# Food Intolerance Test Validated as a Treatment for IBS



## justwanttoteach (May 30, 2003)

Did anyone else see this out on the newswires today? - Martha===========================================Finger-Stick Test For Food Intolerance Validated as a Treatment for the Symptoms Associated With Irritable Bowel SyndromeHOLLYWOOD, Fla.--(BUSINESS WIRE)--May 29, 2003--The results of a recent independent clinical trial designed and conducted by University Hospital of South Manchester were unveiled on May 19, 2003 at Digestive Disease Week in Orlando, Florida, and offers hope to the many thousands of people suffering from IBS.According to Professor Trevor Sheldon, Department of Health Sciences, University of York: "This double-blind, placebo-controlled randomized trial of 150 patients suffering from IBS showed significant improvements for those who followed the dietary recommendations compared to those people who followed a sham diet. People, who acted upon the test results, significantly benefited. It proves that food elimination can improve symptoms of IBS."The study assessed the effectiveness of an exclusion diet based on the foodSCAN IgG ELISA Food Intolerance Test for the presence of IgG antibodies in patients with IBS. The results show that a true diet based on the foodSCAN test results was significantly superior to a placebo diet in reducing the severity of symptoms associated with IBS. The conclusion of the study is that a clinically significant improvement can be achieved in patients with IBS using a food elimination diet based on IgG food antibodies."This is the first time a commercially available blood test for food intolerance has been subjected to scientific scrutiny in patients with irritable bowel syndrome. In a controlled trial, patients eliminating foods to which they had antibodies as determined by Yorktest Laboratories experienced a significant improvement in their symptoms, providing evidence that this approach may be very valuable in treating this condition," Dr. PJ Whorwell, Consultant Gastroenterologist, University Hospital of South Manchester.Dietary intervention can significantly improve symptoms of patients suffering from IBS. By using the foodSCAN IgG ELISA Food Intolerance Test, removing the offending foods from the diet, together with nutritional and dietary support and advice offered by York Nutritional Laboratories, IBS patients can find symptomatic relief and increase their quality of life.For more information on the foodSCAN IgG ELISA Food Intolerance Test or the University Hospital of South Manchester's Double-Blind, Placebo-Controlled Study, contact John Kernohan, York Nutritional Laboratories Inc., 2700 North 29th Avenue, # 205, Hollywood, Florida 33020 USA, (888) 751-3388, info###yorkallergyusa.com, <http://www.yorkallergyusa.com.>


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## ohnometo (Sep 20, 2001)

Didnt see it but the food intolerance test I had with LEAP really helped me out a great deal...as long as I stick to the plan it works


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## alex36 (May 31, 2003)

I had the foodSCAN IGG test from York Labs performed and it was the answer to my years of suffering. All my IBS symptoms dissapeared completely for the first time ever about a week after removing the 7 foods identifed by the York test as me being allergic to. I tried all sorts of meds and even another lab's food test prior to having the test from York labs, but none of those treatments worked.alex


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## Julia37 (May 9, 2001)

The ELISA test mentioned here checks only for IgG cell reaction, which is the original definition of an allergy. That's fine as far as it goes, but there are several other immune system reactions to foods that do not involve the IgG cells, and this test won't find those. These reactions involve other immune cell reactions with symptoms similar to allergy.The LEAP blood test checks for non-IgG reactions to foods and common chemicals and medicines. That bit about "This is the first time a commercially available blood test for food intolerance has been subjected to scientific scrutiny in patients with irritable bowel syndrome" confuses me because my understanding is that the LEAP test was thoroughly tested and has been used to help hundreds (probably thousands by now) of people. Maybe they're referring only to England, where the LEAP test is not yet available.


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## alex36 (May 31, 2003)

i think what is being referred to is that apparently no other tests have been independently validated and studied in a non-commercial double-blind, placebo-controlled trial. all labs have their own internal studies or studies they have had some kind of financial investment in, but it appears the study out of the UK is the first which was done for science and not for profit. at least that is how i'm interpreting it. does anyone know of any other food intolerance test that has been validated as a treatment for ibs by real third party (independent) validation study?alex


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## Mike NoLomotil (Jun 6, 2000)

Hi Alex.The biggest problem is that many food intolerance reactions do not involve IgG (and not IgE at all). There are several other mechanisms of food and chemical sensitivity which do not involve any circulating antibodies.This does not mean that an IgG test done properly, and a diet modification based on it, will not help. It should produce improvements to vafrying degree, as this investigation shows.This finding is hardly new, nor startling, though, since many investigations have been done into oligoantigenic dieting for IBS in the last 30 years using various ways of arriving at the correct dietary regimen. Each method has had its pros and cons.However, keep in mind in the case of any single-parameter test (In this case an IgG assay as performed by York) the degree of reversibility will be directly proportionate to the degree of IgG involvement in any given patients food intolerance.So if a person avoids 100% of their IgG test positive foods and they constitute say 50% of the problem (either 50% of the mechanisms, 50% of the offending foods are invoking IgG mediated reactions or a combination) that patient can achieve 50% symptomatic relief. Pretty good. But not as good as it would be if you could isolate ALL the offending foods. As well as chemical sensitivity (additives) which is a whole different set of mechansisms and quite critical to the symptoms of many American IBS victims due to the high chemicakl additive content of our American diet.The reason LEAP does not use IgG testing is just that: its a single-parameter. The common end point of all cellular reactions, including IgG, is release of proinflammtory mediators from one or more circulating immunocyte classes...lymphocytes, granulocytes, phagocytes, even platelets. So if you can find something which can detect all of the possibilities of non-allergic (non IgE) cellular reactions with one method rather than haveing to use a seprate method for each meahcnism (a battery of tests woudl be necessary) you can go further down that road as the diet will be more inclusive.So the immunologists behind LEAP developed a test which can detect the common end point of any cellular reaction regardless of mechanism...mediator release. It was first published in American Clinical Laboratory (3 times in the late '90;s) describing the technology and initial experience clinically.Plus, the way the tets works, you can detect reactions in vitro whose onset may be seriously delayed (72 hours or more from ingestion) by detecting the preliminary stages of reaction which occur and end up leading to mediator release.Studies to validate cell mediated reaction testing that do not involve circulating immunoglobulins is almost impossible to do by the classic means of oral challenge because these reactions are highly dose-dependent. You often cannot get enough of the provoking food INTO the person "blinded" in capsules as they would have to swallow 100 capsules of each and every one of the foods challenged.For this reason people have used other means.For example the MRT test claims WERE proven by an Independent Allergy Center back in 1997 (first-generation of MRT; we are now on the fourth generation or "improvement" as technology advances are made over the last few years...mostly more pwoerful computers so you can use even more complex programming in the intruments for more precise data analysis of the data streams or "ribbon" generated by the MRT instrument).This was done using milk-sensitive subject kids where the milk sensitivity could be provoked by oral challenge which was duplicatable (did not need high doses of milk fractions to provoke symtoms). These were kids who ï¿½present clinicallyï¿½ with what would be termed ï¿½pediatric IBSï¿½ by most American doctors, as their diarrhea and bloating fit the clinical picture (and the ROME Criteria) and they did not have lactose intolerance (lactase did not reverse the symptoms). In Europe they would not be diagnosed with so called IBS, they would be dioagnosed with ï¿½Food Sensitivityï¿½ or ï¿½Intoleranceï¿½ as opposed to food ï¿½allergyï¿½ (IgE). __________________________________ Pediatryczny(Pediatrics Review)1997, SUPLEMENT 1, 61-65THE M.R.T. TEST:A NEW GENERATION OF TESTSFOR FOOD HYPERSENSITIVITYIN CHILDREN AND ADULTSKaczmarski, Maciej, M.D.; Pasula, Mark, Ph.D.; Sawicka, Ewa, M.D., Werpachowska, Irena, M.D.Childrenï¿½s Clinic, University of Bialystok Medical School, Poland(TRANSLATED ABSTRACT)In this paper an assessment of the diagnostic usefulness of the new Mediator Release Test (MRT) in 21 children between the ages of 2 to 5 years with known hypersensitivity to cowï¿½s milk is made and discussed. The novel feature of MRT is the ability to detect cellular reactions (granulocytes, lymphocytes and blood platelets ) to food antigens using a newly invented in vitro method. Using the test in question the MRT method yielded a sensitivity of 94.5 percent. It was also determined that the most frequent reactions in the subjects were to alfa-lactoalbumin in 85.7 percent, beta-lactoglobuline in 66.7 percent, whey proteins in 57.1 percent and casein in 47.6 percent. It was demonstrated that the differentiated cell types were involved in the reaction to antigen challenge with the following frequency: lymphocytes 38.5%; granulocytes 47.6%; mixed reactivity (combination of lymphocytes an platelets) 14.2%. In the control group consisting of 6 control children, test- negative results were found in 67 % for the four tested antigens. In two exceptional cases, MRT Test identified a reaction to the fraction of alfa-globuline of 16.6% and beta-globuline of 16.5% respectively. These results suggest that the new MRT Test will be useful in identifying varying degrees of cell-mediated food hypersensitivity through detecting reactions of specific cell groups. In a further assessment, the MRT Test also demonstrated more reliable diagnostic results then the prior-generation ALCAT Test currently in use in Europe. _________________________________They did this study in Europe so that the new MRT could be compared to the old ALCAT test which is in fairly wide use in Europe for food sensitivity testing the last ten years or so. The allergists who did the investigation and published it are widely respected in Europe and this was a peer reviewed journal.The solution to being able to test a wide array of foods blinded for a wide array of reactions as is seen in food intolerance or "sensitivity", besides just the type of Gel & Coombs reactions involving IgG, was developed in Sweden.Bengtsson and Bjoronson and others woprking primarily at Sahlgrhens Medical University in Sweden have been studying IBS patients whose symptoms are evoked by food sensitivities using jejunal isolation methods. They get volunteers to let them put a multi-lumen tube into the jejunum and they inflate the cuffs to isolate a part of the small bowel (where food is digested and the immune system begins performing its normal "oral tolerance" functions of differentiating food from pathogens).In this way they could use the tube to introduce enough of the challenge foods in slurry to elicit an abnormal inflammatory response and do it double-blind (patient has no idea what is going down the tube and neither does the investigator since a third party prepares the food slurries for challenges).From this these investigators have proven, and published, that many people diagnosed with IBS have symptoms from loss of oral tolerance. They recovered a wide array of mediators both from the gut washings and from the gut wall via biopsy after challenge....and some of the mediators are from cell types which are not involved in IgG type reactions.Signet (developers of MRT) have been in touch with this group via their chief consulting immunologist Jonathan Brostoff, MD in an effort to get a study done with MRT testing done concurrent with the jejunal challenges. But the group has been "booked up in advance" with prefunded studies for some time.Brostoff will be able to get this done in the U.K. is sufficient funding can be arranged as this is quite expensive and of course there is no ï¿½industry moneyï¿½ bag to dip into for it since no drug development is involved as the end game.However the valid alternative which can be done here in the USA and is being done at this time is "outcome investigations". That is, the LEAP protocol is implemented which is based on testing and then outcomes are assessed using validated outcome assessment instruments.Several LEAP physician providers are now working to compile and present retrospective reports of their excellent outcomes. We also have several groups of people working to put together a long term prospective multicenter clinical study of the LEAP program for both IBS and Migraine patients with food intolerance. This type of investigation if done properly is also valid and does not require the invasive methods of jejunal isolation that would be needed to duplicate the Swedish work.In the interim here is a link to some discussion showing outcomes from the patient perspective: http://www.ibsgroup.org/ubb/ultimatebb.php...ic;f=1;t=033220 Hope that explains the issue a bit.MNL


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## justwanttoteach (May 30, 2003)

MNL,You mention the ALCAT test. Wasn't that banned (maybe Oslo, Norway ) awhile back after it was discovered it could not reproduce a split sample? I'm almost 100% sure I read about this during my travels. I'll double check my files and post what I find. Here is the abstract on the test from the study out of the University Hospital of South Manchester on the York Labs' test, which I, my husband and our five children had done here in the US. It allowed me to be IBS-free for the first ever in my life and it only cost me $349, which our insurance reimbursed almost $300.00. It also was a great asset in our children's and my husband's health. - Martha----------------------Do food elimination diets improve Irritable Bowel Syndrome? A double blind trial based on IgG antibodies to food.W. Atkinson, R. Gurney, T. A. Sheldon, P.J. WhorwellIntroduction: Many patients with irritable bowel syndrome [IBS] feel that they have some form of dietary allergy or intolerance. IgE mediated food reactions [classic allergies] are probably rare in IBS but little attention has been paid to the potential role of IgG responses. This study aimed to assess the efficacy of an exclusion diet based on testing for the presence of IgG food antibodies in patients with IBS. Methods: A double blind randomised controlled trial was undertaken in which 150 unselected out-patients with IBS [all subtypes] were randomised to receive either a diet excluding, for 3 months, all foods to which they had IgG antibodies [titre >3:1] or a sham diet excluding the same number of foods but not those to which they were sensitive. Symptom severity, non-colonic symptoms, anxiety/depression and quality of life were recorded at 0 and 3 months, and the primary outcome measure was a change in symptom severity score. Global outcome was also recorded on a seven point scale with only ï¿½betterï¿½ and ï¿½excellentï¿½ regarded as an improvement. Patients who withdrew before the end of the study were also assessed after 3 months. Analysis was by ï¿½intention to treatï¿½ using a generalized linear model for severity and ordinal regression for global outcomes in SPSS. Results: The true diet was significantly superior to the shame diet in reducing symptom severity scores [average reduction 34; 95% Cl: 17.3, 68.6; p=0.049]. However, response to the diet was significantly affected by dietary adherence and the number of foods to which the patient was sensitive. When these factors were accounted for in the analysis, the difference in symptom scores rose to 89 [95% Cl :41, 137; p<0.001]. It is of interest that adherence to the diet affected the response observed in patients on the true diet, but not those on the sham diet [p=0.038]. The analysis also revealed a significant difference in favor of the true diet with respect to global symptomatology [p=0.007]. All other outcome measures showed a trend towards benefit, but did not reach statistical significance. Conclusion: A clinically significant improvement can be achieved in some patients with IBS using a food elimination diet based on IgG food antibodies. The number needed to treat is 3-4.Please Note:The above abstract is of the independent clinical trial performed by the University Hospital of South Manchester, which validates the foodSCAN IgG ELISA Food Intolerance Test as a treatment for Irritable Bowel Syndrome and that was presented at Digestive Disease Week 2003 in Orlando, Florida on May 19, 2003.


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## Mike NoLomotil (Jun 6, 2000)

Teacher,Thanks but I do have the abstract among the 1,900+ others in my files on the subject matter at hand.Also I do recall, as you suggest, that in the past there were from some source issues concerning the reproducibility of test results produced by one or more ALCAT labs either here or in the UK or Ireland. I forget, as it was some time ago and we both do know that ALCAT is older technology, developed in the 1980's. I do not come across any physicians using this method so I have sort of focused on the newest literature rather than going back over stuff I read a long time ago unless it comes up. I am fairly certain that there was not any "published" investigation into the reproducibility of the ALCAT method as I do not see own in my files. I think it was "industry scuttlebutt". You waouldhave to contact the ALCAT people at AMTL to clarify that. As such it is unwise to set it forth as fact so as to not expose anyone to cries of "foul" or worse from that company/lab which markets that technology.







Indeed, to repeat, also I do not doubt either that IBS patients tested and placed on diets based upon IgG testing will experience symptom reduction if the test positive foods are removed.And of course if you leave some patients ON a diet which includes test positive foods rthey will not get better...hence the sham aproach as true placebo controlled oral challnge (as I described) is only possible in vivo when we are not dealing with Type I Gel & Coombs reactions.The point is that there are, like with any assay, limitations. In the case of diarrheic IBS victims, not all food reactions are Type III Gel & Coombs hypersensitivity reactions.So we can isolate those and avoid those ansd achieve a degree of relief proportionate to the degree of involvement of this mechanism in any given patients symptoms.However, there are other mechanisms which not only do not inovlve IgG, nor IgE, in fact cell medietaed reactiosn which do not involve circulating antibodies at all but which are responsible for food intoelrance in IBS. Some are immunologic and some are not.Also, some patients suffer lost oral tolerance to certain food addivies or colorings...and this cannot be detected with any antibody testing regardless and these reactions are not antibody related. So one can check the range of what is offered as one definition of the bounds of applicability. If one wants to check for additive, coloring and other chemical sensitivity one must use a different method. So they could be considered complementary for example, just as any non-IgE method is complementary to IgE assays, not a replacement. Its 2 different animals: food allergy is a comorbidity in a larger number of IBS patients, it appears fropm some studies, than it is in the general population.Just consider the rate of comorbodoity of asthma and IBS and go down that path a ways...or studies where IgE testing and oral challenge correlated in IBS subpopulations.Anyway, if one can develop a test and a lifestyle protocol which addresses methods and means of isolating as wide a range of food and chemical sensitivities as may be possible, then one can achieve a greater degree of remission in many patients than one can using only one marker...of one pathway to symptomology. Its just a fact of life, not a critique. For many families a car is more than adequate to carry everyone on a trip. for some families you simply need a van. Its analagous. So keep in mind this is not intended as I said to derogate a product or service, rather to discuss the wider ranging issues of disease management in IBS objectively rather than getting breathless over what is already obvious when you look at the wide range of investigations over the years in the area of food and chemical sensitivity.Indeed many patient sneed no test at al, of any kind, to achieve some degree of symptomatic relief. The oligoantigenic dietary approaches involved, their methods, and strwengths and weaknesses are also well documented in the literature spanning 25 years.There will be some patient sfor whom this is enough and many for whom it is not. But it is effective.Also. optimal effectiveness is futher enhanced when combining multiple modlaities of treatment. Just as astma management involves dietary, environmental, and stress-management modalities combined with titrated pharmacotherapy, so goes it with functional bowel disorders.It would not be difficult to sit back and do what many selective-thinking "experts" will do with Yorks claim of a "validated study of diet therapy"....it is only 3 months long, the sham diet does not constitute a placebo controlled oral challenge protocol so it is not valid, the outcome assessmenets were not done using industry validated instruments or cirteria blah blah blahTo me the proff is in the pudding....if the patient follows the diet and achieves relief and enhancem,ent to their quality of life, then the patient should not be dissuaded from investigating any treatament as an option based upon some opinion leaders presumptions of "what is and is not IBS" ad nauseaum.Oh also, some critics will spout that it is fudging to adjust the outcome assessment for those who did not comply with the diet...it simply needs to be acknowkledged that everyone knows that ALL lifestyle modification programs are specifically reliant upon patient adherence for their outcomes. It is one of the standard variables and the hardest to control...so the results need to be evaluated by looking at the adherent group outcomes vs. the non adherent group outcomes vs the conmtrol grouop and its sub groups.There is then benefit to assesing the reasons for non-compliance...and seeing if the patient followup procedures can be improved to reduce recidivism.At least it is pleasing to an old "IBS Disease Mangement Advocate" and 'Dietary therapy first, drugs last' advocate to see that the paper was permitted to be presented! Thats a step forward since so much of this is already in the literature and is usallu roundly ignored becasue it is from the UK or Italy or Sweden or the Czech republic and/or in a europena immunology journal...or for 100 other reasons that peopel turn a jaundiced eye to the fact that food intolerance and hypersensitivities play a major role in the symptom generation of a large IBS subpopulation.Stay well! Oh, one presumption that is made which should not be made is "but it appears the study out of the UK is the first which was done for science and not for profit. "No company on the planet develops relationships with clinciains or investigators nor commissions an investigation into their technology or product with the sole intent of not achieveing positive reportable outcomes which will support sales...if this was the case there would be no press releases. It would not be touted on company websites or in marekting materials. It would just be published as "science". This is not an indictment as it is the nature of business, healthcare and otherwise. Certainly the information that is being compiled by independent physicians working on outcome assesssment of the LEAP DM protocol for IBS patients once made public will not be simply set forth as a scientific finding, anymore than it was the first time (as in the investigation whcih validated that MRT technology doeas accurately detect cell mediated reactions in food sensitivie patients when the reaction is non-IgE mediated).That was independent. The investigators received no stipend.., indeed they do not even have ACCESS to any MRT instrumentation for their own use...it was provided solely for the purpose of Kaczmarski et al doing the validation study which quantified what the first generation of the tehcnology was able to do: accurately detect the common end point of cell mediated reactiosn to the challenged food.So this indeed was done for science by the investigators, as they were looking (as TEACHER suggests) for something better than the commonly usede ALCAT methiod at that time. But once some third party does validate a claim, nobody in their right mind is not going to point out that their technology works. So ultimately it is all comes to commercial use. In all fields, healthcare and the like. But this investigation is certainly not unique in verifiying the claims of the company whose method was tested. MRT was validated in 1997 indepebndently and even the old ALCAT test has had a number of publications (they are agaion from back in the 1980's) where theior technology was "validated independently". One must simply look at each investigation to see how it may define the range of validity of any given method...range of applicability. Then use the method with an undertanding of what it does and does not do.In this case the informatuon is useful and simply shows that, at least within the paranmeters of the investigation, the use of this method has valid application for dietary treatment of certain IBS patients. But it is not a "first and only" prooof of effectiveness of any dietary protocol or technology. But it is nice to have another to add to the mix. Indeed, my remission dates back over a decade, and was originally based on dietary therapy from the old ALCAT method. As advances have been made I have been able to refine my own (and others) patient specific programs further to gain added degrees of remission.Have a DFD!







MNLPSSorry for the typos...gotta hurry today.


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## Mike NoLomotil (Jun 6, 2000)

Oh, Hey Teach,I see you live down where York Labs USA is located. Do you or a family memeber work for them? Most members who have been here know up front, or new ones read my file info or case history or thousands of posts, then understand that I am VP/COO of Signet Diagnostics.Just want to know if I am talking to a patient or a principal or employee of the lab. It is easier to talk to another person in the field than it is directly to patients as there are certain formalities and obligations we have to adhere to when speaking to the sick that can be dispensed with when talking to another "person in healthcare".Indeed insurance reimbursement is important to people as we have so far about 300 insurance plans which reimburse for testing and physician counselling. I do not know how many AMTL has for their ALCAT testing, but they are not "banned" here...in fact their lab I beleive is right up the street from York in Hollywood Fla..I am curious how you got insurance reimbursement from a a home test, as a dignosis code is need to file a claim and a doctor cannot make a diagnosis without examining someone. I thought the vast majority of Yorks patients are home tested and not seen by a physician, only an order for the testing is written in absentia. Or maybe you went to your own physician to get that done in which case he could assign a dx code so insurance could be filed.Anyway, glad it helps, as it should, and hope you stick to the rotation diet long term and stay well!MNL


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## justwanttoteach (May 30, 2003)

MNL,Actually York Nutritional Laboratories is located about 45 minutes south of us. In answer to you question, "no" I don't work for York nor do I personally know of anyone who does. I find it odd that you would ask. In regards to the insurance reimbursement question, our family did get our kits directly from York after we contacted the office in England (we didn't know there was a US location). A statement was provided with each of our results and my husband submitted these to our insurance company. We're very happy - we all feel 100% better and we didn't have to spend anywhere near as much money as what other procedures cost.Martha


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## Mike NoLomotil (Jun 6, 2000)

Hi MarthaActually its not odd at all to ask as it is a natural part of being in the healthcare industry that company officials participate in online communities, vhats, etc which are pplicable to their services. Often people do that without just being open and saying, like we do, that we are with a company that does such and such. Recently one or more people from York have contacted our company not only without identifying their affiliation but in a manner suggesting they are interested in our services, pricing etc. and are impatient as to the pace with which we are provoding saidm informatiopn, as if the are a healthcare provider intersted in the program.I just wanted to let anyone from York who is here know that it is OK, in fact it is better, to just say it and have open dialogue.Sorry to take so long to reply. Been busy. Not here much these days.MNL


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## justwanttoteach (May 30, 2003)

MNL,Been busy with graduations, proms and getting ready for the family vacation - I'm looking forward to taking some time off. For your assurance, I was a patient with York, but am not affiliated with them other than wanting to sing their praises for helping our household. Enjoy your summer - hope to talk with everyone again soon.Martha


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