Without evidence of benefit, an intervention should not be presumed to be beneficial or safe.

- Rogue Medic

Cardiac arrest victim Trudy Jones ‘given placebo’ – rather than experimental epinephrine

 

As part of a study to find out if epinephrine (adrenaline in Commonwealth countries) is safe to use in cardiac arrest, a patient was treated with a placebo, rather than the inadequately tested drug. Some people are upset that the patient did not receive the drug they know nothing about.[1]

The critics are trying to make sure that we never learn.

We need to find out how much harm epinephrine causes, rather than make assumptions based on prejudices.

When used in cardiac arrest, does epinephrine produce a pulse more often?

Yes.

When used in cardiac arrest, does epinephrine produce a good outcome more often?

We don’t know.

In over half a century of use in cardiac arrest, we have not bothered to find out.
 


 

We did try to find out one time, but the media and politicians stopped it.[2]

We would rather harm patients with unreasonable hope, than find out how much harm we are causing to patients.

We would rather continue to be part of a huge, uncontrolled, unapproved, undeclared, undocumented, unethical experiment, than find out what works.

Have we given informed consent to that kind of experimentation?

Ignorance is bliss.

The good news is that the enrollment of patients has finished, so the media and politicians will not be able to prevent us from learning the little that we will be able to learn from this research.[3]

Will the results tell us which patients are harmed by epinephrine?

Probably not – that will require a willingness to admit the limits of what we learn and more research.

What EMS treatments have been demonstrated to improve outcomes from cardiac arrest?

1. High quality chest compressions.
2. Defibrillation, when indicated.

Nothing else.

All other treatments, when tested, have failed to be better than nothing (placebo).

Footnotes:

[1] Cardiac arrest victim Trudy Jones ‘given placebo’
BBC News
23 March 2018
Article

[2] Effect of adrenaline on survival in out-of-hospital cardiac arrest: A randomised double-blind placebo-controlled trial
Jacobs IG, Finn JC, Jelinek GA, Oxer HF, Thompson PL.
Resuscitation. 2011 Sep;82(9):1138-43. Epub 2011 Jul 2.
PMID: 21745533 [PubMed – in process]

Free Full Text PDF Download from reanimacion.net
 

This study was designed as a multicentre trial involving five ambulance services in Australia and New Zealand and was accordingly powered to detect clinically important treatment effects. Despite having obtained approvals for the study from Institutional Ethics Committees, Crown Law and Guardianship Boards, the concerns of being involved in a trial in which the unproven “standard of care” was being withheld prevented four of the five ambulance services from participating.

 

In addition adverse press reports questioning the ethics of conducting this trial, which subsequently led to the involvement of politicians, further heightened these concerns. Despite the clearly demonstrated existence of clinical equipoise for adrenaline in cardiac arrest it remained impossible to change the decision not to participate.

 

[3] Paramedic2 – The Adrenaline Trial
Warwick Medical School
Trial Updates
 

Trial Update – 19 February 2018:
PARAMEDIC2 has finished recruitment and we are therefore no longer issuing ‘No Study’ bracelets. The data collected from the trial is in the process of being analysed and we expect to publish the results in 2018. Once the results have been published, a summary will be provided on the trial website.

 

.

Happy Darwin Day 2018

 
Why do some people reject science? Evolution is just one aspect of science that some people claim, almost always without any scientific experience, is not real. The rest of the scientific community generally ignores these fringe dwellers, but politicians and the media love them.

The science deniers claim that scientists are arrogant, but science requires scientists to be transparent in their methods. Science requires scientists to invite criticism.

If you think that you can provide valid evidence to show that a scientific theory is wrong, you can expect to become rich and famous. Go ahead. Show the world that you know more than those arrogant scientists. I am sure that you will straighten those scientists out.
 


 

Science deniers are almost never open to criticism. Some even call for attacks on their critics. Mike Adams is one of the recent examples of these, but someone will probably do something more extreme before the decade is out.[1]

Flat Earthers, Creationists, anti-vaxers, climate change deniers, medicine deniers (alternative medicine quacks), anti-GMO activists, et cetera. They all lack credibility among scientists, because they all lack valid evidence. The same is true of Holocaust deniers, 9/11 Truthers, and others promoting revision of history without any valid evidence.

The most famous example of a victim of science deniers is probably Galileo, who was threatened with torture by the Inquisition (known as the Congregation for the Doctrine of the Faith since 1983), in order to coerce a recantation from Galileo for teaching the heretical idea of Nicolaus Copernicus that the Earth revolves around the Sun (helicentrism).
 

The proposition that the Sun is the center of the world and does not move from its place is absurd and false philosophically and formally heretical, because it is expressly contrary to Holy Scripture.[2]

 

In 1615, Galileo had been ordered to give up the said doctrine and not to teach it to others, not to defend it, nor even to discuss it;[2]

Don’t even discuss your ideas.

This time he was sentenced to house arrest for the rest of his life. His books, and other books on heliocentrism were prohibited by the Inquisition.

Ironically, many of the science deniers claim to be modern versions of Galileo, persecuted for their ideas. The reality is that they are ignored, because they do not produce valid evidence. Galileo was far from perfect, but he did produce valid evidence. Some of the evidence was misinterpreted by Galileo, but removing that evidence did not invalidate heliocentrism.

The scientific community does not prevent science deniers from publishing valid evidence.

The research presented by the science deniers has to meet the same standards as the rest of the research published in science journals.

The problem with the science deniers is that their research either does not meet the standards of publication in a science journal, does not contradict the existing research, or both.

What scientific evidence is there that Creationism is true?

Nothing.

The promotion of a claim as scientific, without any scientific evidence, is an excellent example of arrogance.

What scientific evidence is there that evolution is true?

Some people claim that evolution is anti-Christian, but this is not true. Most Christians accept that evolution is real. This is from BioLogos, a Christian science organization.

What does the fossil record show? [3]

The Smithsonian also has a lot of information specifically about human evolution.

Human Evolution Research [4]

DNA (DeoxyriboNucleic Acid) demonstrates how closely related any two living creatures are. You can see that we are related to other apes, as well as bananas and bacteria. Wikipedia’s primary rule for entries is that the information has to be supported by verifiable evidence. Here is the Wikipedia page on genetics, the science of examining DNA –

Genetics – Wikipedia [5]

Science is objective and has rules to eliminate, as much as possible, the role of prejudice.

As if that is not enough, science also takes all of its results and challenges people to find any flaws in the work.

Is there a problem with the way the evidence was obtained?

Is there a problem with the way the data were calculated?

Are there other valid interpretations that have not been considered (interpretations that are not ruled out by the evidence)?

DNA had not even been discovered at the time Darwin published On the Origin of Species.

DNA is probably most objective tool available for showing that all life on Earth has evolved from the same original species.

Footnotes:

[1] Mike Adams, Monsanto, Nazis, and a Very Disturbing Article
Discover Magazine
By Keith Kloor
July 22, 2014 5:05 pm
Article

[2] Papal Condemnation (Sentence) of Galileo
June 22, 1633
Trial of Galileo (1633)
Famous Trials
Professor Douglas O. Linder
Translation of Papal Condemnation

But whereas it was desired at that time to deal leniently with you, it was decreed at the Holy Congregation held before His Holiness on the twenty-fifth of February, 1616, that his Eminence the Lord Cardinal Bellarmine should order you to abandon altogether the said false doctrine and, in the event of your refusal, that an injunction should be imposed upon you by the Commissary of the Holy Office to give up the said doctrine and not to teach it to others, not to defend it, nor even to discuss it; and your failing your acquiescence in this injunction, that you should be imprisoned.

[3] What does the fossil record show?
BioLogos
Article

[4] Human Evolution Research
Smithsonian
Human Origins
Web page

[5] Genetics
Wikipedia
Web page

.

Baltimore Hospital Dumping Patients – Is it that simple?

 
You watch the video and wonder how could anyone be so callous and cold, to leave someone outside with only a hospital gown to wear – especially when it is so cold outside.

Is what we are seeing callous, or uncaring?

In the video farther down, there is a nice discussion of the problems, which are much more complicated than somebody being refused care for some bad reason.

I found a site that did mention her clothes being with her, but stated with her clothes and belongings scattered on the sidewalk. Here is the picture they posted. The clothes are in plastic patient belongs bags.
 


 

Psychotherapist Imamu Baraka was walking near the University of Maryland Medical Center’s midtown campus location when he saw a woman being dropped off by security at a bus stop with her clothes and belongings scattered on the sidewalk.[1]

 

Why didn’t she put her clothes on?

One of the first things discharged patients will do, if they can, is put their own clothes on.

There is no evidence that anyone was refused care. That would be an EMTALA (Emergency Medical Treatment and Labor Act) violation, resulting in a very big fine, which would be reported. Maybe I am wrong, but I do not expect that an investigation will end with any finding of any refusal to provide care.

But we saw it on the video!

No. I think that you saw someone being removed from private property for bad behavior in a hospital gown, and she refused to put on her own clothes on (the clothes in her bag) for reasons of her own.

Here is a video explaining this in more detail, but a couple of notes about people mentioned in the video.

Charlie Gard was an infant with irreversible MDDS (Mitochondrial DNA Depletion Syndrome). The doctors and nurses seem to have understood this, but parents, politicians, preachers, and the press thought that it would be a good idea to torture Charlie Gard with an experimental treatment with no expectation of a better outcome.

How would Solomon decide? To torture, on the ridiculously small chance of a better outcome, or to do not further harm?

Peter Gallogly is a doctor, who was selectively recorded on video to make it seem as if his unprofessional behavior was unprovoked. If you watch the video of Dr. Gallogly, realize that it is edited to distort reality. If you watch the ironically named Project Veritas videos of abortion clinics, they are similarly edited to distort reality, which is why they have been rejected as evidence in court. You might as well watch a Michael Moore film, if you want a highly edited distortion of reality.

The Delnor nurse protected staff from an escaped prisoner, when the corrections officer apparently fled. The nurse ended up being abducted for hours, grazed by a bullet, pistol whipped, and raped, but was reported as being unharmed after the inmate was killed.

 


 

We need to learn how to find out accurate information for ourselves, rather than blindly accept propaganda from far left or far right news sources. Even the mainstream news will often get information in specialized fields wrong and not realize it. When the story is from a specialized field, such as medicine, we should obtain our information from trustworthy people in that field.

More information on Charlie Gard.

More information on Peter Gallogly.

More information on the Delnor nurse.

All of the videos are from ZDoggMD.com

Footnotes:

[1] Video shows Baltimore hospital discharging half-naked woman into cold winter night
Ana Valens
Jan 11 at 7:27AM | Last updated Jan 12 at 3:36AM
The Daily Dot
Article

.

Does the parachute study prove that research doesn’t matter? Part III

Also to be posted on ResearchBlogging.org when they relaunch the site.
 

Continuing from Part II, which looked at the way the satirical parachute paper misrepresents EBM (Evidence-Based Medicine), but that is expected from satire. You could also provide a great defense of blood-letting as the best medicine using satire.

In the comments to Does the parachute study prove that research doesn’t matter? Part I is the following from Kevin –
 

After claiming to know what he is writing about, Kevin finishes with this –
 

As a reminder, there is not level 1 evidence that oxygen works during an acute heart attack either. That is because we do not withhold it from anyone to study it in randomized fashion due to ethical concerns and assumptions made from non-level 1 evidence.

 

What does Kevin mean by level 1?

There have been some studies of oxygen. It is unethical to not study the drug oxygen.
 

3D Isolated Oxygen Tank


Image credit.
 

For example, there was a study of One hundred percent oxygen in the treatment of acute myocardial infarction and severe angina pectoris in JAMA (Journal of the American Medical Association) way back in 1950.

If oxygen is so much better than room air for heart attack patients, the patients receiving 100% oxygen should have dramatically better outcomes than patients receiving room air by mask in this double-blinded study. The results were not statistically significant, but patients receiving 100% oxygen did not do as well as the patients receiving room air by mask.[1]

Hypoxic patients were treated with oxygen, rather than enrolled in the study, because the study looked at treating heart attack, rather than treating hypoxia. Whether we should treat hypoxia without symptoms is also a different question.

Kevin’s comment was written in September, which is ironically when the paper Oxygen Therapy in Suspected Acute Myocardial Infarction was published. We have stopped using blood-letting to treat patients, even though withholding blood-letting used to be considered just as unethical.
 

CONCLUSIONS: Routine use of supplemental oxygen in patients with suspected myocardial infarction who did not have hypoxemia was not found to reduce 1-year all-cause mortality.[2]

 

The evil scientists did not uphold dogma? Burn the heretics.

The acronym for the study reflects the addiction to continuing questionable treatments, which must not be questioned. DETO2X.

Have competent people condemned this research as unethical?

I have not looked at any of the other medical research blogs, but you should go ahead and read them (listen to the podcasts, watch the videos) and see what they write. Tell me if anyone condemns the research. Don’t quote Gwyneth Paltrow or Dr. Oz, but competent science bloggers.

The actual dogma was to give oxygen to heart attack patients, so is routine oxygen for heart attack just another case of harming patients with tradition?

What does Cochrane tell us?
 

Authors’ conclusions There is no evidence from randomised controlled trials to support the routine use of inhaled oxygen in people with AMI, and we cannot rule out a harmful effect. Given the uncertainty surrounding the effect of oxygen therapy on all-cause mortality and on other outcomes critical for clinical decision, well-conducted, high quality randomised controlled trials are urgently required to inform guidelines in order to give definitive recommendations about the routine use of oxygen in AMI.[3]

 

well-conducted, high quality randomised controlled trials are urgently required

The purpose of research is to learn what is effective and what is safe. We should only be using treatments that are both effective and safe outside of well-controlled trials.

We have been harming too many patients with treatments that should never have been used outside of well-controlled trials.

We need to stop trying to make treatments look better than they are.

We need to stop coming up with rationalizations for hurting patients.

We need higher standards.

 

I have also written about EBM and the parachute paper in these posts –

Does the parachute study prove that research doesn’t matter? Part I – Wed, 22 Aug 2012

Common Sense vs. Evidence – Thu, 28 Mar 2013

The Parachute Study as an Objection to Studying Ventilations in Cardiac Arrest – Mon, 08 Apr 2013

Do we know that these treatments do not help? – Mon, 15 Apr 2013

Why Ignoring Evidence Based Medicine Kills Patients – Fri, 28 Jun 2013

JAMA Opinion Article in Support of Anecdote-Based Medicine – Thu, 28 Nov 2013

Why US EMS will never get to sit at the adult table – The Appeal to Authority – Sun, 04 May 2014

Natural Alternatives to the EpiPen, Because We Believe in Parachutes – Wed, 23 Dec 2015

Does the parachute study prove that research doesn’t matter? Part II – Thu, 30 Nov 2017

Footnotes:

[1] One hundred percent oxygen in the treatment of acute myocardial infarction and severe angina pectoris.
RUSSEK HI, REGAN FD, NAEGELE CF.
J Am Med Assoc. 1950 Sep 30;144(5):373-5. No abstract available.
PMID: 14774103 [PubMed – indexed for MEDLINE]

[2] Oxygen Therapy in Suspected Acute Myocardial Infarction.
Hofmann R, James SK, Jernberg T, Lindahl B, Erlinge D, Witt N, Arefalk G, Frick M, Alfredsson J, Nilsson L, Ravn-Fischer A, Omerovic E, Kellerth T, Sparv D, Ekelund U, Linder R, Ekström M, Lauermann J, Haaga U, Pernow J, Östlund O, Herlitz J, Svensson L; DETO2X–SWEDEHEART Investigators.
N Engl J Med. 2017 Sep 28;377(13):1240-1249. doi: 10.1056/NEJMoa1706222. Epub 2017 Aug 28.
PMID: 28844200

[3] Oxygen therapy for acute myocardial infarction.
Cabello JB, Burls A, Emparanza JI, Bayliss SE, Quinn T.
Cochrane Database Syst Rev. 2016 Dec 19;12:CD007160. doi: 10.1002/14651858.CD007160.pub4. Review.
PMID: 27991651

.

Honoring a Do Not Resuscitate tattoo in an unconscious patient

Also to be posted on ResearchBlogging.org when they relaunch the site.
 

The DNR (Do Not Resuscitate) tattoo is the kind of problem that leads doctors, nurses, and EMS to pretend to be lawyers, lawyers to pretend to be ethical, and patients to be treated against their wishes.

EMS transports a patient to the emergency department. The patient has a chest tattoo of Do Not Resuscitate and what appears to be a signature.
 

Paramedics brought an unconscious 70-year-old man with a history of chronic obstructive pulmonary disease, diabetes mellitus, and atrial fibrillation to the emergency department, where he was found to have an elevated blood alcohol level.[1]

 

It appears that they have access to the patient’s history, but they do not have information about a DNR in the history.
 

Because he presented without identification or family, the social work department was called to assist in contacting next of kin. All efforts at treating reversible causes of his decreased level of consciousness failed to produce a mental status adequate for discussing goals of care.[1]

 


 

The patient does not currently appear to need an invasive airway, or anything else that would be prohibited by a DNR, so there is time to consult with others.
 

This decision left us conflicted owing to the patient’s extraordinary effort to make his presumed advance directive known; therefore, an ethics consultation was requested.[1]

 

Do we honor the stated, although perhaps not letter of the law until after a court decision, DNR?

If you want to be resuscitated, do not tattoo DNR, or Do Not Resuscitate, on your chest.

But what if he did it while drunk?

There was a case of a patient doing that.
 

When asked why his tattoo conflicted with his wishes to be resuscitated, he explained that he had lost a bet playing poker with fellow ancillary hospital staffers while inebriated in his younger years; the loser had to tattoo “D.N.R.” across his chest.[2]

 


 

They are called Darwin awards for a reason.

Hold my beer and watch this is not usually the start of a tale of wisdom, but of providing a learning opportunity for others.
 

It was suggested that he consider tattoo removal to circumvent future confusion about his code status. He stated he did not think anyone would take his tattoo seriously and declined tattoo removal.[2]

 

After driving to the bar, while sober, an individual decided to drive home, while drunk.

The person should clearly not be held accountable for a decision made while drunk.

A person puts a mask on and uses a cap gun to hold up a store where a friend works, because that kind of thing is funny. Someone calls 911, or . . ., and the humor loses something in translation to reality.

I can be very silly, but I take the wishes of the patient seriously.

If a DNR tattoo was a joke, well, that was may be a bad decision, because you don’t know who is going to be deciding how to treat you when you are not capable of expressing your wishes competently.

The EMS laws tell me that I should always start CPR (CardioPulmonary Resuscitation), while calling a doctor for permission to stop, because the wishes of the patient are less important than the wishes of the doctor on the other end of the phone.

I know too many immoral doctors, nurses, and EMS personnel.

For example, a patient who has a clear DNR, clearly states that intubation is not wanted, but is deteriorating. The doctor occasionally returns to ask the hypoxic patient, Do you want to breathe? The patient keeps indicating that intubation is not wanted. Finally, the patient, through surrender to the harassment or disorientation secondary to hypoxia, says, Yes.

The doctor gets to perform a procedure and satisfy himself that the right thing was done, because it is what the doctor wanted.

Is that an extreme example? It was not seen as extreme a couple of decades ago. Maybe today it is recognized as abuse, because we recognize that the purpose of patient care is to take care of the patient, not the doctor, not the nurse, not EMS, not the supervisors, and definitely not the lawyers.

But you have to obey orders. If the military did not obey orders, we would have chaos.

Even the military does not require that anyone obey any unlawful order.
 

Any person subject to this chapter who–

(1) violates or fails to obey any lawful general order or regulation;
(2) having knowledge of any other lawful order issued by any member of the armed forces, which it is his duty to obey, fails to obey the order; or
(3) is derelict in the performance of his duties;

shall be punished as a court-martial may dire(ct.)[3]

 

Refusing to follow unlawful orders is not easy.

People in EMS will often state that the reason they did something wrong (as in something bad for the patient) is that they did not want to get yelled at by the doctor and/or nurse.

Clearly, our integrity is not what it should be.

Should we only go out of our way for the patients we like? No. My objection to using the guy who obtained the tattoo while drunk, abd does not want to remove it is nothing to do with his drinking or his bad decision, but with his lack of concern for others. My concern is for people who do care what is done to them, regardless of the lack of concern of this uncaring patient.

Of course, the uncaring patient has had the opportunity to have this explained to him and he has decided to live with that risk. He may not have made the best decision, but it is his decision and it probably will not affect him.

But the person with just a tattoo does not have a legal tattoo!

Maybe it is not legal.

Maybe it is legal.

That is for a lawyer to decide.

As the article states, this patient has gone to extraordinary effort to make a statement with this tattoo.

In the absence of something to show that the tattoo does not express the patient’s informed decision, I accept it as expressing the patient’s wishes.

If I am there it is to take care of the patient, not the medical command physician, not the protocol, not the quality control department, not the legal department, not the supervisors, not the doctors, or nurses, in the emergency department, . . . .

When our medical and legal systems are so broken that we feel that we are forced to harm our patients to be able to do our jobs, we need to stop making excuses and start to change things.

Footnotes:

[1] An Unconscious Patient with a DNR Tattoo.
Holt GE, Sarmento B, Kett D, Goodman KW.
N Engl J Med. 2017 Nov 30;377(22):2192-2193. doi: 10.1056/NEJMc1713344. No abstract available.
PMID: 29171810

Free Full Text from NEJM.

[2] DNR tattoos: a cautionary tale.
Cooper L, Aronowitz P.
J Gen Intern Med. 2012 Oct;27(10):1383. Epub 2012 May 2. No abstract available.
PMID: 22549297

Free Full Text from J Gen Intern Med.

[3] UCMJ 892. Article 92—Failure to obey order or regulation.
Uniform Code of Military Justice
Subchapter 10
Punitive Article

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Does the parachute study prove that research doesn’t matter? Part II

 
I have finally written Part II. Part III will be next week

In the comments to Does the parachute study prove that research doesn’t matter? Part I is the following from Kevin –
 

The parachute study is meant to address persons who regard only level 1 evidence as evidence. It does not mean to suggest that one should proceed with zero evidence. In fact, we have great evidence that parachutes do indeed work, just not level 1 evidence (that’s why we divide them into various levels–some are better than others, but the lower levels may still be good and adequate). That is why the authors wrote the tongue in cheek article.

 

The authors of the parachute paper were using an extreme position – a straw man – for the purpose of satire. There may be some people who insist on only randomized, placebo controlled, double-blinded, studies of every treatment, but even they should know that a meta-analysis of these would be higher level evidence than what your comment seems to suggest is level 1 evidence.
 

Evidence Pyramid

Evidence Pyramid


Image credit.
 

What does Evidence-Based Medicine (EBM) actually require?

If only there were a paper to clearly and concisely state what EBM actually is and what EBM is not. It might be called, Evidence based medicine: what it is and what it isn’t.

That paper does exist. The paper is over 20 years old. The full text of the paper is available for free from PubMed Central, so there is no valid reason for anyone examining EBM to be unfamiliar with the paper.
 

Evidence based medicine is not restricted to randomised trials and meta-analyses. It involves tracking down the best external evidence with which to answer our clinical questions.[1]

 

Why the confusion?

Is it because a lot of people just do not understand science?

Science requires humility and a lot of people are just not good at putting aside their assumptions in order to find out if those prejudices are true.

The truth is more important than our egos.

It is much more important to protect patients from harmful treatments, than to protect treatments that do not provide more benefit than harm. We have to learn from our mistakes.
 

Evidence based medicine is the conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients. The practice of evidence based medicine means integrating individual clinical expertise with the best available external clinical evidence from systematic research.[1]

 

What is the objection to EBM?

The use of evidence appears to hurt the feelings of some people.

We have been harming too many patients with treatments that should never have been used outside of well-controlled trials.

We need to stop trying to make treatments look better than they are.

We need to stop coming up with rationalizations for hurting patients.
 
 
 

I have also written about EBM and the parachute paper in these posts –

Does the parachute study prove that research doesn’t matter? Part I – Wed, 22 Aug 2012

Common Sense vs. Evidence – Thu, 28 Mar 2013

The Parachute Study as an Objection to Studying Ventilations in Cardiac Arrest – Mon, 08 Apr 2013

Do we know that these treatments do not help? – Mon, 15 Apr 2013

Why Ignoring Evidence Based Medicine Kills Patients – Fri, 28 Jun 2013

JAMA Opinion Article in Support of Anecdote-Based Medicine – Thu, 28 Nov 2013

Why US EMS will never get to sit at the adult table – The Appeal to Authority – Sun, 04 May 2014

Natural Alternatives to the EpiPen, Because We Believe in Parachutes – Wed, 23 Dec 2015

Footnotes:

[1] Evidence based medicine: what it is and what it isn’t.
Sackett DL, Rosenberg WM, Gray JA, Haynes RB, Richardson WS.
BMJ. 1996 Jan 13;312(7023):71-2.
PMID: 8555924 [PubMed – indexed for MEDLINE]

Free Full Text from PubMed Central.

.

Is placebo better than aggressive medical treatment for patients NOT having a heart attack?

Also to be posted on ResearchBlogging.org when they relaunch the site.
 

Is cardiac catheterization placebo better than aggressive medical treatment for patients not having a heart attack?

No.
 

The answer is not really different from before. This should not be surprising for anyone who pays attention to EBM (Evidence-Based Medicine). We should all pay attention to EBM, because it is the best way to find out what works.

Many routine treatments are not beneficial to patients, but are considered to be standards of care. We continue to give these treatments out of unreasonable optimism, a fear of litigation, or fear of criticism for not following orders. The difference between the banality of evil and the banality of incompetence does not appear to be significant in any way that matters.

PCI (Percutaneous Coronary Intervention) treatment does not add any benefit – unless you are having a heart attack.

The placebo group received sham PCI in addition to optimized medical treatment. this did not provide any benefit over actual PCI in addition to optimized medical treatment. The patients in the placebo group received all of the same medications that the patients in the PCI group received.

Why is this news today?

A recent article in The Lancet is encouraging snake oil salesmen and snake oil saleswomen to claim that it shows the miracle healing power of placebos, but this is not true.

Apparently, Big Placebo (the multi-billion dollar alternative medicine industry) is trying to use this to promote their scams (homeopathy, acupuncture, Reiki, naturopathy, prayer, . . . ).

Big Placebo seems to think that this study shows that placebo is better than medical treatment. A placebo is an inactive intervention that is undetectable when compared with the active treatment. The placebo group received the same aggressive medications that the treatment group received.
 

All patients were pretreated with dual antiplatelet therapy. In both groups, the duration of dual antiplatelet therapy was the same and continued until the fial (unblinding) visit. Coronary angiography was done via a radial or femoral arterial approach with auditory isolation achieved by placing over-the-ear headphones playing music on the patient throughout the procedure.[1]

 

What is new about this?

A much larger study a decade ago showed that aggressive medical therapy was as good as PCI and aggressive medical therapy. The difference is the use of sham PCI to create a placebo group for comparison, rather than using a No PCI group for comparison.
 

CONCLUSIONS:
As an initial management strategy in patients with stable coronary artery disease, PCI did not reduce the risk of death, myocardial infarction, or other major cardiovascular events when added to optimal medical therapy.
[2]

 

Compare that with the conclusion (interpretation) of the new paper.
 

INTERPRETATION:
In patients with medically treated angina and severe coronary stenosis, PCI did not increase exercise time by more than the effect of a placebo procedure. The efficacy of invasive procedures can be assessed with a placebo control, as is standard for pharmacotherapy.
[1]

 

The unfortunate outcome is that we will have fewer hospitals providing PCI, so patients with heart attacks (STEMI – ST segment Elevation Myocardial Infarctions) may have to wait longer for emergency PCI, which really does improve outcomes.
 

What other Standards Of Care are NOT supported by valid evidence?

Amiodarone is effective for cardiac arrest, whether unwitnessed, witnessed, or witnessed by EMS.

Kayexalate (Sodium Polystyrene) is a good treatment for hyperkalemia. Anything that causes diarrhea will lower your potassium level, but that does not make it a good treatment, unless you are in an austere environment (in other words – not in a real hospital).

Amiodarone is effective for VT (Ventricular Tachycardia).

Backboards are effective to protect against spinal injury while transporting patients.

Blood-letting is effective for anything except hemochromatosis (and some rare disorders).

More paramedics are better for the patient.

Prehospital intravenous lines save lives.

IV fluid saves lives in hemorrhagic shock.

Oxygen should be given to everyone having a heart attack.

The Golden Hour is important.

Driving fast saves lives. For only some rare conditions, it probably does – and that depends on traffic.

Flying people to the hospital saves lives. Again, for only some rare conditions, it probably does – and that depends on traffic and distance.

Tourniquets are dangerous. As with anything else, if used inappropriately, they are dangerous, but tourniquets save lives.

Prehospital intubation saves lives.

Ventilation in cardiac arrest improves outcomes (other than for respiratory causes of cardiac arrest, which are easy to identify).

Epinephrine improves outcomes in cardiac arrest. It does produce a pulse more often, but at what cost to the long-term survival of the patient and the patient’s brain? PARAMEDIC2 should help us to identify which patients benefit from epinephrine, since it is clear that many patients are harmed by epinephrine in cardiac arrest. If we limit treatment to patients reasonably expected to benefit from the treatment, we can improve long-term survival.

And there are many more.

Footnotes:

[1] Percutaneous coronary intervention in stable angina (ORBITA): a double-blind, randomised controlled trial.
Al-Lamee R, Thompson D, Dehbi HM, Sen S, Tang K, Davies J, Keeble T, Mielewczik M, Kaprielian R, Malik IS, Nijjer SS, Petraco R, Cook C, Ahmad Y, Howard J, Baker C, Sharp A, Gerber R, Talwar S, Assomull R, Mayet J, Wensel R, Collier D, Shun-Shin M, Thom SA, Davies JE, Francis DP; ORBITA investigators.
Lancet. 2017 Nov 1. pii: S0140-6736(17)32714-9. doi: 10.1016/S0140-6736(17)32714-9. [Epub ahead of print]
PMID: 29103656

[2] Optimal medical therapy with or without PCI for stable coronary disease.
Boden WE, O’Rourke RA, Teo KK, Hartigan PM, Maron DJ, Kostuk WJ, Knudtson M, Dada M, Casperson P, Harris CL, Chaitman BR, Shaw L, Gosselin G, Nawaz S, Title LM, Gau G, Blaustein AS, Booth DC, Bates ER, Spertus JA, Berman DS, Mancini GB, Weintraub WS; COURAGE Trial Research Group.
N Engl J Med. 2007 Apr 12;356(15):1503-16. Epub 2007 Mar 26.
PMID: 17387127

Free Full Text from N Engl J Med.

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Have a Slow, Quiet Friday the Thirteenth

Also to be posted on ResearchBlogging.org when they relaunch the site.
 

 

Superstitious appears to be common among medical people, so this may be seen as offensive. If you doubt me, comment that it is slow or quiet and see how many respond negatively, while they do not receive any criticism for their superstition-based complaints. Rather, people will make excuses for coddling the superstitions of those who are entrusted with the lives of patients.

The evidence does not support their superstitions.

One study did appear to show that women die in motor vehicle collisions more often on Friday the 13th, but that appears to be due to a lack of understanding of statistics by many who cite the article.
 

An additional factor is anxiolytic medication, used by significantly more women than men in Finland (7), which has been reported to reduce attention span and worsen driving performance (8). . . . Why this phenomenon exists in women but not in men remains unknown, but perhaps the twice-as-high prevalence of neurotic disorders and anxiety symptoms in women (7) makes them more susceptible to superstition and worsening of driving performance.[1]

 

The author suspects that those people with conditions that could be diagnosed as neuroses or anxiety disorders may be disproportionately affected by superstition.

In other words, superstition is not an external force affecting you. You are doing it to yourself.

The sample size was national, but still small, and was not able to adjust for many possible confounding variables, so the study would need to be replicated using a much larger data base to be useful.

In other superstition news – the next apocalypse, in a long line of predicted apocalypses, is going to be this Sunday – the 15 of October, 2017, according to David Meade. Meade twice previously predicted that a magical planet would hit the Earth and kill us all. This time he claims that his calculations are accurate, because that was the problem with his previous calculations – inaccuracy, not that they were a superstition deserving of derision.

If you are superstitious, and feel that your neuroses/anxieties will cause you to harm others, or yourself, you may want to stay home today and Sunday – perhaps even until you are capable of grasping reality.

Of course, we would never base treatment on superstition in medicine.

Amiodarone is the go to antiarrhythmic drug for cardiac arrest and ventricular tachycardia, but there are much safer much more effective drugs available. We have our own prophets misrepresenting research results to make it seem that using amiodarone for these is a good idea. The research says these preachers are wrong. The next guidelines will probably promote the superstition and reject the science.[2],[3]

Ventilation during cardiac arrest has been shown to be a good idea only for patients who arrested for respiratory reasons. We do a great job of identifying these patients. We have our own prophets misrepresenting research results to make it seem that providing ventilations for these is a good idea. The research says these preachers are wrong. The next guidelines will probably promote the superstition and reject the science.[4]

Medicine is full of superstition and superstitious people.

Why?

Too many of us believe the lie that, I’ve seen it work.

I have also written about the superstition of Friday the 13th here –

Acute coronary syndrome on Friday the 13th: a case for re-organising services? – Fri, 13 Jan 2017

The Magical Nonsense of Friday the 13th – Fri, 13 May 2016

Happy Friday the 13th – New and Improved with Space Debris – Fri, 13 Nov 2015

Friday the 13th and full-moon – the ‘worst case scenario’ or only superstition? – Fri, 13 Jun 2014

Blue Moon 2012 – Except parts of Oceanea – Fri, 31 Aug 2012

2009’s Top Threat To Science In Medicine – Fri, 01 Jan 2010

T G I Friday the 13th – Fri, 13 Nov 2009

Happy Equinox! – Thu, 20 Mar 2008

Footnotes:

[1] Traffic deaths and superstition on Friday the 13th.
Näyhä S.
Am J Psychiatry. 2002 Dec;159(12):2110-1.
PMID: 12450968

Free Full Text from Am J Psychiatry.

[2] The PROCAMIO Trial – IV Procainamide vs IV Amiodarone for the Acute Treatment of Stable Wide Complex Tachycardia
Wed, 17 Aug 2016
Rogue Medic
Article

There are a dozen links to the research in the footnotes to that article. There are also links to other articles on the failure of amiodarone to live up to its hype.

[3] Dr. Kudenchuk is Misrepresenting ALPS as ‘Significant’
Tue, 12 Apr 2016
Rogue Medic
Article

[4] Cardiac Arrest Management is an EMT-Basic Skill – The Hands Only Evidence
Fri, 09 Dec 2011
Rogue Medic
Article

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