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Crohn's Disease Forum » Treatment » Low Dose Naltrexone » Low Dose Naltrexone Studies and Links


01-13-2012, 12:43 AM   #1
DustyKat
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Low Dose Naltrexone Studies and Links

Here are the two studies conducted by Pennsylvania State:

Low Dose Naltrexone Crohn's Study One
Low Dose Naltrexone Crohn's Study Two
Low Dose Naltrexone in Children

Other links to the same data:

http://www.ncbi.nlm.nih.gov/pubmed/17222320

http://www.sciencedaily.com/releases...0902133047.htm

Please add any reputable links to this thread that you think may be of benefit to those visiting this forum.

Dusty.
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01-13-2012, 12:58 AM   #2
DustyKat
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I have seen that quite few members also suffer with Fibromyalgia...

Naltrexone May Ease Fibromyalgia Symptoms

April 17, 2009 -- An inexpensive drug called naltrexone may make a good treatment for fibromyalgia, report researchers at Stanford University.

Naltrexone isn't a new drug; it's been around for more than 30 years and is used to treat opioid addiction.

Stanford's Jarred Younger, PhD, and Sean Mackey, MD, PhD, tested a low dose of naltrexone as a fibromyalgia treatment in 10 women who had had fibromyalgia for about 10 years, on average.

First, the women spent two weeks recording the severity of their fibromyalgia symptoms every day using a handheld computer. And they took lab tests to gauge their fibromyalgia pain and sensitivity to heat and cold.

After that, the women took a placebo pill every day for two weeks, but they didn't know it was a placebo pill. At the end of the placebo period, the women took a naltrexone pill once a day for eight weeks. Finally, they spent the last two weeks of the study not taking naltrexone or the placebo.

All along, the women continued to rate their fibromyalgia symptoms every day, and they repeated their lab tests every two weeks.

While taking the placebo, the women reported a 2.3% drop in the severity of their fibromyalgia symptoms, compared to their symptom ratings at the start of the study.

When they switched from the placebo to naltrexone, they reported an additional 30% drop in their fibromyalgia symptom severity.

The women also showed greater tolerance for pain and for hot (but not cold) temperatures while taking naltrexone.

Most of the women -- six out of 10 -- responded to naltrexone.

Side effects were mild and brief.

Two women reported having more vivid dreams during the study, and one woman reported transient nausea and insomnia during the first few nights of taking the pills, note Younger and Mackey.

The study, which appears online in Pain Medicine, was a small, preliminary project to see if low-dose naltrexone showed promise. It did, so Younger and Mackey are already working on a new study that will test low-dose naltrexone in 30 fibromyalgia patients for 16 weeks.

Article: http://www.webmd.com/fibromyalgia/ne...src=RSS_PUBLIC

Dusty.
01-13-2012, 01:10 AM   #3
DustyKat
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Low Dose Naltrexone: Side Effects and Efficacy in Gastrointestinal Disorders:

http://www.gidoctor.net/client_files...-Disorders.pdf

Dusty.
01-27-2012, 11:33 PM   #4
Alanschachter
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Here is the PDF for the complete Penn State Clinical trial http://crohnsdad.files.wordpress.com...crohns2011.pdf
02-12-2012, 10:36 PM   #5
mnsun
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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/2...?dopt=Abstract )

-Here is the link to the phase III trial info and the company buying LDN patents:
http://www.tnibiotech.com/investor-r...s-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.
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Last edited by mnsun; 07-23-2013 at 04:19 PM.
02-13-2012, 08:44 AM   #6
Alanschachter
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Here is the most recent published article from Ian Zagon, lead researcher at Penn State, discussing why LDN works for Crohn's

Targeting opioid signaling in Crohn’s disease: new therapeutic pathways Expert Rev. Gastroenterol. Hepatol. 5(5), 555–558 (2011)
02-21-2012, 07:35 AM   #7
ljelen
 
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I have only been able to find one study relating to LDN and Crohn's. Both of these links relate to that study carried out at Pennsylvania State University...

Dusty.
I participated in the 2009 Penn State study. My CDAI went from 425 to below 150, which is considered a success. Relief came in the first week of starting LDN. I'm still taking it in 2012 and it's still working.
02-21-2012, 08:47 AM   #8
Alanschachter
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My 18 year old Daughter with Crohn's has been on LDN for the past 2 years now. Latest blood results show an ESR of 18, CRP of .56 and she is symptom free. No side effects. Doctor doesn't want to see her for a year. Not bad for $250/year from Skips!
02-23-2012, 02:15 PM   #9
ljelen
 
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. Not bad for $250/year from Skips!
I found I could order all the refills on a prescription at once from Skips and pay only one shipping fee. That's the advantage of paying cash.
02-23-2012, 02:40 PM   #10
ljelen
 
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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.
(Clarified for personal experience.)
During the Penn State clinical study, I took LDN at night and prednisone in one dose in the morning so I could get the benefit of both without adverse interactions between them. I was not permitted to try to wean off the prednisone during the study. Since TNF inhibitors work 24/7, the interactions between the two would have confounded the Penn State clinical study results and made them useless. After the study was completed, I tried to wean off prendisone and was unable to. I'm still taking both. Every attempt to wean off prednisone has failed.

Last edited by ljelen; 02-23-2012 at 03:34 PM. Reason: Clarified for personal experience
02-23-2012, 02:48 PM   #11
Alanschachter
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Just to clarify. The Naltrexone blocks your opioid receptors for about 4 hours while you sleep, this creates an endorphin rebound that carries you through the rest of the day. While you may see some benefit while taking with prednisone, you should see even more without it. Most suggest using LDN while on 10mg or less of prednisone. On the other hand, there are many using LDN with biologics with good success. They do not counteract each other.
03-03-2012, 08:20 PM   #12
Alanschachter
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http://www.medscape.com/viewarticle/759253?src=stfb

Confirmation: Low-Dose Naltrexone Eases Fibromyalgia Pain - Stanford double blind study.
03-10-2012, 06:29 AM   #13
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Hey Dusty,

Do you know of any doctors in Australia who prescribe LDN?

Cheers
Sharyn
03-10-2012, 06:51 AM   #14
DustyKat
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No, sorry I don't as I haven't been down this treatment path. There is a compounding pharmacy in SA. Maybe you could ring or email them and see if they will provide you with some information on what sort of conditions it is being prescribed for and what MD's are prescribing it. Worth a try I reckon...

Antony Condina (per Judy Rice)
Compounding Pharmacist
The Green Dispensary Compounding Pharmacy
46 Beulah Rd
Norwood SA 5067
Tel (08) 83637322
Fax (08) 83637244
[email protected]
http://www.greendispensary.com
Good luck!

Dusty. xxx
07-10-2012, 01:46 PM   #15
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How long should i allow LDN, my consultant (GI) is only using it for me as i pushed for it, and has no previous experience. It keeps telling me to up the dose, and as i haven't seen any results with my abcess/fissturla's clearing up i've gone along with it. I'm now on 25mg per day started at 2.5mg.

The reason i got my abcess is because of anti-TNF drugs (infliximab) so i don't want to go down that route again.
09-01-2012, 07:17 PM   #16
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Is LDN effective for Ankylosing Spondylitis? I may be prescribed Humira in the next week which, to according the experts, is supposed to treat both "maladies".
09-02-2012, 08:02 PM   #17
David
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Both studies are now linked in the first post.
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11-07-2012, 11:56 AM   #18
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Which study or information would be the best to take to a gi who isnt open to other treatments? And if he's not interested, maybe I can take it to our d.o.

best info would be from another dr or medical institution
11-07-2012, 12:32 PM   #19
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Has anyone gotten into remission from using LDN? I have been considering it and still am. Really not liking the options of other drugs such as biologics, but was dx in August with severe Crohn's. Tapering off Prednisone has been a struggle, am steady at 8mg now, going lower symptoms creep back immediately. My Naturopath would be hapy to prescribe it if I really want to, however has never had a Crohn's patient on it...I also tried the chinese herbs that were promising, but I couldn't tolerate them :-(
11-07-2012, 12:50 PM   #20
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Mattannika, Kev has several threads throughout the forum about utilizing LDN and he has good results. I think one of the threads he mentions being in remission for 5 years but it could be longer.
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11-07-2012, 08:25 PM   #21
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Hi all. I have been symptom free since starting LDN 5 years ago. LDN has provided me a rock solid performance... thru hi's N low's, stressors off the scale, you name it. It literally has saved my life... (and no, I'm not speaking figuratively). However, I do not consider it 'remission'. Same as I wouldn't consider treating diabetes with insulin as being in remission from that disease. Stop taking either drug, and those respective diseases come back full throttle. I have had periods of remission... where my symptoms/disease seemed to just go away without my using any medications at all. That is what I consider 'remission'.. My definition may not conform to the textbook definition of remission. I guess it all depends on how you look at it. In any event, I'll keep taking my LDN. At least until somebody comes up with a better solution. I'm not going to hold my breath on that one. Personally, I don't think there is a better option.
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01-02-2013, 12:57 AM   #22
ctrl z
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Here is the full paper for LDN for children
Attached Files
File Type: pdf 00004836-900000000-98944.pdf (218.4 KB, 130 views)
03-09-2013, 10:01 PM   #23
ljelen
 
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[I'm now on 25mg per day started at 2.5mg.


The usual adult dose is 4.5 mg. Anything over this is counterproductive. LDN must be compounded with a fast-release filler such as Avicel. Skip's Pharmacy in Boca Raton, FL is experienced in compounding LDN. Send them a prescription for 4.5 mg LDN and they'll fill it right.

Good luck!
08-07-2013, 04:46 PM   #24
Jmrogers4
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More information about Phase III trials hopefully coming in early 2014
http://www.tnibiotech.com/investor-r...rohn-s-disease
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Vitamin D -2000mg
Remicade - started 1/9/14; 7.5ml/kg every 6 weeks
Centrum for Him teen multivitamin
Past meds: Imuran/Azathioprine; allopurinol; methotrexate; LDN; Prednisone; Apriso; Pentasa; EEN

Husband dx Crohn's 3/1993
currently none due to liver issues
08-08-2013, 09:20 PM   #25
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oh that IS exciting news. Thanks for posting!
06-08-2014, 10:19 AM   #26
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How long should i allow LDN, my consultant (GI) is only using it for me as i pushed for it, and has no previous experience. It keeps telling me to up the dose, and as i haven't seen any results with my abscess/fissturla's clearing up i've gone along with it. I'm now on 25mg per day started at 2.5mg.

The reason i got my abscess is because of anti-TNF drugs (infliximab) so i don't want to go down that route again.
Did the LDN help clear up your abscesses & fistulas?
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10-21-2014, 07:43 AM   #27
jdawg
 
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I agree. Very exciting. Many doctors are stilvery reticent about prescribing, but maybe that will change with time.
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