Below is an abstract for a placebo controlled double blind study of LDN in Crohn's published in 2011 in Dig Dis Sci, a mainstream GI journal. The full article is here:
http://crohnsdad.files.wordpress.com/2011/12/ldncrohns2011.pdf
I believe it is the best evidence to take to a doctor if you want to try LDN.
Therapy with the Opioid Antagonist Naltrexone Promotes
Mucosal Healing in Active Crohn’s Disease: A Randomized
Placebo-Controlled Trial
Jill P. Smith • Sandra I. Bingaman • Francesca Ruggiero •
David T. Mauger • Aparna Mukherjee •
Christopher O. McGovern • Ian S. Zagon
Received: 9 August 2010 / Accepted: 17 February 2011
Springer Science+Business Media, LLC 2011
Abstract
Background Endogenous opioid peptides have been
shown to play a role in the development and/or perpetuation
of inflammation. We hypothesize that the endogenous
opioid system is involved in inflammatory bowel disease,
and antagonism of the opioid–opioid receptor will lead to
reversal of inflammation.
Aims A randomized double-blind placebo-controlled
study was designed to test the efficacy and safety of an
opioid antagonist for 12 weeks in adults with active
Crohn’s disease.
Methods Forty subjects with active Crohn’s disease were
enrolled in the study. Randomized patients received daily
oral administration of 4.5-mg naltrexone or placebo. Providers
and patients were masked to treatment assignment.
The primary outcome was the proportion of subjects in
each arm with a 70-point decline in Crohn’s Disease
Activity Index score (CDAI). The secondary outcome
included mucosal healing based upon colonoscopy
appearance and histology.
Results Eighty-eight percent of those treated with naltrexone
had at least a 70-point decline in CDAI scores
compared to 40% of placebo-treated patients (p = 0.009).
After 12 weeks, 78% of subjects treated with naltrexone
exhibited an endoscopic response as indicated by a 5-point
decline in the Crohn’s disease endoscopy index severity
score (CDEIS) from baseline compared to 28% response in
placebo-treated controls (p = 0.008), and 33% achieved
remission with a CDEIS score <6, whereas only 8% of
those on placebo showed the same change. Fatigue was the
only side effect reported that was significantly greater in
subjects receiving placebo.
Conclusions Naltrexone improves clinical and inflammatory
activity of subjects with moderate to severe
Crohn’s disease compared to placebo-treated controls.
Strategies to alter the endogenous opioid system provide
promise for the treatment of Crohn’s disease.
This is from the side effect section of the paper:
"Side Effects and Toxicity
The incidence of side effects reported during the study is
shown in Table 2. Although some side effects were frequently
reported (insomnia, diarrhea, pain) there was no
difference in the incidence of these complaints between
patients receiving naltrexone compared to placebo. The
only side effect reported with increased frequency in placebo-
treated subjects compared to naltrexone-treated
patients was fatigue (p = 0.04). Two patients exhibited a
flare of Crohn’s disease with worsening of gastrointestinal
symptoms during the first month of the study. One patient
had been randomized to naltrexone and was rescued with
steroids and withdrawn from the study. The other patient
was in the placebo arm and was crossed over prematurely
to naltrexone therapy; his symptoms responded to naltrexone,
and he successfully completed the study with
significant improvement. One patient with reflux sympathetic
dystrophy experienced aggravation of her neurogenic
pain on naltrexone suggesting an interaction with the opioid
receptors on nerve tissue. Two patients had transient
elevation in liver transaminases on naltrexone which
resolved the following month. In one of these patients the
liver enzyme increase coincided with a respiratory
infection."
Here's the table:
Table 2 Number of patients reporting side effects
Side effect/symptom Placebo Naltrexone p value
Insomnia 5 5 0.3
Unusual dreams 3 2 0.3
Headache 2 4 1.0
Flatulence 5 6 0.5
Loss of appetite 0 2 0.6
Vomiting 1 3 1.0
Diarrhea 5 7 0.7
Abdominal pain 5 5 0.3
Nausea 4 4 0.5
Hair loss 1 0 1.0
Fatigue 3 0 0.04*
Constipation 0 2 0.6
Hair growth 0 1 1.0
* Statistically significant (p\0.05)
