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What does remission mean in clinical trials?

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Ulcerative Colitis
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Posted 2/5/2013 9:20 AM (GMT 0)
When clinical trials say x% achieved remission, does that mean no blood or mucus, normal BM frequency (1-2/day) with well formed stools, scopy indicating no inflammation? Or is remission to them no bleeding and thats it?

Why cant clinical trials also give us an idea of what the diet of the folks who achieved remission was like? Not to form any conclusions, but to give others an idea as to what diet could do?

This is my second post and In my first post I had ranted about having many urgent BMs in a day without blood or mucus. I am on 5ASAs. That is not remission for me as I am still stuck in my home. If clinical trial participants have everything normal why is such complete remission not achieved by many of us here even after changing our diets?
Posted 2/5/2013 9:51 AM (GMT 0)
It depends on the definition of remission.
Most of clinical trials declare the clinical remission as a primary endpoint.

Clinical remission for UC means not more than 3 BM per day, no blood, no urgency, no extraintestinal symptoms etc.

Another definition is the endoscopic remission (ER), another the mucosal healing.
(For ER there are also different definitions, first one is no lesion at all or scarred lesions, second definition is minor lesion at most.
But even for mucosal healing (MC) there is currently no validated definition of what constitutes MC in IBD.)

These different definitions make it difficult to compare clinical trials.


For CD the crohns disease activity index (CDAI) is a measurement of remission (should be less than 150).

Post Edited (emboodoo) : 2/5/2013 2:58:06 AM (GMT-7)

Posted 2/5/2013 9:59 AM (GMT 0)
Thanks emboodoo for that reply.

So I am still confused as to why wont I get normal BMs from my meds (5ASAs) when they clearly seemed to have helped me in keeping blood free. darn you 5ASAs!
Posted 2/5/2013 10:21 AM (GMT 0)
..one possible side effect of mesalazin (5ASas) is diarrhea...
Posted 2/5/2013 11:05 AM (GMT 0)
You could always write the investigators and ask the questions you like.
Posted 2/5/2013 2:31 PM (GMT 0)
Found a simple yet detailed answer to my own question - http://www.medscape.com/viewarticle/746144_1
Posted 2/5/2013 2:45 PM (GMT 0)
seems to be a membership required link.

Good questions, and I feel/live your frustration.

Anyway, you need to consider that in those trials it is typically 11% to 35% (more than placebo, so 30% to 63% 'ish) who get remission - usually defined by a score on some colitis rating scale of <2. There might be several ways to get <2 with some still having traces of frequency.

So this means that 35% to 70% get no remission. Yet you ask why aren't the pills working. You further speculate it is diet.

I am annoyed that I am in the sizable group that studies show do not get remission on 1st line drugs. I even wonder if some studies showing lower success rates got suppressed. But I am grateful for the relief I have gotten.

I have fairly strong scoping evidence that over 18 months 5-asa (the only medication I was on at the time) cleared my right and transverse colon. Do I want more? Hell yes. Do I damm 5-asa that gave me this gift? Hell no.

Also consider that the folks who responded and got remission, or who got noticeable clinical improvement, generally don't end up here. THis place is selection biased towards those who did not respond, or those who did not want medications, or those who might have multiple morbidities (e.g., IBS) in addition to IBD.

It is not such a puzzle why so many here have not gotten full remission. It is only a puzzle (to be solved by more research) why the cases that do not respond didn't.

Keep asking the good questions, but examine how you frame them.
Posted 2/5/2013 3:08 PM (GMT 0)
I hate to be negative but I doubt diet played a major role in too many of the cases. People who go into clinical trials typically haven't responded to other treatments, diet included. I went into a trial when I was uninsured and nothing was working for me, did I try diet first? yes, of course. I was on the strictest diet and I didn't see even a slight improvement in my condition.

I think remission in a trial means no signs of inflammation. The trial I was in had a colonoscopy at the start and one at the end to check for inflammation. I ended up unable to participate. I think you would have to ask the administrator of the trial for more details on how they are determining remission.
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