Weekend Links: Drugs Cut Surgery by 60%, Texting, SCD Diet Study, Marijuana Helps Crohn's, JAK1 Study for Crohn's, Golimumab, Fecal Transplant Helps UC and IBS

(Note: I started this post on Saturday however wasn't able to finish it as I saw some more stories to add).

Drugs Cut Need for Surgery By 60% 

     You could say if there is any time to get Crohn's if you had to get it. So in a study that looked at 5,000 patients and looked at the effect of the thiopurine drugs. Azathioprine  for more than 12 months had a 60% reduction within the first 5 years of diagnosis. Thiopurines have been around since the 1970's.  

Texting Helping Children with Crohn's 
      The medical expenses for treating IBD are quite high. Estimates place of IBD is roughly $1.8 billion according to the CCFA. So one way to bring down the costs may be using doctors in order to get patients and doctors to communicate with one another. A clinical trial is taking place at Cincinnati Children's Hospital were an application which uses information from the user and sends it back to the doctor. Patients can respond if they are taking their daily medications and how many times the patient felt sick. The app can track the behavior and get an early idea of when a flare up might occur. The CCFA website has an app called GI Buddy that people can download and track nearly everything related to IBD (bowel movements, what you eat, how you feel, etc). Technology is a no brainer is reducing costs related to not only Crohn's but other chronic illnesses. If you had data on 1,000 different Crohn's patients and ran some analysis on it you could find patterns (what foods help with Crohn's, what foods are likely to cause a flare, what medication works, etc). If patients were able to have their information sent to doctors and doctors could data mine the data to see what patients needed to be responded to first it would make things much more efficient (for both the doctor and patient).
    

Small Study on SCD Diet 
     So in a very small and uncontrolled trial Dr. Ece Mutlu at Rush University looked at 20 patients who adhered to the specific carbohydrate diet (SCD). There is plenty of controversy about this diet. The Crohn's and Colitis Foundation (CCFA) doesn't believe that diet helps. However, if you read internet stories you can find dozens of people who have seemed it helped. This study just looked at the intestinal bacteria. Mutlu claims that some of his own IBD patients have "drastically improved" with mucosal healing and were able to discontinue their immunosuppressants for several years.

Marijuana Treats Crohn's (How Many More Studies Do We Need)
     In a recent study published in the journal Pharmacology showed that cannabis has been shown to help people with cannabis. I have not seen anything published that shows marijuana has a negative impact on Crohn's. This study showed that 70% of patients improved after treatment (this first study was done in 2011). In a follow up study found that 90% of patients had a decrease in their symptoms while 45% of patients had a remission of their Crohn's. Clearly, cannabis should be something that is studied more to see if it can help people with Crohn's. With Colorado allowing people to possess cannabis without any legal trouble it seems perhaps more people will be able to experiment and see if it helps them.

Galapagos Phase 2 Trial For JAK1 Inhibitor for Crohn's 
According to this press release to conduct a phase 2 trial on a JAK1 inhibitor. In the past JAK1 inhibitor as pointed out by Dr. William Sandborn here. Dr. Edward Loftus had a concern about the lipid effects as the drug did increase LDL (bad cholesterol) however Loftus said it wouldn't be a deal breaker. The trial will enroll 180 patients (over 49 different clinic centers around the world) for a 20 week trial.

Golimumab Maintains Clinical Response in Patients With Ulcerative Colitis
     In this phase 3 trial patients were given either 50 mg or 100 mg (subcutaneous injection). There were 464 patients that were enrolled in the trial. Roughly 47% of patients who took the 50 mg treatment were in remission as opposed to the nearly 50% of patients that were in remission in the 100 mg group. 3 patients did die (they were all taking the 100 mg dosage too). Also remember that 3 patients out of 464 is a little more than 1/2 of 1%.

Fecal Transplant Shows More Promise for Ulcerative Colitis and IBS
      So fecal transplant which by the way I believe saved my life is being studied for digestive disease such as Crohn's and ulcerative colitis. All the data I have suggests that fecal transplant would benefit ulcerative colitis patients more than Crohn's patients. Dr. Brandt who has been doing fecal transplants for a long time reported that 63% of his patients (16 patients had IBD-with 14 having UC and 2 having Crohn's) had a lower frequency of flares after they had fecal transplants. The diarrhea also decreased by 56% (8.2 bowel movements to 3.6 bowel movements) after the fecal transplant. Symptoms resolved in 29% of patients and decreased by 43% of patients (21% of patients saw no change). Which means almost 80% of patients saw some benefit to a fecal transplant. Dr. Brandt also looked at fecal transplant for IBS patients and found that 73% of patients had a complete or partial resolution of their symptoms.

Weekend Links: FDA Worries Theoretical Side Effect from Vedolizumab, Fecal Transplant Houston, Women Goes On Macrobiotic For Crohn's, Colon Test Detects 85% of Cases, NOTES Surgery for Gastrointestinal

FDA Worries About Theoretical Risk for Vedolizumab

So the great geniuses at the FDA have called into question the drug Entyvio (vedolizumab) for concerns that it could theoretically could happen. The FDA in their wisdom wrote a 177 report that can be found here. When I have some more time I will write a full blog post on this. What the FDA is worried about is that since vedolizumab operates similar to a drug named Tysabri (natalizumab). One potential side effect is PML which is a fatal brain infection that can be acquired from taking Tysabri. However, the risk of getting PML is estimated to be 1 in 1000. So even though 31 confirmed cases of PML have been reported you have to look at how many people overall are taking it. What is interesting is that now there is a test JC Virus Test to see if there is a presence of the virus to see if it can lead to PML. The JC Virus test is required in order before one takes Tysabri. Even having the JC Virus doesn't mean one will get PML it just means that one has an increased risk of getting it. With costs are benefits. Vedolizumab seems to be most beneficial for patients who have ulcerative colitis as in the clinical trial 47% of patients who took it after six weeks were in remission compared to the placebo of just 25.5% (result was statistically significant). 

The FDA said basically well since this drug vedolizumab is similar to Tysbari we should expect the same thing to happen. However, what is quite interesting is that even the FDA report states that "at this time no en cases [of PML] have be reported in patients taking vedolizumab. In the trial over 1400 patients received vedolizumab and not one patient actually contracted PML. The FDA is as usual over concerned about the potential side effect of a literal 1 in 1000 chance (the trial proves it is probably less considering no one actually got PML) when the condition of Crohn's or ulcerative colitis one could argue is much more dangerous.

Fecal Transplant Now Done In Houston

Here is a story out of Houston showing how a patient with c difficle got their life back after a fecal transplant. Dr. Herbert Dupont is leading the fecal transplant program in Houston. The procedure only takes 10 minutes and patients feel much better very soon. Dr. Dupont is currently doing a study to see if c difficle can help patients with Crohn's disease and ulcerative colitis. 

Women Goes On Macobiotic Diet for Crohn's: No Pain 

So I am always interested in seeing stories about diet and Crohn's disease. I think diet does play some role in Crohn's, however it is important to remember some patients can go decades without symptoms of Crohn's. So Ruth Twort has had Crohn's disease for 30 years (since 1983) she is now 49. She has changed her diet to just eat macrobiotic foods (she eats porridge, brown toast, and roast chicken). She substitutes agave syrup for sugar. She also eats Sushi 2-3 times per week. For Crohn's flare ups she will eat miso soup with soba noodles. She also never drinks whole milk. I think eating well in general is good for health. Being diagnosed with Crohn's has made me more health conscious in what I select as food. I really would like to see a study done of people before and after they try these diets (a colonoscopy at the beginning and one done 6 months to 1 year after the diet has been tried). 

Blood Test 85% Effective for Colon Cancer
So many people don't like having a scope inside of them (really a colonoscopy is a piece of cake the prep is the hardest part). About 50% of people avoid them because they don't want to deal with it which could mean many people have possible colon cancer or other gastro issues. A new blood test can now with 85% accuracy detect cases. I am sure as more people are studied (200 have been studied so far) the test will only become better and cheaper which can spare many people from having a colonoscopy which would free up gastro docs to see IBD patients and save insurance companies bundles of money.

NOTES (Natural Orifice Surgery) Being Used For Gastroenterologists: No Incision/Scar

I am always a fan of doing things better and more effective. NOTES (Natural Orifice Surgery) allows surgeons seems to offer advantages over conventional minimal surgery by avoiding incisions and as the name suggests goes through natural orifices in order to perform surgery. Some of the procedures that can be performed by NOTES are bariatric repairs, fistulas, and ulcers. Patients usually go home after 1-2 days with less pain and best of all no incision or scar. Currently, NOTES is relatively new and will take time before it becomes adopted by more surgeons. 

Weekend Links: IBD and Race, Surgery Rates IBD Falling!, Vitamin D & Crohn's, Paneth Cells, and Poop Pills

Risks of Inflammatory Bowel Disease Between Racial and Ethnic Groups
This article discusses the rate at which various types of ethnic groups get diagnosed with IBD. What I also learned is that it is estimated that 1.8 million adults have IBD (usually the estimate is around 1.0-1.1 million).  What is interesting is that Non-Hispanic Whites have the highest rate (70.2 people/100,000 people) while Hispanics have the lowest rate at (9.9 people per 100,000). However the article concluded that deaths and hospitalizations and deaths from IBD was higher in Non-Hispanic Blacks. So to summarize white individuals are more likely to get IBD, however African Americans are more likely to be hospitalized and die from it.

Changes in medical treatment and surgery rates in IBD (1979-2011)
Long term studies like this always interest me. This study found that the chances of requiring surgery (for Crohn's disease) over a 5 year period have decreased from 44.7% (if you got diagnosed between 1979-1986) to 19.6% (if you were diagnosed between 2003-2011). I was diagnosed in 2011 so the percentage might actually be lower since people didn't  use biologics until after 2008.  The requirement of surgery for UC also decreased from 11.7% (if diagnosed from 1979-1986) to 7.5% (if diagnosed between 2003-2011). I have seen other studies that show the cumulative risk of surgery increases over time. However, other factors like how severe the disease is, the age at which you are diagnosed, and the location of the disease can play a factor in when you need surgery and how often.

Stool Banks for Fecal Transplants: Crap Now Worth Something!
As someone who earlier this year had c difficle and then a fecal transplant at the Mayo Clinic I am always interested in fecal transplants. This story is interesting in that Dr. Lawrence Brandt believes that in the future there will be stool banks just like blood and sperm banks which makes sense consider the stool can be used to save people with c difficile. What would be interesting is people actually getting paid for their crap! What would even be more interesting is if certain stuff is more valuable in terms of a curing c difficile. Also if people knew they could get paid to donate their stuff they make have an incentive to take care of themselves and not do things that may exclude them from being a donor (taking an antibiotic, living a risky lifestyle, etc.). Fecal transplants are also being studied in other disease such as Parkinson's, obesity, and even IBD. It would be nice to study if certain fecal material is better than others in helping people with these horrible illnesses.

Too Much Vitamin D for Crohn's Patients?
This article on vitamin D is interesting because it often contradicts what I have heard saying that people with Crohn's usually have low levels of vitamin D. What is interesting is right before I was diagnosed with Crohn's my doctor told me to take a vitamin D supplement (which in all honesty does make me feel better when I take it. The research was done by Dr. Maria Abreu (she is with the University of Miami IBD department). In the study (which is in Gut magazine) showed that Crohn's patients 42% of patients have "inappropriately high" levels of vitamin D levels. The same was true for 7% of patients with UC. The theory is high vitamin D levels are most likely a manifestation of the underlying gut inflammation.

New clinical trial for antibiotic to help Crohn's (possible cure?) 
Dr. Saleh Naser out of UCF College of Medicine has spent 18 years studying mycobacterium avium subspecies paratuberculosis (MAP) in Crohn's disease. There is a debate in the scientific community as to what actually causes Crohn's disease. Dr. Naser is trying to enlist 240 patients in a clinical trials for basically what is an antibiotic therapy. There is also a test being developed to see what patients have MAP in their systems in order to determine who would benefit most from the new treatment. What is very promising is that Dr. Naser believes that patients with the treatment may instantly improvement and this could possibly believe a cure for Crohn's if MAP is truly the underlying cause.

Paneth Cells Role in Inflammation for Crohn's Disease
According to this article from Nature . This Science Daily article breaks the research down into plain English. What the research shows is that there may actually be subsets of Crohn's disease. What was learned is that Paneth cells' play a role in inflammation for inflammatory bowel disease. Hopefully, this will lead to more targeted therapies for Crohn's.

Poop Pills: Now Serving C Difficile Patients
Speaking of fecal transplant apparently Dr. Thomas Louie out of University of Calgary developed a "poop pill" to help people who suffered from c difficile. I know people in the media will say "poop pill" how gross and make fun of the name. However, there is nothing funny about c difficle (I know I have been through it and felt like I was partly dying). At any rate, 32 patients were treated with the pills and didn't have a recurrence of c difficile which is a 100% success rate. If fecal transplants could be done in pills instead of via colonoscopy it would be far cheaper, easier, and free up doctors to do procedures on people who might need them more (people who may have colon cancer). This pill came faster than I thought. I thought it would take many years to develop this but apparently it is here faster than we could have imagined.

Mid-Week Links: Increase Pediatric Rate For Crohn's, Mayo Opens C Diff Clinic, and Crohn's Man Has Colon Removed Is Able To Swim...

Increasing rates of pediatric Crohn's
     My heart always goes out to children who get Crohn's. I was diagnosed with Crohn's when I was 26. However, I really don't know how bad it would be to be a young kid and be told you have Crohn's. This study shows that from 2000-2009 the hospitalization discharge rate for Crohn's increased 59% while the percentage for ulcerative colitis increased 71%.

Mayo Clinic Opens C. Difficle Clinic
     I am glad I received my fecal transplant at the world class Mayo Clinic in Rochester, MN. I am pleased to see that the Mayo Clinic is now opening a c difficile clinic.

Crohn's Man Swims Across Lake Erie (Without Colon)
     In this great story Ryan Stevens (who suffers from Crohn's disease) had 5 feet of his colon removed (temporary ileostomy which was later reversed). This article shows a picture of Ryan in the pool and you barely notice any scarring from the surgery. Ryan is raising money for Crohn's. Ryan has his own website too.

Biologics Reduce Crohn's Stomas by 33%

As a Crohn’s patient one thing I always wonder/worry about is whether or not I will get a stoma. New research shows that in the era of post-biologics the rate of stomas has decreased by 33%. Maurizio Coscia and his colleagues looked at 51 patients to determine who underwent a colectomy between 1995 and 2002 and then 182 patients who had abdominal surgery after 2002. 2002 is seen as the year post biologics however one could argue with this given Humira wasn’t approved for Crohn’s until 2007. Cimiza another biologic wasn’t approved until 2008. Remicade was really the only drug that was approved for use before 2002 (approved in 1998). So really you can argue that the future rates might be even lower given more entrants into the Crohn’s market. Personally I believe the new treatments for Crohn’s will be as effective as biologics with less side effects (TSO whipworms) being one of these.  

I have actually blogged about this before in a Saturday Study series. Dr. Fabrizio Michelassi did a study while he was at the University of Chicago (he is now at Cornell) and found that only 7% of patients needed a permanent stoma. The time period studied was 1970 through 1998.

With more time, surgeries performed, and research performed I believe the rate of stomas will decrease which is positive. Hopefully more novel treatments will come out in order to better treat Crohn’s and ulcerative colitis. Doctors are always remarking how they never would have imagined the current treatments for IBD. Hopefully the future will have an unexpected way of arriving. 

Michael Seres Crohn’s Transplant for Bowel

I saw this pretty cool story about Michael Seres who got a transplant for his bowel. Michael who is 42 years old for the past three years had to have feeding tubes in order to eat like a regular person. Michael has had Crohn’s since 1982 and already had 20 surgeries (poor guy!). His bowel went from 197 inches to 27 inches. The procedure Michael had is still risky (only 10 are done a year). Rejection of the tissue transplanted to the new bowel is a concern. Michael had to stay in the hospital for three months because his immune system was so weak. These days he is back to eating regular meals.

Hopefully, the procedure Michael had will be studied more to where it can be safe and effective and present as another option for people with Crohn’s. No question the procedure will get safer and better the more times it is done. 

Crohn’s Surgery Without Scars? Natural Orifice Surgery

Natural orifice surgery has been around for a couple of years now. The idea of natural orifice surgery is to remove organs through natural orifices (mouth, rectum, vagina, and urethra. This has an advantage over existing laparoscopic surgeries considering there is minimal cutting which reduces the risk of infection and complications. However, only 1,000 of these surgeries have been performed and although they are safe they haven’t been around long enough to show if they are more beneficial than existing methods. Sometimes I wonder if minimally invasive means it is a minimally effective. My guess is that natural orifice is safe as either an open or laparoscopic procedure and in time it will only get better and safer.

                The first procedure was performed by Kurt Roberts a surgeon at Yale University who took out an appendix in 2008. The surgery took less than an hour and half. I would point out that as surgeons do more of these surgeries they not only get better at them but also faster. Dr. Vikram Reddy a surgeon also at Yale University has performed a natural orifice surgery on a patient with ulcerative colitis. The patient had his entire colon and rectum removed with the largest incision being less than one inch. I emailed Dr. Reddy and asked him about the applications of this type of surgery on people with Crohn’s disease. According to Reddy he believes there might be a role depending on where the Crohn’s is located and how severe it is.

If natural orifice surgery was able to be shown to be both safe and effective for people with Crohn’s then it would be an improvement over the traditional approaches of an open surgery or laparoscopic procedure. However, much more research needs to be done on natural orifice surgery.