NEW covid19 vaccine

I am sure many of you have heard it is the first of its kind. It uses mRNA technology. I am not going to discuss what that means ebcasue so many people already have on other podcasts and publications but the question is should you get the vaccine. I have read many opinons on this from experts for example
Dr. Michal Elovitz, a preterm labor researcher and obstetrician at the University of Pennsylvania.
Said its possible the mRNA and the bubble it travels in, made of lipid nanoparticles, could cross the placenta, and This might, in theory, cause inflammation in utero that could be harmful to the developing fetal brain” she went on to say, “It’s also possible the new vaccines could be totally safe in pregnancy, like the flu shot.”

No pregnant patients were enrolled in the accessible trials, although some people got pregnant during the course of the study. Researchers are monitoring them to see how they do.

We have not even tested this on pregnant animals—we have no idea if this is safe for pregnant women and this is exactly what I am talking about when I say inclusion drift. It was something that big pharm thrives on.

You get your drug approved in one condition or pt population then you market the drug as this great drug and then quickly the providers forget that the benefit found in the trial was only under perfect conditions with mean age of 25 yrs old and no health problems…. The chance you will see the same benefit in your 75 year old HONDA is almost impossible….. BUT as long as you prescribe the drug they don’t care about your individual patient and their lack of benefit because they care about selling more drugs.. in the drug company world this is comparible to a bait and switch seen by car salesman. Show you the fancy benefits with the drug seen in their perfect patients and perfect environment then take your money or your patients money for much less impressive results.

Studying pregnant people requires extra effort in safe study design and recruitment efforts, Anything you do to a pregnant woman also has a chance of affecting the developing offspring


pregnant women are often just excluded altogether.


https://pubmed.ncbi.nlm.nih.gov/21766440/


a paper from 2011
Evolving knowledge of the teratogenicity of medications in human pregnancy

Which looked at all 172 FDA drugs approved from 2000 to 2010 and guess hoa many had known teratogenic risk??? Whatever you said the answer is wrong because they found most had “undetermined” risk -- in fact “The teratogenic risk in human pregnancy was "undetermined" for 168 (97.7%) of drug treatments approved between 2000 and 2010.”

“we have adequate data on the risk of birth defects in less than 10 percent of medications approved by the Food and Drug Administration since 1980. “

If someone on rounds says “med student, tell me the risk of this medication and in pregnancy” you are going to be right 9 out of 10 times if you say “we have no FDA proven data on that”


And speaking of the FDA what did they say about this --
F.D.A. left the choice of whether or not to get the Covid-19 vaccine up to pregnant women,



· The American College of Obstetricians and Gynecologists per usual isn’t worth their weight in feathers as they said- “ACOG recommends that COVID-19 vaccines should not be withheld from pregnant individuals who meet criteria for vaccination based on Advisory Committee on Immunization Practices recommended priority groups.”
I swear the ability to critically think or form your own opinion must occur some place around the second year of OB/gyn residency because their guidelines and opinions are almost always the least imformative or evidence based documents to ever be published. In their released statement they try to state some small crappy observational studies
One which showed if you were preg and had covid you were more likely to go to the ICU—well ist hat cause you are sick or because you are pregnant and have covid and realistically back in April if you were pregnant and had covid and even sneezed you were admitted to the ICU

The other was a morbidity and mortality weekly report which 598 hospitalized pregnant women with COVID-19- now most of these women were hospitalized for labor and delivery and then were asymptomatic and tested positive for covid19
And of those almost 600 women hospitalized lets get to the scary part
16.2% were admitted to an intensive care unit (ICU), and 8.5% required invasive mechanical ventilation.
Which sounds scary but we care about is pregnancy loss
And turns out 2.2% of the women had a pregnancy loss
Which is scary but we know spontaneous abortion is a real thing especially at <20weeks and it is almost impossible to tease out is this a spontaneous abortion in someone who has covid or is this covid causing a spontaneous abortion

Now rates of abortion after 20 weeks is much less.
So in this a morbidity and mortality weekly they estimate that risk of stillbirth was
5 per 458 which is about 1.6 per 160 covid births
And when you look at the CDC data on this they average the risk of stillbirth in the US is
Around 1/160
https://www.cdc.gov/mmwr/volumes/69/wr/mm6938e1.htm
BUT BUT BUT when you break that down by those women who had symptoms at initial presentation and those that did not have symptoms it tells a much different story
Remember the baseline risk of still birth is around 0.6%
If you came in with symptoms of COVID at time of admission your risk of still birth was 2.8%
4x greater risk of still birth if you came in with symptoms of covid19
Now if you didn’t have symptoms what was your rate of stillbirth? And the answer is 0.3%
Yes HALF the rate of still birth from the general if you didn’t come in with symptoms. You could make the hypothesis that those women who have covid but are asymptomatic are protected from having a still birth…
Which begs the questions of why do some have symptoms and why are some are asymptomatic---and what we seem to know from pure observation data is those individuals with co-morbid conditions or said differently those individuals who are already not living a healthy lifestyle are at great risk of getting a virus and dying from a virus. For many the thought that being unhealthy could lead to death or leave you prone to severe infection is a very new and foreign concept!

https://obgyn.onlinelibrary.wiley.com/doi/full/10.1111/aogs.13901
https://www.acog.org/en/clinical/clinical-guidance/practice-advisory/articles/2020/12/vaccinating-Pregnant-and-Lactating-Patients-Against-COVID-19

For those of you wondering the CDC has said – “Health care personnel who are pregnant may choose to be vaccinated.”
Which is what they should say because what they are really saying is “we are not going to stop you from doing it but we are certainly not going to promote you getting it”

What you see is what you get- no more clearly seen then in
This paper titled

Nutritional Analysis of Foods and Beverages Depicted in Top-Grossing US Movies, 1994-2018

In JAMA internal medicine which looked at the nutritional quality of foods and beverages depicted in
the 250 top-grossing US movies from 1994 to 2018
these 250 movies sold 10 billion box office tickets and grossed $164 billion in theaters
worldwide. These are popular movies we all watch or are aware of
and what they put on the screen as a societal “norm”
in this study-
Two trained researchers viewed movies in their entirety and listed all
foods and beverages depicted in each scene.
they used the Nutrient Profile Index (NPI) to classify foods and beverages as healthy or not
penalizes components that should be limited like
sugar, sodium, and saturated fat and rewards fiber, protein, and fruit and vegetable
Now I understand this is not a one size fits all and the authors admit there is not portion control
on this so if the movie had a thimble full of high sugar intense soda and a whole garden of
lettuce the were considered “equal”
The results showed that-
nutrition ratings showed that 72.7% received a less healthy food nutrition score and 90.2%
received a less healthy beverage nutrition score.
But did it get better with time, I mean people use to smoke and now they don’t-
“We found no evidence of improvement over time in sugar, saturated fat, total fat, or sodium
content of foods or in sugar content of beverages”
part of the reason I bring up this article is because There were many disturbing findings like
G-rated movies, nearly 1 in 5 beverages (23 of 127 [18.1%]) were alcoholic beverage and 50%
of the time it was an alcoholic beverage in rated R movies!
the beverage sugar content was higher in movies targeting younger audiences --- on
average movies depicted 121 g (95% CI, 116-125 g) of total sugar per 2000 kcal, which is
higher than the total sugar content in 3 cans of Coca-Cola.
in summary- what you see is what you get and if you see your favorite actors eating junk food it
makes it ok to also eat junk food. . we already live in an obese society and any opportunity we
can to prvent or promote healthy eating should be done, even if that means during a movie
while you stuff your face with a 120oz coke and 620ounces of buttery popcorn.

But speakig of movies what do yu think of when you think of tom cruise or maybe I should say if
someone says the move “Jerry maguire” what do you think of?

I think “show me the money” which is a perfect segway to this paper in annals of IM titlted

https://www.acpjournals.org/doi/10.7326/M20-5665
Are Financial Payments From the
Pharmaceutical Industry Associated With
Physician Prescribing?
A Systematic Review
This was a systematic review to look to see if
payments from the drug industry is associated with physician prescribing practices.
The results were obvious, if you got money then you prescribed the drug companies drug more
often, and this was also associated with increase prescribing cost… the total cost and rates of
prescribing varied BUT NONE
And I repeat NONE OF THE identified studies had all null findings.
The easy answer is Receiving payments from a drug company may lead a physician to
prescribe more of that company's drug in the future.
Or you can sit back and question medicine and look at it from a different perspective--
prescribing may cause payments:
Drug companies may target payments to physicians who are already high prescribers of their
drugs. Both mechanisms are plausible.
The studies the look at temporal prescribing found substantial increases in prescribing immediately
after receipt of each industry payment.
Industry spending on drug promotion disproportionately targets drugs that are less effective or
offer little therapeutic advancement BECAUSE physicians want to use effective drugs
REGARDLESS OF THE PROMOTION!!! whereas marginally effective drugs require more
intensive promotion to increase prescribing!!
ASA after a stroke- we know it works, you odnt need to sell it to me
Statins after and MI- we know it works
Metformin for type 2 diabetes- we know it works

No need to show up at my door. I think the pharmacuetical industry is like the necessary evil, we
need them, they do great things and have the money to do fantastic trials because they have
the money to chase people down to get the outcome data we need but taking money from them
tugs on our need to prescribe their medications EVEN when our patients may benefit from
another or different or cheaper drug and if you think well this doesn’t apply to mean I want to
repeat what I said earlier
NONE OF THE identified studies had all null findings.
So unless you think you are magically different than every other provider that has ever been
studied then yes, even you are affected by drug money money and meals. Money talks so if you
cant stand the heat get out of the kitchen and speaking of heat
This next article titled
Associations between high temperatures in pregnancy and risk of preterm birth, low birth weight, and
stillbirths: systematic review and meta-analysis
Found a small but very real and consistent association between exposure to high enviromental
temperatures and pregnancy outcomes,
odds of a preterm birth rose 1.05-fold (95% confidence interval 1.03 to 1.07) per 1°C increase in
temperature and 1.16-fold (1.10 to 1.23) during heatwaves which were defined as two or more
days with temperatures above a predefined threshold.

This gives me two pieces of informtion which is those individuals who workout a lot should
probably avoid the hot yoga during pregnancy, stick to the regular yoga for 9 months and those
individuals with low economic status and no access to air conditioning will suffer and on a grand
scale will see higher rates of preterm delivery. This is sad and if a real finding it is one we will
never see on microscopic data remember it is only a 5% increase risk with the 95% confidence
interval going all the way down to 1.03% we are not good enough to pick up such small
differences in our day to day clinical practice but with macroscopic data. It becomes clear, I am
eager for more information on this in the future.

Remember when I said last year that according to me and now according to ACOG for almost
10 plus years we should let women get birth control over the counter!! When I told you that this
is insane that we has providers think we are so special they must come to us to get
contraception?? Well we are one step closer in this paper titled
https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)31785-
2/fulltext?utm_source=The+Scope&utm_campaign=f2254e45a6-
Weekly_Scope_Jan_12_2018_COPY_01&utm_medium=email&utm_term=0_809ad7d22b-
f2254e45a6-180869057

“Use of effective contraception following provision of the progestogen-only pill for women
presenting to community pharmacies for emergency contraception (Bridge-It): a pragmatic
cluster-randomised crossover trial”

pragmatic cluster-randomised crossover trial of almost 600 women receiving emergency
contraception in a pharmacy were randomized to either an intervention group or a control group.
In intervention group, women received a 3-month supply of the progestogen-only pill (75 μg
desogestrel) plus a rapid access card to a participating sexual and reproductive health clinic. In
the control group, pharmacists advised women to attend their usual contraceptive provider
The primary outcome was the use of effective contraception (hormonal or intrauterine) at 4
months.

Although there was a significant amount of people lost to follow up, almost 40% which was
higher than the expected 25% lost to follow up expected by the authors, however at 4 months
The proportion of women using effective contraception was 20·1% greater in the intervention
group, than in the control group. (mean 40·5%, 29·7–51·3 [adjusted for recruitment period,
treatment group, and centre]; p=0·011).

But taking birthcontrol or on BC is a surrogate outcomes so lets look at the secondary outcome-
--
Secondary outcomes were incidence of abortion in the 12 months following recruitment and an
economic evaluation of the intervention.
Sadly this study would have needed about 2000 patients to clearly tell a difference in
unexpected pregancy or abortion.
I guess the summary is that if you want women to be on birth control you have to make it easier
for them to acccess it and whatever format that is then fine, let them access it. Their risk of
children far exceeds your need for another easy RVU patient.

https://www.nejm.org/doi/full/10.1056/NEJMc2031173?utm_source=The+Scope&utm_campaign
=f2254e45a6-
Weekly_Scope_Jan_12_2018_COPY_01&utm_medium=email&utm_term=0_809ad7d22b-
f2254e45a6-180869057

https://www.nejm.org/doi/suppl/10.1056/NEJMc2031173/suppl_file/nejmc2031173_appendix.pdf



https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/10.1001/jamainternmed.2020.283
4?guestAccessKey=4474ae2b-f5ad-45c1-a5b9-
4735927592c1&utm_source=silverchair&utm_medium=email&utm_campaign=article_alert-

But the next article is breath-taking

Titled- Managing Asthma in Adolescents and Adults2020 Asthma Guideline Update From the National
Asthma Education and Prevention Program

The important thing to know is
Those with mild persistent asthma should use either regular daily ICS with an as-needed
inhaled (SABA), or to use both ICS and SABA on an as-needed basis.
Those with moderate persistent asthma should use ICS and formoterol daily with additional
doses of the ICS/formoterol as needed
Some will say this is different than the gina guidelines which say ICS/formoterol right from the
start. I will say you are right this is different than the global initiative for asthma guidelines. And
you may be asking, well then what is the right thing to do and my answer is---
The only correct answer is not what you should be doing but what you should not be doing and
that means those individuals coming in with mild persistent asthma, the newly diagnosed
asthma patient really should no longer be on just prn albuterol. Those days are done, the data
and the guidelines agree. ----

Get the best evidence because you want to know what they are looking at and occasionally people send me articles I was not aware of. Plus I ate spending my time sending them all the information then people say well ya but you are looking at the wrong evidence just right off the bat say “I will explain but tell me the evidence you are looking at”
So he sent me 5 articles and I going to break them down in hopefully a rapid fire dissection
And before we get started there is a very important piece of information that we all need to be clear on, low vitamin d DOES not mean that replacing the vitamin d then fixes the problem. We knew for a while that high HDL seem to have a protective cardiovascular effect but when we looked at the data it didn’t appear raising the HDL with a drug called niacin had an effect on cardiovascular events. This is the ultimate association and correlation connection. Sure it appears more popsicles consumed are associated with higher rates of drowning but getting rid of popsicles will not get rid of drowning. It appears more car accidents happen within 5 miles of your house and even more car accidents happen within 100 miles from your house but if you get rid of driving within 5 or 100 miles of your house you do not get rid of car accidents so it takes me to the

First article-
https://www.mdpi.com/2072-6643/12/9/2757/htm
In journal of Nutrients titled

Vitamin D Deficiency and Outcome of COVID-19 Patients

This is observational data looking at the associations of vitamin D (VitD) status with disease severity and survival and

Quick take away- Our study demonstrates an association between VitD deficiency and severity/mortality of COVID-19, highlighting the need for interventional studies on VitD supplementation in SARS-CoV-2 infected individuals.


Yes I agree with everything they just said but does replacing the vitamin level with supplements then mean you have a better outcome. This article doesn’t touch on that

Second article-
Also in journal of nutrients titled-

Evidence that Vitamin D Supplementation Could Reduce Risk of Influenza and COVID-19 Infections and Deaths
This is a review article. Review articles are never ever to be used as evidence because the authors have a story they want to tell and they set out to write a paper that tells their story. When you write a review article you never set out with a hypothesis and then you the scientific method to accept or reject the null. You start with a goal in mind and look for papers to confirm your goal. Review articles are the ultimate in confirmation bias. Anytime anyone ever gives you a review article as evidence you should automatically question medicine and politely hand it back to them and say, “thank you but I would prefer something higher than “expert opinion”.

Articles 3- next article was from scientific reports, titled-
https://www.nature.com/articles/s41598-020-77093-z
Analysis of vitamin D level among asymptomatic and critically ill COVID-19 patients and its correlation with inflammatory markers
This was a continuous prospective observational study that look to analyze the vitamin D level in COVID-19 patients and its impact on the disease severity.
Basically they looked at patients vitamin d level during the course of follow up and then used statistical analysis to see if there was an association between vit d levels and severity of illness.
The results found that “vitamin D deficiency (as suggested by serum 25 (OH)D concentration So what they are saying is if you are in the ICU you are more likely to die. They are also saying that those individuals who are sick and in the ICU are more likely to have vit d. deficiency. Wait, you mean I am saying that if you are in the hospital then you have a lower laboratory value that is associated with being outside???? Ya, shocking statement to think of!! This is completely a duh statement, and being admitted to the ICU is also associated with higher rates of intubation. The authors are not saying replacing vit d levels with supplements PREVENTS ICU admission or death.

Next article- https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2770157
In JAMA titled-
Association of Vitamin D Status and Other Clinical Characteristics With COVID-19 Test Results
This is a cohort study that looked to see if vitamin D status was associated with test results for coronavirus disease 2019 (COVID-19)
Remember a cohort study is observational data, they look at people at one point in time and then again at another point in time. They don’t intervene, they don’t treat, they don’t do anything. They look at a point in time called ‘x’ and follow up at a future point in time ‘x’ and see what happens.
This study looked at 500 people who had a vit. D level within the previous year prior to being testing for covid-19 and found that if you had a low vitamin d level you were at 1.8 times greater risk for testing positive for covid-19
This study does not say that if we replaced the vitamin d levels with vit d supplements that then they would have tested neg for covid-19
It really just says if you have a lab value which is already associated with decreased activity and decrease going outside that you are more likely than to test positive for a virus in the next year. Wait, did I just say that if you don’t have a great lifestyle you are more likely to test positive for a virus or get sick from a virus?? Yes that is exactly what I said and I know I am sure this is another shocking finding.


Last article- https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7456194/
In journal of steroid biochemistry and molecular biology
Effect of calcifediol treatment and best available therapy versus best available therapy on intensive care unit admission and mortality among patients hospitalized for COVID-19: A pilot randomized clinical study”
On the surface this seems like a potentially good study, it even says randomized in the titled, But then you go on to read that this was a randomized open label, double-masked clinical trial.
You think to yourself, wow double masked, that seems like a good thing. The key is who is masked? Because you also know open label is a bad thing because open label means that someone knows exactly what the drug is so that leads to a little bit of bias, if you really want something to work, you will alter your treatment towards that patient based on your own believe. The key is who is masked
This is a problem because the authors wanted this treatment to work and believed this treatment would work and you know how I know this, because they randomized participants in a 2 to 1 fashion. Normally you should enroll people 1:1 it is the most efficient method of randomization from a statistical perspective and requires the fewest number of patients. Enrolling in a 2:1 fashion usually requires about 12% more people to achieve the same level of statistical power.

Now, The reason you make it 2:1 is because you either think that it is easier to enroll patient-subjects in a trial if they believe they are more likely to receive the new/active treatment, or at least that is a reason stated by many authors and experts but this is really only valid when there is clearly one far superior drug from a non-superior drug. There is not enough evidence to say vit d is better than placebo or nothing thus is not valid UNLESS YOU IN YOUR HEART OF HEARTS BELIEF vit d is so much better based on faith and belief and no on evidence.
Another reason to randomize patients 2:1 is a budget issue and one arm of the trial is significantly cheaper BUT that is not the case in this trial because you either got an active drug or nothing. Not an active drug or placebo, it was an active drug or nothing and nothing is free.
Now if you are going to make unequal randomization then you should state why you did it that way. The authors did not. So we will never know the reason they did it.

But I will say the authors believed in vit dand this is easy to see if you know methods of a trial or you can just read the trail and the authors say. “The working hypothesis of this pilot trial was that calcifediol treatment would decrease the need for ICU admissions and the potential risk of death associated with these admissions.”
Said differently “we the authors of this trial have a belief that vitamin d will decrease the need for icu admission and potential risk of death.”

The primary outcomes was rate of ICU admission and deaths
Remember I said this was a “double-masked clinical trial”. The question is, who is masked.”
It is not clear who is masked but it appears the treatment list was “accessible only to non masked specialists in the study”. So some providers in the study had access to who was being treated with vit d. This obviously brings in observation bias and confirmation bias.


So in this study the outcome that showed such a huge benefit was the decrease risk of transfer to the ICU. This is a made up and bs endpoint because it is subjective!! In the paper it says

“A multidisciplinary Selection Committee was created, made up of intensivists, pulmonologists, internists and members of the ethics committee who decided on admission to the ICU.”

So what they are really saying is we have an endpoint for which human error is involved and the individuals who are involved in this outcome or endpoint have access to the information on which group the patient was randomized. So if you know the patient is getting the placebo, you may be a little more likely to transfer them to the ICU than you are if the patient is on vit d. Are you maybe a little more likely to try and treat them on the floor if you know the patient is already getting vit d and you want a positive trial so you can get a publication?? Ya I think so.

Plus they don’t give us the information on the patients transferred vs not transferred to the ICU. Why were they transferred? Did they need intubation? Was it maybe from a low sodium, maybe it wasn’t even covid related. FINALLY—the didn’t factor weight into their final analysis. They didn’t factor in BMI into the rates of severe covid! We know those that have larger bodies are more likely to have a poor outcome in covid and they didn’t include it because they say “ given the isolation characteristics of the patients, we did not collect the BMI,” which is total b.s. in most hospitals you can take a weight on the bed scale. The nurse already has to go into the room to deliver the meds and she or he can't hit one button on the bed to get the results of a bmi.

This paper while may look good just on the service is far far far far far from a slam dunk and between the combination of being open label, randomizing people 2:1, and outcome that is subjective by individuals who may know arm of the trial the patient is in and not including bmi in your analysis there are too many red flags to say this is even useable evidence.

And really this should only be used by attendings to teach students and others how to appraise the medical lit.



In summary- no vitamin d should not be used to prevent or treat covid19 or at least not with the current data I am aware of or have been presented.

2020 Update to The Top Articles of 2019

Alzheimers disease—doesn’t say what you think it says

https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/10.1001/jamainternmed.2020.6432?guestAccessKey=807ca0d3-63aa-48f9-8a1d-16df0d828d42&utm_source=silverchair&utm_medium=email&utm_campaign=article_alert-jamainternalmedicine&utm_content=olf&utm_term=113020

Conclusions and Relevance Alzheimer disease and related dementias were associated with adverse financial events years prior to clinical diagnosis that become more prevalent after diagnosis

I listen to a podcast and read articles and it seems omg this is great!! Maybe we look to see if people are missing payments or making poor financial decisions and screen them for alzheimers. Currently screening for alzheimers is difficult because we don’t have good treatment to slow or prevent the progression of the disease.

Remember a few basic principles of screening are

The condition should be an important health problem.
There should be a treatment for the condition that can change the outcome.
Total cost of finding a case should be economically balanced in relation to medical expenditure as a whole.
As I say those I cant think can we apply those to covid screening?? (say it again)

retrospective secondary data analysis of consumer credit report outcomes from 1999 to 2018 linked to Medicare claims data of 81 364 individuals

and they were looking for Missed payments on credit accounts (30 or more days late) and subprime credit scores.

Does an individual with Alzheimer disease and related dementias miss more financial payments than those individuals without alzheimers and they found

“Alzheimer disease and related dementias were associated with adverse financial events years prior to clinical diagnosis that become more prevalent after diagnosis”

But lets look at some of the results—


Overall, 54 062 pts without the diagnoses of ADRD were included and 27 302 who had the diagnosis of ADRD were included.
Those Medicare beneficiaries diagnosed with ADRD were more likely to miss payments on credit accounts at a rate of 7.7% compared to only 7.3% of missed payments in those individuals without a diagnosis of ADRD (7.7% vs 7.3%; absolute difference, 0.4 percentage points [pp]; 95% CI, 0.07-0.70:). You might say wait a second a 0.4 percent absolute difference is statistically significant?? Yes, remember the more people you have in a study the more likely even a very very very small difference is statistically significant.

This study also looked at those individuals who develop subprime credit scores 2.5 years prior to diagnosis – for those individuals with ADRD this occurred 8.5% of the time compared to only 8.1% of the time in those individuals without the diagnosis of ADRD. This was an absolute difference, 0.38 pp; 95% CI, 0.04-0.72

Once again this is statistically significnat because so many people were enrolled. HOWEVER here is the problem and somehitng to notice. The authors gave you percent here, not the actual number which is what you are a question medicine individual needs to know! The reason being is because it drastically changes the outcome and results

Lets look at the first outcome of miss payments on credit account, this occurred 7.7% of those with ADRD compared to only 7.3% of missed payments in those individuals without a diagnosis of ADRD. BUT REMEMBER the people that were enrolled in this study- 54 062 pts without the diagnoses of ADRD were included and 27 302 who had the diagnosis of ADRD were included

This mean you have to take 7.7% of 27000 patients with a dx of ADRD
And 7.3% of 54000 patients without a dx of ADRD

This works out to a total of 6000 patients but it breaks down to 2000 individuals diagnosed with ADRD missed a credit card payment and 4000 individuals without a diagnosis of ADRD missed a credit card payment. So 2/3 of individuals who missed a credit card report did not have a diagnosis of ADRD!!

When you look at the second outcome of a subprime credit score you find almost the same thing! Remember the results were 8.5% vs 8.1% WHICH CLEARLY shows that those individuals with alheimers dementia diagnosis are more like to develop a subprime credit score but when you look at 8.5% of 27000 and 8.1% of 54000 it is clear at 8.1% of 54000 is a much bigger number so the actual numbers work out to almost 2/3 of those indivudials with a subprime credit score DO NOT have diagnosed dementia.


The authors say in the discussion that the findings “suggest that ADRD is associated with adverse financial outcomes even in the prediagnosis stage”

Yes they are right it is associated with adverse outcomes, but so is breathing!! So it brushing your teeth, more people without ADRD had or made poor financial decisions than those with ADRD.

The outcomes of this paper would change drastically if they ssaid we looked at the numbers and out of almost 80,000 patients it turns out that of those individuals who missed a credit card payment or a had subprime credit score 1/3 of the time these individuals had ADRD and 2/3 of the time they did not have.

This is a drastically different conclusion than what the authors said which was

“ Alzheimer disease and related dementias were associated with adverse financial events years prior to clinical diagnosis”


I think the take home is we still don’t have good screening for alzheimer disease and looking at adverse financial events is still not the magic bullet of alzheimers screening. AND don’t be confused if the authors don’t give you the exact numbers.. if they give you percent or ratios then you need to calculate the numbers yourself because likely they are trying to hide something or spin the results

https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2771041#:~:text=Conclusions%20and%20Relevance%20Initiation%20of,effective%20as%20brand%2Dname%20levothyroxine.

Comparative Effectiveness of Generic vs Brand-Name Levothyroxine in Achieving Normal Thyrotropin Levels
JAMA Netw Open. 2020;3(9):e2017645. doi:10.1001/jamanetworkopen.2020.17645


Quick history lesson- levothyroxine was cleared and approved for generic use in 2004 – until then Synthroid had enjoyed a huge market share. The only market share. They were it and there is soooo much money when you are the only drug on the market and the most prescribed drug on the market—in 2002 the revenue was estimated at 1 billion dollars.

I was alive in 2002 and I can tell you back then 1 billion dollars was a lot of money.

But then 2004 there is now competition, a generic drug.! What does the drug company do? Use some of their small fortune to trash the drug, pay of some doctors to write a paper and later in 2004 there was a paper released by The Endocrine Society released the paper citing concern for the generic drug and the bioavailability.
https://www.endocrine.org/advocacy/position-statements/bioequivalence-of-sodium-levothyroxine

as recent as 2014 the
American Thyroid Association guideline specifically recommends
“Switches between levothyroxine products could
potentially result in variations in the administered dose and
should generally be avoided for that reason”

Meaning don’t have them on brand name synthroid and then switch them to generic. Stay constant!

But todays study wanted to look at the comparative effectiveness of generic vs brand-name levothyroxine in patients initiating therapy for hypothyroidism

4570 patients initiating therapy with thyrotropin levels ranging from 4.5 to 19.9 mIU/L were 1:1 propensity–matched

One group was started on generic levothyroxine and the other group was started on brand-name levothyroxine also known as Synthroid.

As an outcome they looked at three different things
the numbers of individuals who attained a normal thyrotropin level within 3 months,
the clinically meaningful abnormal thyrotropin level within 3 months
the number of people with stable thyrotropin level(s) 3 months AFTER having a normal thyrotropin level

Among 4570 propensity score–matched patients those that received generic levothyroxine had a normal TSH 75.4% of the time and those that got brand-name levothyroxine had a normal TSH 76.9%
And in both groups about 4% of the individuals had a markedly abnormal TSH level (94 [4.1%; 95% CI, 3.4%-5.0%] vs 88 [3.9%; 95% CI, 3.1%-4.7%]; P = .65).

They then took the individuals who had a normal TSH at 3 months and propensity matched those individuals to 3 MORE months and the proportion maintaining normal TSH levels during the next 3 months was similar regardless if you received generic or brand name levothyroxine, 82% vs 83% respectively. (427 [82.6%] vs 433 [83.8%]; P = .62).

Here is the kick in the pants-
Per good RX

Levothyroxine is $4 on good RX
Synthroid is $45

www.bmj.com/content/368/bmj.m149

No one wants to get pregnant two minutes after having a baby. And also agrees that an IUD is most effective form of conception. However placing IUD after delivering a child seems to be a point of debate as the risk of expulsion seems to be significantly higher immediately post pregnancy
In this study titled
Averbach SH, Ermias Y, Jeng G, et al. Expulsion of intrauterine devices after postpartum placement by timing of placement, delivery type, and intrauterine device type: a systematic review and meta-analysis. Am J Obstet Gynecol 2020;223:177-188.

They looked at the different rates of IUD expulsion postpartum. As you can imagine the rates vary based on if the IUD was placed within 3 minutes of child delivery or 3 weeks after child delivery. There also seemed to be a difference between hormonal IUD (LNG-IUD) compared with a copper T-shaped IUD. Finally there was a difference whether she had a C-section or a vaginal delivery as you can imagine the vaginal delivery was associated with significant less rates of expulsion which is the numbers we are going to talk about going forward as the rates of expulsion following C-section were significantly lower around 0-2%.
Brand progesterone IUD are called Skyla, Liletta, Mirena -- but in this study they only included those papers which she used MIRANA.
Copper IUD goes by paragard
Ultimately the authors looked at 3 different timeframes for placement of the IUD. 1-immediate placement within 10 minutes postpartum, or IUD placement anywhere from 10 minutes postpartum to 72 hours postpartum or early outpatient placement somewhere between 72 hours to 4 weeks postpartum
So let’s break them down by timeframe-
Those individuals who had an IUD placed immediately following delivery had a 27% exposure rate with Mirena and a 12% exposure rate with ParaGard
Those individuals who had an IUD placed not immediately but within the first 72 hours the exposure rate was 37% with the hormonal IUD and 7% for the copper IUD
And finally for those women who had an IUD placed in the outpatient setting at some point between 72 hours in 4 weeks there was no expulsion that occurred for either the hormonal or copper IUD.

I think the final answer here is for a woman who has a vaginal delivery and would like to have IUD placement following delivery there is almost no way we can justify placing hormonal IUDs within the first 72 hours as the expulsion rate of 30ish percent is way too high to justify. The ideal situation would be IUD placement in the outpatient setting at sometime point between 72 hours in 4 weeks however if you’re patient is insisting on IUD placement while still in the hospital then it appears the best option would be a copper IUD and this likely should be placed as close to discharge as possible because even those individuals who had a copper IUD placed prior to 72 hours still had a 7% exposure rate which seems a little high. If you’re going to use this paper and practice I think important thing to remember is that it was for woman with vaginal deliveries and not for women with C-sections as those individuals had near 0% expulsion rates.



The next our article talks about one of the most irritating conditions to treat and of course that is irritable bowel syndrome. In this randomized double-blind placebo controlled trial titled
Hamatani T, Fukudo S, Nakada Y, Inada H, Kazumori K, Miwa H. Randomised clinical trial: minesapride vs placebo for irritable bowel syndrome with predominant constipation. Aliment Pharmacol Ther 2020;52(3):430-441.

Author still just over 400 patients with a history of severe irritable bowel syndrome predominant constipation who were having less than 3 spontaneous bowel movements per week and randomized them to placebo or minesapride 10 mg, 20 mg, or 40 mg daily for 3 months.

The primary endpoint—an increase in one or more complete spontaneous bowel movements and in the end it didn’t matter what dose of minesapride you got because it was no better than placebo. All groups had about a 40% improvement in their rates of spontaneous bowel movement.
Irritable bowel is irritating to treat because pooping and bowel movement are so mental. Anxiety and stress and tension can back you up like a hoover damn and then a magical pill even if it is placebo can put you at ease and open the flood gates…running a trial is hard because you need to beat placebo and speaking of things that didn’t beat placebo

This paper titled

Boesen AP, Boesen MI, Hansen R, et al. Effect of platelet-rich plasma on nonsurgically treated acute achilles tendon ruptures: a randomized, double-blinded prospective study. Am J Sports Med 2020;48(9):2268-2276.

Looked to see if platelet rich plasma could be placebo in the treatment of acute Achilles tendon rupture.

In this randomized double-blind placebo controlled trial of 40 patient’s with acute Achilles rupture confirmed on ultrasound-
All patients were treated with a continuously worn ankle casts that kept the foot plantar flexed for 8 weeks. Every 2 weeks, the researchers lessened the degree of plantarflexion. After 9 weeks, all patients began an ankle rehabilitation program
But half were randomized to placebo or and half platelet rich plasma injections.
The patient’s were injected every 2 weeks starting within 4 days of the injury they then evaluated patient function via the Achilles tendon total rupture score at the time of removing the cast and then again at 3, 4-1/2, 6, 9, and 12 months after injury. In the end there was no difference between whether patient was randomized to receive platelet rich plasma injections or saline injections. Granted this study was only 40 patient’s and too small to determine differences such as the re-rupture rate but this was a really well done study that I think is hard to refute, they did a lot of things exactly how you want to see them done.
For example,
None of the patient’s nor providers nor the statistician’s nor the outcome assessors were aware of
Whether the patient had received saline or platelet rich plasma. There is only one person who did the injections which was an experience sports medicine physician and injected all patients under ultrasound but this provider had no other influence on the patient’s outcome or care and was also blinded to saline or platelet rich plasma injections as a sheeth was placed over the syringe and the help of the needle. This in all actuality was a very well done trial and methadone neurologically was one of the most sound trials I have read in a long time, if he ever want to read how a method section should be written then he should read this paper. The methods were given in such extreme detail right down to the exact gauge of the needle and to the to the brand of ultrasound machine was used.
If you doubt this trial then there is more than enough information in the method section you could easily repeat it in your office tomorrow without any questions.
But otherwise said placebo was not nothing placebo is hard to be especially if you’re trying to be treated with platelet rich plasma for an Achilles tendon rupture

The man noticed that I said they did a method section really well and if he doesn’t agree with the outcome then you can repeat the study yourself in your clinic. I notice when he comes a cold literature as well as vitamin D literature and other such literature which is borderline terrible those individuals who believe in something so powerful such as mask refuses to believe the outcome of the well done trial regardless of how well the trial was done. However the most important part of the paper size for the results is the method section. If you know exactly what gauge needle, what size syringe, what lab assay, what number years of experience the provider giving the intervention has you can almost do an exact simulation in your office and see if you, with the exact results because sometimes the results very just based on something he would never think of like the laboratory which is no more clearly seen in this article titled

Potter JM, Hickman PE, Oakman C, Woods C, Nolan CJ. Strict preanalytical oral glucose tolerance test blood sample handling is essential for diagnosing gestational diabetes mellitus. Diabetes Care 2020;43(7):1438-1441.

Which looked at the effect of processing and oral glucose tolerance test with either delayed or early centrifuge protocol.
There is a total of just over 12,000 women in this study approximately 7000 women received delayed centrifuge protocol and approximately 5000 women received in early centrifuge protocol.
The lumen that had the delayed centrifuge protocol Heather blood collected but then it was sent off to a central laboratory for blood glucose analysis those when that had a early centrifuge protocol underwent the same oral glucose tolerance testing but when they had their blood drawn for analysis but glucose testing was performed immediately.
All things being equal they’re really shouldn’t be much of a difference here the results showed that those individuals who had immediate glucose testing rales twice as likely to be diagnosed with gestational diabetes than those individuals with delayed glucose testing

Fasting- with fasting there was a difference of 4 mg/dl
1-hour samples 6.1 mg/dL and the two hour measurement was a difference of - 2.8 mg/dL (0.16 mmol/L; 2.3%).. this may sound very small change in the overall glucose but remember the fasting blood glucose concentration is less than 95 so a difference of 4 just based on higher lab processes the blood draw is almost a 5% error in the test.. Likely in the United States for many oral glucose tolerance test we use Accu-Chek monitors however the same question in the same importance and relevant supplies to the calibration and accuracy of the monitor being used.
We have a chance grab 2 different brand monitors and check the same person at the exact same time just with different fingers and all certainly you’ll come up with a slight difference in their blood sugar. I’m not surprised by these findings which is a constant reminder that will be due in medicine is small. Nothing is a parachute. Nothing is absolute. I recently heard someone compare a certain intervention to Russian Roulette which implies a 1-6 chance of dying, this is follow-up taking that gives us an over his zealous and heightened sense of our work almost nothing that we do as a number needed to treat of 6 and especially not for death. We have to keep this in mind make sure that our patients are also aware of the inconsistencies in our practice of medicine which is also clearly seen in this paper titled

McCormack JP, Holmes DT. Your results may vary: the imprecision of medical measurements. BMJ 2020;368:m149. doi: 10.1136/bmj.m149

Which looked at the variation or error that surrounds laboratory testing. This paper found much of what I mentioned previously on questioning medicine about laboratory findings such as a single HbA1c test result of 6.3% (45 mmol/L) could actually be as low as 5.5% (39 mmol/mol) or as high as 7.1% (51 mmol/mol).
The lab findings are thrown off by variability in the analytic or lab process (4.3%), as well as biologic variability meaning the variation in the same person over the course of days caused by physiologic changes.
Combined, these challenges to precision can make a single iron, bilirubin, or triglyceride level be inaccurate by as much as 50%.
That means you would require at least a 50% change in the levels to be considered valid true actual change and not just a stastical variability.

I have put a link to the office calculator as the very first piece of information in this podcast and think everyone should save it to their favorites to either bring up with the patient sitting in clinic or to discuss with your colleagues at the next zoom conference

Let’s recap the articles discussed today before this ship set sale in the sea of evidence

Questioning medicine daily


https://www.acpjournals.org/doi/10.7326/M20-7448

https://www.acpjournals.org/doi/10.7326/M20-6817

Effectiveness of Adding a Mask Recommendation to Other Public Health Measures to Prevent SARS-CoV-2 Infection in Danish Mask Wearers
FREE
A Randomized Controlled Trial

Masks!!!! Do they prevent COVID19 transmission by preventing spread from infected people to others OR do they work by protecting wearers OR is it both.
We now have an answer to the second question, Do the mask work by protecting the wearers and in short the answer is no.
Fresh out november 18.
The DANMASK-19 trial

It a trial designed to examine the masks' protective effect.

Spring 2020 in Denmark, Social distancing recommendations were in effect, but masks were not recommended, they were rarely worn outside of hospitals, and the infection rate was modest around 2% per month which is pretty close to what we were seeing because remember we were around 1-3% here in american depending on where you lived with some places much much higher like New york but many places down to almost 0% like the fly over states and even places like salt lake city.
The endpoint was infection in the mask wearer!!! NOT infection in their contacts or the overall community infection rate.

This study enrolled 6024 adults who spent at least 3 hours outside their homes per day, had occupations that did not require masks, and did not have a previous known diagnosis of SARS-CoV-2 infection.
All participants were told to follow social distancing measures but randomized to wear or not wear a mask when outside the home.

The primary outcome was SARS-CoV-2 infection, defined as a positive COVID nasal swab OR development of a positive COVID antibody test OR a hospital-based diagnosis of COVID-19.
They powered it to find a 50% reduction in infection risk
After 1 month of follow-up, 1.8% (42 of 2392) of participants in the mask group and 2.1% (53 of 2470) in the control group developed COVID19 infection (risk difference, −0.3 percentage point [95% CI, −1.2 to 0.4 percentage point] [P = 0.38]; odds ratio, 0.82 [CI, 0.54 to 1.23] [P = 0.33]).
THERE WAS NO DIFFERENCE!!

BOOM FIRST RCT we have on wearing mask during COVID19 pandemic and it says that wearing a mask does not protect you from getting COVID19.
As with all trials which dont show what you want them to show there are people already knocking this well done trial. This is a common event and happens often in the cardiology or vit d literature. The study doesnt show what they want to they use very simplistic thinking to knock it down. Don’t get me wrong it has it’s flaws but use your brain to think deep and dont use the easy answer because they are not correct, in my opinion
Here are some of the things I have heard people say
1- “Well the study only looked at the effect of recommending mask use, not the effect of actually wearing them.”-In the study people were recommended to wear a mask not required to wear one-- yes, but that goes for every study—we recommend you to take a pill not the effect of actually taking them since we have no way of knowing they actually took them…This is every trial and either you believe in science and trials or you dont and you cant now all of a sudden not believe in medicine because the trial didnt show what you wanted.
2- How do we know people are wearing mask accurately??? Well in the trial 46% wore the mask as recommended and 47% wore it "predominantly as recommended," for a total of 93%. That is probably better than america, go to the grocery store and just walk around you might need more noses than heads of lettuce.
3- Some people say well this was done in denmark, we live in america so you cant use this evidence in america. This arguement works for some conditions and some treatments but I have no idea how this arguements works for wearing and not wearing mask. Unless there is a cultural difference in Denmark I am not aware of.
AND FINALLY---
4- Some say it is irresponsible to publish these results because this will give antimask people ammo--- I couldn't disagree any more-- More irresponsible would be to not publish the results of carefully designed research because the findings were not as favorable or definitive as some may have hoped. Science is not to be cherry picked






Here are one of the issues that are deeper thinking
Remember-
1) They powered it to find a 50% reduction in infection risk-- remember when you power your study you power it to find an outcome that you think is worth finding. Sure maybe they could find maybe a 1% reduction and it would be a positive study but people would say wait these stupid mask only give me a 1% reduction?? Also the smaller the benefit you want to find the more people you have to enroll. If you only wanted to find a true 1% difference you have to enroll over a million people depending on your standard deviation. That is just not feasible.
2) either you believe in science or you dont and if you want randomized control trials for the medications that you prescribe then you need have to be ok with them for mask that you tell your patient to wear. You dont get to change your belief on RCT because it didnt show what you wanted.
And finally
3) This trial does not tell us that mask dont work. We dont know if mask work to prevent us from spreading covid19 to other individuals. That trial could be done and should be done. You would have to randomized cities or areas to mask and no mask and see what happens. It would have to be done in other countries or small town america
My final thoughts are
Lots of people want to knock this study because it didnt show what they wanted- People wanted this to show how great mask are. People want to believe mask are a holy grail of wonderfulness. They want to shame people and post memes on social media shaming those individuals for not wearing a mask. in the end this study is a well done study that gives us good information. Unfortunately mask have become such a strong belief. It is like antivaccine people, their belief of evidence is much stronger than the actual evidence. Mask have sadly become political not science. I am not saying dont wear a mask and Im not saying always wear a mask. Do your best to try to wear them but if you dont have one on or you forget one, its OK!!! Mask are not parachutes. They are far from it. With all things being equal the NNT of masks is likely in the millions, especially for events we care about. Remember we don't care about catching a virus, people catch viruses all the time!! EVERY SINGLE DAY! Keep in mind we care if you have any morbidity and mortality from the virus. The event rate is still just a fraction of a fraction of a percent.

And with that!

Thanks for listening, thanks for your time and until next time keep the quest in questioning medicine

https://www.clinicalkey.com/#!/content/journal/1-s2.0-S0140673620322339?scrollTo=%23hl0000424

https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)32233-9/fulltext

do statins work in old people?? This study in the lancet says-

“In a contemporary primary prevention cohort, people aged 70–100 years with elevated LDL cholesterol had the highest absolute risk of myocardial infarction and atherosclerotic cardiovascular disease and the lowest estimated NNT in 5 years to prevent one event.’

researchers calculated that 80 adults aged 80–100 years — would need to receive a moderate-intensity statin for 5 years to prevent one MI.
and145 adults aged 70–79 years — would need to receive a moderate-intensity statin for 5 years to prevent one MI.
and to prevent just one ASCVD event, the numbers needed to treat were 42 and 88, respectively.

But anytime you read the results you have to say “how did you come up with that number” what were your methods?

In this study they took a sample of people from a large Danish database and these were low risk individuals not on statin therapy. They calculated the number of reduced events by calculating the event rate they expected and dividing it by the number of events during the follow up.

But remember youi have to ask how did you come up with your calculation???

“For these calculations, we assumed 30% and 22% relative risk reduction of myocardial infarction and atherosclerotic cardiovascular disease, respectively, per 1·0 mmol/L reduction in LDL cholesterol in individuals free of atherosclerotic cardiovascular disease, as observed in the Cholesterol Trialist Collaboration meta-analyses.”

THIS IS FRUSTRATING because if you have read the cholesterol trialist you collaboration you know that the individuals in the studies were HONDA they were not low risk individuals. The higher the risk you are the more likely a drug is to work. Think about it like this a statin is more likely to work on someone who is really high risk because they are way more likely to have a MACE. Just like breast cancer chemo therapy is more likely to work on someone who has breast cancer and is even more likely to work if the person is a women.

So in this study they estimated the event rate based on really sick people and then said based on that we can say the likelihood for benefit in these more healthy patients would have a benefit or NNT of 42 or 80 to prevent just one MACE.

NOOOOO you cant take the odds of sick people or people with breast cancer and then say well look how it worked in them so it must work the same way in this population over here.


Do the trial of statins in the elderly or don’t publish the paper

https://www.acpjournals.org/doi/10.7326/M20-2470

Pharmacologic Approaches to Glycemic Treatment of Type 2 Diabetes: Synopsis of the 2020 American Diabetes Association's Standards of Medical Care in Diabetes Clinical Guideline
FREE
Which is as the artciel suggest in a sypnopsis of the 2020 ADA guidelines


metformin is still universal fist line but now the guideline says

The choice of agent to add to metformin therapy should be individualized on the basis of patient characteristics, preferences, and drug-specific effects.

The big rec from this paper is
Among patients with type 2 diabetes who have established ASCVD or established kidney disease, or heart failure, a sodium–glucose cotransporter-2 (SGLT2) inhibitor or glucagon-like peptide-1 receptor agonist (GLP-1 RA) with demonstrated cardiovascular disease benefit is recommended (Grade A recommendation).

they go on to say maybe one of the key lines--------The addition of these medications should be considered independent from HbA1c level in this patient population.

You might remember dapaggliflozin – the article last year that I said was one of the top articles of the year because it changed how we practice for both diabetes and heart failure!! Well now---I give you--- https://www.nejm.org/doi/10.1056/NEJMoa2022190

Cardiovascular and Renal Outcomes with Empagliflozin in Heart Failure in the NEJM

EMPEROR-Reduced trial recently out which looked to see if empagliclozin could join dapagliflozin for risk reduction in heart failure!!
This was a double-blind, randomized, placebo-controlled, using empagliflozin (10 mg daily)


At a mean follow-up of 16 months, patients receiving empagliflozin had a lower risk for the primary endpoint of cardiovascular death or hospitalization for worsening HF than placebo recipients with a shocking NNT of 20 although this was mainly driven by heart failure hospitalizations these numbers are similar to dapagliflozin -- (19.4% vs. 24.7%). –AND THIS was INDEPENDENT OF DIABETIC DIAGNOSIS!! AND when you looked at the change in A1C at the end of the trial—there was no difference, just maybe these SGLT2 inhibitors really are people drugs, not diabetic drugs which has to make everyone question the relevance of the surrogate marker we use for diabetes, A1C.

not to go on too much of a rant but if we look at A1C and say this is the standard by which all drugs should be measured and some drugs DO NOT CHANGE THE A1C or at least not with any clinical significance but they do prevent death, MI and hospisitliations while other drugs dont change any of the hard outcomes but they change the A1C we have to say maybe just maybe A1C is not the marker we should care about.
and as excited as I am abou the rush of evidence around SGLT2 inhibitors.
Sadly the best medication is likely still prevention, with healthy lifestyle- these drugs are still around $500 a month so we are talking at least 6grand a year for a drug that 95 out of 100 people will never benefit from. Which means we are talking roughly 120,000$ per event saved! So I grant you this is a really impressive article and empagliflozin is now joining dapagliflozin to prevent heart failure hospitalistizations, and I still think the SGLT-2 inhibitors are quickly becoming king of the castle for diabetes treatment—I also think they will never truly take the thrown till they are $4 a month like metformin.

next article

And while talking guidelines

Synopsis of the 2020 U.S. Department of Veterans Affairs/U.S. Department of Defense Clinical Practice Guideline: The Diagnosis and Management of Hypertension in the Primary Care Setting
FREE

Also in annals of internal medicine but had a couple interesting or new recommendations like

we suggest using attended or unattended, fully automated blood pressure measurement. A fully automated BP programmed to wait 5 minutes and recod the average of threee measurements separated by at least 30 seconds
there goal bp is <130
unless you are 60yrs old and older then <150
but If you are 60yrs and older AND DM then <140

with any of the main medication- ACE, ARB, CC, thiazide and if they are on 3 or more of these medications then it is resistant and give spironolactone

nothing too shocking in this paper but just a good refresher and something to keep in mind, and speaking of keeping in mind!!


Seminowicz DA, Burrowes SA, Kearson A, et al. Enhanced mindfulness-based stress reduction in episodic migraine: a randomized clinical trial with magnetic resonance imaging outcomes. Pain 2020;161(8):1837-1846.


this RCT of almost 100 people recruited mostly white women who had on average about 8 headaches a month and 85% were not on prophylaxis medications
pts were enrolled in either mindfulness-based stress reduction classes or stress management for headaches classes. The classes met weekly for 8 weeks, then biweekly for another 8 weeks.
Those in the mindfulness classes went from 8 headaches a month down to 5 and those in the stress management classes went down to 7. So there was a much bigger difference in the group randomized to mindfulness classes. You might be saying this is a really small reduction in headaches to only go from 8 to 5 and at 1 year of follow up there was no difference, which is likely because the people stopped doing mindfulness. However I will remind you the treatment we have for headaches is some of the worst in medicine. We pass and prescribe drugs all the time that reduce your month headache burdon by 1 or 2 and part of what makes treating headaches so difficult is the mental aspect which is why placebo does so well in most trials.
a paper
Verhagen AP, Damen L, Berger MY, Passchier J, Koes BW. Lack of benefit for prophylactic drugs of tension-type headache in adults: a systematic review. Fam Pract 2010;27(2):151-165.
which was a systematic review looking at prophylaxis treatment of tension headaches. They looked at antidepressants, muscle relaxants, benzodiazepines, or vasodilators
and found There is no evidence -- or only poor quality -- that any of these prophylactic agents are effective for tension-type headaches

so keep in mind while a mindfulness course might night sound like a good headache treatment plan, it might be the best thing we have…..

effective as prophylaxis for patients with frequent tension headaches?

and while this podcast might be torture to your eardrums this last article should fall under torture and stupid-

Fitzgerald RC, di Pietro M, O'Donovan M, et al. Cytosponge-trefoil factor 3 versus usual care to identify Barrett's oesophagus in a primary care setting: a multicentre, pragmatic, randomised controlled trial. Lancet 2020;396(10247):333-344.

which was a nonblinded trial that looked to see if swallowing a special sponge to sample esophageal epithelial cells for biomarker testing identify patients with Barrett's esophagus in primary care settings?
basically is it possible to diagnose BE in the outpatient primary care setting. the authors enrolled patients at least 50 years old who had received H2 receptor antagonists or proton pump inhibitors for at least 6 months in the previous year. The researchers randomized the patients to receive usual care which was continue acid surpression and maybe an EGD if the provider felt like it OR they would undergo this toture office-based screening. In total around 1500 patients underwent this torture procedure. before I tell you what the procedure was I will say that 89% of the patients felt the procedure was tolerable but while getting a foley cath is technically tolerable I would want one and while getting a rectal tube is tolerable, no….no thank you. soo

the intervention consisted of swallowing a capsule containing a sponge attached to a thread. After the patient swallows the capsule, the nurse yanks on the thread and pulls out the sponge and sends it for analysis looking at a couple markers found in the gut to tell us if the patient had barrients esophogus.
YOU SWALLOWED A PILL THEN JUST A NURSE PULL IT BACK OUT OF YOUR FROM WITH A STRING---THIS IS A PILL ON A STRING!!!!!

The results did show that who that had this string torture procedure were diagnosed more often, twice as often. The usual care was diagnosed with BE around 1% and the tampon string pill people were diagnosed with it a whopping 2% of the time. You were 2x as likely to be diagnosed with BE!!!
2 TIME AS LIKELY!!!
BUT we always have to ask whats the outcome… BE means nothing without cancer. afib means nothing without a stroke.
well the rate of BE turning to cancer is RARE- a cohort study titled
Hvid-Jensen F, Pedersen L, Drewes AM, Sørensen HT, Funch-Jensen P. Incidence of adenocarcinoma among patients with Barrett's esophagus. N Engl J Med 2011;365(15):1375-1383.
estimated an annual incidence of esophageal cancer to be LOW, real LOW they say--
Barrett's esophagus is a strong risk factor for esophageal adenocarcinoma, but the absolute annual risk, 0.12%, is much lower than the assumed risk of 0.5%, which is the basis for current surveillance guidelines. Data from the current study call into question the rationale for ongoing surveillance in patients who have Barrett's esophagus without dysplasia.