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

- Rogue Medic

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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The Medical Journal of Australia is Scammed by Acupuncturists

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

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]

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.

Footnotes:

[1] Acupuncture for analgesia in the emergency department: a multicentre, randomised, equivalence and non-inferiority trial
Marc M Cohen, De Villiers Smit, Nick Andrianopoulos, Michael Ben-Meir, David McD Taylor, Shefton J Parker, Chalie C Xue and Peter A Cameron
Med J Aust 2017; 206 (11): 494-499. || doi: 10.5694/mja16.00771
Abstract from MJA

Free Full Text in PDF format from MJA

[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

[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 [PubMed – indexed for MEDLINE]

[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 [PubMed – indexed for MEDLINE]

Free Full Text from PubMed Central.

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

[6] Acupuncture in the ED
Steven Novella
Neurologica
Article

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

[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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D10 in the Treatment of Prehospital Hypoglycemia: A 24 Month Observational Cohort Study

ResearchBlogging.org
 

Why treat hypoglycemia with 10% dextrose (D10), rather than the more expensive, potentially more harmful, and less available, but traditional treatment of 50% dextrose (D50)? Why not? The only benefit of 50% dextrose appears to be that it is what people are used to using, but aren’t we used to starting IVs (IntraVenous lines) and running fluids through the IVs?

We should be much more familiar with running in fluid, than in pushing boluses of syrup.

What happens when we have temporary shortages of 50% dextrose? Do we stop treating hypoglycemia? Are we supposed to panic, because we can no longer follow tradition? No. We give the more appropriate, and lower, dose of the much lower concentration of dextrose. We provide better care because of our need.
 

Despite the traditional use of D50, there is a minimal amount of data to support it as the standard of care.[1]

 

Is 10% dextrose the perfect treatment for hypoglycemia? No, but it does appear to be less likely to cause harm than the current overtreatment with 50% dextrose.
 

Seven patients had a drop in blood glucose after D10 administration, all of 10 mg/dL or less except for one patient with a drop of 19 mg/dL who had an insulin pump infusing that was not removed by EMS personnel during D10 infusion.[1]

 

Is that any different from what happens with 50% dextrose? If this is different from D50, how does the potential harm from giving too much dextrose to most hypoglycemic patients compare to the potential harm of giving a first that is too small to fewer than 1% of hypoglycemia patients?
 

There were no reported adverse events related to dextrose infusion. Six patients who received intravenous D10 were pronounced dead in the field during the period of study. On investigator review, all patients had altered level of arousal or were in cardiac arrest prior to arrival of EMS personnel and their deaths were deemed to be unrelated to dextrose administration.[1]

 

Dextrose does not reverse death, so there is no reason to expect a better outcome for dead patients with a higher concentration of a drug that does not reverse death. Go read the excellent review of the evidence on hypoglycemia, death, and the potential of dextrose to improve outcomes from death.[2]

But is 10% really better? We don’t have any good research, but is there any good reason to give all 25 grams of dextrose in a syringe of 50% dextrose if the patient wakes up before the full dose has been administered? Would we continue to give the entire syringe of morphine, or fentanyl, or most of the other drugs that we give, if our assessment shows that the patient no longer meets the protocol criteria for administration of the drug?
 


 

76% of patients received only 10 grams of dextrose, rather than the usual 25 grams. While it is not known if any of these patients required any further dextrose, or oral glucose, while in the hospital, they should have been awake enough to take any further dextrose orally, as they would the rest of the time.

23% of patients received only 20 grams of dextrose, rather than the usual 25 grams.

Fewer than 1% of hypoglycemia patients received a dose as large as we traditionally give.
 

We do not appear to be concerned with harm from administering more aggressive treatment than is justified by the evidence.

We do appear to be concerned about our anxiety of deviating from the traditional too much is not enough approach to hypoglycemia.

Footnotes:

[1] D10 in the Treatment of Prehospital Hypoglycemia: A 24 Month Observational Cohort Study.
Hern HG, Kiefer M, Louie D, Barger J, Alter HJ.
Prehosp Emerg Care. 2017 Jan-Feb;21(1):63-67. doi: 10.1080/10903127.2016.1189637. Epub 2016 Dec 5.
PMID: 27918858
 

Of the 1,323 patients administered D10 during the study period, the 452 patients excluded from the study cohort for the aforementioned reasons were similar demographically to the study cohort. The median initial blood glucose was the same at 37 mg/dL and the median age was also 66. There were slightly more women at 229 (51%) in the excluded group compared to the cohort.

 

[2] Using Dextrose in Cardiac Arrest
Wednesday, March 14, 2012
Mill Hill Ave Command
Dr. Brooks Walsh
Article

Hern, H., Kiefer, M., Louie, D., Barger, J., & Alter, H. (2016). D10 in the Treatment of Prehospital Hypoglycemia: A 24 Month Observational Cohort Study Prehospital Emergency Care, 21 (1), 63-67 DOI: 10.1080/10903127.2016.1189637

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Acute coronary syndrome on Friday the 13th: a case for re-organising services?

ResearchBlogging.orgAcute coronary syndrome on Friday the 13th - a case for re-organising services 1
 
There has been a bunch of research on the likelihood of bad things happening on Friday the 13th. These researchers thought that the big problem with all of the available research is that the populations studied have been too small. The authors took information on over 56,000 patients with acute coronary syndromes, broke them down into 217 day/date combinations (Friday the 1st, Saturday the 1st, . . . ,Wednesday the 31st, Thursday the 31st), and compared the outcomes of those 216 groups with their Friday the 13th group.

Cut to the conclusion –
 

Conclusion: On most days, there was no difference in the 13-year mortality rate for patients admitted with their first ACS from that for “unlucky” Friday the 13th. However, patients admitted on five day/number combinations were 20-30% more likely to survive at 13 years. These findings could be explained by subgroup analysis inflation of the type I error, although supernatural causes merit further investigation.[1]

 

No. Supernatural causes do not merit further investigation, at least, not based on anything in this paper.

The authors used Friday the 13th as their normal date for comparison with every other date, but the outcomes from Friday the 13th are not the true statistical mean. The outcomes on Friday the 13th were just chosen because of the superstition being investigated. Friday the 13th is so close to the statistical mean that this mistake is easy to make.
 

Surprisingly, however, we also identified five potentially “lucky” days on which mortality rates were significantly lower, by 20-30%.[1]

 

When analyzing 217 samples, it is not surprising that some of the data deviate from average by an amount that is expected to produce no more than one significant deviation out of every twenty comparisons. The authors had over 200 comparisons, so we should not have been surprised by up to 11 day/date combinations with p values of less than 0.05. There were only 5. Should anyone go looking for supernatural explanations for statistically normal outcomes?

While Friday the 13th was not the statistical mean, it was very close. Look at the five potentially “lucky” days and how close the ranges are to 1.00. If the range crosses (includes) 1.00, the results are not statistically significant according to the prospectively determined criteria of the authors. Crossing 1.00 is just another way of expressing P <0.05. Sunday the 1st and Monday the 29th each produced outcomes 29% worse than Friday the 13th. Saturday the 31st produced outcomes that were 36% worse. If we compared these with the actual statistical mean, Monday the 29th and Saturday the 31st become significantly “unlucky” using a p value of less than 0.05 and all of the significantly “lucky” days become insignificant.

As we should expect, the most extreme benefit and harm both fall on the 31st. Only 7/12 (58.3%) of months have 31 days, so these days have much smaller sample sizes. With smaller samples, the appearance of deviance is expected to be greater. The actual deviation is less important, because the sample size is smaller.

Friday the 13th is only slightly different from the statistical mean, using the data in this paper, which may be the largest examination of a possible Friday the 13th effect.

Once again, the biggest problem with Friday the 13th is that we end up listening to people promoting superstition.
 

I have also written about this kind of superstition here –

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] Acute coronary syndrome on Friday the 13th: a case for re-organising services?
Protty MB, Jaafar M, Hannoodee S, Freeman P.
Med J Aust. 2016 Dec 12;205(11):523-525.
PMID: 27927150

Protty, M., Jaafar, M., Hannoodee, S., & Freeman, P. (2016). Acute coronary syndrome on Friday the 13th: a case for re-organising services? The Medical Journal of Australia, 205 (11), 523-525 DOI: 10.5694/mja16.00870

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The PROCAMIO Trial – IV Procainamide vs IV Amiodarone for the Acute Treatment of Stable Wide Complex Tachycardia

ResearchBlogging.org
 

This is a very interesting trial that may surprise the many outspoken amiodarone advocates, but it should not surprise anyone who pays attention to research.

ALPS showed that we should stop giving amiodarone for unwitnessed shockable cardiac arrest. The lead researcher is still trying to spin amiodarone for witnessed shockable cardiac arrest, even though the results do not show improvement in the one outcome that matters – leaving the hospital with a brain that still works.[1],[2],[3]

There is an excellent discussion of the study on the podcast by Dr. Salim Rezaie and Dr. Anand Swaminathan REBELCast: The PROCAMIO Trial – IV Procainamide vs IV Amiodarone for the Acute Treatment of Stable Wide Complex Tachycardia.

One problem with the study that they do not address on the podcast is that the patients in the study appear to have had time to watch Casablanca before treatment started. Here’s looking at you, while we’re waiting, kid. This is apparently unintentional one way of doing a placebo washout. If we wait long enough . . . .
 

Time from arrival to start of infusion was 87 ± 21 min for procainamide and 115 ± 36 min for amiodarone patients (P = 0.58).[4]

 

If nothing else, this demonstrates how little we need to worry about immediately pushing drugs for stable monomorphic VT (V Tach or Ventricular Tachycardia). Should we expect much from antiarrhythmic treatment?

Research shows that for stable monomorphic VT (V Tach or Ventricular Tachycardia) amiodarone is not very likely to be followed by an improvement. Only 29%[5] or only 25%[6] or only 15% within 20 minutes, but if we don’t mind waiting an hour it can be as much as 29%.[7] For those of you who are not good at math, that means amiodarone is about the same as doing nothing, only it comes in a syringe. Even though these poor outcomes ignore the side effects, they are the best evidence in favor of amiodarone, so what Kool-Aid are the advocates drinking?

Adenosine, yes adenosine the SVT (SupraVentricular Tachycardia) drug, appears to be more effective at treating ventricular tachycardia than amiodarone – and adenosine is faster and safer than amiodarone.[8]

What if the patient becomes unstable? First start an IV (IntraVenous) line. Then sedate the patient. Then apply defibrillator pads. After the patient is adequately sedated, then cardiovert. We do not need the pads on the patient first. If it takes a while to put the pads on, that is a problem with the ability of the doctors and nurses, not a medical problem.

It does not appear as if any patient received amiodarone or procainamide until after waiting in the ED (Emergency Department) for over an hour. Were some patients cardioverted in well under an hour? Probably. The important consideration is that the doctors and nurses be able to apply the defibrillator pads properly and quickly and deliver a synchronized cardioversion in less than a minute. If the patient has not yet been sedated, the cardioversion should be delayed until after the patient is adequately sedated, so the intervention that depends most on time is the sedation of the patient.
 

VT + Amiodarone Cardioversion
 

Is there a better treatment than amiodarone? Sedate the patient before the patient becomes unstable, then cardiovert. How do the MACEs (Major Adverse Cardiac Events) compare with sedation and cardioversion vs. antiarrhythmic treatment.
 

5.4 Proarrhythmia
Amiodarone may cause a worsening of existing arrhythmias or precipitate a new arrhythmia. Proarrhythmia, primarily torsade de pointes (TdP), has been associated with prolongation, by intravenous amiodarone, of the QTc interval to 500 ms or greater. Although QTc prolongation occurred frequently in patients receiving intravenous amiodarone, TdP or new-onset VF occurred infrequently (less than 2%). Monitor patients for QTc prolongation during infusion with amiodarone. Reserve the combination of amiodarone with other antiarrhythmic therapies that prolong the QTc to patients with life-threatening ventricular arrhythmias who are incompletely responsive to a single agent.
[9]

 

All antiarrhythmic drugs can cause arrhythmias. In the absence of information about a specific problem that is best addressed by a specific drug (amiodarone is the opposite of specific), we should avoid treatments that have such a high potential for harm.

Amiodarone doesn’t even do a good job of preventing arrhythmias.
 

Intravenous amiodarone did not prevent induction of sustained ventricular tachycardia in any of five patients inducible at baseline. Of six patients with non-sustained ventricular tachycardia, five had sustained ventricular tachycardia or fibrillation induced after amiodarone infusion.[10]

 

Is anything worse than amiodarone? Even epinephrine, yes epinephrine the inadequately tested cardiac arrest drug, has been followed by improved outcomes from V Tach after amiodarone failed.[11]
 

What is best for the patient?

Sedation, search for reversible causes, apply defibrillator pads, and be prepared to cardiovert.

Maybe sedation isn’t that important? This is by Dr. Peter Kowey, one of the top cardiologists in the world.
 

The man’s very first utterance was, “If it happens again, just let me die.”

As I discovered, the reason for this patient’s terror was that he had been cardioverted in an awake state. Ventricular tachycardia had been relatively slow, he had not lost consciousness, and the physicians, in the heat of the moment, had not administered adequate anesthesia. Although the 5 mg of intravenous diazepam had made him a bit drowsy, he felt the electric current on his chest and remembered the event clearly.

The patient’s mental state complicated the case considerably.[12]

 

How unimportant is sedation? How unimportant is consent?

For sedation, I would recommend ketamine, but etomidate was recommended in the podcast. Both work quickly and the most important obstacle to immediate treatment of a patient who suddenly deteriorates is the time to effect of sedation. Neither drug is expected to interfere with perfusion, which is the main excuse given for avoiding sedation for cardioversion.

This study is very small (not the fault of the authors), but it adds to the evidence that amiodarone is not a good first treatment for the patient.
 

Go listen to the podcast by Dr. Salim Rezaie and Dr. Anand Swaminathan REBELCast: The PROCAMIO Trial – IV Procainamide vs IV Amiodarone for the Acute Treatment of Stable Wide Complex Tachycardia

 

Over the years, I have written a bit about cardioversion and the importance of sedation –

Cardioversion – I’m not doing that, you do it! – Mon, 24 Mar 2008

Cardioversion – 2010 ACLS – Part I – Mon, 25 Oct 2010

Cardioversion – 2010 ACLS – Part II – Sun, 31 Oct 2010

Cardioversion – 2010 ACLS – Part III – Thu, 11 Nov 2010

On the relative wisdom of synchronized cardioversion without sedation – Part I – Thu, 11 Nov 2010

On the relative wisdom of synchronized cardioversion without sedation – Part II – Fri, 12 Nov 2010

Synchronized Cardioversion Without Sedation – Part II Scallywag’s Response – Sun, 14 Nov 2010

On the relative wisdom of synchronized cardioversion without sedation – Part III – Tue, 16 Nov 2010

On the relative wisdom of synchronized cardioversion without sedation – Part IV – Wed, 24 Nov 2010

Comments on Cardioversion – 2010 ACLS – Part II – Mon, 16 Apr 2012
 

I have also written a bit about amiodarone –

Merit Badge Courses, Amiodarone, and tPA – Fri, 17 Sep 2010

Amiodarone for Cardiac Arrest in the 2010 ACLS – Part I – Wed, 01 Dec 2010

Amiodarone for Cardiac Arrest in the 2010 ACLS – Part II – Fri, 03 Dec 2010

Is Nexterone the Next Amiodarone? – Sat, 04 Dec 2010

Amiodarone for Cardiac Arrest in the 2010 ACLS – Part III – Mon, 06 Dec 2010

Where are the Black Box Warnings on These Drugs – I – Mon, 05 Dec 2011

Where are the Black Box Warnings on These Drugs – II – Sun, 11 Dec 2011

Is Amiodarone the Best Drug for Stable Ventricular Tachycardia – Wed, 14 Dec 2011

V Tach Storm – Part I – Wed, 28 Dec 2011

V Tach Storm – Part II – Thu, 29 Dec 2011

Nifekalant versus lidocaine for in-hospital shock-resistant ventricular fibrillation or tachycardia – Wed, 04 Jan 2012

NIH launches trials to evaluate CPR and drugs after sudden cardiac arrest – Sun, 29 Jan 2012

What Will Be the Next Standard Of Care We Eliminate – Wed, 28 Mar 2012

Happy Adenosine Day – Tue, 12 Jun 2012

Too Much Medicine and Evidence-Based Guidelines – Part I – Tue, 26 Jun 2012

Too Much Medicine and Evidence-Based Guidelines – Part II – Tue, 03 Jul 2012

Ondansetron (Zofran) Warning for QT Prolongation – is Amiodarone next? – Part I – Mon, 02 Jul 2012

Ondansetron (Zofran) Warning for QT Prolongation – is Amiodarone next? – Part II – Thu, 05 Jul 2012

Wide variability in drug use in out-of-hospital cardiac arrest: A report from the resuscitation outcomes consortium – Part I – Mon, 17 Sep 2012

Wide variability in drug use in out-of-hospital cardiac arrest: A report from the resuscitation outcomes consortium – Part II – Tue, 18 Sep 2012

How do we measure the QT segment when there are prominent U waves? – Thu, 13 Dec 2012

Woman with Risks for Torsades de Pointes Dying within Hours of Leaving the Emergency Department – Wed, 02 Jan 2013

Examples of Ventricular Tachycardia Caused by Amiodarone – Part I – Tue, 28 May 2013

Publication Bias – The Lit Whisperers – Tue, 11 Jun 2013

Standards Of Care – Ventricular Tachycardia – Wed, 31 Jul 2013

Footnotes:

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

[2] Amiodarone, Lidocaine, or Placebo in Out-of-Hospital Cardiac Arrest
Mon, 04 Apr 2016
Rogue Medic
Article

[3] Amiodarone, Lidocaine, or Placebo in Out-of-Hospital Cardiac Arrest.
Kudenchuk PJ, Brown SP, Daya M, Rea T, Nichol G, Morrison LJ, Leroux B, Vaillancourt C, Wittwer L, Callaway CW, Christenson J, Egan D, Ornato JP, Weisfeldt ML, Stiell IG, Idris AH, Aufderheide TP, Dunford JV, Colella MR, Vilke GM, Brienza AM, Desvigne-Nickens P, Gray PC, Gray R, Seals N, Straight R, Dorian P; Resuscitation Outcomes Consortium Investigators.
N Engl J Med. 2016 May 5;374(18):1711-22. doi: 10.1056/NEJMoa1514204. Epub 2016 Apr 4.
PMID: 27043165

CONCLUSIONS
Overall, neither amiodarone nor lidocaine resulted in a significantly higher rate of survival or favorable neurologic outcome than the rate with placebo among patients with out-of-hospital cardiac arrest due to initial shock-refractory ventricular fibrillation or pulseless ventricular tachycardia.

[4] Randomized comparison of intravenous procainamide vs. intravenous amiodarone for the acute treatment of tolerated wide QRS tachycardia: the PROCAMIO study.
Ortiz M, Martín A, Arribas F, Coll-Vinent B, Del Arco C, Peinado R, Almendral J; PROCAMIO Study Investigators.
Eur Heart J. 2016 Jun 28. pii: ehw230. [Epub ahead of print]
PMID: 27354046

Free Full Text from European Heart Journal.

[5] Amiodarone or procainamide for the termination of sustained stable ventricular tachycardia: an historical multicenter comparison.
Marill KA, deSouza IS, Nishijima DK, Senecal EL, Setnik GS, Stair TO, Ruskin JN, Ellinor PT.
Acad Emerg Med. 2010 Mar;17(3):297-306.
PMID: 20370763 [PubMed – indexed for MEDLINE]

Free Full Text from Academic Emergency Medicine.

[6] Amiodarone is poorly effective for the acute termination of ventricular tachycardia.
Marill KA, deSouza IS, Nishijima DK, Stair TO, Setnik GS, Ruskin JN.
Ann Emerg Med. 2006 Mar;47(3):217-24. Epub 2005 Nov 21.
PMID: 16492484 [PubMed – indexed for MEDLINE]

[7] Intravenous amiodarone for the pharmacological termination of haemodynamically-tolerated sustained ventricular tachycardia: is bolus dose amiodarone an appropriate first-line treatment?
Tomlinson DR, Cherian P, Betts TR, Bashir Y.
Emerg Med J. 2008 Jan;25(1):15-8.
PMID: 18156531 [PubMed – indexed for MEDLINE]

[8] Adenosine for wide-complex tachycardia – diagnostic?
Thu, 23 Aug 2012
Rogue Medic
Article

[9] AMIODARONE HYDROCHLORIDE- amiodarone hydrochloride injection, solution
DailyMed
5 WARNINGS AND PRECAUTIONS
FDA Label

[10] Effects of intravenous amiodarone on ventricular refractoriness, intraventricular conduction, and ventricular tachycardia induction.
Kułakowski P, Karczmarewicz S, Karpiński G, Soszyńska M, Ceremuzyński L.
Europace. 2000 Jul;2(3):207-15.
PMID: 11227590 [PubMed – indexed for MEDLINE]

Free Full Text PDF + HTML from Europace

[11] Low doses of intravenous epinephrine for refractory sustained monomorphic ventricular tachycardia.
Bonny A, De Sisti A, Márquez MF, Megbemado R, Hidden-Lucet F, Fontaine G.
World J Cardiol. 2012 Oct 26;4(10):296-301. doi: 10.4330/wjc.v4.i10.296.
PMID: 23110246 [PubMed]

Free Full Text from PubMed Central.

[12] The calamity of cardioversion of conscious patients.
Kowey PR.
Am J Cardiol. 1988 May 1;61(13):1106-7. No abstract available.
PMID: 3364364

Kudenchuk PJ, Brown SP, Daya M, Rea T, Nichol G, Morrison LJ, Leroux B, Vaillancourt C, Wittwer L, Callaway CW, Christenson J, Egan D, Ornato JP, Weisfeldt ML, Stiell IG, Idris AH, Aufderheide TP, Dunford JV, Colella MR, Vilke GM, Brienza AM, Desvigne-Nickens P, Gray PC, Gray R, Seals N, Straight R, Dorian P, & Resuscitation Outcomes Consortium Investigators (2016). Amiodarone, Lidocaine, or Placebo in Out-of-Hospital Cardiac Arrest. The New England journal of medicine, 374 (18), 1711-22 PMID: 27043165

Ortiz M, Martín A, Arribas F, Coll-Vinent B, Del Arco C, Peinado R, Almendral J, & PROCAMIO Study Investigators (2016). Randomized comparison of intravenous procainamide vs. intravenous amiodarone for the acute treatment of tolerated wide QRS tachycardia: the PROCAMIO study. European heart journal PMID: 27354046

Marill KA, deSouza IS, Nishijima DK, Senecal EL, Setnik GS, Stair TO, Ruskin JN, & Ellinor PT (2010). Amiodarone or procainamide for the termination of sustained stable ventricular tachycardia: an historical multicenter comparison. Academic emergency medicine : official journal of the Society for Academic Emergency Medicine, 17 (3), 297-306 PMID: 20370763

Marill KA, deSouza IS, Nishijima DK, Stair TO, Setnik GS, & Ruskin JN (2006). Amiodarone is poorly effective for the acute termination of ventricular tachycardia. Annals of emergency medicine, 47 (3), 217-24 PMID: 16492484

Tomlinson DR, Cherian P, Betts TR, & Bashir Y (2008). Intravenous amiodarone for the pharmacological termination of haemodynamically-tolerated sustained ventricular tachycardia: is bolus dose amiodarone an appropriate first-line treatment? Emergency medicine journal : EMJ, 25 (1), 15-8 PMID: 18156531

Kułakowski P, Karczmarewicz S, Karpiński G, Soszyńska M, & Ceremuzyński L (2000). Effects of intravenous amiodarone on ventricular refractoriness, intraventricular conduction, and ventricular tachycardia induction. Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology, 2 (3), 207-15 PMID: 11227590

Bonny A, De Sisti A, Márquez MF, Megbemado R, Hidden-Lucet F, & Fontaine G (2012). Low doses of intravenous epinephrine for refractory sustained monomorphic ventricular tachycardia. World journal of cardiology, 4 (10), 296-301 PMID: 23110246

Kowey PR (1988). The calamity of cardioversion of conscious patients. The American journal of cardiology, 61 (13), 1106-7 PMID: 3364364

.

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

ResearchBlogging.org
 

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.
 

fire walking 1
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],[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 aren’t 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?
 

Acupuncture versus intravenous morphine in the management of acute pain in the emergency department 1 with caption
 

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

[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

[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

[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

[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 [PubMed – indexed for MEDLINE]

[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

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

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

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

.

Dr. Kudenchuk is Misrepresenting ALPS as ‘Significant’

ResearchBlogging.org
 

The results of ALPS (Amiodarone, Lidocaine, Placebo Study) are clear. There is no statistically significant difference in cardiac arrest outcomes with amiodarone or lidocaine, when compared with placebo.
 

Conclusions Overall, neither amiodarone nor lidocaine resulted in a significantly higher rate of survival or favorable neurologic outcome than the rate with placebo among patients with out-of-hospital cardiac arrest due to initial shock-refractory ventricular fibrillation or pulseless ventricular tachycardia.[1]

 

This study was very well done, but it was not designed to provide valid information about the effects of amiodarone or lidocaine on witnessed arrests or on EMS Witnessed arrests. Maybe the authors were overconfident.

In resuscitation research, we have abundant evidence that overconfidence is much more common than improvements in outcomes. There is no study that has shown an improvement in neurologically intact survival to discharge with any drug. Leaving the hospital with a working brain is the result that matters most to patients. We give drugs because we have too much confidence in the drugs and we are treating our confidence, not because we are doing anything to benefit the patients.
 

I WANT TO BE DECEIVED version of Domenichino, Virgin and Unicorn 1 copy
 

In ALPS there was a subgroup that might have reached statistical significance, but the researchers never determined what would be statistically significant when setting up the study, so these results are merely post hoc data mining (fitting the numbers to allow for a positive spin).

This is the Texas sharpshooter fallacy. The Texas sharpshooter shoots at the side of a barn, then draws targets around the bullet holes so that the the bullet holes are in the bull’s eyes.
 


 

The Texas sharpshooter didn’t shoot at any target, but he went back later and made it look like he hit the center of the target, because he drew the target around the bullet holes. Science requires that we state our hypotheses ahead of time, so that scientists are kept honest. Science requires that we calculate statistical significance ahead of time, especially for secondary outcomes/subgroup analysis, which may mean decreasing the p value to less than 0.03, or to less than 0.01, or even lower to reach statistical significance, so that scientists are kept honest. You are not permitted to bet on the outcome of a horse race that is already in progress for the same reason.

Why do we need to keep scientists honest? Because, as Dr. Peter Kudenchuk unintentionally demonstrates, scientists are just as biased as everyone else. Scientists need to follow the rules of science to minimize the influence of prejudices, such as overconfidence. When scientists do not follow these rules, they are just as easily fooled as everyone else and they may use that self-delusion, and their reputation, to fool others. Dr. Oz makes a fortune telling people what they want to hear about treatments that do not work.

I don’t claim that Dr. Kudenchuk, or even Dr. Oz, is deliberately fooling others, only that they have fooled themselves and are trying to convince others that their prejudices are accurate representations of reality. Here is what Dr. Kudenchuk has been telling people –
 

Researchers have confirmed that certain heart rhythm medications, when given by paramedics to patients with out-of-hospital cardiac arrest who had failed electrical shock treatment, improved likelihood of patients surviving transport to the hospital.[2]

 

The researchers have not confirmed any such thing.

If Dr. Kudenchuk wants to study whether amiodarone or lidocaine or both improve outcomes for witnessed cardiac arrest patients, or for EMS witnessed cardiac arrest patients, he needs to set up a study with all of the criteria for a positive result specified before the start of the study, because this study did not. The study explicitly states this, so Dr. Kudenchuk should be able to just read the study and see that he is wrong. Here is another statement that contradicts the information that was published.
 

Two groups of patients were pre-specified by the study as likely to respond differently to treatment: those with a witnessed cardiac arrest and those with an unwitnessed arrest. When it was originally designed, the study predicted that because patients with witnessed cardiac arrest are recognized and treated sooner, they would more likely be responsive to effective treatments than unwitnessed arrests. When first discovered, patients with an unwitnessed arrest are more likely to have already sustained irreversible organ damage resulting from a longer “down time” and less likely to respond to any treatment. This is precisely what was seen in the study – a statistically significant 5% improvement in survival to hospital discharge in witnessed arrests, and no effect from the drugs in unwitnessed arrests.[3]

 

Why does the published version of the paper contradict Dr. Kudenchuk? One of our biases is to remember things differently from the way things really happened. This is why eyewitness testimony is so often wrong. Here is what the published paper states about the witnessed arrest results.
 

We observed an interaction of treatment with the witnessed status of out-of-hospital cardiac arrest, which is often taken as a surrogate for early recognition of cardiac arrest, a short interval between the patient’s collapse from cardiac arrest and the initiation of treatment, and a greater likelihood of therapeutic responsiveness. Though prespecified, this subgroup analysis was performed in the context of an insignificant difference for the overall analysis, and the P value for heterogeneity in this subgroup analysis was not adjusted for the number of subgroup comparisons. Nonetheless, the suggestion that survival was improved by drug treatment in patients with witnessed out-of-hospital cardiac arrest, without evidence of harm in those with unwitnessed arrest, merits thoughtful consideration.[1]

 

The authors did not adjust the p value, so the authors do not claim that the witnessed cardiac arrest results are statistically significant. They only state that these results merit thoughtful consideration. In other words, if we want to claim this hypothesis is true, we need to set up a study to actually examine this hypothesis.

One earlier study (also by ROC – the Resuscitation Outcomes Consortium) even has similar results.[4],[5] These results are also not statistically significant, but suggest that with larger numbers the results might be significant. So why did the authors set up such a small study? Overconfidence and an apparent lack of familiarity with their own research.
 


 

The Seattle phenomenon (they claim that their resuscitation rate is the highest in America) seems to be due to excellent bystander CPR rates (apparently the highest in America), but that is only good enough for them to be experts on improving bystander CPR rates. The rest is probably due to defibrillation and chest compressions, which are the only prehospital interventions demonstrated to improve neurologically intact survival.

Why does a bystander CPR specialist focus on drugs? Overconfidence and an apparent lack of understanding of the resuscitation research. Dr. Kudenchuk preaches like Timothy Leary about the benefits of drugs and with just as little evidence. We should give appropriate credit for Dr. Kudenchuk’s work on CPR, but we should not mistake that for a thorough understanding of the resuscitation research, even the research with his name attached.
 

A new podcast reviews ALPS. Dominick Walenczak does not notice the mistakes of Dr. Kudenchuk, but he is not one of the researchers, so that is easy to overlook. The rest of the podcast is excellent. Listen to it here.
 

Episode 8: Conquering the ALPS (Study)
CritMedic – Critical Care Paramedicine Podcast
Dominick Walenczak
April 7, 2016
Podcast page
 

Footnotes:

[1] Amiodarone, Lidocaine, or Placebo in Out-of-Hospital Cardiac Arrest.
Kudenchuk PJ, Brown SP, Daya M, Rea T, Nichol G, Morrison LJ, Leroux B, Vaillancourt C, Wittwer L, Callaway CW, Christenson J, Egan D, Ornato JP, Weisfeldt ML, Stiell IG, Idris AH, Aufderheide TP, Dunford JV, Colella MR, Vilke GM, Brienza AM, Desvigne-Nickens P, Gray PC, Gray R, Seals N, Straight R, Dorian P; Resuscitation Outcomes Consortium Investigators.
N Engl J Med. 2016 Apr 4. [Epub ahead of print]
PMID: 27043165

Free Full Text from NEJM

[2] Antiarrhythmic drugs found beneficial when used by EMS treating cardiac arrest
Press release
For Immediate Release:April 4, 2016
NHLBI (National Heart Lung and Blood Institute)
Press release

[3] Dr. Kudenchuk: Study reveals exciting news about cardiac arrest treatment
Lindsay Bosslet
18 hours ago
Public Health Insider
Article

[4] Wide variability in drug use in out-of-hospital cardiac arrest: A report from the resuscitation outcomes consortium.
Glover BM, Brown SP, Morrison L, Davis D, Kudenchuk PJ, Van Ottingham L, Vaillancourt C, Cheskes S, Atkins DL, Dorian P; Resuscitation Outcomes Consortium Investigators.
Resuscitation. 2012 Nov;83(11):1324-30. doi: 10.1016/j.resuscitation.2012.07.008. Epub 2012 Jul 31.
PMID: 22858552 [PubMed – indexed for MEDLINE]

Free Full Text from PubMed Central.

[5] Wide variability in drug use in out-of-hospital cardiac arrest: A report from the resuscitation outcomes consortium – Part I
Mon, 17 Sep 2012
Rogue Medic
Article

 
Kudenchuk, P., Brown, S., Daya, M., Rea, T., Nichol, G., Morrison, L., Leroux, B., Vaillancourt, C., Wittwer, L., Callaway, C., Christenson, J., Egan, D., Ornato, J., Weisfeldt, M., Stiell, I., Idris, A., Aufderheide, T., Dunford, J., Colella, M., Vilke, G., Brienza, A., Desvigne-Nickens, P., Gray, P., Gray, R., Seals, N., Straight, R., & Dorian, P. (2016). Amiodarone, Lidocaine, or Placebo in Out-of-Hospital Cardiac Arrest New England Journal of Medicine DOI: 10.1056/NEJMoa1514204

 

Glover BM, Brown SP, Morrison L, Davis D, Kudenchuk PJ, Van Ottingham L, Vaillancourt C, Cheskes S, Atkins DL, Dorian P, & the Resuscitation Outcomes Consortium Investigators (2012). Wide variability in drug use in out-of-hospital cardiac arrest: A report from the resuscitation outcomes consortium. Resuscitation PMID: 22858552

.