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Crohn's Disease
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Posted 5/5/2010 6:32 PM (GMT 0)

For those (it seems many!) following research on naltrexone, an abstract of the latest study has been posted in the material for Digestive Disease Week. My take (from the point of view of someone who is not a medical doctor but who has read thousands of clinical studies): this is starting to look promising, although the data is still very limited. There are three important pieces of data in this abstract:

 

1. Clinical remission rate after 12 weeks of treatment was 45%. That places the efficacy within the upper end of the realm achieved with the placebo-controlled studies of the mesalamine drugs (Pentasa, Asacol), which show remission rates of 30 to 45% after around the same time period.

            Missing information: The abstract does not give the clinical remission rate with placebo. This is important because there is often a high placebo remission rate in trials of this length and longer. If the placebo remission rate was 25 or 30%, then we're looking at a product that is showing a clinically significant, not just statistically significant, benefit over placebo. If the placebo remission rate was high, say 40%, then the results are less impressive.

 

2. What they call "endoscopy and histology inflammatory scores" improved significantly compared with placebo. I'd like a little bit more detail on how they scored this, but still, showing any endoscopic or histologic improvement is strong evidence that the medication being tested is having a clinically useful effect.

 

3. There was no significant difference between the two groups in "laboratory tests for safety." This is promising for the short-term safety of the medication, although they will have to evaluate long-term safety data.

 

There is no indication whether the laboratory values tested included erythrocyte sedimentation rate (ESR) or C-reactive protein. One would hope to see a significant drop in both in conjunction with the endoscopic and histologic improvement. I will be interested to see if any of these questions are answered in reports on the meeting. Now, what you have been waiting for, the abstract: http://download.abstractcentral.com/DDW2010/myddw/646.html

Posted 5/6/2010 4:20 PM (GMT 0)
Thank you Writer,
for trying to translate this abstract, and well, I have to say that this is interesting.
Not quite as impressive a result as the first study but at least as good as many other treatments and with a lot, lot less side effects (Only reversible liver enzyme changes reported)...

I have used LDN for 3 years, and I have not been in full remission, I honestly don't know exactly how being in remission is like. But LDN is the only medication I have used for 3 years. I have no diarrhea, I have no pain, I have no anemia or cramps. I have no stomach discomfort either. Now and then during these 3 years I have got a partial obstruction and a small flare, and then I have used only 10 mg prednisone and lower to stop the flare. I have used it for 7 - 10 days and then slowly tapered from 10 to 5 mg and 5 mg every second day, third day, and then stopped. In total 3 app. 3 weeks.

Vitamin D, zink, selenium and omega 3./ Bee
Posted 5/6/2010 4:59 PM (GMT 0)
Allow me to add my Thanks,

I know Dr Smith is having issues getting her results published in the NEJM, read on yahoo group.

May I ask for the source of this, I'd like to send it to my doctors too, actually, I'd like the report to be published or at least accessible....

Thanks again :)
Posted 5/7/2010 2:09 AM (GMT 0)
Deserves a bump, although I'm too tired to really take this in.

Funnily enough, I picked up a leaflet from the hospital yesterday about trials for LDN and autoimmune diseases (including, of course, Crohn's). If I wasn't about to embark on a new med regime I'd be tempted to call the number.

And now I'm off to bed before I drop off the chair >_>
Posted 5/7/2010 4:36 AM (GMT 0)
6 weeks in, minimal side effects and I am feeling better both in my gut and my crohnsie shoulder. Whoo! Finally a drug that works for me, weeeee!

Now for this f*ng abscessed fistula, sigh...
Posted 5/7/2010 4:51 AM (GMT 0)
Glad to hear it! It seems like joint pains are often the first to go with people on LDN.

As far as the safety of the drug, I feel pretty good about it, since it was approved ages ago at the 50 mg dosage. At the low doses we take the drug, there shouldn't be much of an issue at all. I didn't even get insomnia, which seems to be the main side effect reported.
Posted 5/7/2010 5:29 AM (GMT 0)
I do, but then I don't sleep well when I am not eating enough and I am sleeping better than when I'm in pain. But hey, I am amusing myself at.. 1:30 am.. man I need to sleep.

:)
Posted 5/7/2010 2:32 PM (GMT 0)
Thanks for the thanks, all. I'm glad it was helpful.

MToronto2,

With regard to your question about the source of the abstract, it is one of those that will be presented at Digestive Week 2010, and you can search the abstracts from this page: http://www.ddw.org/wmspage.cfm?parm1=603

Conference abstracts are just that, abstracts, so if the researcher wants to publish more information, then he/she has to submit a full paper to a journal. Gastroenterology and Gut are the two that come to mind that would have particular interests in research of this nature. Getting in to NEJM I'm sure would be much tougher, not because the research isn't interesting, but because the study only had 40 patients, and they tend to focus on large, definitive studies given the number of topics they need to cover and the large volume of submissions.

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