Saturday Study: Saturday Study: Primary and Recurrent Crohn’s Disease. Experience with 1379 Patients

In this study from the Annals of Surgery in 1991 by Fabrizio Michelassi at the time at University of Chicago (he is now at Cornell University) from the period of 1970-1998 1379 patients with Crohn’s were studied. In 92% of patients a surgical resection was necessary. What I found interesting was that only 7% of patients needed a permanent stoma. I know many who suffer from Crohn’s that are worried about getting a stoma. Also these people were studied in the 1970’s and 1980’s. Since then treatment has improved and the quality of surgeries has improved. The recurrence rate for patients was 20% in 5 years while 34% at the end of a decade. This shows that the chance of surgery rises with time. Also if more than one site is involved then it increases the chances of having recurring surgery.

Crohn's Top 10 Treatments

In this informal study from CureTogether 178 people were asked to rate different treatments for Crohn’s. Some of these treatments are not approved or even legal (cannabis). I think it is great though that data can be gained by the experience of many different people. Here is a list of top 10 treatments for Crohn’s:

1. Low-Dose Naltrexone (LDN)
2. Surgery
3. Steroids
4. Humira
5. Cannabis
6. Specific Carbohydrate Diet
7. Remicade
8. Stress reduction
9. Small meals
10. Gluten-free/low fiber diets

I still don’t know why low dose naltrexone (LDN) is not FDA approved for Crohn’s. As I mentioned in this post LDN has shown that it is effective and with very few side effects (and also has been used since 1985). Surgery is often seen as a last resort but odds are Crohn’s patients could need more than one surgery in their lifetime. However, as my GI has said he has seen fewer and fewer patients going into surgery with the introduction of the biologics (Humira and Remidcade). I have been on steroids (Prednisone). I am currently taking 20 mg and tapering off after a flare up after Spring Break. I have noticed prednisone makes me pretty hungry and I currently weigh around 153 even though I am usually in the mid 140’s. On rare occasion I have noticed joint pain but this could be that I work out almost every day. I haven’t tried Humira however my GI said that if I continue to have flare ups I will have to go on it. Cannabis by the definition of this chart seems to be a little more effective then Remicade which is interesting. More clinical trials have to be done on cannabis. The thing I wonder is if smoking it can lead to lung cancer. This article shows that even people who smoked 22,000 joints over their lifetime did not have a higher risk for getting lung cancers than people who didn’t smoke cannabis. Perhaps ingesting cannabis through food (cookies or brownies) would be more effective than smoking it. I would think that if you ingested the cannabis it could reach the digestive tract easier. There really hasn’t been any good evidence I have seen on the Specific Carbohydrate Diet. Although, to me what you eat does play a role in how you feel with Crohn’s. Stress reduction is interesting. One possible theory is when people get stressed they eat more (I know I do) and therefore have more pain. When they reduce their stress they are getting less which could lead to less pain. Someone should conduct a study on Crohn’s patients who get massages. Small meals I think helps although I would have to research just how effective this is. Last but not least gluten free diets are just like Specific Carbohydrate Diet where there are many testimonials; however there really isn’t good evidence that it has a major effect.

Marijuana Treatment For Crohn's?

I came across an article a while back that looked to see if marijuana was beneficial for people who had Crohn’s. This study was the first study ever to look at cannabis use in Crohn’s patients (why did it take this long to begin with). The study found that 70% (21/30) of patients had a statistically significant (p value <.001) improvement in their condition. Also close to the number of medications required were reduced while using cannabis. Also the average number of surgeries required after using cannabis decreased. I would point out though that prior surgery probably reduces the chance of needing future surgery. The fact that 79% (15/19) of patients had surgery were in this study tells me that these patients had a moderate to severe form of Crohn’s. Another trial is now underway to study the effects of cannabis on inflammatory bowel disease (Crohn’s and Ulcerative Colitis). It looks as if the trial should be completed in June 2012.

There are of course some problems with this study. The study was did not have a placebo control meaning the observers just looked at people who took the drugs and didn’t compare it to anything. Also the some people were initially in the study took cannabis but then dropped out when their condition didn’t improve. These people were not counted in the study. Lastly, 87% (26/30) of the patients were male.

One major problem with future research is the fact that currently the United States makes cannabis illegal (even though I have never consumed an illegal substance). Even before I was diagnosed with Crohn’s I was in favor of legalizing all drugs because of the medical benefits that could result from research. Also many thousands of people die each year because drugs are made illegal not because of the underlying drugs themselves. It is hard to study a substance that is illegal.  To me people are free to choose what they eat, drink, and ingest. Even though I have Crohn’s if cannabis were legalize tomorrow I wouldn’t purchase it until more research was done to see if it was effective and safe. People try to make the argument that cannabis is unsafe however I would ask them just how many people have overdosed on it. I would argue more people die from consuming too many Twinkies, Big Macs, and Cokes then from using cannabis.

Stem Cell Therapy: Treatment or Cure for Crohn's?

Stem cells have been talked about a lot in recent years. Usually it is in the news when discussing whether or not stem cells should be funding. These days stem cells are being used to try to treat various diseases like cancer, heart disease, and even things like baldness. There are different types of stem cell transplants are well. In hematopoietic stem cell transplantation stem cells are taken from bone marrow, blood, or umbilical cord blood and then the patient’s immune system is destroyed with chemotherapy before the cells from the bone marrow are transplanted back into the patient. As with any procedure there are risks associated with doing this. For Crohn’s patients this procedure is seen as what I would call a last last resort.

The actual treatment using stem cells for Crohn’s disease has been around since 2001 when Joy Weiss had the treatment. Weiss was part of study conducted by Dr. Richard Burt and Dr. Robert Craig of Northwestern University Medical School. The study only looked at 10 patients who had failed every other Crohn’s therapy. Weiss ended up in Crohn’s remission for the first time in the 11 years that she had it. One thing that comes to mind is that if patients who are using this a last resort felt better how would people who have moderate Crohn’s do?

                In this study from 2010 in the Blood Journal Burt and Craig conducted a study in which they did stem cell therapy on 24 patients and looked at the patients after 5 years. The clinical remission at year one was 91% but then gradually decreased to 19% by year five. In this 2003 study remission was achieved by 92% (11/12) of patients and after around an average of 19 month follow up only 1 (8.33%) which happened 15 months after the transplant. Clearly, more research has to be done to see how effective this therapy is in the long run. Also safety is a major issue with stem cell therapy which is why long term studies have to be performed. As I write this around 26 studies are being performed on stem cells for Crohn’s according to ClinicalTrials.gov

                Celegene a biopharma company in 2010 in a Phase trial showed that experimental stem cell were 67%  (4/6) of patients in the low dose group  showed clinical remission. Patients who took the lower dose saw more dramatic results than those that took the higher dose. The study also met its primary safety goal. According to Celegene’s pipeline it looks as if the treatment is now in Phase II trials. The company is also using the same treatment to investigate whether or not there is any benefit for people with multiple sclerosis, ischemic stroke, and rheumatoid arthritis.

                The future has an uncertain way of arriving. Time will only tell if stem cell therapy is just a fad or actually can prove worthwhile. One idea might be to get doctors in these trials to sequence the genes of patients who are getting the stem cell therapy to perhaps figure out who has a better chance of achieving remission.

CCFA Partners Survey

The other day I signed up for CCFA Partners. CCFA Partners is trying to enroll over 10,000 individuals with inflammatory bowel disease (IBD) in a survey to look under the issues that IBD patients face such as symptoms, medication, quality of life, etc. This information I believe will help researchers understand issues that patients of IBD face as well as possible ideas as to what makes symptoms worse or better. The idea of the survey is to survey patients around every couple of months to see how they are doing. As I write this 9,334 patients have signed up. I hope more than 10,000 people sign up so researchers can get a good understanding of what IBD patients face. This is a great way to help IBD patients help each other!

For more information:

https://cgibd.med.unc.edu/ccfapartners/

MAP Blood Test For Crohn's?

One news story that caught my eye was the development of a possible test for Crohns. The test lets doctors look at certain pathogens that can cause Crohn’s disease. The test works by taking blood from a Crohn’s patient and looking at microbes that often can’t be detected. One major advantage to this new test is that instead of waiting weeks or even months to treat a patient doctors can perform the test within hours. The test was created by Dr. Saleh Naser at University of Central Florida. Diagnosing Crohn’s is somewhat difficult. I remember when I was in the hospital I had stool tests done for the first couple of days, and blood tests just about every day. A resident believed I had celiac disease, however due to the fact that there isn’t a Crohn’s test it is hard to diagnose. Even a colonoscopy is 70% effective in diagnosing the Crohn’s.

One prevailing theory is that Crohn’s is created by bacteria called mycobacterium pratuberculosis (MAP).  It is estimated that around 40%-50% of Crohn’s patients have MAP in their bodies. A company called RedHill Biopharma is licensing Dr. Naser’s technology in order to develop a drug called RHB-104 to treat Crohn’s patients who have MAP in their bodies. However, one downside is that RHB-104 and the MAP test won’t be available until possible 2016. One way to treat MAP is by giving patients a combination of rifabutin, clarithromycin, and clofazimine. A trial of this course of treatment was done in 2006 entitled “Two-Year Combination Antibiotic Therapy With Clarithromycin, Rifabutin, and Clofazimine for Crohn’s Disease” concluded that there was no evidence of a sustained benefit over a 2 year period.  The study seemed to show an improved in those taking the cocktail (combination of all three drugs). However, once year two rolled around the benefit between the treatment and placebo (sugar pill) were similar. This may cast doubt on how much the new MAP test will help   

Time will tell how effective this new MAP test is. There is no doubt however that there needs to be more innovation in diagnosing Crohn’s. Figuring out the causes of Crohn’s I believe will help solve how to treat it and maybe even one day find a possible cure. Galieo once said “All truths are easy to understand once they are discovered; the point is to discover them”. 

Crohn's App: GI Monitor

For a while now (since early March) I have used the WellApp's GI Monitor. The app is really useful for those that have Crohn's disease. It is a great way to monitor symptoms, track what you eat, and keep all your medications straight. The app has a meter that shows your wellness and tells how you are doing. You can also report how many stools and the quality which is important. The app is very useful. The most useful thing is that you can create reports based off all the data you enter and send it to your doctor. When I want to get a chance I want to closely analyze the relation between what I eat and pain.

Hopefully, more people will use this app and perhaps data could be aggregated that could give doctors, researchers, and scientists, new clues on ways patients could help themselves.

SSI Treatment For Crohn's Remission?

The video above talks about Tyler Wilson's battle with Crohn's and how he is currently in remission after taking SSI (Site Specific Immunotherapies) that activate the body's natural anti-cancer immune response. SSI has been used in people who have cancer. Tyler has been in Crohn's remission with no symptoms for a year and a half. A small clinical trial was done with SSI and showed that 75% of people went into remission and everyone showing a response to the treatment. Clearly, many more people will need to be studied for SSI and the long-term safety of the treatment also has to be evaluated. Clinical trials are now underway that will take place in the fall of this year. Right now the clinical trial is not filled. For more information on the trial e-mail robfreeman@look.ca

Low Dose Naltrexone Treatment for Crohn's?

One medication that currently is not approved for treatment in Crohn’s is low dose naltrexone (also known as LDN). People have claimed it can help patients with Crohn’s. Others say it is wishful thinking. I like to evaluate things based off evidence and facts and from what I have seen LDN seems like it could be another tool doctor’s use in the battle against Crohn’s.

Dr. Jill Smith professor of gastroenterology at Penn State University’s College of Medicine has done some studies looking at the effectiveness of LDN. One study in the April 2007 American Journal of Gastroenterology found that 67% of patients who took LDN went into remission.  What is even more remarkable is that 89% of patients had some type of response to the treatment. These results were statistically significant meaning they were not due to just chance alone. There was also endoscopic evidence meaning when a colonoscopy was performed there was less inflammation and mucosal healing.

In another study published in 2011 entitled “Therapy with the opioid antagonist naltrexone promotes mucosal healing in active Crohn's disease: a randomized placebo-controlled trial” Dr. Smith and her colleagues found that 88% of those treated with LDN saw a drop in their CDAI scores. Also after 3 months, 78% of patients had endoscopic evidence showing improvement. Fatigue was the only side effect reported. Over half the patients who failed or couldn’t handle biologics were enrolled in this study.

Naltrexone itself has been around since 1992 when it was used for people who were alcohol dependent. It is important to point out that people who take naltrexone for alcohol dependence take a much higher dose (100mg) as opposed to low dose naltreone which is only 4.5 mg. The side effects of LDN should be much less than the regular version.  It would be interesting to see if increasing the LDN higher would create even better results in patients.

The data is in and it looks like LDN could provide help for Crohn’s patients. Although, more studies and long term safety data have to be evaluated naltrexone can be prescribed however this is considered an “off-label use”. Dr. Jill Smith and a colleague have the patent for naltrexone in people who have inflammatory bowel disease. Remember just because a drug gets approved doesn’t mean it is approved for all illnesses and diseases.  If a drug is safe and has been around for two decades why on earth are people not allowed to take LDN?

My own view is that once the FDA deems a drug safe (Phase I) people should be allowed to take it to determine the drug’s effectiveness. Millions of people are suffering in pain because the FDA won’t let them consume drugs that could help.  Everyone has different body chemistry and reacts differently. I would rather have this then the FDA make blanket statements saying this group or that group can’t consume a drug.  

Crohn's Disease: My Story

         

I am currently a 25 year old male who suffers from Crohn's disease. My diagnosis came in December 2011 after not knowing for a few weeks what I had. I don't know how typical my story is but I was diagnosed with bronchitis first in around late October early November of 2011. I took Biaxin, Prednisone, and Levaquin. I actually had been having some diarrhea a little before this but started to notice I was very tired and weak. If I had to guess how long I had diarrhea I would say 3 weeks but I thought it was due to the medication. I can still remember eating a calzone while on Biaxin and having to hurl. I had no idea what was going on with my body. In February of 2011 my GI believed I had irritable bowel syndrome. Apparently there was some small liquid in my abdominal area but then went away after doing various tests. I started to get very sick right before Thanksgiving. I was amazed that I had done well on one my exams despite feeling at death's door. 

I traveled home from graduate school on November 23, 2011 and had an appointment to see my doctor. That morning when I had to drive to the airport I could barely get out of bed (I am not quite sure how I got to the airport). When I returned home I went to a local diner and ate some grilled cheese but had a hard time eating since I didn't feel too hungry. It was noticed that I had lost significant weight even though I hadn’t even noticed. It was odd because I have usually been on the thin side my whole life. When I went to the doctor he told me I was anemic and needed to immediately check myself into the hospital. We were able to do a direct admit which was very nice and the hospital was very close. Before this time period the previous time I was in the hospital was 1986 (which is when I was born). I remember being in the doctor's office scared since I had no idea what was going on with my body. When I was admitted to the hospital I was only 125 lbs (I am normally 145). I am 5'11 though which made me skins and bones almost. In the hospital I was hooked up to an IV and given fluids. The IV is a pain though if you had to go to the bathroom because it goes wherever you go (your little buddy). Once the fluids started going through my body I felt better. The doctor on my case ran different blood tests and stool tests and suggested it was a gastro issue. A resident suggested it was celiac disease.

 While doctors were diagnosing my case I was actually resting which I wasn't use to since I was in graduate school. The hospital was actually a pretty good experience. The food was pretty good and the menu had more options than I thought it would. For Thanksgiving dinner in the hospital I ate chicken fingers with mashed potatoes. Over time my appetite gradually came back. While I was in the hospital they put me in Flagyl which did make the food taste funny but after a while I was taken off this. The staff at the hospital was very nice and I felt like a prince being able to hit a button and have someone wait on me. The only thing I didn't enjoy was getting blood tests every morning at around 4 or 5 in the morning. A nurse would come in turn on this low level light and draw blood. Usually after this I would watch the daybreak news and fall back asleep until my parents came to visit. I am usually a night owl and was able to catch old reruns of the Cosby show at 1:30 in the morning. Anyway I was released from the hospital a week or so after being admitted and told I would need a colonscopy. I never had one before and it wasn't too bad. The worst part is drinking this liquid the night before (known as the prep) and you have to drink a lot of it.  The actual procedure is a piece of cake. After the colonoscopy my GI said that the inflammation looked like it was Crohn's disease. I had never heard of Crohn's disease. In light of this news I begin researching everything I could about it. My doctor told me to go on a good fat/bad fat diet which allowed me to eat whatever I wanted to put weight back on. At first it was fun going to Whataburger, McDonalds, and every fast food place under the sun. Although, after a while eating so well does got old. One of the reasons I was eating so much was due the Prednisone creates an appetite. The only other side effects I noticed was little bit of a moon face and some slight hair thinning.

I went off Prednisone over spring break and started to have a flare up again. I was fine in February and had my first rectal exam (I passed out by the way) and no blood was seen which according to my GI meant my Crohn’s was in remission. My doctor put me back on Prednisone and talked about going to a biologic (Humira) after I tapered off the Prednisone.