Question:

Remicade blocks TNF alpha. Debs – Hide quoted text — Show quoted text – Anyone tried anything natural to block TNF? I found a site that stated green tea, tumeric,  SamE, Feverfew, and Evening Primrose oil all block TNF. Let me hear from you if you have and how’d it go? Thanks Please explain why you would want to block TNF. Tumor Necrosis Factor prevents malignancies from obtaining the blood supply they need to grow. If you block it you are essentially encouraging cancer to spread in your body. Larry — Larry Finch N 40

Question:

That is because once you have Crohns reducing sugar is not what helps . The sugar may be a factor in getting Crohns but then it is the bacterial invasion that is really the main factor in the continuation of the disease. Decreasing sugar at that point is like closing the door after the horse has already left the barn. At that point you need other intervention. But decreasing sugar is still indicated because it was a contributing factor in the first place, and if you don’t decrease it you may be setting yourself up for future problems. But you need to take other steps to get your disease under control. Please refer to the basic dietary recommendation of the CCFA if you have any questions on what the proper dietary recommendations are. Thank you very much. Jeff 2

– Hide quoted text — Show quoted text – Again I see the important line as the last one: There appeared to be no clinical advantage to the use of reduced sugar diets in Crohn’s disease treatment. Debs Eur J Clin Nutr 1998 Apr;52(4):229-38   Related Articles, Links                               A review of associations between Crohn’s disease and consumption of sugars.                               Riordan AM, Ruxton CH, Hunter JO.                               Addenbrookes Hospital, Cambridge.                               OBJECTIVES: To critically review the available literature reporting associations between the onset of Crohn’s disease and intakes of sugars or sugar-containing foods. To evaluate                               published evidence on the use of dietary manipulation of sugars in the treatment of Crohn’s disease. DESIGN: All publications from refereed journals which reported intakes of                               sugars and sugar-containing foods in the context of Crohn’s disease onset or treatment were selected. CONCLUSION: Evidence suggesting a relationship between sugars and onset                               of Crohn’s disease was inconsistent and subject to important methodological limitations. There was a clear lack of distinction between reporting of current, as opposed to,                               retrospective intakes. There appeared to be no clinical advantage to the use of reduced sugar diets in Crohn’s disease treatment.

Response:

Yes, and the tests are very expensive. I believe 250k on average and probably much more. This is why I believe (oh oh, here we go) that the drugs companies can only fund studies that will create a marketable product. Of course universities are much freer to study other things such as the worm treatment. This was a good example of statistics too. The group was only 6 people. 5 people achieved remission -short term though. They did not have a placebo group. They just gave everyone the same thing. They stated that this was only a small group and needs much more study to validate, however the results where "interesting". But good information on how studies are done. Regards, Jeff 2

– Hide quoted text — Show quoted text – Paul, When you are doing studies a statistical test for significance is done to determine if the effect seen is from the medication by comparing it to the placebo.  Therefore, significance of results is important.  When a sampling of too few people is done, your 2 or 3 example, then the scientists will say that trails need to be done with larger test samplings, i.e. more people, to determine if the effects are significant or not.  This is one reason why drug approvals take so long.  First, a few people are tested to ensure safety and some efficacy, then larger groups are tested for efficacy.  At any time in the process a study can be halted if the researchers feel there is a danger to the volunteers participating.  mgbio My understanding is that when they say the results are statistically

insignificant, they mean that either the study group was not large enough or the results were not much better then that

of a control group that did not get the treatment. If 2 out of 3 responded to the treatment the results would be

considered statistically insignificant because of the small group even though 66% of the people improved. The clinical trial I am currently trying to get into is very strict with

their requirements. I am only aloud to take certain medications and I must be on a therapeutic dose for at least a

minimum amount of time. I am not allowed to change the dose throughout the study. My colon also must meet certain

requirements. I wouldn’t exactly call this picking – Hide quoted text — Show quoted text – the people at random. — Paul Visit our photo albums at http://www.laflammefamily.ca To reply, replace "deadspam.com" with "laflammefamily.ca" — Jeff where did you see a paper that saw 66% of people mproving but said it wasn’t stat sig? I don’t believe that so I really need to see proof. What were they comparing the improvement to? standard therapy where there was 67% or 70% or 60% improvement or were they comparing it to placebo where there was probably anout a 15% improvement? Also significance is a statistical term and implies, or really states, that statistical tests have been run. It isn’t some scientist or Dr deciding by himself that something is or isn’t significant. I thought you said you had experience with science and math? You can’t have your cake and eat it too Jeff. If you don’t pick people randomly for these studies then you will skew the results and they will be meaningless. Also the reason that there are strict inclusion and exclusion criteria is that they scientists are trying to answer a SPECIFIC question and the study is DESIGNED to answer that question. How many people they need to enroll in each group, what the groups are, what the controls are, it is all designed to answer a question. If you are not rigorous then you will not be able to prove ANYTHING. Debs One of the problems I see with these scientific studies is that they, by design, can only focus on one thing. Yet it is probably a combination of different things that may be involved. Also when they say statistically insignificant, I saw a study that said 66% of the people improved but they considered this statistically insignif. To me 66% means that 2/3rds of the people improved. I don’t think this is insignificant. At what level do they consider it significant? And another problem they have is that they usually just pick the people for the sample groups at random. If they knew how to look for certain predesposing factors or other related factors they may be better able to determine what types of people are more likely to benefit from one particular treatment or another. Just a few thoughts. Jeff 2 Again I see the important line as the last one: There appeared to be no clinical advantage to the use of reduced sugar diets in Crohn’s disease treatment. Debs Eur J Clin Nutr 1998 Apr;52(4):229-38   Related Articles, Links                               A review of associations between Crohn’s disease and consumption of sugars.                               Riordan AM, Ruxton CH, Hunter JO.                               Addenbrookes Hospital, Cambridge.                               OBJECTIVES: To critically review the available literature reporting associations between the onset of Crohn’s disease and intakes of sugars or sugar-containing foods. To evaluate                               published evidence on the use of dietary manipulation of sugars in the treatment of Crohn’s disease. DESIGN: All publications from refereed journals which reported intakes of                               sugars and sugar-containing foods in the context of Crohn’s disease onset or treatment were selected. CONCLUSION: Evidence suggesting a relationship between sugars and onset                               of Crohn’s disease was inconsistent and subject to important methodological limitations. There was a clear lack of distinction between reporting of current, as opposed to,                               retrospective intakes. There appeared to be no clinical advantage to the use of reduced sugar diets in Crohn’s disease treatment. — <<<<<<<<<< Deborah Schuback Lab Manager/Senior Tech 149 13th St Rm 6101 Molecular Neurogenetics Charlestown, MA 02129 617 726 5730

Response:

Well put Paul. That’s what I was trying to say. It’s not that the patients are chosen at random, it’s that they are randomly assigned to treatment groups. Debs – Hide quoted text — Show quoted text – My understanding is that when they say the results are statistically insignificant, they mean that either the study group was not large enough or the results were not much better then that of a control group that did not get the treatment. If 2 out of 3 responded to the treatment the results would be considered statistically insignificant because of the small group even though 66% of the people improved. The clinical trial I am currently trying to get into is very strict with their requirements. I am only aloud to take certain medications and I must be on a therapeutic dose for at least a minimum amount of time. I am not allowed to change the dose throughout the study. My colon also must meet certain requirements. I wouldn’t exactly call this picking the people at random. — Paul Visit our photo albums at http://www.laflammefamily.ca To reply, replace "deadspam.com" with "laflammefamily.ca" — Jeff where did you see a paper that saw 66% of people mproving but said it wasn’t stat sig? I don’t believe that so I really need to see proof. What were they comparing the improvement to? standard therapy where there was 67% or 70% or 60% improvement or were they comparing it to placebo where there was probably anout a 15% improvement? Also significance is a statistical term and implies, or really states, that statistical tests have been run. It isn’t some scientist or Dr deciding by himself that something is or isn’t significant. I thought you said you had experience with science and math? You can’t have your cake and eat it too Jeff. If you don’t pick people randomly for these studies then you will skew the results and they will be meaningless. Also the reason that there are strict inclusion and exclusion criteria is that they scientists are trying to answer a SPECIFIC question and the study is DESIGNED to answer that question. How many people they need to enroll in each group, what the groups are, what the controls are, it is all designed to answer a question. If you are not rigorous then you will not be able to prove ANYTHING. Debs One of the problems I see with these scientific studies is that they, by design, can only focus on one thing. Yet it is probably a combination of different things that may be involved. Also when they say statistically insignificant, I saw a study that said 66% of the people improved but they considered this statistically insignif. To me 66% means that 2/3rds of the people improved. I don’t think this is insignificant. At what level do they consider it significant? And another problem they have is that they usually just pick the people for the sample groups at random. If they knew how to look for certain predesposing factors or other related factors they may be better able to determine what types of people are more likely to benefit from one particular treatment or another. Just a few thoughts. Jeff 2 Again I see the important line as the last one: There appeared to be no clinical advantage to the use of reduced sugar diets in Crohn’s disease treatment. Debs Eur J Clin Nutr 1998 Apr;52(4):229-38   Related Articles, Links                               A review of associations between Crohn’s disease and consumption of sugars.                               Riordan AM, Ruxton CH, Hunter JO.                               Addenbrookes Hospital, Cambridge.                               OBJECTIVES: To critically review the available literature reporting associations between the onset of Crohn’s disease and intakes of sugars or sugar-containing foods. To evaluate                               published evidence on the use of dietary manipulation of sugars in the treatment of Crohn’s disease. DESIGN: All publications from refereed journals which reported intakes of                               sugars and sugar-containing foods in the context of Crohn’s disease onset or treatment were selected. CONCLUSION: Evidence suggesting a relationship between sugars and onset                               of Crohn’s disease was inconsistent and subject to important methodological limitations. There was a clear lack of distinction between reporting of current, as opposed to,                               retrospective intakes. There appeared to be no clinical advantage to the use of reduced sugar diets in Crohn’s disease treatment. — <<<<<<<<<< Deborah Schuback Lab Manager/Senior Tech 149 13th St Rm 6101 Molecular Neurogenetics Charlestown, MA 02129 617 726 5730

– <<<<<<<<<< Deborah Schuback Lab Manager/Senior Tech 149 13th St Rm 6101 Molecular Neurogenetics Charlestown, MA 02129 617 726 5730

Response:

Paul, When you are doing studies a statistical test for significance is done to determine if the effect seen is from the medication by comparing it to the placebo.  Therefore, significance of results is important.  When a sampling of too few people is done, your 2 or 3 example, then the scientists will say that trails need to be done with larger test samplings, i.e. more people, to determine if the effects are significant or not.  This is one reason why drug approvals take so long.  First, a few people are tested to ensure safety and some efficacy, then larger groups are tested for efficacy.  At any time in the process a study can be halted if the researchers feel there is a danger to the volunteers participating.  mgbio – Hide quoted text — Show quoted text – My understanding is that when they say the results are statistically insignificant, they mean that either the study group was not large enough or the results were not much better then that of a control group that did not get the treatment. If 2 out of 3 responded to the treatment the results would be considered statistically insignificant because of the small group even though 66% of the people improved. The clinical trial I am currently trying to get into is very strict with their requirements. I am only aloud to take certain medications and I must be on a therapeutic dose for at least a minimum amount of time. I am not allowed to change the dose throughout the study. My colon also must meet certain requirements. I wouldn’t exactly call this picking the people at random. — Paul Visit our photo albums at http://www.laflammefamily.ca To reply, replace "deadspam.com" with "laflammefamily.ca" — Jeff where did you see a paper that saw 66% of people mproving but said it wasn’t stat sig? I don’t believe that so I really need to see proof. What were they comparing the improvement to? standard therapy where there was 67% or 70% or 60% improvement or were they comparing it to placebo where there was probably anout a 15% improvement? Also significance is a statistical term and implies, or really states, that statistical tests have been run. It isn’t some scientist or Dr deciding by himself that something is or isn’t significant. I thought you said you had experience with science and math? You can’t have your cake and eat it too Jeff. If you don’t pick people randomly for these studies then you will skew the results and they will be meaningless. Also the reason that there are strict inclusion and exclusion criteria is that they scientists are trying to answer a SPECIFIC question and the study is DESIGNED to answer that question. How many people they need to enroll in each group, what the groups are, what the controls are, it is all designed to answer a question. If you are not rigorous then you will not be able to prove ANYTHING. Debs One of the problems I see with these scientific studies is that they, by design, can only focus on one thing. Yet it is probably a combination of different things that may be involved. Also when they say statistically insignificant, I saw a study that said 66% of the people improved but they considered this statistically insignif. To me 66% means that 2/3rds of the people improved. I don’t think this is insignificant. At what level do they consider it significant? And another problem they have is that they usually just pick the people for the sample groups at random. If they knew how to look for certain predesposing factors or other related factors they may be better able to determine what types of people are more likely to benefit from one particular treatment or another. Just a few thoughts. Jeff 2 Again I see the important line as the last one: There appeared to be no clinical advantage to the use of reduced sugar diets in Crohn’s disease treatment. Debs Eur J Clin Nutr 1998 Apr;52(4):229-38   Related Articles, Links                               A review of associations between Crohn’s disease and consumption of sugars.                               Riordan AM, Ruxton CH, Hunter JO.                               Addenbrookes Hospital, Cambridge.                               OBJECTIVES: To critically review the available literature reporting associations between the onset of Crohn’s disease and intakes of sugars or sugar-containing foods. To evaluate                               published evidence on the use of dietary manipulation of sugars in the treatment of Crohn’s disease. DESIGN: All publications from refereed journals which reported intakes of                               sugars and sugar-containing foods in the context of Crohn’s disease onset or treatment were selected. CONCLUSION: Evidence suggesting a relationship between sugars and onset                               of Crohn’s disease was inconsistent and subject to important methodological limitations. There was a clear lack of distinction between reporting of current, as opposed to,                               retrospective intakes. There appeared to be no clinical advantage to the use of reduced sugar diets in Crohn’s disease treatment. — <<<<<<<<<< Deborah Schuback Lab Manager/Senior Tech 149 13th St Rm 6101 Molecular Neurogenetics Charlestown, MA 02129 617 726 5730

Response:

I understand that the tests, by design, have to be constructed to test for one thing in order for science to make any determination. But if the problem is not caused by one thing then the test will likely find nothing. Also as with anything there are goods or well designed tests and then there are bad ones because they didn’t take all of the important factors into account. It seems like they do tests and then years later someone else comes out with a test that refutes the earlier finding. I’m just saying that it can take time for them to figure out what they are testing for or what to look at. In the past it seemed that tests denied there was a connection with diet yet now that they are getting better at knowing what to look at it seems they are reversing those earlier conclusions. Also I thought you cited a test where they tried to get people who might be predetermined to be at risk for get IBD and tried to track results. What is wrong with trying to do tests on certain types of subjects. They do this all the time. You might do a test on people with schizophrenia to see how they react to something. I know where you can find some subjects ))) Regards, Jeff 2

– Hide quoted text — Show quoted text – Jeff where did you see a paper that saw 66% of people mproving but said it wasn’t stat sig? I don’t believe that so I really need to see proof. What were they comparing the improvement to? standard therapy where there was 67% or 70% or 60% improvement or were they comparing it to placebo where there was probably anout a 15% improvement? Also significance is a statistical term and implies, or really states, that statistical tests have been run. It isn’t some scientist or Dr deciding by himself that something is or isn’t significant. I thought you said you had experience with science and math? You can’t have your cake and eat it too Jeff. If you don’t pick people randomly for these studies then you will skew the results and they will be meaningless. Also the reason that there are strict inclusion and exclusion criteria is that they scientists are trying to answer a SPECIFIC question and the study is DESIGNED to answer that question. How many people they need to enroll in each group, what the groups are, what the controls are, it is all designed to answer a question. If you are not rigorous then you will not be able to prove ANYTHING. Debs One of the problems I see with these scientific studies is that they, by design, can only focus on one thing. Yet it is probably a combination of different things that may be involved. Also when they say statistically insignificant, I saw a study that said 66% of the people improved but they considered this statistically insignif. To me 66% means that 2/3rds of the people improved. I don’t think this is insignificant. At what level do they consider it significant? And another problem they have is that they usually just pick the people for the sample groups at random. If they knew how to look for certain predesposing factors or other related factors they may be better able to determine what types of people are more likely to benefit from one particular treatment or another. Just a few thoughts. Jeff 2 Again I see the important line as the last one: There appeared to be no clinical advantage to the use of reduced sugar diets in Crohn’s disease treatment. Debs Eur J Clin Nutr 1998 Apr;52(4):229-38   Related Articles, Links                               A review of associations between Crohn’s disease and consumption of sugars.                               Riordan AM, Ruxton CH, Hunter JO.                               Addenbrookes Hospital, Cambridge.                               OBJECTIVES: To critically review the available literature reporting associations between the onset of Crohn’s disease and intakes of sugars or sugar-containing foods. To evaluate                               published evidence on the use of dietary manipulation of sugars in the treatment of Crohn’s disease. DESIGN: All publications from refereed journals which reported intakes of                               sugars and sugar-containing foods in the context of Crohn’s disease onset or treatment were selected. CONCLUSION: Evidence suggesting a relationship between sugars and onset                               of Crohn’s disease was inconsistent and subject to important methodological limitations. There was a clear lack of distinction between reporting of current, as opposed to,                               retrospective intakes. There appeared to be no clinical advantage to the use of reduced sugar diets in Crohn’s disease treatment. — <<<<<<<<<< Deborah Schuback Lab Manager/Senior Tech 149 13th St Rm 6101 Molecular Neurogenetics Charlestown, MA 02129 617 726 5730

Response:

Hmm, interesting, I thought it was statistically insignificant because it would not be marketable enough to make a profit, ha ha – sorry I couldn’t resist that one. Jeff 2

My understanding is that when they say the results are statistically

insignificant, they mean that either the study group was not large enough or the results were not much better then that

of a control group that did not get the treatment. If 2 out of 3 responded to the treatment the results would be

considered statistically insignificant because of the small group even though 66% of the people improved. The clinical trial I am currently trying to get into is very strict with

their requirements. I am only aloud to take certain medications and I must be on a therapeutic dose for at least a

minimum amount of time. I am not allowed to change the dose throughout the study. My colon also must meet certain

requirements. I wouldn’t exactly call this picking – Hide quoted text — Show quoted text – the people at random. — Paul Visit our photo albums at http://www.laflammefamily.ca To reply, replace "deadspam.com" with "laflammefamily.ca" — Jeff where did you see a paper that saw 66% of people mproving but said it wasn’t stat sig? I don’t believe that so I really need to see proof. What were they comparing the improvement to? standard therapy where there was 67% or 70% or 60% improvement or were they comparing it to placebo where there was probably anout a 15% improvement? Also significance is a statistical term and implies, or really states, that statistical tests have been run. It isn’t some scientist or Dr deciding by himself that something is or isn’t significant. I thought you said you had experience with science and math? You can’t have your cake and eat it too Jeff. If you don’t pick people randomly for these studies then you will skew the results and they will be meaningless. Also the reason that there are strict inclusion and exclusion criteria is that they scientists are trying to answer a SPECIFIC question and the study is DESIGNED to answer that question. How many people they need to enroll in each group, what the groups are, what the controls are, it is all designed to answer a question. If you are not rigorous then you will not be able to prove ANYTHING. Debs One of the problems I see with these scientific studies is that they, by design, can only focus on one thing. Yet it is probably a combination of different things that may be involved. Also when they say statistically insignificant, I saw a study that said 66% of the people improved but they considered this statistically insignif. To me 66% means that 2/3rds of the people improved. I don’t think this is insignificant. At what level do they consider it significant? And another problem they have is that they usually just pick the people for the sample groups at random. If they knew how to look for certain predesposing factors or other related factors they may be better able to determine what types of people are more likely to benefit from one particular treatment or another. Just a few thoughts. Jeff 2 Again I see the important line as the last one: There appeared to be no clinical advantage to the use of reduced sugar diets in Crohn’s disease treatment. Debs Eur J Clin Nutr 1998 Apr;52(4):229-38   Related Articles, Links                               A review of associations between Crohn’s disease and consumption of sugars.                               Riordan AM, Ruxton CH, Hunter JO.                               Addenbrookes Hospital, Cambridge.                               OBJECTIVES: To critically review the available literature reporting associations between the onset of Crohn’s disease and intakes of sugars or sugar-containing foods. To evaluate                               published evidence on the use of dietary manipulation of sugars in the treatment of Crohn’s disease. DESIGN: All publications from refereed journals which reported intakes of                               sugars and sugar-containing foods in the context of Crohn’s disease onset or treatment were selected. CONCLUSION: Evidence suggesting a relationship between sugars and onset                               of Crohn’s disease was inconsistent and subject to important methodological limitations. There was a clear lack of distinction between reporting of current, as opposed to,                               retrospective intakes. There appeared to be no clinical advantage to the use of reduced sugar diets in Crohn’s disease treatment. — <<<<<<<<<< Deborah Schuback Lab Manager/Senior Tech 149 13th St Rm 6101 Molecular Neurogenetics Charlestown, MA 02129 617 726 5730

Response:

I blieve that was the same study where the placebo group got better results then the group taking the 100mg. I’ll see if I can find it. Jeff 2

– Hide quoted text — Show quoted text – Jeff where did you see a paper that saw 66% of people mproving but said it wasn’t stat sig? I don’t believe that so I really need to see proof. What were they comparing the improvement to? standard therapy where there was 67% or 70% or 60% improvement or were they comparing it to placebo where there was probably anout a 15% improvement? Also significance is a statistical term and implies, or really states, that statistical tests have been run. It isn’t some scientist or Dr deciding by himself that something is or isn’t significant. I thought you said you had experience with science and math? You can’t have your cake and eat it too Jeff. If you don’t pick people randomly for these studies then you will skew the results and they will be meaningless. Also the reason that there are strict inclusion and exclusion criteria is that they scientists are trying to answer a SPECIFIC question and the study is DESIGNED to answer that question. How many people they need to enroll in each group, what the groups are, what the controls are, it is all designed to answer a question. If you are not rigorous then you will not be able to prove ANYTHING. Debs One of the problems I see with these scientific studies is that they, by design, can only focus on one thing. Yet it is probably a combination of different things that may be involved. Also when they say statistically insignificant, I saw a study that said 66% of the people improved but they considered this statistically insignif. To me 66% means that 2/3rds of the people improved. I don’t think this is insignificant. At what level do they consider it significant? And another problem they have is that they usually just pick the people for the sample groups at random. If they knew how to look for certain predesposing factors or other related factors they may be better able to determine what types of people are more likely to benefit from one particular treatment or another. Just a few thoughts. Jeff 2 Again I see the important line as the last one: There appeared to be no clinical advantage to the use of reduced sugar diets in Crohn’s disease treatment. Debs Eur J Clin Nutr 1998 Apr;52(4):229-38   Related Articles, Links                               A review of associations between Crohn’s disease and consumption of sugars.                               Riordan AM, Ruxton CH, Hunter JO.                               Addenbrookes Hospital, Cambridge.                               OBJECTIVES: To critically review the available literature reporting associations between the onset of Crohn’s disease and intakes of sugars or sugar-containing foods. To evaluate                               published evidence on the use of dietary manipulation of sugars in the treatment of Crohn’s disease. DESIGN: All publications from refereed journals which reported intakes of                               sugars and sugar-containing foods in the context of Crohn’s disease onset or treatment were selected. CONCLUSION: Evidence suggesting a relationship between sugars and onset                               of Crohn’s disease was inconsistent and subject to important methodological limitations. There was a clear lack of distinction between reporting of current, as opposed to,                               retrospective intakes. There appeared to be no clinical advantage to the use of reduced sugar diets in Crohn’s disease treatment. — <<<<<<<<<< Deborah Schuback Lab Manager/Senior Tech 149 13th St Rm 6101 Molecular Neurogenetics Charlestown, MA 02129 617 726 5730

Response:

My understanding is that when they say the results are statistically insignificant, they mean that either the study group was not large enough or the results were not much better then that of a control group that did not get the treatment. If 2 out of 3 responded to the treatment the results would be considered statistically insignificant because of the small group even though 66% of the people improved. The clinical trial I am currently trying to get into is very strict with their requirements. I am only aloud to take certain medications and I must be on a therapeutic dose for at least a minimum amount of time. I am not allowed to change the dose throughout the study. My colon also must meet certain requirements. I wouldn’t exactly call this picking the people at random. — Paul Visit our photo albums at http://www.laflammefamily.ca To reply, replace "deadspam.com" with "laflammefamily.ca" — – Hide quoted text — Show quoted text – Jeff where did you see a paper that saw 66% of people mproving but said it wasn’t stat sig? I don’t believe that so I really need to see proof. What were they comparing the improvement to? standard therapy where there was 67% or 70% or 60% improvement or were they comparing it to placebo where there was probably anout a 15% improvement? Also significance is a statistical term and implies, or really states, that statistical tests have been run. It isn’t some scientist or Dr deciding by himself that something is or isn’t significant. I thought you said you had experience with science and math? You can’t have your cake and eat it too Jeff. If you don’t pick people randomly for these studies then you will skew the results and they will be meaningless. Also the reason that there are strict inclusion and exclusion criteria is that they scientists are trying to answer a SPECIFIC question and the study is DESIGNED to answer that question. How many people they need to enroll in each group, what the groups are, what the controls are, it is all designed to answer a question. If you are not rigorous then you will not be able to prove ANYTHING. Debs One of the problems I see with these scientific studies is that they, by design, can only focus on one thing. Yet it is probably a combination of different things that may be involved. Also when they say statistically insignificant, I saw a study that said 66% of the people improved but they considered this statistically insignif. To me 66% means that 2/3rds of the people improved. I don’t think this is insignificant. At what level do they consider it significant? And another problem they have is that they usually just pick the people for the sample groups at random. If they knew how to look for certain predesposing factors or other related factors they may be better able to determine what types of people are more likely to benefit from one particular treatment or another. Just a few thoughts. Jeff 2 Again I see the important line as the last one: There appeared to be no clinical advantage to the use of reduced sugar diets in Crohn’s disease treatment. Debs Eur J Clin Nutr 1998 Apr;52(4):229-38   Related Articles, Links                               A review of associations between Crohn’s disease and consumption of sugars.                               Riordan AM, Ruxton CH, Hunter JO.                               Addenbrookes Hospital, Cambridge.                               OBJECTIVES: To critically review the available literature reporting associations between the onset of Crohn’s disease and intakes of sugars or sugar-containing foods. To evaluate                               published evidence on the use of dietary manipulation of sugars in the treatment of Crohn’s disease. DESIGN: All publications from refereed journals which reported intakes of                               sugars and sugar-containing foods in the context of Crohn’s disease onset or treatment were selected. CONCLUSION: Evidence suggesting a relationship between sugars and onset                               of Crohn’s disease was inconsistent and subject to important methodological limitations. There was a clear lack of distinction between reporting of current, as opposed to,                               retrospective intakes. There appeared to be no clinical advantage to the use of reduced sugar diets in Crohn’s disease treatment. — <<<<<<<<<< Deborah Schuback Lab Manager/Senior Tech 149 13th St Rm 6101 Molecular Neurogenetics Charlestown, MA 02129 617 726 5730

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Jeff where did you see a paper that saw 66% of people mproving but said it wasn’t stat sig? I don’t believe that so I really need to see proof. What were they comparing the improvement to? standard therapy where there was 67% or 70% or 60% improvement or were they comparing it to placebo where there was probably anout a 15% improvement? Also significance is a statistical term and implies, or really states, that statistical tests have been run. It isn’t some scientist or Dr deciding by himself that something is or isn’t significant. I thought you said you had experience with science and math? You can’t have your cake and eat it too Jeff. If you don’t pick people randomly for these studies then you will skew the results and they will be meaningless. Also the reason that there are strict inclusion and exclusion criteria is that they scientists are trying to answer a SPECIFIC question and the study is DESIGNED to answer that question. How many people they need to enroll in each group, what the groups are, what the controls are, it is all designed to answer a question. If you are not rigorous then you will not be able to prove ANYTHING. Debs – Hide quoted text — Show quoted text – One of the problems I see with these scientific studies is that they, by design, can only focus on one thing. Yet it is probably a combination of different things that may be involved. Also when they say statistically insignificant, I saw a study that said 66% of the people improved but they considered this statistically insignif. To me 66% means that 2/3rds of the people improved. I don’t think this is insignificant. At what level do they consider it significant? And another problem they have is that they usually just pick the people for the sample groups at random. If they knew how to look for certain predesposing factors or other related factors they may be better able to determine what types of people are more likely to benefit from one particular treatment or another. Just a few thoughts. Jeff 2 Again I see the important line as the last one: There appeared to be no clinical advantage to the use of reduced sugar diets in Crohn’s disease treatment. Debs Eur J Clin Nutr 1998 Apr;52(4):229-38   Related Articles, Links                               A review of associations between Crohn’s disease and consumption of sugars.                               Riordan AM, Ruxton CH, Hunter JO.                               Addenbrookes Hospital, Cambridge.                               OBJECTIVES: To critically review the available literature reporting associations between the onset of Crohn’s disease and intakes of sugars or sugar-containing foods. To evaluate                               published evidence on the use of dietary manipulation of sugars in the treatment of Crohn’s disease. DESIGN: All publications from refereed journals which reported intakes of                               sugars and sugar-containing foods in the context of Crohn’s disease onset or treatment were selected. CONCLUSION: Evidence suggesting a relationship between sugars and onset                               of Crohn’s disease was inconsistent and subject to important methodological limitations. There was a clear lack of distinction between reporting of current, as opposed to,                               retrospective intakes. There appeared to be no clinical advantage to the use of reduced sugar diets in Crohn’s disease treatment.

– <<<<<<<<<< Deborah Schuback Lab Manager/Senior Tech 149 13th St Rm 6101 Molecular Neurogenetics Charlestown, MA 02129 617 726 5730

Response:

One of the problems I see with these scientific studies is that they, by design, can only focus on one thing. Yet it is probably a combination of different things that may be involved. Also when they say statistically insignificant, I saw a study that said 66% of the people improved but they considered this statistically insignif. To me 66% means that 2/3rds of the people improved. I don’t think this is insignificant. At what level do they consider it significant? And another problem they have is that they usually just pick the people for the sample groups at random. If they knew how to look for certain predesposing factors or other related factors they may be better able to determine what types of people are more likely to benefit from one particular treatment or another. Just a few thoughts. Jeff 2

– Hide quoted text — Show quoted text – Again I see the important line as the last one: There appeared to be no clinical advantage to the use of reduced sugar diets in Crohn’s disease treatment. Debs Eur J Clin Nutr 1998 Apr;52(4):229-38   Related Articles, Links                               A review of associations between Crohn’s disease and consumption of sugars.                               Riordan AM, Ruxton CH, Hunter JO.                               Addenbrookes Hospital, Cambridge.                               OBJECTIVES: To critically review the available literature reporting associations between the onset of Crohn’s disease and intakes of sugars or sugar-containing foods. To evaluate                               published evidence on the use of dietary manipulation of sugars in the treatment of Crohn’s disease. DESIGN: All publications from refereed journals which reported intakes of                               sugars and sugar-containing foods in the context of Crohn’s disease onset or treatment were selected. CONCLUSION: Evidence suggesting a relationship between sugars and onset                               of Crohn’s disease was inconsistent and subject to important methodological limitations. There was a clear lack of distinction between reporting of current, as opposed to,                               retrospective intakes. There appeared to be no clinical advantage to the use of reduced sugar diets in Crohn’s disease treatment.

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To get into the tests is hard I tried and failed once because I had surgery and the meds I was taking including supplements made me not a canidate. Maybe, just a thought, but that 66% who improved didn’t last in their improvement or it didn’t heal like it was supposed to.  You need to look at all the reasons that’s why I ask Debs or Bruce because they help put a lot of it in laymans terms for me.  :-))  UM MOM Susan

– Hide quoted text — Show quoted text – One of the problems I see with these scientific studies is that they, by design, can only focus on one thing. Yet it is probably a combination of different things that may be involved. Also when they say statistically insignificant, I saw a study that said 66% of the people improved but they considered this statistically insignif. To me 66% means that 2/3rds of the people improved. I don’t think this is insignificant. At what level do they consider it significant? And another problem they have is that they usually just pick the people for the sample groups at random. If they knew how to look for certain predesposing factors or other related factors they may be better able to determine what types of people are more likely to benefit from one particular treatment or another. Just a few thoughts. Jeff 2 Again I see the important line as the last one: There appeared to be no clinical advantage to the use of reduced sugar diets in Crohn’s disease treatment. Debs Eur J Clin Nutr 1998 Apr;52(4):229-38   Related Articles, Links                               A review of associations between Crohn’s disease and consumption of sugars.                               Riordan AM, Ruxton CH, Hunter JO.                               Addenbrookes Hospital, Cambridge.                               OBJECTIVES: To critically review the available literature reporting associations between the onset of Crohn’s disease and intakes of sugars or sugar-containing foods. To evaluate                               published evidence on the use of dietary manipulation of sugars in the treatment of Crohn’s disease. DESIGN: All publications from refereed journals which reported intakes of                               sugars and sugar-containing foods in the context of Crohn’s disease onset or treatment were selected. CONCLUSION: Evidence suggesting a relationship between sugars and onset                               of Crohn’s disease was inconsistent and subject to important methodological limitations. There was a clear lack of distinction between reporting of current, as opposed to,                               retrospective intakes. There appeared to be no clinical advantage to the use of reduced sugar diets in Crohn’s disease treatment.

Response:

Again I see the important line as the last one: There appeared to be no clinical advantage to the use of reduced sugar diets in Crohn’s disease treatment. Debs Eur J Clin Nutr 1998 Apr;52(4):229-38   Related Articles, Links                               A review of associations between Crohn’s disease and consumption of sugars.                               Riordan AM, Ruxton CH, Hunter JO.                               Addenbrookes Hospital, Cambridge.                               OBJECTIVES: To critically review the available literature reporting associations between the onset of Crohn’s disease and intakes of sugars or sugar-containing foods. To evaluate                               published evidence on the use of dietary manipulation of sugars in the treatment of Crohn’s disease. DESIGN: All publications from refereed journals which reported intakes of                               sugars and sugar-containing foods in the context of Crohn’s disease onset or treatment were selected. CONCLUSION: Evidence suggesting a relationship between sugars and onset                               of Crohn’s disease was inconsistent and subject to important methodological limitations. There was a clear lack of distinction between reporting of current, as opposed to,                               retrospective intakes. There appeared to be no clinical advantage to the use of reduced sugar diets in Crohn’s disease treatment.

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Question:

Hmmm… interesting, but it does leave out a few drugs, like clarithromycin, salazopyrin and methotrexate. Sam

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A friend recently forwarded me an article about CD, I thought fellow Crohnies may find it interesting. Apologies if you already know about this, but I don’t usually read this newsgroup these days. http://pharmacotherapy.medscape.com/Medscape/CNO/1999/DDW/Story.cfm?stor y_id=678   Digestive Disease Week         Day 3 – May 18, 1999           Is It Time to Rethink Our Approach to Newly Diagnosed Crohn’s Disease?   Gary R. Lichtenstein, MD and Richard P. MacDermott, MD   In an American Gastroenterological Association clinical symposium on the role of immunomodulators for new onset Crohn’s disease, Dr. Bruce Sands of Massachusetts General Hospital outlined the problems with our current "step-up approach" to Crohn’s disease treatment.[1] The step-up approach is additive and often leads to a complex medical regimen. Furthermore, Dr. Sands pointed out that drugs which are ineffective are nevertheless continued. Dr. Sands stated that despite our current available medical therapy, the rate of surgery early in the course of Crohn’s disease is high. Finally, he noted that we are unable to predict a specific response any given individual may have to therapy. Dr. Sands then proceeded to review the current status of medical therapy for new onset Crohn’s disease. Azulfidine Since initially used to treat individuals with inflammatory bowel disease (IBD) in the 1930s, azulfidine has been the cornerstone of medical therapy in this setting. Azulfidine appears to provide benefits in patients with colonic (ie, ileocolonic and colonic) Crohn’s disease, but not in those with small bowel disease alone. Thus, the site of disease activity is important to know when administering azulfidine. These data are derived from the National Crohn’s Disease Cooperative Study and the European Cooperative Crohn’s Disease Study where a sum total of over 500 patients were assessed with active Crohn’s Disease. Doses of azulfidine ranging from 3 to 5 grams daily were more effective than placebo in these patient populations. Although azulfidine and steroids have been widely used for ulcerative colitis and Crohn’s disease for many years, recent clinical studies have clarified new approaches to IBD management strategies. Mesalamine Specifically designed mesalamine products have been developed in order to provide new ways of delivering 5-aminosalicylic acid (5-ASA) topically to specific sites of intestinal inflammation. The oral mesalamine agents have also been proven effective in individual patients with Crohn’s disease. The oral 5-ASA preparations are more effective in small bowel (ileal) Crohn’s disease than large bowel Crohn’s disease. Mesalamine compounds have also been shown to maintain remission in Crohn’s disease. Mesalamine agents are often not as effective in Crohn’s disease as in ulcerative colitis, perhaps because they are topically delivered to the mucosa. Recent observations have clearly demonstrated that oral mesalamine agents are able to prevent or delay both endoscopic and clinical recurrences of Crohn’s disease following resection and anastomosis. Use of 5-ASA for the prevention of the recurrence of Crohn’s disease following surgical resection has been evaluated using both endoscopic and clinical endpoints. Mucosal aphthous ulcerations, consistent with early Crohn’s disease, can be observed by colonoscopy in up to 90% of patients 1 year after surgical resection. Studies have been carried out using oral 5-ASA products to determine if endoscopic recurrence can be prevented. Blinded control trials have convincingly demonstrated that oral 5-ASA will reduce the endoscopic recurrence rate of Crohn’s disease post surgery. 5-ASA has also been observed to decrease the clinical (symptomatic) recurrence rate with the highest rate of prevention of clinical recurrence being in patients with large bowel or small bowel plus large bowel Crohn’s disease (with less effect observed in patients with disease of the small bowel only). Metronidazole Experimental and clinical evidence suggests that bacterial flora may play a role in the pathogenesis of IBD. Antibiotics, including metronidazole and ciprofloxacin, are being used very successfully in patients with active Crohn’s disease. Metronidazole can be effective in inducing remission in active Crohn’s colitis and in treating fistulae, sinus tracts, and abscesses that occur in Crohn’s disease involving the perineum. Metronidazole also decreases the endoscopic recurrence of aphthous ulcerations associated with early Crohn’s disease at the site of the anastomosis following intestinal resection for Crohn’s disease. For patients with perianal Crohn’s disease, higher doses of metronidazole for longer periods of time are often required and the relapse rate on withdrawal of therapy is high. Epigastric distress, nausea, anorexia, headaches, yeast infections, and a metallic taste in the mouth are common but reversible side effects of metronidazole. The patient must avoid alcohol while on this agent. Peripheral neuropathy from long-term administration of metronidazole (3 to 6 months at 750 mg/day or greater) is the most severe side effect. Neuropathy is a dose-cumulative side effect and is seen in one-third of patients. An additional one-third of patients may have subclinical neuropathy detected after formal neurologic testing. The neuropathy reverses very slowly (6 to 18 months) and sometimes only incompletely after metronidazole is discontinued. Therefore, every attempt should be made to keep long-term doses of metronidazole at less than 750 mg per day. Ciprofloxacin Ciprofloxacin is a very good alternative for Crohn’s disease patients with perineal disease or fistulae, who have either become refractory to metronidazole or who can no longer tolerate its side effects. Ciprofloxacin has been used successfully in the treatment of active Crohn’s disease with improvement in symptoms in 50-60% of patients. Combination Metronidazole and Ciprofloxacin Metronidazole plus ciprofloxacin has been examined for the treatment of active, refractory Crohn’s disease. In a comparison trial with steroids, ciprofloxacin, 500 mg bid plus metronidazole, 250 mg qid were evaluated. Ten out of 22 Crohn’s disease patients treated with antibiotics (45.5%) compared with 12 out of 19 Crohn’s disease patients treated with steroids (63%) obtained clinical remission as defined by a CDAI (Crohn’s Disease Activity Index) of less than 150. Therefore, ciprofloxacin plus metronidazole may be useful in some patients with active Crohn’s disease. Oral Steroids Corticosteroids modify almost every part of the inflammatory response, including cell-mediated immunity and the production of inflammatory mediators such as prostaglandins, leukotrienes, platelet activating factors, and cytokines. They are well established as being efficacious for the treatment of active Crohn’s disease, regardless of disease distribution. Most patients who are given oral steroids will have already received one or more 5-ASA medications, and either will not have responded or occasionally will have been intolerant. Oral steroids have been shown to be effective in moderate to severe active Crohn’s disease. There is no proven benefit of oral steroids in maintaining remission in this disease setting. Prednisone is the most commonly used oral steroid and is usually initiated at a dose of, at most, 40 mg per day. Dosage varies depending on the severity of the inflammation and the size of the patient. Initial prednisone therapy is usually continued for 2 to 3 weeks, by which time a successful response should be seen. Prednisone can then be slowly tapered by 5 to 10 mg, each 1 to 3 weeks. In Crohn’s colitis, adding sulfasalazine to corticosteroids does not result in better efficacy compared with corticosteroids alone. It is well established that there is no role for steroids in remission maintenance in Crohn’s disease. However, long-term alternate-day corticosteroid therapy, ie, 20-25 mg of prednisone qod, may be useful in patients with refractory Crohn’s disease. Steroids do not prevent relapses of disease. Many patients who respond to the prednisone at higher doses often have a flare of their symptoms as the drug is tapered. These steroid-dependent and/or steroid-refractory Crohn’s disease patients are the most at risk for long-term steroid side effects, and every effort must be made to find a way to treat their IBD without steroids. Our current strategy is to use 6-mercaptopurine (6-MP) or azathioprine for steroid dependent patients who can then have their steroids tapered. Patients with severe to fulminant Crohn’s disease require hospitalization. In addition to receiving intravenous fluids and electrolytes, being made NPO, being given intravenous nutrition, and usually being placed on antibiotics, severely ill Crohn’s disease patients should be treated with high doses of intravenous steroids — either hydrocortisone at a dose of up to 300 mg per day or methylprednisolone at a dose of up to 60 mg per day. The same steroid dose can be given in divided boluses or as continuous infusions. There has been no trial to date which has compared the efficacy of continuous versus divided dosage infusions. Once improvement is achieved, patients can be switched to an oral steroid, such as prednisone, 40 mg per day, which can then be gradually tapered. The beneficial effects of corticosteroids are counterbalanced by side effects that are frequently seen with their prolonged use. Insomnia, hyperactivity, night sweats, and hyperglycemia are common side effects with high steroid doses. With long-term steroids, even at lower doses (ie, prednisone at a dose of 10 mg), a moon face, acne, development of a fatty (buffalo) hump at the base of the neck, and excessive hair growth are often noted. The use of systemic corticosteroids is severely limited by the more serious side effects, such as … read more »

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Question:

Do you know what any of the side effects are? And where is this drug coming from what research hospital? Thanks

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I may be participating in a study on this drug — or another like it — here in southside Virginia. I will be meeting with the clinic in South Boston on June 8. I’ll try to provide as much info about this as I can. I have also heard that other trials were being conducted in Fairfax, Va and in Georgetown, but the clinic could not give me any details on those studies. Steve – Hide quoted text — Show quoted text – Do you know what any of the side effects are? And where is this drug coming from what research hospital? Thanks

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U.S. FDA panel recommends Crohn’s disease treatment  By Patrick Connole WASHINGTON, May 28 (Reuters) – A new way of treating the intestinal inflammation caused by Crohn’s disease won backing on Thursday from a U.S. Food and Drug Administration advisory panel, which recommended it be granted regulatory approval. The FDA’s gastrointestinal drugs committee found that  Centocor Inc.’s <CNTO.O Avakine, was effective in reducing the fistulas, or small holes in the intestine wall, often caused by the disease. The FDA is not bound by the opinions of its advisory panels but usually follows them when deciding whether to approve a new drug or therapy. Avakine is a monoclonal antibody treatment that moderates the inflammatory response of cells in the intestinal tract. Antibodies are natural immune system proteins. Crohn’s disease affects about one million people in the United States and Europe. Although the disease may come and go over a lifetime, the condition is serious for many sufferers. More than half of patients eventually require surgery for removal of parts of their bowels. There is no known cure. Current Crohn’s therapies include antibiotics and anti-inflammatory drugs. But most treatments either decrease in effectiveness over time or have side effects associated with long-term use. The advisory panel recommended Avakine for treatment of moderate to severe Crohn’s disease despite some reservations about its long-term effectiveness. "The data is quite good in my mind that it works acutely (initially)," said panel member Loren Laine, a professor of medicine at the University of Southern California. Lee Simon from Harvard Medical School said the long-term impact of taking the drug worried him. "You can’t think of biological therapies in the same way we think about drugs," he said. But Sidney Getz, a patient representative on the committee, said Crohn’s sufferers were anxious for any effective therapy. "I don’t think you’d find any Crohn’s patient that would say no," to trying this drug. "It is no less safe than any of the other drugs we take," said Getz. Centocor presented results of two studies to the committee. In the first, 65 percent of patients showed improvement following a single infusion of the antibody. In a second study of 94 patients with draining fistulas, three treatments over six weeks saw 62 percent of Avakine-treated patients experience closure of at least half of fistulas for at least a month compared with 26 percent of patients treated with a placebo. In the same trial, 46 percent of Avakine-treated patients experienced closure of all their fistulas compared with 13 percent of placebo patients. Further studies are under way to establish whether the initial success of Avakine is sustained with further treatments over a longer period.   22:11 05-28-98

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