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Celiac.com 05/29/2019 - Many practitioners of alternative medicine make marketing claims about diagnosis and treatment of celiac disease and non-celiac gluten sensitivity (NCGS) A team of researchers recently set out to assess the validity of marketing claims about diagnosis and treatment of celiac disease and non-celiac gluten sensitivity (NCGS) made by American chiropractors, naturopaths, homeopaths, acupuncturists, and integrative medicine practitioners. The research team included Graham Boyer; Timothy Caulfield, BSc, LLB, LLM; Peter H. R. Green, MD; and Benjamin Lebwohl, MD, MS. They are variously affiliated with the Department of Medicine, the Celiac Disease Center at Columbia University, New York, New York, USA; the Health Law Institute, University of Alberta, Edmonton, Alberta, Canada; and the Department of Epidemiology, Mailman School of Public Health, Columbia University, New York, New York, USA. The team conducted a cross-sectional analysis of practitioner websites in ten US cities, looking for any mention of celiac or NCGS as well as specific claims of ability to diagnose, ability to treat, and treatment efficacy. The team then classified promoted treatments as true, false, or unproven, as assessed independently by two researchers. Out of 500 clinics identified by the team, 178 (35.6%) made a claim regarding celiac disease, NCGS, or a gluten-free diet. Websites for Naturopathic clinics showed the highest rates of advertising for diagnosis, treatment, or efficacy for celiac disease (40%), followed by integrative medicine clinics (36%), homeopaths (20%), acupuncturists (14%), and chiropractors (12%). Integrative medicine clinics showed the highest rates of advertising for diagnosis, treatment, or efficacy for NCGS (45%), followed by naturopaths (37%), homeopaths (14%), chiropractors (14%), and acupuncturists (10%). They found no real differences in marketing rates from city to city. The team notes that, 138 of 232 marketing claims made by these complementary and alternative medicine (CAM) clinic websites were either false or unproven, that's nearly 60%. However, the figure may be misleading. It is unclear why the abstract for the paper lumps together false claims with unproven claims, when the study clearly created separate categories and data for each. It gives the impression of some sleight of hand. How many were false, and how many were unproven. Remember false claims are almost always groundless, and have no basis in fact. Unproven claims may in fact prove to be true. There may be some basis or data to support unproven claims. That's not to say unproven claims are good, just that they are different from claims that are known to be false. By lumping together the numbers for false claims with those for unproven claims, and not clearly listing the data for each category in their abstract, the team does a disservice to their efforts, which is a pity, because the team's conclusions are sound: "A significant number of CAM clinics advertise diagnostic techniques or treatments for celiac disease or NCGS. Many claims are either false or unproven, thus warranting a need for increased regulation of CAM advertising to protect the public." Clearly better information and regulation of false or misleading advertising claims will be in the public's interest. However, so will more transparency in communication about the problem. Conflating data from separate categories may make for an alarming headline, but it doesn't tell the story accurately or clearly. Readers deserve to know the exact breakdown of false information compared to unproven information. That said, take advertising claims made by alternative health practitioners with a grain of salt. Do your research and know your facts. Read more in the American Journal of Gastroenterology: May 2019 - Volume 114 - Issue 5 - p 786–791 doi: 10.14309/ajg.0000000000000238
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Celiac.com 07/05/2016 - Principal Investigator: Amrit P.S. Narula M.D, F.A.C.P, F.A.C.G, F.A.C.N., A.G.A.F Study Coordinator: Alicia Mercuri, PA-C Background Research estimates that approximately 18 million Americans have gluten sensitivity. That is six times more than patients confirmed with celiac disease. Non-celiac gluten sensitivity is defined as those individuals who cannot tolerate gluten in the diet and experience the same symptoms attributed to celiac disease, but lack antibodies and intestinal damage as seen in celiac disease. A dietary supplement called ZyGluten was developed from in vitro studies, not in vivo. The primary aim in its development was a supplement which, if taken at the beginning of a meal, would hydrolyze gluten concentration in ingested food. Foods tested included McDonald's hamburger, white sliced bread, a plain bagel, macaroni and cheese, spaghetti, a muffin, and frozen pizza. The amount of gluten was measured at 0, 30 and 60 minutes after the introduction of ZyGluten. In all samples, gluten measured at the end of 60 minutes was less than 20 ppm. ZyGluten is a compound of amylases, proteases, and lipase enzymes with probiotics, specifically Lactococcus lactis and Lactococcus cremoris. It is derived from plant and microbial sources. Inclusion Criteria Ages 18-80 years Physician diagnosed gluten sensitivity by history and experienced symptoms of gluten sensitivity for at least 1 month prior to involvement Willing to take supplement twice daily for 2 weeks Sign informed consent Exclusion criteria Active Inflammatory Disease Celiac disease confirmed by antibodies and duodenal biopsy Peptic ulcer disease Lactose intolerance Pregnant or lactating women Received any experimental drug within 30 days of enrollment Methods 27 patients, all of whom met the inclusion criteria, were selected to take 2 capsules of ZyGlutens before 2 major meals of the day for 2 weeks. 23 patients were female and 4 were male, with ages ranging from 25-77. The following symptoms were assessed at baseline, week 1, and week 2 which was the conclusion of the study: Abdominal pain Diarrhea Constipation Headaches Joint pain Fatigue The severity of symptoms was measured as mild, moderate, or severe, and none if symptoms were absent. All patients were contacted by phone within 48 hours of start of the trial to assess for any adverse effects. Following parameters were checked at baseline, week 1, and week 2: Weight Height Blood pressure Pulse rate Respiration rate Patients were not charged or reimbursed for their participation in the study. Results The following number of patients (27) had these symptoms at baseline: None Mild Moderate Severe Abdominal Pain/Cramping 1 1 16 9 Bloating/Distention 0 3 9 15 Diarrhea 10 4 2 11 Constipation 16 2 3 6 Headaches 11 5 7 4 Joint Pains 12 2 9 4 Fatigue 3 4 5 15 The following number of patients (23) had these symptoms at week 1: None Mild Moderate Severe Abdominal pain/Cramping 10 7 4 2 Bloating/Distention 9 10 1 3 Diarrhea 16 5 2 0 Constipation 20 1 1 1 Headaches 17 2 3 1 Joint Pains 14 2 4 3 Fatigue 7 8 3 5 The following number of patients (23) had these symptoms at week 2: None Mild Moderate Severe Abdominal Pain/Cramping 15 4 2 2 Bloating/Distention 14 6 1 2 Diarrhea 21 1 1 0 Constipation 21 1 0 1 Headaches 16 5 1 1 Joint Pains 17 3 2 1 Fatigue 10 7 1 5 The following number of patients rated their symptom improvement as: No improvement: 0 Improved: 4 Markedly improved: 19 Adverse Effects No patients reported any adverse effects. Participants Twenty-seven participants were enrolled in the study. Two patients withdrew from the study; one of which had a scheduling conflict with follow-up visits and one stopped taking the medication due to increased sleepiness after two pills. Two patients were lost to follow-up. These four patients were excluded from analysis. Conclusion In conclusion, ZyGluten study is a 2 week open labeled trial. Our outcome so far has shown to be extremely efficacious with no significant side effects. There was no significant difference found in patients who complained of headaches or joint pain. The majority of the patients found significant improvement in their symptoms of abdominal pain, bloating, changes in bowel habits, and fatigue. In fact, 83% of patients rated that their symptoms markedly improved, and 17% rated an improvement in their symptoms. Patient Testimonials *The medication was known by patients as ‘Gluten Buster' during the clinical trial. "Medication has given me more freedom. I am no longer afraid to eat, especially away from home. I am very pleased with the medication".-MF "My symptoms have improved. I would like to keep taking this if I can, especially since it's natural, to see how long I can go without an endoscopy".-MH "I feel that this pill has made a tremendous improvement in my condition". –BW "Bloating is gone. Stools seem to be more formed. Feeling good". –PS "It's wonderful to not be limited in what I can eat. It's great not to have the symptoms of pain, etc. when eating gluten foods". –JH "Great for bloating".-JF "Very little of passing gas. I feel good". -PW "Bloating is a lot better". -LW "I have not had any cramping or urgency to have a BM after a meal. My bowel movements are now normal. I have had no GI distress since on the meds". –KY "Gluten Buster has been a miracle pill. After so many years of having bowel problems, I never knew what it was like to have a regular bowel movement. I have had no problems with digestive system since I starting taking these pills". -JM "Medication was very helpful". –KO "My experience with the Gluten Buster that Dr. Narula has given me to take has been simply amazing. It has made my quality of life so much better. He is an amazing doctor to help those that otherwise thought there was no hope! I feel great"!-CM "Seems a little bit better. Still have IBS. Still have a lot of gas and bloating."-AM "It has been helping to go to the bathroom. The weight is going up and the stomach is going down a little bit".-SH "Before taking the medicine, mornings were hard because of bloating and diarrhea. Now I feel great in the morning".-GK "Gluten Buster is a life changer. Will definitely go on it when available in market." -MC "It is helping with bloating and gas. Has improved all of my GI symptoms. Overall, I can eat anything, including French fries and food I could not eat before (Super Pill)". -MK "I feel it has improved. Still have bloating, but eating regular food. Diarrhea has improved, no pain in stomach or abdomen". -BS "I feel 10x better than I did before starting the medication. No stomach cramps of bloating, I only have a BM twice/day. Feel great!" -JB "I am doing 100% better now since I have been taking the Gluten Buster meds". - JZ "Passing more gas, feeling better". -ML "I'm feeling better. I'm eating anything I want, not sticking with gluten free food. If it's due to taking the Gluten Buster, then I would still take it". -BS "It has made a big difference in bloating and abdominal pain. I would like to continue taking it". -JP "My stomach feels fantastic when I take the product. This should be available for all people with gluten sensitivity. This would be a great idea for Shark Tank. It needs to be available to the masses! I don't know how my stomach will survive without it, especially at the holidays". -LT References Am J Gastroenterol. 2011 Mar;106(3):508-14; quiz 515. doi: 10.1038/ajg.2010.487. Epub 2011 Jan 11. Gluten causes gastrointestinal symptoms in subjects without celiac disease: a double-blind randomized placebo-controlled trial. Biesiekierski JR1, Newnham ED, Irving PM, Barrett JS, Haines M, Doecke JD, Shepherd SJ, Muir JG, Gibson PR. The Oslo definitions for celiac disease and related terms. Jonas F Ludvigsson,1,2 Daniel A Leffler,3 Julio C Bai,4 Federico Biagi,5 Alessio Fasano,6 Peter H R Green,7 Marios Hadjivassiliou,8 Katri Kaukinen,9 Ciaran P Kelly,3 Jonathan N Leonard,10 Knut Erik Aslaksen Lundin,11 Joseph A Murray,12 David S Sanders,13,14 Marjorie M Walker,14 Fabiana Zingone,15 Carolina Ciacci16 Food Allergy - An Overview (PDF|1 MB). DHHS. NIH. National Institute of Allergy and Infectious Diseases. Gastroenterol Hepatol. 2014 Jun-Jul;37(6):362-71. doi: 10.1016/j.gastrohep.2014.01.005. Epub 2014 Mar 22. [Non-celiac gluten sensitivity: a critical review of current evidence]. [Article in Spanish] Molina-Infante J1, Santolaria S2, Montoro M2, Esteve M3, Fernández-Bañares F3. Gluten Causes Gastrointestinal Symptoms in Subjects Without Celiac Disease: A Double-Blind Randomized Placebo-Controlled Trial. Jessica R Biesiekierski, Evan D Newnham, Peter M Irving, Jacqueline S Barrett, Melissa Haines, James D Doecke, Susan J Shepherd, Jane G Muir and Peter R Gibson. Nutrients. 2013 Sep 26;5(10):3839-53. doi: 10.3390/nu5103839. Non-Celiac Gluten sensitivity: the new frontier of gluten related disorders. Catassi C1, Bai JC, Bonaz B, Bouma G, Calabrò A, Carroccio A, Castillejo G, Ciacci C, Cristofori F, Dolinsek J, Francavilla R, Elli L, Green P, Holtmeier W, Koehler P, Koletzko S, Meinhold C, Sanders D, Schumann M, Schuppan D, Ullrich R, Vécsei A, Volta U, Zevallos V, Sapone A, Fasano A. BMC Med. 2014 May 23;12:86. doi: 10.1186/1741-7015-12-86. Non-celiac gluten sensitivity - why worry? Lundin KE. BMC Med. 2014 May 23;12:85. doi: 10.1186/1741-7015-12-85. An Italian prospective multicenter survey on patients suspected of having non-celiac gluten sensitivity. Volta U1, Bardella MT, Calabrò Neurogastroenterol Motil. 2013 Nov;25(11):864-71. doi: 10.1111/nmo.12216. Epub 2013 Aug 12. Non-celiac gluten sensitivity: clinical relevance and recommendations for future research. Mooney PD1, Aziz I, Sanders DS. World J Gastroenterol. 2014 Jul 21;20(27):8837-45. doi: 10.3748/wjg.v20.i27.8837. Irritable bowel syndrome and food interaction. Cuomo R, Andreozzi P, Zito FP, Passananti V, De Carlo G, Sarnelli G. Expert Rev Gastroenterol Hepatol. 2012;6(1):43-55. Problems of an Emerging Condition Separate From Celiac Disease. Amy C Brown Dig Dis Sci. 1999 Jul;44(7):1317-21. Pancreatic supplements reduce symptomatic response of healthy subjects to a high fat meal. Suarez F1, Levitt MD, Adshead J, Barkin JS.
Celiac.com 12/13/2011 - Alvine Pharmaceuticals, Inc. has announced that efficacy data from its Phase 2a clinical trial of ALV003 shows that oral ALV003, administered as part of a gluten free diet, reduced gluten-induced intestinal mucosal damage in people with well-controlled celiac disease. Alvine presented the study findings in a session of the 19th United European Gastroenterology Week (UEGW) in Stockholm. "These results are groundbreaking as they demonstrate for the first time, in a controlled clinical trial, that a drug has the potential to diminish gluten-induced injury in celiac disease patients," says Markku Maeki, M.D., chair and professor of pediatrics at the University of Tampere and Tampere University Hospital in Finland, and coordinating investigator of the ALV003 Phase 2a trial. Most people with celiac disease control their disease by following the gluten-free diet that is the only current treatment. Of those, many still suffer gluten-related discomfort and gut damage. In fact, Mr. Maeki adds, "up to 60 percent of adult celiac disease patients continue to experience symptoms and up to 80 percent continue to have persistent intestinal inflammation despite adhering to a strict gluten-free diet." Since gluten is so common in food processing, it's almost impossible to avoid ingesting tiny amounts of gluten, even for people with celiac disease. Gluten contamination commonly occurs via cross-contamination in the processing of food products, incorrect or inaccurate labeling, lack of dietary education and awareness, and even due to willful back-sliding on the part of otherwise faithful gluten-free dieters. According to Dr. Maeki, non-dietary treatment options that either eliminate, or significantly reduce gluten ingestion by those attempting a gluten-free diet are needed, "ecause it is all but impossible to avoid gluten, even while adhering to a gluten-free diet, celiac patients are at continued risk for gastrointestinal symptoms and potentially serious long-term medical consequences." The study is constructed as a double-blind, placebo-controlled Phase 2a clinical trial on 41 adults with well-documented celiac disease, who had followed on a gluten-free diet for one or more years. Study participants were randomly given ALV003 or a placebo each day for six weeks. At the same time, they were given 2g of gluten in the form of bread crumbs. Each member of the study received small bowel biopsy at the beginning of the trial, and then again after six weeks of daily gluten challenge. The study's primary endpoint was intestinal mucosal morphometry (villus height:Crypt depth)(or vh:celiac disease) measured at baseline and at six weeks. Secondary endpoints included intraepithelial lymphocyte (IEL) density (cells/mm), gastrointestinal symptoms as measured by Gastrointestinal Symptom Rating Scale (GSRS) scores, celiac serologies, safety and tolerability. The study was statistically powered for the primary endpoint of change in Vh:celiac disease with six weeks of gluten exposure. Results from 34 celiac disease patients eligible for analysis showed that after six weeks: -- Biopsy data demonstrated significantly less small intestinal mucosal injury as measured by Vh:celiac disease in patients treated with ALV003 than in placebo-treated patients (p=0.0133). -- IELs, including CD3+ and CD3+ alpha/beta and gamma/delta subsets, which measure inflammatory response, were essentially unchanged in the ALV003-treated patients but significantly increased in the placebo-treated patients. ------------------------------------------------------------------------ Change from Week 0 p value to Week 6 ------------------------------------------------------------------------ ALV003 (n=16) Placebo (n=18) ------------------------------------------------------------------------ Vh:celiac disease -0.2 -0.8 0.0133 ------------------------------------------------------------------------ CD3+ IELs +2.4 +30.8 0.0152 ------------------------------------------------------------------------ CD3 alpha/beta IELs -1.8 +24.2 0.003 ------------------------------------------------------------------------ CD3 gamma/delta IELs +0.5 +10.9 0.003 ------------------------------------------------------------------------ -- Overall GSRS scores and scores for indigestion and abdominal pain symptoms were lower in ALV003-treated patients than in placebo-treated patients, although the results were not statistically significant. -- No statistically significant changes were observed in celiac disease serology tests between the ALV003 and placebo-treated patients, although positive trends were observed for tissue transglutaminase (tTG) and deamidated gliadin peptide (DGP) antibodies in the ALV003-treated group, a measure of immune responsiveness. -- No serious adverse events were reported. Non-serious adverse events consistently occurred more frequently in the placebo-treated patients. Adverse events that occurred in 10 percent or more patients included abdominal distention, flatulence, eructation, abdominal pain and diarrhea. Source: http://www.marketwatch.com/story/alvine-pharmaceuticals-presents-additional-efficacy-data-from-phase-2a-trial-of-alv003-in-celiac-disease-patients-2011-10-24