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. 

Artificial Sweetener and Crohn’s?

In a recent news article it came out that maltodextrin or what are known as artificial sweeteners can may make Crohn’s worse. One problem however is that the study was done in a lab and not on people which makes the link between artificial sweetener and Crohn’s loose. The logic is that the artificial sweetener promotes e-coil which is found usually found in the small intestine of those who have Crohn’s. Although, researchers don’t even know what role e-coli plays in patients with Crohn’s

The research wasn’t even really scientific. All the researchers did was place sweeteners like Equal, Splenda, and Stevia into a dish that had e-coli in it and watched it. What is interesting is that Crohn’s patients have a decreased level of mucus in their gut which could lead to more bacteria which would cause inflammation. A better designed study would be to divide up Crohn’s patients into two groups: one group that was fed high levels of maltodextrin and the other with no maltodextin and see what happens. Simply putting something in a petri dish and watching it doesn’t lead to anything useful or value added.

What also should be pointed out is that there is no conclusive empirical evidence that links diet and Crohn’s. If there is any solid evidence I would be changing my diet in a heart-beat. Although, there might be trigger foods for Crohn’s there isn’t any research suggesting that one type of food or even a group of foods benefits Crohn’s patients.

More research should be done regarding diet and Crohn’s patients. For me at least whatever I eat does seem to give me pain. I haven’t noticed one food or another giving me more pain than the other. As I like to say my gut does not discriminate it treats all food as enemies. As I mentioned in a previous blog post I didn’t eat sugar for one week and by the end of the week felt worse. 

Saturated Milk Fats and Inflammatory Bowel Disease

This article that came out today from the University of Chicago that leads readers to believe that milk fats can change the bacteria in the intestines which may increase the risk of developing inflammatory bowel disease. The key word of course is “may”. In the experiment mice were fed diets that had were high in saturated milk fat and 60% of the mice that were fed high saturated milk fats developed ulcerative colitis compared to only 25%-30% who were fed low fat diets.

Of course, what we eat is only one factor in inflammatory bowel disease. Genes play a part too as well as the environment we live in. Also it is worth noting that trials in mice do not always translate into human results. One reason why I discount this study is for someone to explain to me how we have so many obese people yet so many fewer with inflammatory bowel disease? If diet has such a large role as many claim you would think there would be millions of people with inflammatory bowel disease as opposed to the 1.4 million that is estimated. I don’t discount that diet and what we eat can have a role in whether or not developing inflammatory bowel disease. However understanding what causes inflammatory bowel disease is complicated. What I would question is how much of an influence is diet into developing inflammatory bowel disease. Of course more research and experiments will have to be performed to figure this out.