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.

.

In Defense of No Improvement by Medic Madness – Part IV

ResearchBlogging.org
 

Continuing from Part I, Part II, and Part III in response to what I wrote about the failure of the LUCAS,[1] Sean continues with –
 

Another issue I have with this data, is that it doesn’t address the following variables:

  • Down time
  • Whether or not bystander CPR was performed
  • Medications used
  • Whether or not an advanced airway was placed
  • Length of resuscitation

All of these things are important when looking at the effectiveness of the LUCAS. Had all of these cases been witnessed full-arrests with immediate intervention, then I might feel differently. Perhaps they did look at these things, but from the data that’s available to the general public, I can’t determine whether or not the LUCAS doesn’t “do any good”. From what we can see, at the very worst it keeps up with some of the best-trained responders out there. Not bad, if you ask me.[2]

 

Did you look at the paper?

Are you guessing at what the study shows based on intuition?

The information is there. This will be mostly a picture book response.

Down time?

Whether bystander CPR was performed?
 


Click on images to make them larger.[3]
 

Medications used?
 


Study design.[4]
 

In both groups, ventilation and drugs were given according to guidelines.16 [3]

 

There is no breakdown for medications.

Of course, medications have not been demonstrated to improve any outcome that matters.

The best way to determine this would be by –

Length of resuscitation or time to ROSC (Return Of Spontaneous Circulation).?
 


 

Whether an advanced airway was placed?
 


 

This may favor the LUCAS, since airways seem to interfere with survival.

Maybe manual compressions really are not the same during an intubation attempt. Maybe people back off on compressions. Therefore, maybe it is easier to intubate under those circumstances. We do not know. The LUCAS may make intubation more difficult.

Worse CPR may mean better intubation, but since intubation doesn’t improve anything, is that a good compromise?

Which is our no improvement device of choice? 😳
 

Conclusion

We need to be looking at the whole picture here. If we can design a machine to do textbook-perfect CPR, and it doesn’t produce textbook results, then maybe we need to re-evaluate our textbook. Even if the studies do prove that the device isn’t improving survival rates, we still can’t discard the device as “worthless”. It has its place in situations with limited responders. And yes, the data supports that.[2]

 

Why assume that a textbook is right?

How often do I cite any textbook? The only textbook I regularly (and usually negatively) cite is ACLS.

Textbooks tend to be the last to change, but textbooks do change. The change is because research demonstrates that the textbook is wrong and needs to be revised. Textbooks are expected to be revised as we learn more from research.

When you suggest that the research does not confirm the biases of the textbook writers as evidence of a problem with the research, there is the possibility that you are right. This research may be providing evidence that the assumptions of the textbook writers are wrong. The way we find out is by looking closely at the quality of the research and looking at similar research.

However, LINC is good research.
 

Experimental studies with the mechanical chest compression device used in this study have shown improved organ perfusion pressures, enhanced cerebral blood flow, and higher end-tidal CO2 compared with manual CPR, with the latter also supported by clinical data.9- 11 [3]

 

Why is it that improving these surrogate endpoints does not improve what matters – survival? What do we not understand?

We should be more interested in doing no harm.

We seem to be more interested in throwing the kitchen sink at the patient, because what if the arrest is due to a kitchen sink deficiency?
 

Dr. Brooks Walsh also explains the failure of the LUCAS in this study in “We had a LUCAS save!” – No, you didn’t.

Peter Canning describes the failures of judgment in advocating for the LUCAS in Whup Kits and Chihuahuas.

Footnotes:

[1] The Failure of LUCAS to Improve Outcomes in the LINC Trial
Wed, 05 Mar 2014
Rogue Medic
Article

The LUCAS, Research, and Wishful Thinking
Fri, 07 Mar 2014
Rogue Medic
Article

[2] In Defense of the LUCAS
March 12, 2014
by Sean Eddy
Medic Madness
Article

[3] Mechanical chest compressions and simultaneous defibrillation vs conventional cardiopulmonary resuscitation in out-of-hospital cardiac arrest: the LINC randomized trial.
Rubertsson S, Lindgren E, Smekal D, Östlund O, Silfverstolpe J, Lichtveld RA, Boomars R, Ahlstedt B, Skoog G, Kastberg R, Halliwell D, Box M, Herlitz J, Karlsten R.
JAMA. 2014 Jan 1;311(1):53-61. doi: 10.1001/jama.2013.282538.
PMID: 24240611 [PubMed – indexed for MEDLINE]

Free Full Text in PDF Download format from PEHSC.org.

[4] The study protocol for the LINC (LUCAS in cardiac arrest) study: a study comparing conventional adult out-of-hospital cardiopulmonary resuscitation with a concept with mechanical chest compressions and simultaneous defibrillation.
Rubertsson S, Silfverstolpe J, Rehn L, Nyman T, Lichtveld R, Boomars R, Bruins W, Ahlstedt B, Puggioli H, Lindgren E, Smekal D, Skoog G, Kastberg R, Lindblad A, Halliwell D, Box M, Arnwald F, Hardig BM, Chamberlain D, Herlitz J, Karlsten R.
Scand J Trauma Resusc Emerg Med. 2013 Jan 25;21:5. doi: 10.1186/1757-7241-21-5.
PMID: 23351178 [PubMed – indexed for MEDLINE]

Free Full Text from PubMed Central.

Rubertsson S, Lindgren E, Smekal D, Östlund O, Silfverstolpe J, Lichtveld RA, Boomars R, Ahlstedt B, Skoog G, Kastberg R, Halliwell D, Box M, Herlitz J, & Karlsten R (2014). Mechanical chest compressions and simultaneous defibrillation vs conventional cardiopulmonary resuscitation in out-of-hospital cardiac arrest: the LINC randomized trial. JAMA : the journal of the American Medical Association, 311 (1), 53-61 PMID: 24240611

Rubertsson S, Silfverstolpe J, Rehn L, Nyman T, Lichtveld R, Boomars R, Bruins W, Ahlstedt B, Puggioli H, Lindgren E, Smekal D, Skoog G, Kastberg R, Lindblad A, Halliwell D, Box M, Arnwald F, Hardig BM, Chamberlain D, Herlitz J, & Karlsten R (2013). The study protocol for the LINC (LUCAS in cardiac arrest) study: a study comparing conventional adult out-of-hospital cardiopulmonary resuscitation with a concept with mechanical chest compressions and simultaneous defibrillation. Scandinavian journal of trauma, resuscitation and emergency medicine, 21 PMID: 23351178
.

In Defense of No Improvement by Medic Madness – Part III

ResearchBlogging.org
 

Continuing from Part I and Part II, in response to what I wrote about the failure of the LUCAS,[1] Sean continues with –
 

So do these results reflect on a device that’s over-hyped, or are we missing something in our current CPR guidelines? Keep in mind that this study involved highly trained and prepared responders using the most up-to-date recommendations for CPR delivery. We developed a machine to do exactly what we tell it to. It follows the guidelines exactly as we want, and yet, it can’t produce the results we hoped for. Perhaps the machine isn’t the problem.[2]

 

Maybe the machine was never the answer.
 

In clinical practice, mechanical CPR using the presented algorithm did not result in improved effectiveness compared with manual CPR.[3]

 

This is probably just a reflection of how little we understand of what we are doing.

Everything we do in EMS, and especially in resuscitation, is over-hyped.

If our worry is that we will look like we are not doing enough, then open heart cardiac massage can make it clear that we are doing a lot.[4]   😯
 

Image credit.
 

How many survival studies do we have that randomize patients between a placebo and a vasopressor treatment?

For epinephrine (Adrenaline), vasopressin, norepinephrine (Levophed), or phenylephrine (Neo-Synephrine)?[5]

Here is the evidence of of what happens to survival with epinephrine.[6] I added the two most recent studies.[7],[8] There are no positive epinephrine studies.
 

 

Epinephrine may turn out to be beneficial for some subset of patients, but it is unlikely that epinephrine is beneficial just because the patient remains dead long enough to be given a drug.

A mnemonic for teaching ACLS is – Everybody dead gets epi, because current ACLS (Advanced Cardiac Life Support) guidelines tell us to give epinephrine (or norepinephrine, or vasopressin, or phenylephrine) to all patients who remain dead long enough to be given a drug.

Got a dead patient and can’t think of what to do next? Give epi.

What are we going to do, poison them? Our first dose was so far above the therapeutic range, that it would be considered poisonous if the patient were not already dead.

Vasopressors produce just as much no improvement as a LUCAS.
 

How many survival studies do we have that randomize patients between a placebo and an antiarrhythmic active treatment in cardiac arrest?

Foe amiodarone (Cordarone), lidocaine (Xylocaine), procainamide (Procaine), and magnesium?[9]

In two studies of magnesium, there was no improvement in survival vs. placebo.[10],[11]

In one study of amiodarone, there was improvement in everything except survival to discharge – more patients were resuscitated, but they died in the hospital.[12]

Antiarrhythmics produce just as much no improvement as a LUCAS.
 

There have been other studies of vasopressors and of antiarrhythmics against other unknowns, but does a positive outcome against a different unknown mean more beneficial than the other unknown or just less harmful than the other unknown?

We are aren’t even using Schrödinger’s treatments, because we don’t know if a good outcome means that the patient is surviving because of what we are doing or surviving in spite of what we are doing. We appear to be just happy to be doing something.

Still, we insist on giving these treatments, because we are afraid of doing too little.

We don’t know enough to know what too little is, but it is our fear of doing too little that keeps us from learning what works.

While this is not Sean’s fault, he is aggressively advocating for more of the status quo – the dramatic lack of improvement that we expect from EMS treatments.
 

The LUCAS failed – unless our idea of success is to make no difference in outcomes, because improving resuscitation outcomes is not really our goal.

EMS – we improve nothing more expensively, more dramatically, and more consistently than anyone else!
 

I look at the flawed claims of flaws in the paper in Part IV.

Dr. Brooks Walsh also explains the failure of the LUCAS in this study in “We had a LUCAS save!” – No, you didn’t.

Peter Canning describes the failures of judgment in advocating for the LUCAS in Whup Kits and Chihuahuas.

Footnotes:

[1] The Failure of LUCAS to Improve Outcomes in the LINC Trial
Wed, 05 Mar 2014
Rogue Medic
Article

The LUCAS, Research, and Wishful Thinking
Fri, 07 Mar 2014
Rogue Medic
Article

[2] In Defense of the LUCAS
March 12, 2014
by Sean Eddy
Medic Madness
Article

[3] Mechanical chest compressions and simultaneous defibrillation vs conventional cardiopulmonary resuscitation in out-of-hospital cardiac arrest: the LINC randomized trial.
Rubertsson S, Lindgren E, Smekal D, Östlund O, Silfverstolpe J, Lichtveld RA, Boomars R, Ahlstedt B, Skoog G, Kastberg R, Halliwell D, Box M, Herlitz J, Karlsten R.
JAMA. 2014 Jan 1;311(1):53-61. doi: 10.1001/jama.2013.282538.
PMID: 24240611 [PubMed – indexed for MEDLINE]

Free Full Text in PDF Download format from PEHSC.org.

[4] A Resuscitation Question So Obvious That . . . .
Sun, 19 Jan 2014
Rogue Medic
Article

[5] Vasopressors
2010 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science
Part 8: Adult Advanced Cardiovascular Life Support
Part 8.2: Management of Cardiac Arrest
Medications for Arrest Rhythms
Free Full Text from Circulation with link to PDF Download

[6] 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.

[7] 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.

[8] 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.

[9] Antiarrhythmics
2010 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science
Part 8: Adult Advanced Cardiovascular Life Support
Part 8.2: Management of Cardiac Arrest
Medications for Arrest Rhythms
Free Full Text from Circulation with link to PDF Download

[10] Randomised trial of magnesium in in-hospital cardiac arrest. Duke Internal Medicine Housestaff.
Thel MC, Armstrong AL, McNulty SE, Califf RM, O’Connor CM.
Lancet. 1997 Nov 1;350(9087):1272-6.
PMID: 9357406 [PubMed – indexed for MEDLINE]

[11] Magnesium sulfate in the treatment of refractory ventricular fibrillation in the prehospital setting.
Allegra J, Lavery R, Cody R, Birnbaum G, Brennan J, Hartman A, Horowitz M, Nashed A, Yablonski M.
Resuscitation. 2001 Jun;49(3):245-9.
PMID: 11719117 [PubMed – indexed for MEDLINE]

[12] Amiodarone for resuscitation after out-of-hospital cardiac arrest due to ventricular fibrillation.
Kudenchuk PJ, Cobb LA, Copass MK, Cummins RO, Doherty AM, Fahrenbruch CE, Hallstrom AP, Murray WA, Olsufka M, Walsh T.
N Engl J Med. 1999 Sep 16;341(12):871-8.
PMID: 10486418 [PubMed – indexed for MEDLINE]

Free Full Text from New England Journal of Medicine.

Rubertsson S, Lindgren E, Smekal D, Östlund O, Silfverstolpe J, Lichtveld RA, Boomars R, Ahlstedt B, Skoog G, Kastberg R, Halliwell D, Box M, Herlitz J, & Karlsten R (2014). Mechanical chest compressions and simultaneous defibrillation vs conventional cardiopulmonary resuscitation in out-of-hospital cardiac arrest: the LINC randomized trial. JAMA : the journal of the American Medical Association, 311 (1), 53-61 PMID: 24240611

Larabee TM, Liu KY, Campbell JA, & Little CM (2012). Vasopressors in cardiac arrest: a systematic review. Resuscitation, 83 (8), 932-9 PMID: 22425731

Hagihara A, Hasegawa M, Abe T, Nagata T, Wakata Y, & Miyazaki S (2012). Prehospital epinephrine use and survival among patients with out-of-hospital cardiac arrest. JAMA : the journal of the American Medical Association, 307 (11), 1161-8 PMID: 22436956

Hayashi Y, Iwami T, Kitamura T, Nishiuchi T, Kajino K, Sakai T, Nishiyama C, Nitta M, Hiraide A, & Kai T (2012). Impact of early intravenous epinephrine administration on outcomes following out-of-hospital cardiac arrest. Circulation journal : official journal of the Japanese Circulation Society, 76 (7), 1639-45 PMID: 22481099

Thel MC, Armstrong AL, McNulty SE, Califf RM, & O’Connor CM (1997). Randomised trial of magnesium in in-hospital cardiac arrest. Duke Internal Medicine Housestaff. Lancet, 350 (9087), 1272-6 PMID: 9357406

Allegra J, Lavery R, Cody R, Birnbaum G, Brennan J, Hartman A, Horowitz M, Nashed A, & Yablonski M (2001). Magnesium sulfate in the treatment of refractory ventricular fibrillation in the prehospital setting. Resuscitation, 49 (3), 245-9 PMID: 11719117

Kudenchuk PJ, Cobb LA, Copass MK, Cummins RO, Doherty AM, Fahrenbruch CE, Hallstrom AP, Murray WA, Olsufka M, & Walsh T (1999). Amiodarone for resuscitation after out-of-hospital cardiac arrest due to ventricular fibrillation. The New England journal of medicine, 341 (12), 871-8 PMID: 10486418

.

$16M on EMS Stroke Trial? Dr. Rick Bukata Wants His Money Back!


 

FAST-MAG[1] actually has good methodology, so why is Dr. Rick Bukata so upset? Is this just USC vs. UCLA off the field/court?

Should the hypothesis being tested have received the Queen for a Decade treatment?

He wants his money back? Roughly 160 million tax payers in the US, so $0.10 per tax payer, but he makes more than the average schlub, so maybe as much as 50 cents for him. He can’t even buy enough caffeine to raise his blood pressure with that.
 

In a commentary regarding the IMAGES trial by Larry Goldstein of the Duke Center for Cerebrovascular Disease in the same issue of the Lancet in which the study was published, he noted that of more than 40 clinical trials of “neuroprotectants” involving over 11,000 patients, none has shown any evidence of benefit. Ten years later, the same is true.[2]

 

But look at the animal studies!

But look at the time being saved!

The authors actually like to repeat the term Golden Hour – as if that is new or valid.
 

So, if you are still a believer in the potential of magnesium, why not try and give magnesium in a pilot clinical study involving stroke patients in the ED? It would have been a relatively simple study to do. It could have been performed in selected EDs throughout the country and the answer would have been established in a fraction of eight years and at a very small fraction of $16 million.

Instead, the Fast-Mag investigators decide that giving magnesium in the field (probably about 10-20 minutes faster than could be given in the ED) would be a reasonable study.[2]

 

Gosh, when he brings reason into the argument, it just seems that the other side has none.

What could the money have been spent on?

Epinephrine vs. placebo in cardiac arrest? The number of lives affected is large and we are currently treating based on philosophy, not science.

IV (IntraVenous) bolus NTG (NiTroGlycerin – GTN GlycerylTriNitrate in Commonwealth countries) vs. SL (SubLingual) NTG for acute CHF (Congestive Heart Failure)? This affects even more patients than cardiac arrest and there is good evidence that IV bolus NTG dramatically improves outcomes, while SL NTG is not based on evidence.

Excited delirium treatment with various IM (IntraMuscular) medications to see what is safest and most effective and at what dose. A large trial would be necessary.

With no good reason to be optimistic about outcomes, why take this multimillion dollar long shot?

Maybe it has to do with tPA (tissue Plasminogen Activator) and the failure to get emergency physicians to accept the poor research on tPA – tPA showed harm, or no benefit, in 9 out of 11 studies.[3]

Ironically, if those studies used methodology similar to this study, that could be showed harm, or no benefit, in 11 out of 11 studies.

Dr. Jeffrey L. Saver, one of the authors, has a presentation on FAST-MAG that spends a lot of time on tPA, even prehospital tPA.

What does Dr. Sarver consider to be positive about FAST-MAG? Here are some of his slides.[4]
 


 

FAST-MAG means more tPA use.
 


 

FAST-MAG means doing a lot of things that have not been done before and expecting the outcome to be good.

This is the kind of person who starts turning all of the dials on a ventilator and then looks at the patient to see what the result is.

A reasonable approach to research is to limit variables, not brag about how much prudence has been abandoned.
 


 

FAST-MAG means time will be saved, but . . . .
 

Walter Koroshetz, MD, neurologist and deputy director of the National Institutes of Health’s (NIH’s) National Institute of Neurological Disorders and Stroke, sponsor of the FAST-MAG study, says that lessons can be learned from the trial.[5]

 

“The NIH have a new network to do more prehospital trials, but we need phase 2 studies first that demonstrate some biological effect before going into a large costly phase 3 trials.”[5]

 

This is a $16 million bet that time is the only factor that matters.

I hope these doctors do not drive the way they gamble.

What were the results?

The results were the same as all of the previous studies of magnesium – no improvement.

There is no Magnesium Golden Hour.
 

And, please, no – don’t even consider the idea of giving tPA in the field.[2]

 

Well, . . . .
 

Dr. Saver explained that tPA cannot be given at present in a prehospital setting because hemorrhagic stroke has to be ruled out with computed tomography (CT). The use of ambulances with a CT scanner on board has been studied in Germany and is now starting to be tested in the United States.[5]

 

Be very afraid.

On the other hand, the authors did not rush this treatment into EMS protocols, as we recently have in EMS in so many places with therapeutic hypothermia, based entirely on research done in the ED (Emergency Department). It works in the ED, but not in the ambulance. 😳

FAST-MAG was approved in 1999, several years after the EMS nifedipine (Procardia) for hypertensive crisis crisis. There was no study in the EMS setting of a treatment for the EMS setting. This involved treatment of the surrogate endpoint of blood pressure numbers, which makes for an easy win, such as a systolic drop of 250 -> 90 in ten minutes. 😳

We need a balance between rushing to add the new cool treatment (and the predictable removal of the treatment decades later) and the inappropriate rush to a large scale trial of something that has repeatedly failed smaller studies.
 

Go read Dr. Bukata’s full article.

Footnotes:

[1] Methodology of the Field Administration of Stroke Therapy – Magnesium (FAST-MAG) phase 3 trial: Part 2 – prehospital study methods.
Saver JL, Starkman S, Eckstein M, Stratton S, Pratt F, Hamilton S, Conwit R, Liebeskind DS, Sung G, Sanossian N; FAST-MAG Investigators and Coordinators.
Int J Stroke. 2014 Feb;9(2):220-5. doi: 10.1111/ijs.12242.
PMID: 24444117 [PubMed – in process]

Methodology of the Field Administration of Stroke Therapy – Magnesium (FAST-MAG) phase 3 trial: Part 1 – rationale and general methods.
Saver JL, Starkman S, Eckstein M, Stratton S, Pratt F, Hamilton S, Conwit R, Liebeskind DS, Sung G, Sanossian N; FAST-MAG Investigators and Coordinators.
Int J Stroke. 2014 Feb;9(2):215-9. doi: 10.1111/ijs.12243. Epub 2014 Jan 13.
PMID: 24444116 [PubMed – in process]

[2] $16M on EMS Stroke Trial? I Want My Money Back!
by Rick Bukata, MD
March 24, 2014
Emergency Physicians monthly
Article

[3] The Guideline, The Science, and The Gap
Wednesday, April 17, 2013
Dr. David Newman
Smart EM
Article

[4] Treat Stroke in the Field:
Lessons from the NIH FAST-MAG Trial

Jeffrey L. Saver, MD, Professor of Neurology
UCLA Stroke Center
2012
Presentation Slides in PDF Downoad format.

[5] FAST-MAG: No Benefit of Prehospital Magnesium in Stroke
Sue Hughes
February 14, 2014
Medscape
Article

.

In Defense of No Improvement by Medic Madness – Part II

 

Continuing from Part I, in response to what I wrote about the failure of the LUCAS,[1] Sean continues with –
 

No, there isn’t much data to suggest that using a LUCAS improves outcomes. Likewise, we aren’t discovering that it’s hurting people either. So at the very worst, it’s a luxury item.[2]

 

No.

I am critical of treatments that do not work. Once we start making excuses to use these treatments, we take decades to get rid of them.
 

No difference in survival or neurological outcome was seen for up to 6 months after the cardiac arrest as, by then, the vast majority of survivors had CPC scores of 1 or 2, and most patients with initial CPC scores of 3 or 4 had either improved or died. The numbers of serious adverse events and device-related adverse events were low.[3]

 

The LUCAS failed.

Unless your idea of success is to make no difference in outcomes, because improving resuscitation outcomes is not important.
 

Moving out of the big city and going to work in an area that utilizes volunteers as first-responders means that I often find myself working a resuscitation with just me and my partner. If – and I emphasize the word “if” – we happen to get first-responders to these calls, we still have no idea what kind of training or experience they have.[2]

 

The LUCAS as an excuse to tolerate incompetence.

Over, and over, and over, . . . this has been the main argument for the LUCAS.

We can’t expect EMS to perform high quality CPR.

We are too busy doing other things that do not improve outcomes to make sure that compressions are done well.

There are only two things that a paramedic needs to make sure are done well – compressions and defibrillation.

What do paramedics want to do?

We want to do things that do not improve outcomes, because we do not understand what we are doing and are easily distracted by shiny things. Maybe they can put a flashing light on the LUCAS, or give out badges with each use, and raise the price by $5,000 $10,000.
 


Rather than courage, we can award a LUCAS Save! medal – a shiny one.
 

If I am to take Sean seriously, perhaps it will be because he has taken the same argument against intubation and advocated for protecting patients from incompetent EMS by replacing endotracheal tubes with almost foolproof LMAs (Laryngeal Mask Airways).

More consistent, frees up a set of hands, probably less liability, . . . .

What?

Sean hasn’t applied the same logic to intubation in cardiac arrest?

I am shocked. 😯
 

I too have been a volunteer and I know the value of the care they provide. Having said that, it’s hard to get strict on training when they are already going out of their way to provide service to their community.[2]

 

I don’t blame the volunteer for the quality of care they provide when working with a paramedic right there.

I blame the paramedic.

It is my job to make sure that what is going on is done well. Compressions and defibrillation are all that matter. If I can’t manage that, intubation is definitely beyond my capabilities.
 

What’s the harm of treatments that do not improve outcomes alternative medicine?

I look at the criticisms of the actual research in Part III and Part IV.

Dr. Brooks Walsh also explains the failure of the LUCAS in this study in “We had a LUCAS save!” – No, you didn’t.

Peter Canning describes the failures of judgment in advocating for the LUCAS in Whup Kits and Chihuahuas.

Footnotes:

[1] The Failure of LUCAS to Improve Outcomes in the LINC Trial
Wed, 05 Mar 2014
Rogue Medic
Article

The LUCAS, Research, and Wishful Thinking
Fri, 07 Mar 2014
Rogue Medic
Article

[2] In Defense of the LUCAS
March 12, 2014
by Sean Eddy
Medic Madness
Article

[3] Mechanical chest compressions and simultaneous defibrillation vs conventional cardiopulmonary resuscitation in out-of-hospital cardiac arrest: the LINC randomized trial.
Rubertsson S, Lindgren E, Smekal D, Östlund O, Silfverstolpe J, Lichtveld RA, Boomars R, Ahlstedt B, Skoog G, Kastberg R, Halliwell D, Box M, Herlitz J, Karlsten R.
JAMA. 2014 Jan 1;311(1):53-61. doi: 10.1001/jama.2013.282538.
PMID: 24240611 [PubMed – indexed for MEDLINE]

Free Full Text in PDF Download format from PEHSC.org.

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In Defense of No Improvement by Medic Madness – Part I

 

I wrote about treatment with the LUCAS CPR machine and stated that There is no price that justifies no improvement.[1]

There are plenty people who want to justify the use of placebo treatments – treatments that do not improve outcomes. Here is one –
 

Before writing this response, I took some time to examine the equipment I use on a daily basis. Needless to say, I was shocked to discover that we spend a lot of money of items that really don’t improve patient outcomes at all. One example is the Stryker Power Cot.[2]

 

The LUCAS is a treatment that is a potential substitute for manual chest compressions.

The selling point was supposed to be that the LUCAS improves outcomes – survival with a working brain – that is the whole purpose of the research I have been writing about.
 

Thus, in clinical practice, CPR with this mechanical device using the presented algorithm can be delivered without major complications but did not result in improved outcomes compared with manual chest compressions.[3]

 

The LUCAS failed.

However, Sean is taking my statement about the outcome of a treatment and applying it to the choice of equipment.

Does a power stretcher improve the survival of patients?
 


 

I do not know of any studies that examine this question, but the stretcher is not used as a treatment. The stretcher is used as a means of moving the patient.

What Sean appears to be asking is – since I am going to use a stretcher (is there any state that does not require a stretcher in an ambulance), shouldn’t I use the cheapest stretcher that meets the requirements? Or am I going to base my decision on something other than outcomes?

Is the choice to pay more for a power stretcher based on the outcomes of patients?
 

Although I tried, I couldn’t find any studies that compared patient outcomes to those transported using a manual cot.[2]

 

It is not based on the outcomes of patients, but the choice is based on outcomes.

In a study comparing the injury rate among FTEs (Full-Time Employees), the rate of injury was cut in half after the introduction of a powered stretcher.[4]

Maybe EMS should not consider the outcomes for employees when making decisions?

What is Sean’s next gotcha?
 

Another major purchase was the LifePak 15 ECG monitor / defibrillator. Once again, I couldn’t find anything showing improved patient outcomes.[2]

 

Sean couldn’t find any evidence that waveform capnography improves outcomes for patients?[5] 🙁

Sean couldn’t find any evidence that an EMS 12 lead ECG (ElectroCardioGram) improves outcomes for patients?[6] 😳

Sean couldn’t find any evidence that EMS defibrillation improve outcomes for patients?[7] 😯

Perhaps Sean works in a state that does not require a defibrillator, 12 lead capability, and/or waveform capnography as minimum paramedic equipment and thinks these are just fun to have toys.

Sean appears to be suggesting that the choice of brand and options, except as mandated by EMS regulatory organizations, must be limited to the cheapest available item. Otherwise, I am misleading people by stating – There is no price that justifies no improvement.

Should I be worried at Sean’s failure to find the valid evidence, when I only provided a small sample of the valid evidence?

Does this affect Sean’s argument? The argument is really just a bait and switch – a logical fallacy known as a straw man.[8] I wrote about one thing and Sean represented my argument as something else, because he has an argument against the argument I did not make. However, his argument does not address the claim I actually did make.
 

That is not the only argument Sean makes. I address the rest in Part II, Part III, and Part IV.

Dr. Brooks Walsh also explains the failure of the LUCAS in this study in “We had a LUCAS save!” – No, you didn’t.

Footnotes:

[1] The Failure of LUCAS to Improve Outcomes in the LINC Trial
Wed, 05 Mar 2014
Rogue Medic
Article

The LUCAS, Research, and Wishful Thinking
Fri, 07 Mar 2014
Rogue Medic
Article

[2] In Defense of the LUCAS
March 12, 2014
by Sean Eddy
Medic Madness
Article

[3] Mechanical chest compressions and simultaneous defibrillation vs conventional cardiopulmonary resuscitation in out-of-hospital cardiac arrest: the LINC randomized trial.
Rubertsson S, Lindgren E, Smekal D, Östlund O, Silfverstolpe J, Lichtveld RA, Boomars R, Ahlstedt B, Skoog G, Kastberg R, Halliwell D, Box M, Herlitz J, Karlsten R.
JAMA. 2014 Jan 1;311(1):53-61. doi: 10.1001/jama.2013.282538.
PMID: 24240611 [PubMed – indexed for MEDLINE]

Free Full Text in PDF Download format from PEHSC.org.

[4] Evaluation of occupational injuries in an urban emergency medical services system before and after implementation of electrically powered stretchers.
Studnek JR, Mac Crawford J, Fernandez AR.
Appl Ergon. 2012 Jan;43(1):198-202. doi: 10.1016/j.apergo.2011.05.001. Epub 2011 May 31.
PMID: 21632034 [PubMed – indexed for MEDLINE]

[5] The effectiveness of out-of-hospital use of continuous end-tidal carbon dioxide monitoring on the rate of unrecognized misplaced intubation within a regional emergency medical services system.
Silvestri S, Ralls GA, Krauss B, Thundiyil J, Rothrock SG, Senn A, Carter E, Falk J.
Ann Emerg Med. 2005 May;45(5):497-503.
PMID: 15855946 [PubMed – indexed for MEDLINE]

[6] Effect of prehospital triage on revascularization times, left ventricular function, and survival in patients with ST-elevation myocardial infarction.
Sivagangabalan G, Ong AT, Narayan A, Sadick N, Hansen PS, Nelson GC, Flynn M, Ross DL, Boyages SC, Kovoor P.
Am J Cardiol. 2009 Apr 1;103(7):907-12. doi: 10.1016/j.amjcard.2008.12.007. Epub 2009 Feb 7.
PMID: 19327414 [PubMed – indexed for MEDLINE]

[7] Treatment of out-of-hospital cardiac arrests with rapid defibrillation by emergency medical technicians.
Eisenberg MS, Copass MK, Hallstrom AP, Blake B, Bergner L, Short FA, Cobb LA.
N Engl J Med. 1980 Jun 19;302(25):1379-83.
PMID: 7374695 [PubMed – indexed for MEDLINE]

[8] Straw man
Wikipedia
Article

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Backboards, Evidence and EMS Pay – EMS Office Hours Rapid Fire September 2013


 

On this week’s EMS Office Hours, Jim Hoffman, Josh Knapp, and I discuss EMS pay, reimbursement for patient care, and some topics covered last week at EMS Expo in Las Vegas (the absence of evidence of any benefit from strapping people to backboards, the value of research, and continuing anti-evidence attitude of many in EMS. We even discussed why acupuncture is just a fancy placebo with a lot of hand waving and poking.
 

Backboards, Evidence and EMS Pay | Rapid Fire September 2013
 

Why do we use backboards?

Because we don’t know what we are doing and we are afraid to find out how much harm we may be doing.

Dr. Bryan Bledsoe had a great presentation The Painful Truth About Backboards, that I will cover in more detail next week.

We continue to use a flat piece of plastic/wood to try to stabilize a series of over 30 articulated bones.

We claim that the solution is to pad the voids.

We need to focus on doing what’s best for the patient, rather than trying to defend an antiquated, inefficient, traditional practice that is harmful.

Why are we defending harming our patients?

Where is the evidence of benefit?
 

Evidence in EMS was also covered.

Other evidence-based presentations were by Dr. Jeff Beeson (Developing Evidence-Based Protocols), Baxter Larmon (Evidence-Based Medicine in Education), Raphael Barishansky (Are You Ready for the Next Pandemic?), Dr. Peter Antevy (Pediatric Refusals Gone Wrong), Dr. Paul Pepe (Sweet Spots, Snappy Concepts & Stutter CPR), Greg Friese (Distraction is Deadly), and the keynote presentation was The Evolution of Battlefield Medical Care by Lt. Col. Robert L. Mabry, MD, FACEP. I will write about most of these as well.

The premiere of the movie Paramedico – Around the World by Ambulance was at EMS Expo. The movie is based on the book by Benjamin Gilmour, a paramedic from Australia who filmed EMS care in a variety of places around the world. The full movie is available on line at the following link –

http://paramedico.com.au/film.html

 

 

Why do we use evidence?

Wrong question.

Why do so many of us assume that we know it all and that we cannot learn from unbiased examinations of what we do?

The part we do not seem to like is the unbiased part. We want science to confirm our biases, but the bias of science is reality.

Reality does not care what our biases are.

Too many of us think that science has to be pleasant, or that it is impolite to point out to anti-science people that they are wrong. Intentional ignorance does not deserve any respect, but intentional ignorance still is powerful in EMS.
 

Go listen to the podcast.
 

We also discussed the scams of homeopathy and acupuncture. They are just placebos. We should save our money and use treatments that work better than placebos.[1],[2],[3],

Footnotes:

[1] 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.
PMID: 19433697 [PubMed – in process]

Free Full text from PubMed Central.

Real acupuncture was not any better than fake acupuncture.

[2] 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]

The fake acupuncture was significantly more effective than real acupuncture and better than individualized expert acupuncture.

[3] Is Alternative Medicine Really ‘Medicine’? – Part I
Sun, 28 Jul 2013
Rogue Medic
Article

[4] Homeopathy: what does the “best” evidence tell us?
Ernst E.
Med J Aust. 2010 Apr 19;192(8):458-60. Review.
PMID: 20402610 [PubMed – indexed for MEDLINE]
 

In conclusion, the most reliable evidence — that produced by Cochrane reviews — fails to demonstrate that homeopathic medicines have effects beyond placebo.

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Placebo vs Belief vs Neither – Part III

In response to Placebo vs Belief vs Neither – Part II is this comment from Brian Kellett of Brian Kellett (dot) net and the author behind Random Acts of Reality

All fair enough, and I agree with you completely, however my immediate ‘devil’s advocate’ thought on this (and after too many too long shifts with not enough sleep and I really need to go to bed now…)

Mental stress can make illness worse or prolong recovery – isn’t that an accepted case?

This is true.

Failure to thrive is an excellent example of mental stress producing harm.

Vitamin deficiency can cause problems, but an excess of vitamins does not ward off problems, even though quack like Gary Null preach that this is so. Vitamin excesses can be poisonous, as Gary Null demonstrated when he consumed massive quantities of his Vitamin product.

Electrolyte deficiencies can cause problems, but large doses of electrolytes also cause problems and large doses of some electrolytes will cause deficiencies of other electrolytes. The chemical used to execute people in Texas is potassium – an electrolyte that naturally occurs in the body. Too much can kill you. Too little can kill you. The other chemicals used in executions in Texas are a sedative and a paralytic, but the potassium kills you long before the others would.

Stress (the body’s release of epinephrine, cortisol, and other stress chemicals) can make things worse. Decreased stress can make things better. So is this a case of a placebo helping or just a case of distracting the person from the stressful mental state that is harmful?

I think that the most important thing that I can do as a paramedic is to calm everyone down – everyone, not just the patient.

Less important than calming everyone down is the medical treatment that will be documented.

Does that mean that relaxation cures things other than stress? Vagal stimulus can break an SVT (SupraVentricular Tachycardia). The Vagus nerve is the nerve that slows things down and promotes relaxation. There are probably many other things that are improved by decreasing stress. Some conditions may also be improved by increasing relaxation.

Is this the mind doing anything medical? I don’t know of anything other than some isolated examples of specific benefits, such as relaxation for pain relief. The mind does seem to release endorphins, but does that mean that the mind is capable of releasing chemicals to treat more than just a few conditions?

There also appears to be a placebo response that affects inflammation. Rashes can appear with no apparent cause and go away with no apparent cause.

Fever seems to be good for treating some infections, but fever is almost the opposite of relaxation. Are the number of cases of relaxation being as problem significant? Are the cases of problematic relaxation more likely to be fatal? Too much vagal stimulus may lead to a need for a pacemaker in order to produce cardiac output sufficient to avoid death.

Part of the automatic treatment of asystole was atropine – an anti-vagal drug. I think that one of the reasons that it was removed from the asystole algorithm (and from PEA [Pulseless Electrical Activity] slower than 60 beats per minute) was not that vagal stimulus cannot kill, but that an anti-vagal drug adds noting when it is given after the main stress chemical – epinephrine.

and

People who have car vs car accidents, isn’t there some research about how their whiplash/neck pain gets better quicker if the other driver is insured?
(I think it may have been a study involving Lithuainian drivers – I cannot recall).

I have not been keeping up to date with Lithuanian whiplash studies.

Which might lead one to believe that a patient’s state of mind can have an effect on their health and healing.

It probably does have an effect. We should not be moping like Eeyore, but shouldn’t conventional medicine be trying to get doctors to improve their bedside manner, rather than looking for “alternative” medicine to make up for a bad bedside manner? Doctors should try to put patients at ease, even when delivering distressing news – especially when delivering distressing news.

We need to better understand the placebo effect, not endorse possible placebo treatments just because they might produce a placebo effect. Bernie Madoff was selling placebo stock returns, but we aren’t suggesting that the solution to market problems is more placebo returns. Investors sure did feel good seeing those impressive numbers (positive mental state), but the problem is that financial returns do not always respond to positive mental outlook. The Secret by Rhonda Byrne would be more appropriately named The Scam.

There can be a benefit from placebo, but do we want to ignore the harms from placebo?

What if the illness I have is not the stuff that benefits from placebo?

The things that tend to benefit most from placebo are the things that are made worse by increased stress. When someone comes in with a vague sense of unease or a touch of the nerves or even just more money than sense, placebo is there for them.

[youtube]HMGIbOGu8q0[/youtube]

We do not know how best use placebos to ethically treat patients.

We do not know how best use placebos to medically treat patients.

We don’t know how best to produce a placebo response. A shaman dancing in a headdress claiming to use the Power of God to heal the sick, an acupuncturist claiming to use the Power of Qi to heal the sick (jabbing magic qi points that don’t work any better than the fake qi points), a preacher claiming to use the Power of God to heal the sick, anyone claiming to use the Power of the Mind to heal the sick? What about massage from a prostitute? What about smoking marijuana? What about listening to a soothing speech by a politician? What about smoking a cigarette and/or drinking a shot of whiskey? What about drinking a cup of tea?

The most ethical of these may be the ones that are illegal.

What about when the patient has an illness that will not respond to placebo?

 

Does the shaman admit that the voodoo is not working and refer the patient for a real medical examination, or does the placeboist claim that the problem is just a lack of faith, or a lack of worthiness, or that when the patient has endured enough – then the magic will kick in?

Tough it out?

Even though the response of cancers to chemotherapy has been continually improving, in some cases producing over 95% recovery, people still claim that chemotherapy is evil.

Even though the response of cancers to placebo is probably zero and delays the treatment with real effective medicine, people still try alternative placebo medicine. Maybe they will be lucky and the cancer will be a misdiagnosis or a self-limiting cancer. Is there any benefit from placebo in cancer?

How do we get the benefit from placebo, while avoiding the harms from placebo?

One example of the harm of real placebo effect is probably the inability of getting aggressive orders for pain management, because many doctors/nurses/medics do not see pain as a real problem. Pain is not objective. A 5/10 for you may be an 8/10 for me, while the same sensation in another person is a 3/10. I do try to distract my patients from their pain. Some only receive distraction from me. Others receive whatever pain medicine it takes to get them to answer No to the question Do you want any more pain medicine? Sometimes we never get the patient there for a variety of reasons. One reason is the artificial maximum doses of pain medicines and the requirement of medical command permission to go beyond those doses.

We become ecstatic over improvements in surrogate end points and rush to make treatments the Standard of Care long before we know if these treatments are dangerous.

We need to learn what we are doing before we start prescribing anything – not just placebo.

Is there anything wrong with kissing an injury to make it better?

Do we recognize when there is a serious injury/illness early enough and go to real doctors?

Do we ridicule the insane things, like homeopathic malaria prevention?

Even ignoring the nocebo effect, a placebo can lead to as much harm as any real medicine, so a placebo should not be treated as benign.

(Of course I may have completely misread your post – my brain is a bit like porridge at the moment)

The evidence for Porridge Power is irrefutable. We should put it in the drinking water.

.