Clostridia Difficile Colitis Treatment Pills on the Horizon

Antibiotic related colitis powered by post antibiotic clostridium difficile bacteria infection has become epidemic. Patients suffer from abdominal cramps, fever, recurrent loose and bloody stools. Dehydration and even bowel perforation have occurred. Treatment involves using a non-absorbable antibiotic called vancomycin . If that failed, fidaxomicin has been used in recent years – since its development and approval.

Despite the use of these drugs, patients have been having more frequent recurrences which sometimes require additional treatment. When these treatments fail to stop recurrences, researchers have gone to fecal transplants – tried via collected stool enemas. The idea that an individual suffering from fevers, severe recurrent abdominal pain and diarrhea, sometimes grossly bloody would consent to an enema of collected stool points out just how miserable this entity makes the poor suffering individuals.

At a virtual meeting of the American College of Gastroenterology 2021, Jessica Allegreti, MD, MPH, a gastroenterologist at the Brigham and Women’s Hospital in Boston Massachusetts reported on the most recent successful trial of a freeze-dried human stool pill. The pill contains a powder of freeze-dried human stools from pre-selected donors. The study selected patients who had suffered through several bouts of C Difficile colitis and were now symptom free. The group had either been treated for their last recurrence with vancomycin or fidaxomicin.

After a period of days for the antibiotics to wash out of their system, they were either assigned to receive the CP101 pill or a placebo. Normally these patients would be told to resume their lives and receive no treatment unless they developed symptoms of a C Difficile recurrence. The pill was more successful than the placebo in preventing recurrences at the 24-week mark.

Interestingly, when the stool of all the disease victims was looked at for normal bacteria that is supposed to be present in our bowels, they had a paucity of bacterial types expected. One week after taking the freeze-dried pill the numbers and diversity of healthy bacteria had increased due to the CP101 contents.

The pill is made by Finch Therapeutics and now moves into Phase 3 studies prior to being ready to be presented for marketing. Competing firm Vedanta Biosciences is doing similar studies with its whole stool VE303 pill while Seres Therapeutics works with SER-109 which is an accumulation of highly purified Firmicutes spores.

Having an oral pill to replenish our natural micro biome after an unfortunate antibiotic related colitis infection with C Difficile will be a major advance in its treatment. Hopefully it will reduce the recurrences of this miserable disease.

Vitamin D & Autoimmune Disease

Karen Costenbader, MD, of the Brigham and Women’s Hospital in Boston reported at a plenary session of the American College of Rheumatology that adults taking 2000 IU of Vitamin D and one gram of omega 3 fatty acids daily were less likely to develop autoimmune disease than adults taking a placebo. Costenbader’s research group reviewed data from the Vitamin D and Omega 3 Vital trial which included 2,000 men ages 50 and older and women 55 and older.

In her work, Dr. Costenbader looked at almost 17,000 participants who had blood tests for Vitamin D levels and Omega 3 fatty acids. The study groups were followed for over a five-year period. Those supplemented with Vitamin D and Omega 3 fatty acids reduced the incidence of autoimmune disease by 25- 30%.

Vitamin D supplements and Omega 3 Fatty Acid supplements are readily available, inexpensive and non- toxic when taken in appropriate dosages. Their use should be encouraged.

Prediabetes & Exercise

Prediabetes is a condition that identifies individuals who have an increased risk of becoming Type II diabetics. It is diagnosed with either a fasting blood glucose measurement of 100-125 or an elevated Hemoglobin A1C level. The Hemoglobin A1C level provides a look at the average blood sugar level over the previous 8-12 weeks and is fairly independent of the previous few meals.

Gone are the days of the physician saying to his patient, “your blood sugar was elevated at 120” and the patient responding, “Well it was my birthday this week and I had some cake and alcoholic drinks causing the elevation.” The hemoglobin A1C removes that reason.

When physicians diagnose patients with “prediabetes” we try and educate the patient and family encouraging dietary education on a healthy eating lifestyle, weight reduction if they are overweight and regular exercise. Fortunately, in the senior citizen age group, newly diagnosed prediabetics usually don’t end up developing full blown diabetes if they watch their weight and get active.

A recent study published in BMC Endocrine Disorders found that aerobic exercise was best at controlling Hemoglobin A1C levels but resistance training was not far behind. Those individuals who engaged in both aerobic training plus resistance training showed better weight control and fasting blood glucose levels than the control groups or aerobic training alone. When evaluating the data both aerobic training and resistance training helped. The message to me for my patients is, if you are a prediabetic, start exercising doing what you enjoy doing. Make it fun, not work. Couple that with a dietary education from a trained dietitian or diabetes peer educator and you will do well.

Zinc For Colds This Season?

Two weeks ago, my wife was doing her weekly childcare activity of love watching our two toddler grandchildren while our adult kids were on a business trip. The 3.5-year-old had brought home a viral respiratory infection the week before, gave it to his one-year-old brother and both kids were now in the tail stages of recovering from annoying but not serious illnesses.

In today’s world, coming home from school with a sore throat, runny nose and malaise means tea and honey, warm soup and a COVID-19 test. Both kids were negative but several days later my wife, then I, had similar symptoms. My wife’s symptoms settled in her sinuses and 10 days later her doctor put her on antibiotics and nasal spray. I was fortunately much less symptomatic but still have some nasal congestion and dry cough. We have a commercial preparation of a zinc product to prevent and reduce the symptoms of these infections but did not get around to taking them. In the past the literature wanted us to take these lozenges every two hours and I was not going to set an alarm at night to wake up to suck on a zinc tablet.

Jennifer-Hunter, PhD, from the Western Sydney University and associates studied the questions about zinc products’ effect on preventing and abating the common cold and published their findings in the online version of the BMJ Open on November 1, 2021. They looked at 28 randomized controlled studies with 5,456 patients. Their results showed that oral or intranasal zinc did prevent about 5 infections of those exposed per 100 persons when compared to a placebo. They found that if you challenged healthy individuals with a human rhinovirus inoculation the sublingual zinc did not prevent a clinical cold. Those who continued the zinc tended to have resolution of symptoms two days earlier than those who took placebo. For those who took the zinc prep there were more episodes of nausea and mouth and nose irritation.

I appreciate the science and think I will pass on the zinc for now and stick with avoidance of sick individuals plus chicken soup, tea and honey when I catch the virus anyway.

FDA Approves New Non-Verbal Computerized Test for Cognitive Impairment

Many of you are used to the Mini Mental Status Test or Montreal Cognitive Assessment Test during which an examiner asks you verbal questions and there are some pictures to interpret. This week the FDA approved a new test taken on an iPad or tablet using images of animals. The test asks you to classify the pictures as either an animal or nonanimal. The advantage of using the nonverbal picture test is it eliminates bias based on level of education and culture. In addition, it eliminates a successful score on subsequent tests due to a “learning the test” effect.

The test results can be incorporated into a patient’s electronic health medical record and become a part of the patient’s permanent chart. The test was given to 230 volunteers. There were eighty individuals with mild cognitive impairment, 55 with mild Alzheimer’s Disease and 95 healthy individuals. The results revealed the test was as sensitive as current verbal tests currently used to detect early dementia.

CognICA is the name of this new test and will be available for purchase in the next few months

Blood Pressure Control Becoming Trickier & More Personalized

In the era of the COVID-19 Pandemic it’s difficult to find published research which does not deal with the Sars2-Coronavirus. There have been several articles recently about blood pressure that have been of interest. One study previously mentioned discussed the development of a polypill. This pill contained small amounts of four different classes of blood pressure medicine. The researchers noted that in the past physicians were taught to try one pill and keep increasing the dosage until the blood pressure was controlled. The unfortunate part was that as the dosage of the one pill was increased the appearance of adverse side effects took place and patients simply stopped taking their medicines.

The polypill controlled blood pressure better than a single pill and produced fewer adverse effects than a single pill at higher dosages. A separate study reviewed this week looked at the same question. Should we just keep increasing the dosage of a single medication until blood pressure is controlled or should we add a second medication that works by a different mechanism. This study agreed with the polypill study finding that adding a second pill at a lower dosage lowered blood pressure more than a single pill and compliance was better as well due to fewer adverse effects.

A recent publication in the Journal of the American College of Cardiology, published by Tara Chang MD, MS of Stanford University School of Medicine in California, added to the confusion by suggesting that there should be different blood pressure goals for prevention of different diseases. Individuals with heart attacks may do better with a higher diastolic blood pressure than individuals trying to prevent a stroke. Ideally BP would be kept at the 110-120 mm HG to protect the brain, but this range might be too low to protect against another heart attack. For those individuals with both coronary artery disease and cerebrovascular disease the decision on how low to go needs to be discussed with your primary care doctor and cardiologist.

This is clearly an evolving science with more data to come. Hopefully with more data and study it will be less confusing for patients and clinicians as well.

Medicare Part D Annual Enrollment

As of October 15, 2021 traditional Medicare enrollees are encouraged to compare available prescription drug plans under the Medicare Part D program for the 2022 year. Private insurance companies administer these programs for Medicare. The drugs they cover and the amount they cover change from year to year. What was covered this month through December 31, 2021 may not be covered at all on January 1, 2022. The result may be sticker shock when you attempt to refill your normal prescription medications and are presented with a huge bill when you go to pick them up because your insurer no longer carries that medication or covers it through their formulary of medications. The open enrollment period ends December 15, 2021. A Kaiser Foundation poll and research study found that 70% of Medicare beneficiaries do not even compare plans during the October 15 – December 7th enrollment period.

If you have a computer log onto www.Medicare.gov. You will be given a choice to look at Medicare plans as an existing beneficiary or a new one. It will then ask if you wish to sign in with an account or as a guest. Either path will take you through.

You need to then choose Medicare Part D Prescription plans. It will ask for identifying information including your date of birth, initial date as a Medicare recipient and your zip code. It will request that you choose a participating pharmacy. If you use a chain pharmacy such as CVS or Walgreens, choosing any branch will do. It will then ask you to list your medications including dosage and how many you take daily and monthly. Once this task is completed it will allow you to select a plan.

Plans available in Palm Beach County, Florida are different than plans available in Dade County, Florida or even Nassau County, New York. If you wish to have a plan with no deductible the monthly premium will be more costly.

The computer program lists your current plan at the top with anticipated costs to you for 2022 if you keep your current plan. Underneath they list the best plans for you and the member ratings of those plans’ performance in previous years.

The process takes about twenty minutes but can save you hundreds of dollars and much aggravation. In my medical practice, we print out the data for our elderly patients who don’t have access to a computer or lack the skills to use the website.

Aspirin & Heart Disease Prevention Recommendations

In the 1950’s a research paper based on work done at a Veterans Administration Hospital found that men 45 years of age who took a daily aspirin tended to have fewer heart attacks and strokes. The VA patients were mostly male WWII and Korean War Veterans. That was the basis for most of the men in my Baby Boomer generation to take a daily aspirin.

Yes, we knew that aspirin gives us an increased risk of bleeding from our stomach and intestine. And we knew that if we hit our head while on aspirin the amount of bleeding on the brain would be much greater. It was a tradeoff – benefits versus risks.

Over the years the science has advanced to now distinguish those taking aspirin to prevent developing heart disease, cerebrovascular disease or primary prevention and those seeking to prevent an additional health event such as a second heart attack or stroke. To my knowledge there are no studies that examine what happens to someone in their 60a or 70s who has been taking an aspirin for 40 plus years daily and suddenly stops. It’s a question that should be answered before electively stopping daily aspirin.

Over the last few years researchers have hinted that the daily aspirin may protect against developing colorectal cancer and certain aggressive skin cancers. The downside to taking the aspirin has always been the bleeding risk. This data is now being questioned by the USPTF looking for more “evidence.”

The US Preventive Services Task Force was formed in 1984 with the encouragement of employers, private insurers selling managed health care plans and members of Congress to try and save money in healthcare. It is comprised of volunteer physicians and researchers who are supposed to match evidence with medical procedures to ensure that we are receiving high value procedures only.

In 1998 Congress mandated that they convene annually. Under their direction, recommendations were made to stop taking routine chest x rays on adult smokers because it didn’t save or prolong life and it took $200,000 of X Rays to save one life. They reversed their opinion decades later deciding that the math on that study wasn’t quite right and now recommend CT scans on smokers of a certain age and duration of tobacco use. I point this out to emphasize why I am not quite as excited today about their change in aspirin guidelines as the newspaper and media outlet stations seem to be.

I am a never smoker, frequently exercising adult with high blood pressure controlled with medication, high cholesterol controlled with medication and recently diagnosed non obstructive coronary artery disease. What does that mean? At age 45 my CT Scan of my coronary arteries showed almost no calcium in the walls. 26 years later there is enough Calcium seen to increase my risk of a cardiac event to > 10% over the next ten years. I took a nuclear stress test and ran at level 5 with no evidence of a blockage on EKG or films. The calcium in the walls of the arteries however indicates that cholesterol laden foam cells living in the walls of my coronary arteries and moving towards the lumen to rupture and cause a heart attack were thwarted and calcified preventing that heart attack or stroke. I am certainly not going to stop my aspirin.

My thin healthy friend who works out harder than I do told me he doesn’t have heart disease and is going to stop his baby aspirin. I asked him what about his three stents keeping several coronary arteries open? He told me he had heart disease before he got the stents but now he doesn’t. I suggested he talk to his internist or cardiologist prior to stopping the aspirin.

I may take a different path in starting adults on aspirin for cardiovascular and cerebrovascular event protection. I am certainly not going to withdraw aspirin from patients taking it for years unless they are high risk for falls and head trauma or bleeding. I suggest you ask your doctor before considering changing any of your medications.

Try an exercise by writing down all the prescription medicines and next to them list what condition you take them for. Once you have established that information, set up an appointment and talk about it with your physician. The decision-making is much more complicated than the USPTF and headline hungry media discussed and reported.

Exercising With a Mask is Safe

My daughter was trying to come to terms regarding what to do about school with our 3.5year old grandson. Her friends were applying peer pressure to send him to school citing permanent psychological and developmental damage from staying isolated at home. She signed him up for a school that does not have a vaccine mandate for teachers and staff but does require that the children wear a mask indoors and in close contact situations outside. “Don’t you know that masks are unhealthy for children. They have to breathe more carbon dioxide.” said another mom. 

Rising carbon dioxide levels produce a reaction to breathe, which is a good thing. So, I searched the literature to find something that provides evidence that masks are safe.

Matthew Kampert, D.O. and colleagues from the Cleveland Clinic performed exercise stress tests on active young men wearing no mask, wearing a N95 mask and wearing a cloth mask with a charcoal filter. Their results were published as a letter in one of JAMA’s online forums.

These men each exercised until they were exhausted in three scenarios. Without a mask they exercised for a mean duration of 591 seconds versus 548 seconds with a cloth mask and 545 seconds with an N95 mask. They all felt that breathing resistance and humidity was higher with either mask.

There were no arrhythmias nor were there ischemic EKG changes. Their conclusion, based on the small difference in time exercising, is that wearing a mask did not limit physical exercise capacity.

Thus, wearing a mask does not adversely affect your ability to exercise or participate in activities.

Some Health Issues Should Not Be Evaluated in the Office

I received a phone call from an elderly gentleman who was closer to ninety years of age than 80, was taking an aspirin and had just suffered a fall and hit his head. He did not know why or how he fell. He asked for an appointment the same day to “check me out.” 

My staff asked all the pertinent questions and immediately brought the information to me.  After reviewing it, I felt for his safety his best course of action was to immediately call 911 (or have us do it) and go to our local emergency department for evaluation. The patient takes daily aspirins to prevent a second heart attack or stroke.

The antiplatelet action of the aspirin, plus his age and the head trauma necessitate an immediate and thorough evaluation with imaging. I do not have an X Ray unit, CT Scan unit or MRI unit in my internal medicine office. If I bring this gentleman into my office, he must transport himself, wait until I have time later in the day and probably will then have to wait to be scheduled by an imaging facility for a non-contrast CT scan of the brain to make sure doesn’t have a bleed between his brain and skull or a bleed in the brain. The delay in evaluation can threaten his survival and recovery. 

The patient was quite angry at the suggestion – quoting my concierge practice contract that says we will bring you in for a visit same day for an acute condition. The non-stated content is that we will bring you in same day for a condition that is appropriate for evaluation in an office setting. The same can be said for someone calling with acute substernal chest pain which could be a heart attack or sudden inability to breathe.  Add in excessive bleeding that does not respond to compression or loss of consciousness as conditions that are best evaluated and treated in an emergency department. These are all conditions that require a call to EMS via 911 and an immediate evaluation in an Emergency Department where the equipment exists to quickly evaluate and treat these problems safely. 

The patient was worried about the wait in the ED and COVID-19 exposure. Both concerns are understandable despite little transmission of Covid recorded in ED visits or in patient hospitalizations.

This patient has emailed me twice now demanding a full refund of his membership fee due to violation of the contract. The reasoning and concern have been explained to him several times already. My concern is that his new onset short temper and grumpy demeanor are the result of the fall and head trauma which still has not been evaluated.

Patients need to know that there are times a health issue requires evaluation and treatment in an emergency department.  It has nothing to do with a contract.  It has everything to do with making the right clinical recommendation for the patient.