Correction

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

- Rogue Medic

Are We Killing Patients With Parochialism?

Tue, 02 Oct 2018 15:00:29 -0400 by Rogue Medic

The variation in approaches to resuscitation in EMS is tremendous.

Many excuses center around the need for local people to be able to claim that they know something that the evidence does not show, although they consistently fail to provide valid evidence for these claims. This local knowledge appears to be intuitive – they just know it, but cannot provide anything to support their feelings.

The latest research can be interpreted in many different ways, but it definitely does not support the claims of the advocates of parochialism.

Results We identified 43 656 patients with OHCA treated by 112 EMS agencies. At EMS agency level, we observed large variations in survival to hospital discharge (range, 0%-28.9%; unadjusted MOR, 1.43 [95% CI, 1.34-1.54]), return of spontaneous circulation on emergency department arrival (range, 9.0%-57.1%; unadjusted MOR, 1.53 [95% CI, 1.43-1.65]), and favorable functional outcome (range, 0%-20.4%; unadjusted MOR, 1.54 [95% CI, 1.40-1.73]).^[1]

MOR = Median Odds Ratio – how many times more likely is something to happen.

What is most commonly measured is what matters the least – ROSC (Return Of Spontaneous Circulation). Did we get a pulse back, for even the briefest period of time, regardless of outcomes that matter.

What matters? Does the person wake up and have the ability to function as they did before the cardiac arrest.

Those who justify focusing on ROSC claim that, If we don’t get a pulse back, nothing else matters, but that is the kind of excuse used by frauds. How we get a pulse back does matter. The evidence makes that conclusion irrefutable, but there will always be those who do not accept that they are causing harm. They will make excuses for the harm they are causing. Getting ROSC helps them to feel that they are not causing harm. ROSC encourages us to give drugs like epinephrine, which have been demonstrated to not improve any survival that matters.

The means of obtaining ROSC can be compared to the means of doing anything that requires finesse. Sure, it feels good to try to force something. Sure, you can claim that forcing something is the most direct way to accomplish the goal.

Can the advocates of focusing on ROSC produce any valid evidence that their approach leads to improvements in outcomes that matter? No. The evidence contradicts their claims. The evidence has caused us to eliminate many of their treatments – treatments they claimed had to work because of physiology. As it turns out, they were wrong. They were wrong about their treatments and wrong about their understanding of physiology.

If you want to win money, bet that any new treatment will not improve outcomes that matter.

This variation persisted despite adjustment for patient-level and EMS agency–level factors known to be associated with outcomes (adjusted MOR for survival 1.56 [95% CI 1.44-1.73]; adjusted MOR for return of spontaneous circulation at emergency department arrival, 1.50 [95% CI, 1.41-1.62]; adjusted MOR for functionally favorable survival, 1.53 [95% CI, 1.37-1.78]).^[1]

Is presence of a pulse upon arrival at the emergency department an important outcome? Only for billing purposes. The presence of a pulse justifies providing more, and more expensive, treatments. Is the presence of a pulse upon arrival at the emergency department a goal worth trying for? As with ROSC, only if it does not cause us to harm patients to obtain this goal, which is just something that is documented, because it is a point of transfer of patient care.

After restricting analysis to those who survived more than 60 minutes after hospital arrival and including hospital treatment characteristics, the variation persisted (adjusted MOR for survival, 1.49 [95% CI, 1.36-1.69]; adjusted MOR for functionally favorable survival, 1.34 [95% CI, 1.20-1.59]).^[1]

There is a lot of variability.

What did they find?

Most of the people in EMS, who claim to be doing what is best for their patients, are making things worse.

~~69% means that there are two EMS agencies producing bad outcomes for every EMS agency producing good outcomes.~~

Correction – The text crossed out is not accurate. I should have thought that through a bit better before I posted it. My caption for Table 1 is accurate. However, what I should have written afterward is –

The worse half of EMS agencies are only producing half as many good outcomes as the better half of EMS agencies.

We are bad at resuscitation and those doing the most resuscitating are doing the least good.

Why do so many of us refuse to improve our standards?

What is more important than the outcomes for our patients?

Why are we so overwhelmingly bad at resuscitation?

What are the authors’ conclusions?

This study has implications for improvement of OHCA management. First, the analysis indicates that the highest-performing EMS agencies had more layperson interventions and more EMS personnel on scene.^[1]

They do not conclude that we need more doctors, more nurses, or more paramedics responding to cardiac arrest.

Second, our findings justify further efforts to identify potentially modifiable factors that may explain this residual variation in outcomes and could be targets of public health interventions.^[1]

We need to figure out what we are doing, because the people telling us that they know that we need intubation are lying.

We need to figure out what we are doing, because the people telling us that they know that we need epinephrine are lying.

We need to figure out what we are doing, because the people telling us that they know that we need amiodarone are lying.

We need to figure out what we are doing, because the people telling us that they know that we need ________ are lying.

How dare I call them liars?

Let them produce valid evidence that the interventions they claim are necessary actually do improve outcomes that matter.

Have them stop making excuses and start producing results.

I dare them.

The only time we have made significant improvements in outcomes have been when we emphasized chest compressions, especially bystander chest compressions, and when we emphasized bystander defibrillation.

It is time to start requiring evidence of benefit for everything we do to patients.

Our patients are too important to be subjected to witchcraft, based on opinions and an absence of research.

There is plenty of valid evidence that using only chest compressions improves outcomes.

Cardiocerebral resuscitation improves survival of patients with out-of-hospital cardiac arrest.
Kellum MJ, Kennedy KW, Ewy GA.
Am J Med. 2006 Apr;119(4):335-40.
PMID: 16564776 [PubMed – indexed for MEDLINE]

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Cardiocerebral resuscitation improves neurologically intact survival of patients with out-of-hospital cardiac arrest.
Kellum MJ, Kennedy KW, Barney R, Keilhauer FA, Bellino M, Zuercher M, Ewy GA.
Ann Emerg Med. 2008 Sep;52(3):244-52. Epub 2008 Mar 28.
PMID: 18374452 [PubMed – indexed for MEDLINE]

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Minimally interrupted cardiac resuscitation by emergency medical services for out-of-hospital cardiac arrest.
Bobrow BJ, Clark LL, Ewy GA, Chikani V, Sanders AB, Berg RA, Richman PB, Kern KB.
JAMA. 2008 Mar 12;299(10):1158-65.
PMID: 18334691 [PubMed – indexed for MEDLINE]

Free Full Text at JAMA

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Passive oxygen insufflation is superior to bag-valve-mask ventilation for witnessed ventricular fibrillation out-of-hospital cardiac arrest.
Bobrow BJ, Ewy GA, Clark L, Chikani V, Berg RA, Sanders AB, Vadeboncoeur TF, Hilwig RW, Kern KB.
Ann Emerg Med. 2009 Nov;54(5):656-662.e1. Epub 2009 Aug 6.
PMID: 19660833 [PubMed – indexed for MEDLINE]

And more.

It is not ethical to insist on giving treatments to patients in the absence of valid evidence of benefit to the patient. We need to begin to improve our ethics.

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

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Footnotes:

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^[1] Variation in Survival After Out-of-Hospital Cardiac Arrest Between Emergency Medical Services Agencies.
Okubo M, Schmicker RH, Wallace DJ, Idris AH, Nichol G, Austin MA, Grunau B, Wittwer LK, Richmond N, Morrison LJ, Kurz MC, Cheskes S, Kudenchuk PJ, Zive DM, Aufderheide TP, Wang HE, Herren H, Vaillancourt C, Davis DP, Vilke GM, Scheuermeyer FX, Weisfeldt ML, Elmer J, Colella R, Callaway CW; Resuscitation Outcomes Consortium Investigators.
JAMA Cardiol. 2018 Sep 26. doi: 10.1001/jamacardio.2018.3037. [Epub ahead of print]
PMID: 30267053

Free Full Text from JAMA Cardiology

Filed Under: ACLS, Correction, Critical Judgment, Ethics, Heresy, Mythology, Research Blogging

How Bad is Epinephrine (Adrenaline) for Cardiac Arrest, According to the PARAMEDIC2 Study?

Sat, 21 Jul 2018 19:15:59 -0400 by Rogue Medic

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

Do we have to stop using epinephrine (adrenaline in Commonwealth countries) for cardiac arrest?

PARAMEDIC2 (Prehospital Assessment of the Role of Adrenaline: Measuring the Effectiveness of Drug Administration in Cardiac Arrest) compared adrenaline (epinephrine) with placebo in a “randomized, double-blind trial involving 8014 patients with out-of-hospital cardiac arrest”.^[1]

The results showed that 1 mg of epinephrine every 3 – 5 minutes is even worse than I expected, but a lot of the more literate doctors have not been using epinephrine that way. What does this research tell us about their various methods? The podcast REBEL Cast (Rational Evidence Based Evaluation of Literature in Emergency Medicine) has a discussion of this question in REBEL Cast Ep56 – PARAMEDIC-2: Time to Abandon Epinephrine in OHCA?.^[2]

The current ACLS/ILCOR (Advanced Cardiac Life Support/International Liaison Committee on Resuscitation) advice on epinephrine does not state that epinephrine is a good idea, or even require that you give epinephrine to follow their protocol –

The major changes in the 2015 ACLS guidelines include recommendations about prognostication during CPR based on exhaled CO₂ measurements, timing of epinephrine administration stratified by shockable or nonshockable rhythms, and the possibility of bundling treatment of steroids, vasopressin, and epinephrine for treatment of in-hospital arrests. In addition, the administration of vasopressin as the sole vasoactive drug during CPR has been removed from the algorithm.^[3]

What was the ACLS/ILCOR advice in the 2010 guidelines?

The 2010 Guidelines stated that it is reasonable to consider administering a 1-mg dose of IV/IO epinephrine every 3 to 5 minutes during adult cardiac arrest.^[4]

This is in a paragraph that links to the PICO (Population-Intervention-Comparator-Outcomes) question that has been an open question for over half a century – In cardiac arrest, is giving epinephrine better than not giving epinephrine?^[5]

They only considered it reasonable, based on low quality evidence.

What was the ACLS/ILCOR advice in the 2015 guidelines?

Standard-dose epinephrine (1 mg every 3 to 5 minutes) may be reasonable for patients in cardiac arrest (Class IIb, LOE B-R).^[6]

Again, ACLS/ILCOR only considered a dose of epinephrine to be reasonable. Again, this was based on low quality evidence. I am not criticizing the efforts of those who worked on the Jacobs study of adrenaline vs. placebo, because they were stopped by the willfully ignorant opponents of science.^[7]

What about the method of attempting to titrate an infusion to the hemodynamic response, which Dr. Swaminathan and Dr. Rezaie alluded to?

There is a lot of anecdotal enthusiasm from doctors who use this method, but I do not know of any research that has been published comparing outcomes using this method with anything else. How do we know that the positive reports from doctors are anything other than confirmation bias? We don’t.

This year is the 200^th anniversary of the publication of the very first horror novel – Frankenstein; or, The Modern Prometheus. The doctor in the novel used electricity to raise the dead (and the subjects were very dead). There were no chest compressions in the novel, but it is interesting that we have barely made progress from the fiction imagined by an 18 year old with no medical training, although she did have the opportunity to listen to many of the smartest people in England discuss science. Mary Godwin (later Mary Wollstonecraft Shelley by marriage) was 16 when she started writing the novel.^[8]

We have barely made more progress at resuscitation than a teenager did 200 years ago in a novel. Most of our progress has been in finally admitting that the treatments we have been using have been producing more harm than benefit. Many of us are not even that honest about the harm we continue to cause.

We dramatically improved resuscitation in one giant leap – when we focused on high quality chest compressions and ignoring the medical theater of advanced life support.

There are two treatments that work during cardiac arrest – high quality chest compressions and rapid defibrillation.

Why haven’t we made more progress?

We have been too busty making excuses for remaining ignorant.

We need to stop being so proud of our ignorance.

We now know that amiodarone doesn’t work for cardiac arrest (and is more dangerous than beneficial for ventricular tachycardia – even adenosine appears to be better for VTach), atropine doesn’t work for cardiac arrest, calcium chloride doesn’t work for cardiac arrest (unless it is due to hyperkalemia/rhabdomyolysis), vasopressin doesn’t work for cardiac arrest, high dose epinephrine doesn’t work for cardiac arrest, standard dose epinephrine doesn’t work for cardiac arrest – in other words, we have tried all sorts of drugs, based on hunches and the weakest of evidence, but we still haven’t learned that there isn’t a magic resuscitation drug.

Should anyone be using any epinephrine to treat cardiac arrest outside of a well controlled study?

No.

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Also –

A Randomized Trial of Epinephrine in Out-of-Hospital Cardiac Arrest – Part I

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Footnotes:

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^[1] A Randomized Trial of Epinephrine in Out-of-Hospital Cardiac Arrest.
Perkins GD, Ji C, Deakin CD, Quinn T, Nolan JP, Scomparin C, Regan S, Long J, Slowther A, Pocock H, Black JJM, Moore F, Fothergill RT, Rees N, O’Shea L, Docherty M, Gunson I, Han K, Charlton K, Finn J, Petrou S, Stallard N, Gates S, Lall R; PARAMEDIC2 Collaborators.
N Engl J Med. 2018 Jul 18. doi: 10.1056/NEJMoa1806842. [Epub ahead of print]
PMID: 30021076

Free Full Text from NEJM

All supplementary material is also available at the end of the article at the NEJM site in PDF format –

Protocol

Supplementary Appendix

Disclosure Forms

There is also an editorial, which I have not yet read, by Clifton W. Callaway, M.D., Ph.D., and Michael W. Donnino, M.D. –

Testing Epinephrine for Out-of-Hospital Cardiac Arrest.
Callaway CW, Donnino MW.
N Engl J Med. 2018 Jul 18. doi: 10.1056/NEJMe1808255. [Epub ahead of print] No abstract available.
PMID: 30021078

Free Full Text from NEJM

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^[2] REBEL Cast Ep56 – PARAMEDIC-2: Time to Abandon Epinephrine in OHCA?
Anand Swaminathan, MD and Salim Rezaie, MD, FACEP
July 20, 2018
Episode 56 and show notes

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^[3] Introduction
Part 7: Adult Advanced Cardiovascular Life Support
2015 American Heart Association Guidelines Update for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care
Mark S. Link, Lauren C. Berkow, Peter J. Kudenchuk, Henry R. Halperin, Erik P. Hess, Vivek K. Moitra, Robert W. Neumar, Brian J. O’Neil, James H. Paxton, Scott M. Silvers, Roger D. White, Demetris Yannopoulos, Michael W. Donnino
Circulation. 2015;132:S444-S464, originally published October 14, 2015
https://doi.org/10.1161/CIR.0000000000000261
Introduction – scroll down to the last paragraph

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^[4] Vasopressors in Cardiac Arrest: Standard-Dose Epinephrine
Part 7: Adult Advanced Cardiovascular Life Support
2015 American Heart Association Guidelines Update for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care
Mark S. Link, Lauren C. Berkow, Peter J. Kudenchuk, Henry R. Halperin, Erik P. Hess, Vivek K. Moitra, Robert W. Neumar, Brian J. O’Neil, James H. Paxton, Scott M. Silvers, Roger D. White, Demetris Yannopoulos, Michael W. Donnino
Circulation. 2015;132:S444-S464, originally published October 14, 2015
https://doi.org/10.1161/CIR.0000000000000261
2010 epinephrine advice

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^[5] Epinephrine Versus Placebo
ILCOR Scientific Evidence Evaluation and Review
Epinephrine Versus Placebo

Among adults who are in cardiac arrest in any setting (P), does does the use of epinephrine (I), compared with compared with placebo or not using epinephrine (C), change Survival with Favorable neurological/functional outcome at discharge, 30 days, 60 days, 180 days AND/OR 1 year, Survival only at discharge, 30 days, 60 days, 180 days AND/OR 1 year, ROSC (O)?

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^[6] 2015 Recommendation—Updated
Part 7: Adult Advanced Cardiovascular Life Support
2015 American Heart Association Guidelines Update for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care
Mark S. Link, Lauren C. Berkow, Peter J. Kudenchuk, Henry R. Halperin, Erik P. Hess, Vivek K. Moitra, Robert W. Neumar, Brian J. O’Neil, James H. Paxton, Scott M. Silvers, Roger D. White, Demetris Yannopoulos, Michael W. Donnino
Circulation. 2015;132:S444-S464, originally published October 14, 2015
https://doi.org/10.1161/CIR.0000000000000261
2015 Recommendation—Updated

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^[7] 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 semanticscholar.org

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.

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^[8] Frankenstein
Wikipedia
Article

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Edited 12-27-2018 to correct link to pdf of Jacobs study in footnote 7.

Filed Under: ACLS, Correction, Critical Judgment, Epinephrine, Research Blogging

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

Mon, 26 Mar 2018 08:20:13 -0400 by Rogue Medic

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).

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Footnotes:

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

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^[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 semanticscholar.org

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.

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^[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.

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Edited 12-27-2018 to correct link to pdf of Jacobs study in footnote 2.

Filed Under: 'Alternative' Medicine, ACLS, Cardiac Arrest, Cardiology, Correction, CPR, Critical Judgment, Ethics, Evidence, Journalism, Pharmacology, Placebo, Research, Risk Management, Science

The Medical Journal of Australia is Scammed by Acupuncturists

Wed, 21 Jun 2017 12:45:24 -0400 by Rogue Medic

Acupuncture has been thoroughly studied in high quality studies. The result is that we know, yes we know, that acupuncture is just an elaborate placebo – a scam. A reputable journal is claiming that low quality evidence contradicts what we know and we should ignore the high quality evidence.^[1]

So why did the Medical Journal of Australia fall for this? Are their reviewers incompetent, dishonest, or is there some other reason for misleading their readers with bad research?

What is acupuncture?

You stick special needles into magic qi spots on the patient’s body, in order to affect the body’s magic energy. Not mitochondrial energy. Not any real measurable energy, but some psychic powers, some Stephen King kind of energy.

Any competent/honest researcher would compare acupuncture with a valid placebo. What is a valid placebo? A valid placebo is one that the patient believes is the treatment being studied. If the treatment comes in a pill, you provide a pill that is indistinguishable from the pill, but without the active ingredient. If the treatment is to jab you with needles, you provide an experience that is indistinguishable from the needles, but without influencing any mechanism of action the proponents claim makes the needles work.

How do we get people to believe they are being stabbed with needles in magic qi spots, without actually stabbing them with needles in magic qi spots? Use toothpicks at spots that acupuncture specialists specify are definitely not magic qi spots.

Every study of acupuncture that has used a valid placebo has failed to show benefit over placebo.^[2],^[3],^[4],^[5],^[6],^[7],^[8],^[9]

Does this study use a valid placebo?

No. This study uses jargon and misdirection to distract us from the only important part of this study.

This study is just propaganda.

It doesn’t matter where you put the needles.

It doesn’t matter if you use needles.

All that matters is that you believe in voodoo.

We already knew that acupuncture is merely fancy voodoo, with the needles going into the patient, rather than the doll. These researchers want us to ignore the high quality evidence and pretend that the man behind the curtain is as great and powerful as he initially claims to be.

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Footnotes:

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^[1] Acupuncture for analgesia in the emergency department: a multicentre, randomised, equivalence and non-inferiority trial
Cohen MM, Smit V, Andrianopoulos N, Ben-Meir M, Taylor DM, Parker SJ, Xue CC, Cameron PA.
Med J Aust. 2017 Jun 19;206(11):494-499.
PMID: 28918732

Free Full Text in PDF format from MJA

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^[2] A randomized trial comparing acupuncture, simulated acupuncture, and usual care for chronic low back pain.
Cherkin DC, Sherman KJ, Avins AL, Erro JH, Ichikawa L, Barlow WE, Delaney K, Hawkes R, Hamilton L, Pressman A, Khalsa PS, Deyo RA.
Arch Intern Med. 2009 May 11;169(9):858-66. doi: 10.1001/archinternmed.2009.65.
PMID: 19433697

Free Full Text from PubMed Central

In conclusion, acupuncture-like treatments significantly improved function in persons with chronic low back pain. However, the finding that benefits of real acupuncture needling were no greater than those of non-insertive stimulation raises questions about acupuncture’s purported mechanism of action.

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^[3] Acupuncture for treatment of persistent arm pain due to repetitive use: a randomized controlled clinical trial.
Goldman RH, Stason WB, Park SK, Kim R, Schnyer RN, Davis RB, Legedza AT, Kaptchuk TJ.
Clin J Pain. 2008 Mar-Apr;24(3):211-8.
PMID: 18287826

Correction 01-07-2019 – This study used real acupuncture sites, but did not use real needles and the skin was not punctured. The patients outcomes were significantly better in the fake needle group.

The sham group improved significantly more than the true acupuncture group during the treatment period, but this advantage was not sustained 1 month after treatment ended. The difference in pain between sham and true acupuncture groups at the end of treatment (0.75 points on 10-point scale), although statistically significant, probably does not represent a clinically discernible difference.

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^[4] Sham device v inert pill: randomised controlled trial of two placebo treatments.
Kaptchuk TJ, Stason WB, Davis RB, Legedza AR, Schnyer RN, Kerr CE, Stone DA, Nam BH, Kirsch I, Goldman RH.
BMJ. 2006 Feb 18;332(7538):391-7. Epub 2006 Feb 1.
PMID: 16452103

Free Full Text from PubMed Central.

What this study adds

A validated sham acupuncture device has a greater placebo effect on subjective outcomes than oral placebo pills

A placebo analgesia effect beyond the natural evolution of disease is detectable over time

Adverse events and nocebo effects are linked to the information provided to patients

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^[5] Another acupuncture study misinterpreted
Science Blogs – Respectful Insolence
Orac
May 13, 2009
Article

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^[6] Acupuncture in the ED
Steven Novella
Neurologica
Article

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^[7] Emergency acupuncture! (2017 edition)
Science Blogs – Respectful Insolence
Orac
June 20, 2017
Article

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^[8] On the pointlessness of acupuncture in the emergency room…or anywhere else
David Gorski
Science-Based Medicine
July 25, 2016
Article

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Added 01-10-2019 – In going through some old sources, I have been making a few corrections and realized I forgot to include this study –

^[9] Acupuncture for Menopausal Hot Flashes: A Randomized Trial.
Ee C, Xue C, Chondros P, Myers SP, French SD, Teede H, Pirotta M.
Ann Intern Med. 2016 Feb 2;164(3):146-54. doi: 10.7326/M15-1380. Epub 2016 Jan 19.
PMID: 26784863

Free Full Text in PDF format from carolinashealthcare.org

CONCLUSION: Chinese medicine acupuncture was not superior to noninsertive sham acupuncture for women with moderately severe menopausal HFs.

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Marc M Cohen, De Villiers Smit, Nick Andrianopoulos, Michael Ben-Meir, David McD Taylor, Shefton J Parker, Chalie C Xue, & Peter A Cameron (2017). Acupuncture for analgesia in the emergency department: a multicentre, randomised, equivalence and non-inferiority trial Medical Journal of Australia, 206 (11), 494-499 : doi: 10.5694/mja16.00771

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Cherkin, D., Sherman, K., Avins, A., Erro, J., Ichikawa, L., Barlow, W., Delaney, K., Hawkes, R., Hamilton, L., Pressman, A., Khalsa, P., & Deyo, R. (2009). A Randomized Trial Comparing Acupuncture, Simulated Acupuncture, and Usual Care for Chronic Low Back Pain Archives of Internal Medicine, 169 (9) DOI: 10.1001/archinternmed.2009.65

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Goldman, R., Stason, W., Park, S., Kim, R., Schnyer, R., Davis, R., Legedza, A., & Kaptchuk, T. (2008). Acupuncture for Treatment of Persistent Arm Pain Due to Repetitive Use The Clinical Journal of Pain, 24 (3), 211-218 DOI: 10.1097/AJP.0b013e31815ec20f

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Kaptchuk TJ, Stason WB, Davis RB, Legedza AR, Schnyer RN, Kerr CE, Stone DA, Nam BH, Kirsch I, & Goldman RH (2006). Sham device v inert pill: randomised controlled trial of two placebo treatments bmj, 332 (7538), 391-397 : pmid: 16452103

Filed Under: 'Alternative' Medicine, Correction, Evidence, Pain Management, Research Blogging

Acupuncture vs intravenous morphine in the management of acute pain in the ED

Thu, 11 Aug 2016 20:30:47 -0400 by Rogue Medic

What does elaborate placebo mean?

An elaborate placebo is a placebo that does better than a pill, or injection, apparently because the patient has more invested in the belief the placebo will work. An injection of a placebo (saline solution) may be more effective than a pill of real pain medicine because of the ceremony involved in giving the placebo through IV (IntraVenous) access. A placebo that is more expensive tends to have more of an effect than a less expensive placebo.^[1],^[2]

Acupuncture requires a lot of investment on the part of the patient. A more elaborate placebo might be fire walking. I don’t know of any research on fire walking as a treatment for pain, but I would not be surprised if it is extremely effective.

Image credit. Do not try at home.

We know that acupuncture is just a placebo because research shows that sham (fake/placebo) acupuncture works just as well as real acupuncture. Sham acupuncture generally means using toothpicks (rather than needles), not penetrating the skin, but always using locations that are not qi points.^[3],^[4] There is also a study using fake needles at the qi points.^[5] ^*

If the essence of acupuncture is the magic of the qi points, but the same effect is produced when staying away from the qi points, the qi points are not doing anything.

This study did not use a sham acupuncture group. We have no reason to expect real acupuncture to provide more pain relief than sham acupuncture, so how should we use this information?

Should we have people providing fake acupuncture in the ED (Emergency Department)?

If so, how should we do this?

Since it is not the acupuncture, but the patient’s reaction to the ceremony of the placebo that appears to be providing the pain relief, how many different ways might we vary the treatment to improve the placebo effect?

Should we set up a fire walking pit?

What are the ethical concerns of using placebo medicine, when the placebo appears to provide similar, but safer, relief than real medicine?

What are the ethical concerns of using deception to treat patients?

Overall, 89 patients (29.3%) experienced minor adverse effects: 85 (56.6%) in morphine group and 4 (2.6%) in acupuncture group; the difference was signi ficant between the 2 groups (Table 3). The most frequent adverse effect was dizziness in the morphine group (42%) and needle breakage in the acupuncture group (2%). No major adverse effect was recorded during the study protocol. (See Table 4.)^[6]

If we ignore the problems with this study and with the problem of lying to patients to make them feel better, can we expect research journals to look more like alternative medicine magazines with article titles like –

How to lie to patients, so that . . . .

What is the best scam to relieve pain?

How much integrity do we sacrifice?

Since the ED does not appear to be the source of the increase in opioid addiction, should we sacrifice any integrity in pursuit of placebo treatments?

We have an epidemic of opioid addiction because of excessive prescriptions for long-term pain.

The answer is not to try to create an epidemic of magical thinking.

This paper was also covered by –

Emergency Medicine Literature of Note

NEJM Journal Watch Emergency Medicine

Life in the Fast Lane

Science-Based Medicine

And thank you to Dr. Ryan Radecki of Emergency Medicine Literature of Note for providing me with a copy of the paper.

–

Footnotes:

–

^[1] Placebo effect of medication cost in Parkinson disease: a randomized double-blind study.
Espay AJ, Norris MM, Eliassen JC, Dwivedi A, Smith MS, Banks C, Allendorfer JB, Lang AE, Fleck DE, Linke MJ, Szaflarski JP.
Neurology. 2015 Feb 24;84(8):794-802. doi: 10.1212/WNL.0000000000001282. Epub 2015 Jan 28.
PMID: 25632091

Free Full Text from PubMed Central

CONCLUSION: Expensive placebo significantly improved motor function and decreased brain activation in a direction and magnitude comparable to, albeit less than, levodopa. Perceptions of cost are capable of altering the placebo response in clinical studies.

–

^[2] Commercial features of placebo and therapeutic efficacy.
Waber RL, Shiv B, Carmon Z, Ariely D.
JAMA. 2008 Mar 5;299(9):1016-7. doi: 10.1001/jama.299.9.1016. No abstract available.
PMID: 18319411

Free Full Text in PDF format from Duke.edu

These results are consistent with described phenomena of commercial variables affecting quality expectations¹ and expectations influencing therapeutic efficacy.⁴ Placebo responses to commercial features have many potential clinical implications. For example, they may help explain the popularity of high-cost medical therapies (eg, cyclooxygenase 2 inhibitors) over inexpensive, widely available alternatives (eg, over-the-counter nonsteroidal anti-inflammatory drugs) and why patients switching from branded medications may report that their generic equivalents are less effective.

–

^[3] Acupuncture for Menopausal Hot Flashes: A Randomized Trial.
Ee C, Xue C, Chondros P, Myers SP, French SD, Teede H, Pirotta M.
Ann Intern Med. 2016 Feb 2;164(3):146-54. doi: 10.7326/M15-1380. Epub 2016 Jan 19.
PMID: 26784863

Free Full Text in PDF format from carolinashealthcare.org

CONCLUSION: Chinese medicine acupuncture was not superior to noninsertive sham acupuncture for women with moderately severe menopausal HFs.

–

^[4] A randomized trial comparing acupuncture, simulated acupuncture, and usual care for chronic low back pain.
Cherkin DC, Sherman KJ, Avins AL, Erro JH, Ichikawa L, Barlow WE, Delaney K, Hawkes R, Hamilton L, Pressman A, Khalsa PS, Deyo RA.
Arch Intern Med. 2009 May 11;169(9):858-66. doi: 10.1001/archinternmed.2009.65.
PMID: 19433697

Free Full Text from PubMed Central

In conclusion, acupuncture-like treatments significantly improved function in persons with chronic low back pain. However, the finding that benefits of real acupuncture needling were no greater than those of non-insertive stimulation raises questions about acupuncture’s purported mechanism of action.

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^[5] Acupuncture for treatment of persistent arm pain due to repetitive use: a randomized controlled clinical trial.
Goldman RH, Stason WB, Park SK, Kim R, Schnyer RN, Davis RB, Legedza AT, Kaptchuk TJ.
Clin J Pain. 2008 Mar-Apr;24(3):211-8.
PMID: 18287826

^* Correction 01-08-2019 – I was wrong to include this study in those that used fake qi points. In this study real acupuncture sites were used, but not real needles, so this study only examined the justification for using needles, not the effect of the locations. The other studies^[3],^[4] did use fake acupuncture locations and did show that the location also does not matter.

In a twist that the acupuncturist cannot explain, the patients outcomes were significantly better in the group that did not use real needles.

The sham group improved significantly more than the true acupuncture group during the treatment period, but this advantage was not sustained 1 month after treatment ended. The difference in pain between sham and true acupuncture groups at the end of treatment (0.75 points on 10-point scale), although statistically significant, probably does not represent a clinically discernible difference.

–

^[6] Acupuncture vs intravenous morphine in the management of acute pain in the ED.
Grissa MH, Baccouche H, Boubaker H, Beltaief K, Bzeouich N, Fredj N, Msolli MA, Boukef R, Bouida W, Nouira S.
Am J Emerg Med. 2016 Jul 20. pii: S0735-6757(16)30422-3. doi: 10.1016/j.ajem.2016.07.028. [Epub ahead of print]
PMID: 27475042

ClinicalTrials.gov page for this study.

–

Grissa, M., Baccouche, H., Boubaker, H., Beltaief, K., Bzeouich, N., Fredj, N., Msolli, M., Boukef, R., Bouida, W., & Nouira, S. (2016). Acupuncture vs intravenous morphine in the management of acute pain in the ED The American Journal of Emergency Medicine DOI: 10.1016/j.ajem.2016.07.028

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Espay, A., Norris, M., Eliassen, J., Dwivedi, A., Smith, M., Banks, C., Allendorfer, J., Lang, A., Fleck, D., Linke, M., & Szaflarski, J. (2015). Placebo effect of medication cost in Parkinson disease: A randomized double-blind study Neurology, 84 (8), 794-802 DOI: 10.1212/WNL.0000000000001282

–

Waber RL, Shiv B, Carmon Z, Ariely D. (2008). Commercial Features of Placebo and Therapeutic Efficacy JAMA, 299 (9) DOI: 10.1001/jama.299.9.1016

–

Ee, C., Xue, C., Chondros, P., Myers, S., French, S., Teede, H., & Pirotta, M. (2016). Acupuncture for Menopausal Hot Flashes Annals of Internal Medicine, 164 (3) DOI: 10.7326/M15-1380

–

Filed Under: 'Alternative' Medicine, Correction, Critical Judgment, EBM, Heresy, Morphine, Pain Management, Research Blogging

2015 In Review – Superstitious Standards of Care Suffer Small Losses, But Continue to be Favorites

Thu, 31 Dec 2015 14:40:08 -0500 by Rogue Medic

What changed, or almost changed in 2015?

Withholding epinephrine (adrenaline in Commonwealth countries) in cardiac arrest is still heresy. This use of epinephrine is not based on evidence of improved outcomes that matter to patients – unless the patient is a pig/dog/rat with no heart disease having an artificially produced cardiac arrest.

The Jacobs trial ways sabotaged by politicians, the media, and other opponents of science claiming that depriving patients of the standard witchcraft is unethical.^[1] Using inadequately tested hunches on uninformed patients, as long as everyone else is doing it, appears to be their idea of ethical behavior. However, the Paramedic2 trial has been underway for about a year and should provide results in 2018.^[2]

There probably is some benefit for cardiac arrest patients who are not having heart attacks, but we do not currently try to identify them. We also do not know what dose or frequency is best or when to give epinephrine. Paramedic2 will only be able to answer some of those questions.

Withholding ventilation is a less defended heresy, at least in Pennsylvania.

AVOID endotracheal intubation and patient packaging during initial 10 minutes

Ventilation Options⁶:

No Ventilation

1 ventilation every 10-15 compressions⁸ (Monitor Perfusion with Capnography^[3]

However, the AHA (American Heart Association) and ILCOR (International Liaison Committee On Resuscitation) 2015 resuscitation guidelines double down on baseless fears –

2015 Evidence Review
There is concern that delivery of chest compressions without assisted ventilation for prolonged periods could be less effective than conventional CPR (compressions plus breaths) because the arterial oxygen content will decrease as CPR duration increases.^[4]

There is no evidence to support this fear, but using reason against irrational beliefs is often unsuccessful, since the irrational appeals to emotion and avoids reason.

Medical directors have been recognizing that backboards were used because of irrational fear and assumptions of benefit that were based on hunches. Therefore many medical directors now recognize the absurdity of the use of this malpractice device and discourage the use of backboards.

Pennsylvania has also removed chilled IV fluid from protocols following the failure of the treatment to improve outcomes for cardiac arrest patients, when given by EMS.

Chilled IV fluid therapeutic hypothermia does work in the hospital, but not when provided by EMS.

This is one of the reasons EMS should not automatically adopt treatments that work in the hospital. It is difficult for many in EMS to understand, but many in EMS still think that occasionally intubating a patient makes a paramedic as good as an anesthesiologist.

In general, the state of EMS is best summed up by this statement by Prachi Sanghavi –

Our current ambulance system is based on little scientific evidence.

The scary thing for patients is that many in EMS are proud of our ignorance.

Elsewhere in medicine in 2015.

Thousands of Americans travel to regions with outbreaks of Ebola and help to stop the spread of infection. This was in spite of the panic being encouraged by the scientifically illiterate. We should have welcomed them home as we welcome home out military. Both of these groups of Americans risk their lives to protect others and should be treated better. They are far more ethical than our isolationist politicians.

We learned that we need to add rats to the growing list of the non-human animals that exhibit empathy and will sacrifice to help others.^[5] It appears that comparing those who opposed sending Americans to rats is unfair to the rats.

Finally, 2015 was the 100th anniversary of Albert Einstein explaining that Isaac Newton was wrong about gravity, but that is the way science improves.

PS – We also had push dose pressors added to the Pennsylvania protocols in 2015.

–

Footnotes:

–

^[1] 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 semanticscholar.org

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.

–

^[2] Paramedic2 – The Adrenaline Trial
Warwick Medical School
About

–

^[3] General Cardiac Arrest – Adult
3031A – ALS – Adult
Pennsylvania Emergency Health Services Council
PA ALS Protocols in PDF format

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^[4] 2015 Evidence Review
2015 American Heart Association Guidelines Update for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care
Part 5: Adult Basic Life Support and Cardiopulmonary Resuscitation Quality
Adult BLS Sequence—Updated
2015 Evidence Review

–

^[5] Rats forsake chocolate to save a drowning companion
Science Magazine
By Emily Underwood
12 May 2015
Article

–

Edited 12-27-2018 to correct link to pdf of Jacobs study in footnote 1.

Filed Under: 2015 ACLS, Correction, Ethics, Evidence, Heresy, Superstition

Should ACLS Recommend the Unknown Based on Weak Evidence?

Thu, 29 Jan 2015 17:05:03 -0500 by Rogue Medic

The AHA (American Heart Association) and ILCOR (International Liaison Committee on Resuscitation) will be meeting tomorrow to finalize the recommendations for the 2015 ACLS (Advanced Cardiac Life Support) guidelines. Here is the comment I submitted on the proposed recommendation for epinephrine (Adrenaline in Commonwealth countries) in cardiac arrest.

I have not received any information about where to submit SEERS comments, so I am sending this to you. Please forward it to whomever is supposed to receive comments.

Vasopressors for cardiac arrest (1. Epi v Placebo)

Consensus on Science:
For all four long term (critical) and short term (important) outcomes, we found one underpowered trial that provided low quality evidence comparing SDE to placebo (Jacobs, 2001, 1138).^[1]

As a trial that is stated to be underpowered (through no fault of Dr. Jacobs),^[2] is there any valid reason the Jacobs study should be considered to be superior to observational studies?

Among 534 subjects, there was uncertain benefit or harm of SDE over placebo for the critical outcomes of survival to discharge [RR 2.12, 95% CI 0.75-6.02, p=0.16] and good neurological outcome defined as CPC of 1-2 [RR 1.73, 95% CI 0.59-5.11, p=0.32].^[1]

We do not have good evidence to tell us if this is harmful or beneficial and we do not have any way of determining which patients will be harmed or helped by administration of epinephrine.

However, patients who received SDE had higher rates of the two important outcomes of survival to admission [RR 1.95, 95% CI, 1.34-2.84, p=0.0004] and ROSC in the prehospital setting [RR 2.80, 95% CI 1.78-4.41, p<0.00001] compared to those who received placebo.^[1]

Are these surrogate endpoints important?

How do we know?

If these surrogate endpoints are important, why is there no valid evidence to support this claim?

We have a history of being misled by surrogate endpoints. We used to bleed patients and that produced a number of clear benefits in surrogate endpoints.

Physicians observed of old, and continued to observe for many centuries, the following facts concerning blood-letting.

1. It gave relief to pain. . . . .

2. It diminished swelling. . . . .

3. It diminished local redness or congestion. . . . .

4. For a short time after bleeding, either local or general, abnormal heat was sensibly diminished.

5. After bleeding, spasms ceased, . . . .

6. If the blood could be made to run, patients were roused up suddenly from the apparent death of coma. (This was puzzling to those who regarded spasm and paralysis as opposite states; but it showed the catholic applicability of the remedy.)

7. Natural (wrongly termed ” accidental”) hacmorrhages were observed sometimes to end disease. . . . .

8. . . . venesection would cause hamorrhages to cease.^[3]

We don’t do that any more, because medicine is not supposed to just create a superficial improvement.

We should not be making any recommendation to treat based on such weak evidence.

The evidence for the routine use of adrenaline is perceived to be at equipoise within the international community of resuscitation scientists requiring re-evaluation¹⁹ as suggested by this comprehensive systematic review and meta-analysis. There is a need for well-designed, placebo-controlled, and adequately powered RCTs to evaluate the efficacy of adrenaline and to determine its optimal dosing.^11,16,54 The question as to the efficacy of adrenaline for OHCA remains unanswered.^[4]

Since the question as to the efficacy of adrenaline for OHCA remains unanswered, we should avoid substituting a bad answer for We don’t know.

Maybe we should bring back the indeterminate class for these unanswerable questions.

Treatment Recommendation
Given the observed benefit in short term outcomes, we suggest Standard Dose Epinephrine be administered to patients in cardiac arrest.(weak recommendation, low quality)^[1]

The benefit is considered important, but that is just an expert opinion, which is the lowest level of evidence.

A weak recommendation to give a treatment of unknown benefit and unknown harm, based on evidence that is admitted to be of low quality, should not set the standard of care. Even if the guidelines are explicitly stated to not be standards of care, they are adopted as standards of care by the emergency medicine community and by the EMS community.

We don’t know enough to make a recommendation about epinephrine, or most other treatments, in cardiac arrest.

We do not need to keep making the same recommendation just because we have made it before. We can leave it up to the treating physician or to the medical director writing the protocols for EMS.

–

Footnotes:

–

^[1] Vasopressors for cardiac arrest (1. Epi v Placebo)
ILCOR Scientific Evidence Evaluation and Review System
Questions Open for Public Comment
Closing Date – February 28, 2015
Question page

–

Free Full Text PDF Download from semanticscholar.org

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] Blood-Letting
Br Med J.
1871 March 18; 1(533): 283–291.
PMCID: PMC2260507

–

^[4] Adrenaline for out-of-hospital cardiac arrest resuscitation: a systematic review and meta-analysis of randomized controlled trials.
Lin S, Callaway CW, Shah PS, Wagner JD, Beyene J, Ziegler CP, Morrison LJ.
Resuscitation. 2014 Jun;85(6):732-40. doi: 10.1016/j.resuscitation.2014.03.008. Epub 2014 Mar 15.
PMID: 24642404 [PubMed – in process]

–

Edited 12-27-2018 to correct link to pdf of Jacobs study in footnote 2.

Filed Under: ACLS, Correction, Critical Judgment, Epinephrine, Heresy, Pharmacology

Proposed 2015 ACLS Epinephrine Recommendation – Vasopressors for cardiac arrest (1. Epi v Placebo)

Tue, 27 Jan 2015 21:45:10 -0500 by Rogue Medic

What do the AHA (American Heart Association) and ILCOR (International Liaison Committee on Resuscitation) plan to make their recommendation on use of epinephrine (Adrenaline in Commonwealth countries) in cardiac arrest (ACLS – Advanced Cardiac Life Support)?

Full Question:
Among adults who are in cardiac arrest in any setting (P), does does use of epinephrine (I), compared with placebo or not using epinephrine (C), change Survival with Favorable neurological/functional outcome at discharge, 30 days, 60 days, 180 days AND/OR 1 year, Survival only at discharge, 30 days, 60 days, 180 days AND/OR 1 year, ROSC (O)?

The information provided is currently in DRAFT format and is NOT a FINAL version^[1]

Unless you are familiar with the way AHA/ILCOR ask questions, this may not seem to be a helpful way of addressing the question. Here is the format being used –

PICO:

Population/Patient/Problem

Intervention

Comparison/Control

Outcome

The Patients are adults who are in cardiac arrest in any setting.

The Intervention is use of epinephrine.

The Comparison is placebo or not using epinephrine.

The Outcome is a bit complicated – Survival with Favorable neurological/functional outcome at discharge, 30 days, 60 days, 180 days AND/OR 1 year, Survival only at discharge, 30 days, 60 days, 180 days AND/OR 1 year, ROSC. ROSC is Return Of Spontaneous Circulation.

Everything is reasonable – until they get to the outcome. Does anyone still think that it is really an improvement to get pulses back, be transported to the hospital, never wake up, and die in the ED (Emergency Department) or ICU (Intensive Care Unit)? What if the coma lasts for 30 days, 60 days, 180 days AND/OR 1 year. If you think that is an improvement, you may not have considered the cost. How much is it worth to give a family false hope? $10,000? Who pays for this deception?

Should we also try putting the patient in a helicopter to see if the magic rotor blades make the family feel that everything possible was done to deceive them?

These are considered to be important, because we do not seem to know what is important.

Why are ROSC and survival to admission considered important?

Where is the evidence that these measurements lead to better outcomes?

Studies that look at these outcomes show that real world patients treated with epinephrine are more likely to die in the hospital – and those who do not die in the hospital are more likely to have severe neurological impairment.

Click on image to make it larger.^[2] The studies are in the footnotes.^[3],^[4],^[5],^[6],^[7],^[8],^[9],^[10]

Is Adrenaline beneficial in cardiac arrest?

Probably, but only for some patients and we do not know which patients benefit.

Is Adrenaline harmful in cardiac arrest?

Probably, but only for some patients and we do not know which patients are harmed.

The evidence evaluation focused on the Jacobs study,^[8] which is randomized and placebo controlled, but only reaches the level of fair according to the analysis of all of the evidence. The reason is that politicians and the media combined to sabotage the study. Most of the ambulance services dropped out of the Jacobs study because of this interference. This is not the fault of Dr. Ian G. Jacobs, who deserves credit for setting up the first randomized placebo controlled study of this important topic.

For all four long term (critical) and short term (important) outcomes, we found one underpowered trial that provided low quality evidence comparing SDE to placebo (Jacobs, 2001, 1138).^[1]

We need to bring back the Indeterminate class of recommendation for ACLS, because that is the best that we can come up with for epinephrine, unless we ignore the evidence or we just don’t understand the evidence.

Table 3.
Applying Classification of Recommendations and Level of Evidence

. . .

Class Indeterminate.
• Research just getting started
• Continuing area of research
• No recommendations until further research (eg, cannot recommend for or against)^[11]

Does the proposed ACLS recommendation on epinephrine makes sense?

Consider that we do not know which patients benefit from epinephrine. The treatment for every cause of cardiac arrest includes epinephrine as the first drug, even if the cause of cardiac arrest is known to be an overdose of epinephrine.

Is epinephrine better than nothing for some patients in cardiac arrest? Yes.

Is epinephrine worse than nothing for some patients in cardiac arrest? Yes.

We do not know which patients we are harming with epinephrine and we don’t seem to want to stop harming those patients.

–

Footnotes:

–

^[2] Vasopressors in cardiac arrest: a systematic review.
Larabee TM, Liu KY, Campbell JA, Little CM.
Resuscitation. 2012 Aug;83(8):932-9. Epub 2012 Mar 15.
PMID: 22425731 [PubMed – in process]

CONCLUSION: There are few studies that compare vasopressors to placebo in resuscitation from cardiac arrest. Epinephrine is associated with improvement in short term survival outcomes as compared to placebo, but no long-term survival benefit has been demonstrated. Vasopressin is equivalent for use as an initial vasopressor when compared to epinephrine during resuscitation from cardiac arrest. There is a short-term, but no long-term, survival benefit when using high dose vs. standard dose epinephrine during resuscitation from cardiac arrest. There are no alternative vasopressors that provide a long-term survival benefit when compared to epinephrine. There is limited data on the use of vasopressors in the pediatric population.

–

^[3] High dose and standard dose adrenaline do not alter survival, compared with placebo, in cardiac arrest.
Woodhouse SP, Cox S, Boyd P, Case C, Weber M.
Resuscitation. 1995 Dec;30(3):243-9.
PMID: 8867714 [PubMed – indexed for MEDLINE]

–

^[4] Adrenaline in out-of-hospital ventricular fibrillation. Does it make any difference?
Herlitz J, Ekström L, Wennerblom B, Axelsson A, Bång A, Holmberg S.
Resuscitation. 1995 Jun;29(3):195-201.
PMID: 7667549 [PubMed – indexed for MEDLINE]

–

^[5] Survival outcomes with the introduction of intravenous epinephrine in the management of out-of-hospital cardiac arrest.
Ong ME, Tan EH, Ng FS, Panchalingham A, Lim SH, Manning PG, Ong VY, Lim SH, Yap S, Tham LP, Ng KS, Venkataraman A; Cardiac Arrest and Resuscitation Epidemiology Study Group.
Ann Emerg Med. 2007 Dec;50(6):635-42. Epub 2007 May 23.
PMID: 17509730 [PubMed – indexed for MEDLINE]

Free Full Text Download in PDF format from prdupl02.ynet.co.il

–

^[6] Intravenous drug administration during out-of-hospital cardiac arrest: a randomized trial.
Olasveengen TM, Sunde K, Brunborg C, Thowsen J, Steen PA, Wik L.
JAMA. 2009 Nov 25;302(20):2222-9.
PMID: 19934423 [PubMed – indexed for MEDLINE]

Free Full Text from JAMA

–

^[7] Outcome when adrenaline (epinephrine) was actually given vs. not given – post hoc analysis of a randomized clinical trial.
Olasveengen TM, Wik L, Sunde K, Steen PA.
Resuscitation. 2011 Nov 22. [Epub ahead of print]
PMID: 22115931 [PubMed – as supplied by publisher]

–

^[8] 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 semanticscholar.org

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.

–

^[9] Prehospital epinephrine use and survival among patients with out-of-hospital cardiac arrest.
Hagihara A, Hasegawa M, Abe T, Nagata T, Wakata Y, Miyazaki S.
JAMA. 2012 Mar 21;307(11):1161-8. doi: 10.1001/jama.2012.294.
PMID: 22436956 [PubMed – indexed for MEDLINE]

Free Full Text from JAMA.

–

^[10] Impact of early intravenous epinephrine administration on outcomes following out-of-hospital cardiac arrest.
Hayashi Y, Iwami T, Kitamura T, Nishiuchi T, Kajino K, Sakai T, Nishiyama C, Nitta M, Hiraide A, Kai T.
Circ J. 2012;76(7):1639-45. Epub 2012 Apr 5.
PMID: 22481099 [PubMed – indexed for MEDLINE]

Free Full Text from Circulation Japan.

–

^[11] Table 3. Applying Classification of Recommendations and Level of Evidence
2005 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care
Part 1: Introduction
Table 3

I have modified this table solely for the purpose of clarity of presentation, by modifying color and font. None of the words have been changed.

–

Edited 12-27-2018 to correct link to pdf of Jacobs study in footnote 8.

Filed Under: ACLS, Cardiac Arrest, Correction, Epinephrine, Evidence, Pharmacology

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

Are We Killing Patients With Parochialism?

How Bad is Epinephrine (Adrenaline) for Cardiac Arrest, According to the PARAMEDIC2 Study?

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

The Medical Journal of Australia is Scammed by Acupuncturists

Acupuncture vs intravenous morphine in the management of acute pain in the ED

2015 In Review – Superstitious Standards of Care Suffer Small Losses, But Continue to be Favorites

Should ACLS Recommend the Unknown Based on Weak Evidence?

Proposed 2015 ACLS Epinephrine Recommendation – Vasopressors for cardiac arrest (1. Epi v Placebo)

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