Positive Results on first US trial of LDN (for Crohn's)

[lady_express_44]

This is all over the MS boards already, but I didn't notice it here yet . . . so I thought I'd post it.

First Formal Low Dose Naltrexone Study Results to be Presented

May 21st, 2006 will be a red letter day for users of Low Dose Naltrexone (LDN). That is when the *first* formal trial results of an LDN study will be presented, to an audience at the Digestive Disease Week Conference being held in Los Angeles, California USA.

This trial was held on 17 patients who have active Crohn's Disease, and consisted of oral administration of 4.5mgs of naltrexone nightly for 12 weeks. Crohn's is an inflammatory bowel disorder (IBD)-- considered to be auto-immune-- that, along with its partner illness ulcerative colitis, has been linked with multiple sclerosis (IBD'ers are 1.7 times as likely to have MS than controls). Crohn's patients have a relapsing-remitting course disease, with periods of flareups and remission that are all too familiar to MS'ers. Also, remember that the MS-therapy-in-waiting Tysabri was being tested in parallel with Crohn's patients with promising results. As such, the impact of LDN on Crohn's patients likely has some relevance to MS'ers.

The results of the study are intriguing. 15 patients demonstrated some positive response (using a numeric scale called the Crohn's Disease Activity Index), and 11 went into remission. Quality of life was reported to have improved significantly and no abnormal side effects were noted in the lab work.

Now there are a few obvious and significant problems with this trial, which members of This is MS are probably adept at quickly identifying by now. First, this was a very small trial held over a short period of time. Second, and more importantly, there were no controls patients- this was an open label study and everyone knew that they were taking LDN, so the placebo effect cannot be entirely excluded. Finally, the gold standard of Crohn's diagnosis and evaluation is endoscopy (or direct imaging of the digestive tract). That methodology was not part of the trial constructs, which instead had to rely on necessarily less accurate questionnaires and laboratory studies. Incidentally, one patient had an endoscopic procedure unrelated to the trial, and demonstrated healing of the digestive tract.

On the other hand, the results are clearly very positive (and include improvements on quality of life parameters), low dose naltrexone is affordable and easy to administer, and negative physiological effects (limited to what can be detected with bloodwork) were not seen for the 3 month duration of the trial. Certainly, for those looking for an adjunct therapy, this trial-- even with its rather significant flaws-- might be something worthwhile to discuss with your doctor.

On an aside, we also cannot help but congratulate the LDN community on achieving this rather significant milestone. Hopefully this will tip the scales for a larger and placebo-controlled trial for the utility of low dose naltrexone in multiple sclerosis patients.

--For the full abstract, go to http://www.thisisms.com/