For some reason the top two links weren't working for me, so I've included the names and publications of those studies for making the case in the doctor's office documenting Crohn's improvement for LDN:
-American Journal of Gastroenterology, January 2007 issue: "Low-Dose Naltrexone Therapy Improves Active Crohn's Disease" by Jill Smith
-Digestive Diseases and Sciences Journal, 17 February 2011 (published online 08 March 2011): "Therapy with the Opioid Antagonist Naltrexone Promotes Mucosal Healing in Active Crohn's Disease: A Randomized Placebo-Controlled Trial" by Jill Smith
-Journal of Clinical Gastroenterology: April 2013 - Volume 47 - Issue 4 - p 339to 345, doi: 10.1097/MCG.0b013e3182702f2b ALIMENTARY TRACT: Original Articles
"Safety and Tolerability of Low-dose Naltrexone Therapy in Children With Moderate to Severe Crohn’s Disease: A Pilot Study"
Smith, Jill P. MD*; Field, Douglas MD†; Bingaman, Sandra I. RN*; Evans, Robert MD*; Mauger, David T. PhD‡ (*this full study can be viewed/downloaded below by logging into this site and clicking Ctrlz's .pdf posting below...* Here's the abstract:
http://www.ncbi.nlm.nih.gov/pubmed/23188075?dopt=Abstract )
-Here is the link to the phase III trial info and the company buying LDN patents:
http://www.tnibiotech.com/investor-...ammatory-and-ulcerative-diseases-of-the-bowel
The first one proves safety and improvement, to satisfy Phase 1 requirements on the road to AMA acceptance. The second study (for Phase 2) is the vaunted "randomized placebo-controlled trial" which should get the well-heeled, conditioned gastro-docs salivating like Pavlov's dogs. Granted, these aren't very extensive studies, and LDN isn't a cure-all. Any reasonable GI doc should agree that, in the very least, "it can't hurt"--such is the nature of this low dose. The studies needed to get through the 4 phases are not cheap and hopefully Penn State is continuing the process but at this rate acceptance by the AMA will take a few more years, at least (my guess). Actually, it appears J. Smith is currently doing a Vit D/Crohn's study, so who knows how long it will take for approval? *UPDATE*: As the posting above indicates, TNI Biotech is ?apparently? going through the steps to gain the patents and final phases to market the drug for new, specific purposes (including Crohn's) under their proprietary name IR-103.
An issue with many Crohnnies is confirming the filler when LDN is compounded down to a 4.5mg tablet. Lactose and even acidophilus fillers have been reported to cause upset or counteract its effects.
The following excerpt was taken from
http://www.lowdosenaltrexone.org/ :
"Reports have been received from patients that their pharmacies have been supplying a slow-release form of naltrexone. Pharmacies should be instructed NOT to provide LDN in an "SR" or slow-release or timed-release form. Unless the low dose of naltrexone is in an unaltered form, which permits it to reach a prompt "spike" in the blood stream, its therapeutic effects may be inhibited.
Fillers. Capsules of LDN necessarily contain a substantial percentage of neutral inactive filler. Experiments by the compounding pharmacist, Dr. Skip Lenz, have demonstrated that the use of calcium carbonate as a filler WILL interfere with absorption of the LDN capsule. Therefore, it is suggested that calcium carbonate filler not be employed in compounding LDN capsules. He recommends either Avicel, lactose (if lactose intolerance is not a problem), or sucrose fillers as useful fast-release fillers.
> IMPORTANT: Make sure to fill your Rx at a compounding pharmacy that has a reputation for consistent reliability in the quality of the LDN it delivers.
The FDA has found a significant error rate in compounded prescriptions produced at randomly selected pharmacies. Dr. Bihari has reported seeing adverse effects from this problem. Please see our report, Reliability Problem With Compounding Pharmacies. Please see the above list of recommended pharmacies for some suggested sources."
*I would point out that creams are available and seem to be helpful for child dosages. Surf the LDN thread or Parents of Kids w/IBD threads for child dosing.
I would print out both the above studies and explain the drug is a cheap generic for an off label use--cute pharma sales reps aren't going to be inundating his/her office with pretty graphs and selectively picked, company funded studies that minimize risks and exagerate benefits of LDN. My LDN is $45 for 90 days--cheap for a Crohn's med, eh!? No matter how beneficial (though it is not a cure, early studies show it halts progression in 80+% of users and roughly 45+% of those actually show mucosal healing) LDN may be, there is no money to be made on behalf of drug companies.
Most experiences on the site, including my own, lead me to believe LDN is best used in conjunction with individual dietary/supplement regimens as a means to halt progression. Going from memory, some correspondence has been made with Jill Smith confirming LDN's efficacy in conjunction with most other Crohn's meds, also. However, do your own fact checking on possible interactions with anti-TNF biologics--the use of these were not allowed in her trials, though most other Crohn's protocols were. Surfing around others' anecdotes *seems* to conclude that LDN is OK for 10mg, or less, of Prednisone--look around and think for yourself.
*Go to this audio file and skip to 23 minute mark for Jill Smith's info pertaining to the first human trial above, the Q & A section at the end is also thought provoking:
http://www.lowdosenaltrexone.org/_conf2006/J_Smith.mp3
More sites:
http://www.webspawner.com/users/ldnforcrohns/ http://www.ldnscience.org/ http://www.lowdosenaltrexone.org http://www.ldners.org/
Thanks to Jmrogers4 and Ctrlz for info lifted for casual visitors' sake of this thread.
