD behaviors, physiological symptoms, and social behaviors, compared with parents who reported symptoms, diagnoses, or sensitivities in their children (P < 0.05). Parents who reported strict diet adherence, full gluten/casein elimination and infrequent diet errors during and outside of parental care, also reported improvement in ASD behaviors, physiological symptoms, and social behaviors, compared with parents who reported less strict adherence, incomplete gluten/casein elimination, and more frequent diet errors during and outside of parental care (P < 0.05). The full report appears in Nutritional Neuroscience. There, the authors write that findings suggest that diet adherence and GI and immune factors may help to differentiate diet responders from diet non-responders. They also suggest that the findings support the importance of further investigations into the various factors that influence efficacy of treatment in children with ASDs. Source: Nutritional Neuroscience
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Celiac.com 07/12/2010 - Celiac disease was at one time considered a rare disease. However, celiac is now gaining notoriety as a common genetic autoimmune disease that affects approximately 1% of Western countries. As the celiac epidemic starts to rise, the costs of medical diagnosis and treatments for celiac disease are now being scrutinized. The study, approved by the Mayo Clinic and Olmsted Medical Center Institutional Review Boards, involved a group of doctors and researchers who compared population-based administrative data of celiac cases and matched controls from Olmsted County, Minnesota in an effort to evaluate: “direct medical costs 1 year pre- and post- celiac disease diagnosis for 133 index cases” and to compare 4-year cumulative direct medical costs incurred by 153 index cases against 153 controls. Total analysis excluded any diagnostic-related and outpatient pharmaceutical costs. The impacts of diagnostic costs for celiac disease were determined by comparing the costs accrued one year before and one year after receiving a positive celiac diagnosis. Services and costs were identified as related to the celiac diagnosis and included serological testing, endoscopy, surgical pathology and consultation and bone densitometry. One-hundred and fifty-three celiac patients and one-hundred and fifty-three matched controls were evaluated for medical costs that were associated with celiac disease over a four-year observation period. During that four-year period, total cumulative medical costs were observed for those patients with celiac disease. Following a celiac diagnosis, total direct medical costs were decreased by an average of $2,118 per year. Average costs decreased by $1,764, and over a 4-year period, celiac patients experienced higher outpatient costs and higher total costs when compared to the controls. Total excess costs were more significantly concentrated among celiac males. From this study, scientists were able to conclude that associated celiac disease costs indicate a profound economic burden specifically for males with celiac disease. Accurate diagnosis of celiac disease and appropriate treatments for celiac significantly reduces direct medical care costs. From this, it is evident that there is an economic advantage to early diagnosis of celiac disease. Source: Ailment Pharmacol Ther. 2010 Apr 8
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Celiac.com 12/22/2010 - A recent evaluation of the safety and efficacy of small intestinal release mesalamine (SIRM) for symptom relief in refractory celiac disease (RCD) shows that SIRM seems to be a safe and effective treatment option, though larger tests are needed to know for certain. The research team conducting the evaluation included Shailaja Jamma, MD, Daniel A. Leffler, MD, Melinda Dennis, RD, Robert M. Najarian, MD, Detlef B. Schuppan, MD, Sunil Sheth, MD, and Ciaran P. Kelly, MD, They set out to evaluate the safety and efficacy of small intestinal release mesalamine (SIRM) for symptom relief in refractory celiac disease. There are currently no adequate clinical therapies for patients with refractory celiac disease and corticosteroid and/or immunosuppressants treatments are of limited use due to side effects. SIRM has been shown to reduce local inflammation, and it is well tolerated. For the study, the team looked at records of the refractory celiac disease patients who received SIRM in an open-label therapeutic trial. Data included patient demographics, disease characteristics, dose and duration of SIRM therapy, and patient response. The team then categorized each response as complete, if symptoms resolved completely, partial if symptoms improved at least 50%, and non-responsive if symptoms improved less than 50%. The team treated four patients with SIRM alone and six patients with a combination of SIRM and oral budesonide. After four weeks, half of the patients showed complete response, while 10% showed a partial response. Two of the six patients were able to discontinue budesonide. One patient discontinued SIRM after complaining of headaches. These initial results indicate that SIRM seems to be a safe and efficacious treatment option in patients with refractory celiac disease, though a larger, more comprehensive study is needed to confirm these results. Source: J Clin Gastroenterol 2010 Sep 24. doi: 10.1097/MCG.0b013e3181f42401
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Celiac.com 05/04/2010 - A team of clinicians recently set out to assess the effectiveness of treating collagenous sprue with a combination of gluten-free diet and steroids. The team was made up of Alberto Rubio-Tapia, Nicholas J. Talley, Suryakanth R. Gurudu, Tsung-Teh Wu, and Joseph A. Murray. They are affiliated variously with the Division of Gastroenterology and Hepatology of the Mayo Clinics in Scottsdale, Arizona, Jacksonville, Florida, and Rochester, Minnesota, and the Division of Anatomic Pathology in Rochester Mayo Clinic. Deposits of subepithelial collagen that form a distinctive band in the small bowel are one of the clinical hallmarks of collagenous sprue. For the study, the team evaluated clinical characteristics, treatments, and outcomes of patients with collagenous sprue. The team looked at medical records for thirty patients with collagenous sprue from the Mayo Clinics from Scottsdale, Jacksonville, and Rochester, for the periods covering 1993 and 2009. 21 of the patients were female (70%), ranging in age from 53–91 years. The majority of patients suffered from severe diarrhea and weight loss. However, collagenous spore is commonly associated with collagen deposits or chronic inflammation in other parts of the gastrointestinal tract, as well as other immune-mediated disorders. 16 patients (53%) were hospitalized to treat dehydration, while 21 patients (70%) suffered from associated immune-mediated diseases, the most common of which was celiac disease. Other common associated diseases included microscopic colitis, hypothyroidism, and autoimmune enteropathy. Subjects showed subepithelial layers of collagen deposits in the small bowel ranging from 20 –56.5μm, and averaging 29 μm thickness. Eight patients showed subepithelial collagen deposits in the colon or stomach. 24 patients (80%) showed a positive clinical response to treatment with a combination of a gluten-free diet and immunosuppressive drugs. Nine patients showed confirmed histologic improvement, while five patients experienced complete remission. Of two patients who died, one succumbed to complications from collagenous sprue, while one died of another illness. Most patients with collagenous sprue show a positive clinical response to a combination of gluten-free diet and steroids. Source: Clinical Gastroenterology and Hepatology 2010;8:344–349. doi:10.1016/j.cgh.2009.12.023
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Celiac Disease Mass Screening May be Cost Effective
Destiny Stone posted an article in Additional Concerns
Celiac.com 04/21/2010 - Due to the overwhelming number of ways celiac disease can manifest, it is often misdiagnosed by health care professionals. Celiac disease is also commonly diagnosed later in life, resulting in an increase in celiac patient's morbidity and mortality. As such, it has been suggested that early screening of celiac disease is an effective way to eliminate misdiagnosis, and can also minimize symptoms and complications that often manifest as a result of misdiagnosed or undiagnosed celiac disease. To determine the cost effectiveness of early screening for celiac disease, a group of researchers at the Hadassah-Hebrew University Medical Center, Jerusalem developed a state transition Markov model using information that was collected from previous studies of celiac. The model they used, was geared toward defining the parameters that have the greatest impact on the cost-effectiveness of mass screening for celiac disease. The Markov model examined a celiac disease screening program of healthy young-adults in the general population compared with no-screening. The results of the study indicated a gain of 0.0027 quality-adjusted life years (QALY). The cost effectiveness ratio of screening the young adults, versus no screening for celiac at all was $48,000 per QALY. The variables that had the greatest impact on cost-effectiveness were, the time delay from symptom onset to diagnosis, the strict adherence to a gluten-free diet, and the generality of celiac disease. This study determined that celiac screening would be cost effective if the time delay to diagnose is longer than 6 years, and adherence to a gluten-free diet is greater than 0.978. Additionally, the Markov model indicates that mass screening for celiac disease among the young adult general population is associated with improved QALY's and is also a cost effective strategy. However, the authors of the study also state that shortening the time-delay to diagnosis through heightened education and awareness of health-care professionals, may be a legitimate alternative to celiac screening in general. Source: Aliment Pharmacol Ther 31, 901–910-
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Aliment Pharmacol Ther 19(11):1199-1210, 2004. Celiac.com 06/08/2004 - Researchers at the University of California, San Francisco have determined that everyone with Irritable Bowel Syndrome (IBS) should also be screened for celiac disease. The researchers used decision analysis to estimate the number of celiac disease cases detected, quality-adjusted life-years gained, and costs resulting from screening suspected IBS patients for tissue transglutaminase antibody and antibody panel. Positive tests were followed up with an endoscopic biopsy. A gluten-free diet was initiated to improve the quality of life in those with celiac disease. The results of this study indicate that 3% of the 1,000 patients with suspected IBS have celiac disease. Based on these results the researchers analyzed the costs of several celiac disease screening methods used a decision analysis formula to determine whether or not the screening is cost effective. The researchers conclude that celiac disease screening in patients with suspected irritable bowel syndrome is likely to be cost-effective even at a relatively low celiac disease prevalence. Perhaps the researchers should have taken their analysis one step further and concluded that it would make good economic sense to screen the entire population of the USA (as well as that of other countries) for celiac disease, rather than just those with IBS, given the fact that it affects approximately 1% of the population--which is the only conclusion that I could reach after my review of their good work. -Scott Adams
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Celiac.com 09/10/2007 - A study published recently in the journal of Alimentary Pharmacology and Therapeutics shows that the paracellular permeability inhibitor AT-1001 effectively reduces intestinal barrier dysfunction, proinflammatory cytokine production, and gastrointestinal symptoms in people who have celiac disease. At present, a lifetime devoted to following a strict gluten-free diet is the backbone of current treatment for celiac disease. However, as researchers have come to know more about celiac disease, they’re insights are leading to developments that offer more effective prognosis and treatment of the disease. One of those promising new approaches involves treating celiac patients with doses of AT-1001, a paracellular permeability inhibitor that is structurally derived from a protein secreted by Vibrio cholerae. Recently, a team of medical researchers set out to assess the safety and tolerability of 12 mg doses of AT-1001 in people with celiac disease who submitted to acute gluten exposure. For the in-patient, double-blind, randomized placebo-controlled safety study, researchers looked at twenty men and women with celiac disease and measured intestinal permeability, through fractional excretions of lactulose and mannitol, as an exploratory measure of the efficacy of AT-1001 in treating celiac disease. The test subjects were men and women with age ranging from 18 to 59 years old. Each was pre-screened and referred by a gastroenterologist. Each had positive biopsy and antibody screens that indicated celiac disease. Each had also been on a gluten-free diet at least six months, was not known to be IgA deficient, and presented with anti-tTG titres of <10 EU at enrollment. Study shows safety and tolerability of 12 mg doses of AT-1001 in celiac disease In the placebo group, acute gluten exposure brought an observable 70% increase in intestinal permeability, compared to no change at all in the AT-1001 group. Four of seven patients (57%) of the placebo group showed increased levels of Interferon-gamma levels, but in the AT-1001 group only four of 14 patients (29%) showed such increases. Also, the placebo group showed gastrointestinal symptoms more frequently than the AT-1001 group (P = 0.018). From the results, the researchers concluded that AT-1001 is well tolerated and appears to reduce intestinal barrier dysfunction, pro-inflammatory cytokine production, and gastrointestinal symptoms in celiac patients subjected to gluten exposure. Aliment Pharmacol Ther 26, 757-766 health writer who lives in San Francisco and is a frequent author of articles for Celiac.com.
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J Neurol Neurosurg Psychiatry. 2003;74:1225-1230 Celiac.com 10/08/2003 – According to a study done by Dr. Hadjivassiliou and colleagues at the Royal Hallamshire Hospital in Sheffield, U.K., a strict gluten-free diet is effective treatment for gluten ataxia. According to the Dr. Hadjivassiliou: Gluten ataxia is an immune mediated disease, part of the spectrum of gluten sensitivity, and accounts for up to 40% of cases of idiopathic sporadic ataxia, further: In some case reports, adherence to a gluten-free diet is assumed or based on improvement of gastrointestinal symptoms or on duodenal biopsy, without concurrent serological evidence of elimination of circulating antigliadin antibodies. No systematic study of the effect of a gluten-free diet on a cohort of patients presenting with neurological dysfunction with or without an enteropathy has yet been reported. Their study looked at 43 patients with gluten ataxia, 26 of whom adhered to a gluten-free diet for one year (14 patients refused the diet, and three were eliminated after testing positive antigliadin antibodies). After one year the group of 26 on the gluten-free diet showed significant improvement on ataxia tests compared with the gluten-eating group. The researchers conclude: Gluten ataxia responds to a strict gluten-free diet even in the absence of an enteropathy. The diagnosis of gluten ataxia is vital as it is one of the very few treatable causes of sporadic ataxia, further: The evidence that gluten ataxia is a manifestation of gluten sensitivity is now substantial and analogous to the example of dermatitis herpetiformis, from which it is apparent that the gut is not the sole protagonist in this disease."
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