Low Dose Naltrexone for Crohn's: The No-Brainer Case For The FDA

         
           (This picture is of a colonscopy of a before and after of a Crohn's patient who took LDN)

So in a prior post I discussed low dose naltrexone (LDN). LDN was first introduced in 1984 for people with alcohol dependence. The drug has been shown to reduce the relapse rates. What inspired me to write this post was I saw this recent story that talked about how drug company TNI BioTech met with the FDA and Phase III trials may start as early as first quarter in 2014.

The evidence for low dose naltrexone is pretty convincing in terms of being both effective and safer than the current alternativies of Humira, Remicade, and other drugs. This land mark study from Dr. Jill Smith at Penn State University showed that 67% of people went into remission. 89% of patients showed a clinical response which is similar to the rates of Humira and Remicade (however the only real side effects with LDN is vivid dreams and fatigue). In 2011, this study was done by Smith and her colleagues which found that 78% of patients showed an endoscopic response. 88% of patients who took the LDN showed a 70 point decline in their CDAI score (which is a significant decrease). The only side effect was fatigue.

A recent study from April 2013 in children showed that low dose naltrexone was safe and showed reduced activity for Crohn’s patients. However, only 25% of children (between 8-17 years of age) went into remission, however 67% showed improvement. Here is a case study of a 14 year old girl who had Crohn's and pain for 3 years. After a month of taking 4.5 mg of low dose naltrexone she improved. An EGD (esophagogastroduodenoscopy) showed complete muscoal healing and normal biopsies which is quite impressive.

LDN has been shown to be useful in other treatments like multiple sclerosis, prolonging the live of pancreatic cancer patients, and may even help people with HIV and AIDS. There is no question some more studies have to be done on what LDN can exactly help.

Why on earth is this drug still not approved for Crohn's? I would suggest the FDA talk to patients with Crohn's and see how they currently feel given the current state of options in the Crohn's world. Low dose naltrexone seems to show help patients with minimal side effects compared to Humira, Remicade, Enbrel, 6-MP and any other drugs you want to compare it to. The initial study for LDN on Crohn's was done in 2007. So why is it taking 7 years to now just get around to a Phase III trial? 

Mid-Week Links: Crohn's and Sleep, Pellino3, John Hopkins Starts Fecal Transplant Program

Crohn's and Sleep
     In a new study published from Dr. Ananthakrishnan shows that poor sleep may be linked to a flare up in Crohn's. The study was collected by CCFA Partners (which I participate in) which is a study that sends out a periodic survey to Crohn's or ulcerative colitis patients. 50% of Crohn's patients even in remission reported sleep disturbances. I have some personal experience with this as on a Friday night I slept for 10 hours and woke up on Saturday feeling pretty great and almost felt I went into mini-remission.

Pellino3 Found For Crohn's
Researchers at Maynooth (Dr. Paul Moynagh) found Pellino3 could help patients with Crohn's disease and possibly protect people from getting it. The research team found that Crohn's patients have a lower level of Pellino3. The team is now trying to develop a drug that will target this in order to help Crohn's patients.

John Hopkins Launches Fecal Transplant 
     It looks like another medical center is getting into the fecal transplant game. The more places that offer fecal transplant the less patients will have to travel, wait, and worry about whether or not they can get their c difficile cured.

Feeling Better and Worse (1 Month After Humira Dosage Increase To Every Week)

So I have been quite busy/haven’t had internet for almost a week (via Comcast). At any rate my Crohn’s health is both good and bad at the same time. So it seems as if I still have diarrhea (about 4-5 times per day). Although, the other day I did notice that I only had about 3 bowel movements when I ate a little bit lighter. When I ate some rich chocolate cake I had some diarrhea and some pain after. My weight is pretty good and I am at 145 lbs (with hardly anything on). I had a cheese omelet and felt pretty good. It seemed as if the other day when I ate lighter I didn’t have any pain at night (which felt nice). The only other symptom I have notice is very minor joint pain in my wrists (this comes and goes though).

Next week I see my GI and plan to tell him how I feel. I really think diarrhea for nearly 7 months is a bit much. Although my Humira was changed from every other week to every week I feel a tad better but not to where I need to be. Mentally I don’t want to change to a different drug because it would mean I am losing my war with Crohn’s. However, I want to feel better. I feel bad knowing that this flare up may have been caused by just taking an antibiotic which led to c diff which lead to the flare up.

I know my options are possibly Cimzia, Remicade, or another biologic. After that maybe 6MP. After that I would be open to try low dose naltrexone (LDN) which has been very effective and I have no clue why the FDA hasn’t approved it for Crohn’s. If this doesn’t work then I might require surgery. I hope I can get back on the right track and get back into remission. It is time for me to get my life back. 

Crohn's and Stem Cells: Review of The Medical Literature

Recently I saw a story about how two HIV patients after bone marrow transplants  so far have no signs of the disease. People forget but HIV does involve the immune system just like Crohn’s disease. Four months after the transplant doctors could still detect HIV in the blood however 6-9 months later all the HIV was gone.

The first case for use of stem cells in Crohn’s was on Joy Weiss who underwent a stem cell treatment in 2001. It was performed by Dr. Richard Burt who is at Northwestern Medical School in Chicago, Illinois. The process for undergoing the stem cell transplant is not fun. Basically you have to undergo chemotherapy to “reboot” the immune system.  After the procedure though Weiss for the first time in 11 years had a remission of Crohn’s. Sadly 3 years after the procedure (in 2004) was performed Joy Weiss passed away.  Speaking of Northwestern in 2010, this study of 24 patients out of Northwestern by Dr. Burt and Dr. Craig showed the clinical free relapse rate was 96% at 1 year, 63% at 3 years, and 36% at 5 years.

This study from Barcelona by Dr. Julian Panes showed that 80% of patients were in remission after 6 years and 20% of patients have shown constant improvement after the transplant. Hospital Clinic de Barcelona has only done the treatment on 6 patients.

.A study from earlier this year in the journal Stem Cells showed that in 43 patients with Crohn’s that were treated using adipose tissue derived stem cells closed fistulas in 82% of patients.  70% of all patients had their fistulas closed after 1 year. I hope more studies are done on this to show that stem cells could really help close fistulas.  The video can be seen here.

A case study for a 36 year old male patient showed the patient was in complete clinical, endoscopical, and histological remission after 9 months of treatment.

This article talks about how at the Royal Perth Hospital in Australia 80% of patients responded to stem cell therapy with more than 50% going into remission. At DDW 2013 this year Dr. Christopher Hawkey from University of Nottingham showed some positive results with stem cells.  The study looked at 45 patients with Crohn’s who failed at least 3 immunosuppressive drugs (they also took patients who were extremely sick and for whom surgery did not help). What bothers me is that the study used a control group. I know scientists need a control group and treatment group. However, when patients are in dire straits with their health is it really ethical to do? The study showed that 50% of patients were in clinical remission and over 66% of the patients who received treatment stopped immunosuppressive therapy. The downside is there were some adverse effects. One patient did die during the study (from sepsis).

According to this article from the New England Journal of Medicine between 1993-1997 1418 people received allogenic hematopotietic cell transplantation. The mortality decreased 52% over this period of time (some of these people had very serious illnesses like cancer).

Stem cells to treat Crohn's looks like it might have an application for patients who have failed medical therapy, surgery, and all other treatments. It is important to note that stem cell therapy does carry risk. However, over time the treatment will become a lot less risky and hopefully become more effective. 

Crohn’s Weekend Links: Enterovirus, Red Meat & Colon Cancer, LDN for Crohn’s, Vitamin D and Crohn’s

Crohn’s and Enterovirus

                Apparently in children there may be a link between Crohn’s and enterovirus within the intestinal area. The enterovirus could be seen in deeper parts of the intestinal wall. The enterovirus is stored in the nerve cells of the intestine and can spread by other nerve fibers within the intestine.  Hopefully a study on adults can be done.

Red Meat and Colon Cancer

                This really isn’t news in a way. I did blog here about the medical literature on reducing colon cancer (one was to avoid red meat). This study just further confirms that avoiding foods like roast beef (which I love), hot dogs, and sausage can contribute to colon cancer.  Since 1991 colon cancer has declined by 30% for colon cancer which is good but colon cancer can be fatal if not caught early enough.

Low Dose Naltrexone FDA Meeting

                It is good news that TNI BioTech company is having a Type C meeting with the FDA to look over the Phase III trial for Naltrexone HCL. Research from Dr. Jill Smith shows that LDN helped 67% of patients achieve remission (this was back in 2007) and the drug is still not on the market.  LDN really doesn’t have any adverse side effects other than vivid dreams which sounds interesting.

Vitamin D Helps Crohn’s

                This study found that 5,000 IU/d reduced CDAI scores for Crohn’s disease which suggests that Vitamin D might be useful for people with mild-moderate Crohn’s disease.

                

Feeling Better But Not Great (Taking Humira Every Week)

My dosage on Humira increased from every other week to every week on June 14, 2013. So really it has only been a few weeks since I took Humira. After the fecal transplant I have overall felt better (more energy, not dehydrated, and I seem to have gained a few pounds which is good). My own personal theory is since I have had diarrhea since January 6, 2013 my colon and body has been through a lot. So I would expect it to take some time given how much I have been through. I really hope the Humira works. In my mind I wonder what the next step is if Humira doesn't work. I would think my GI would want to try a small dose of Prednisone and if that didn't work Remicade. I have also heard about 6MP which seems to work well in the long-run. I plan to call my GI tomorrow and let him know how things are going.

I honestly don't feel as bad as when I had my flare up last year. I did some research via my GI Buddy App on my IPhone. My pain level was about 4 times as worse as it currently is however my bowel movements were only around 2-3 per day and they were solid. Also last year I was also vomiting which was pretty bad and had a constant pain in my stomach.

2013 might be the year of the flare up. I know Crohn's is something I will live with for the rest of my life. Hopefully through this blog I can spread knowledge and awareness and hopefully in the future uses more of my time and resources to help find a cure for this horrible disease.