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

- Rogue Medic

Answer to What is this Dangerous Treatment and How Long Did it Take to Stop Using it

Earlier I wrote What is this Dangerous Treatment and How Long Did it Take to Stop Using it. The first answer, from Jim Anderson, was the correct answer.

What we have learnt from the experience of the last few years is, that a great number of cases- which our predecessors thought and taught would die without Treatment X, may be spared Treatment X and yet live; and also, that many of the severe symptoms and risks in these cases were in reality the symptoms and risks arising out of Treatment X.[1]

What was Jim Anderson’s answer?

Blood letting as a means to remove evil bodily humors that accumulate and manifest as a myriad of disease processes. E.G. Malaria, TB, Polio, Cancer among others…

Imagine if we were still in the days of barbers doctors bleeding patients to get rid of the bad humors.


Image credit.

What we have learnt from the experience of the last few years is, that a great number of cases- which our predecessors thought and taught would die without blood-letting, may be spared the operation and yet live; and also, that many of the severe symptoms and risks in these cases were in reality the symptoms and risks arising out of loss of blood.[2]

Several people did answer spinal immobilization. While that is not the correct answer, that was what I was thinking of when I wrote this. There are many parallels between the paragraphs I quoted and spinal immobilization. This is also true for any other treatment that is based on wishful thinking or What if . . . ?

If there is no evidence that the treatment works, then we should DEMAND evidence.

 

If no attempts are made to provide evidence,

 

then we should PROHIBIT the treatment.

 

To do otherwise is to experiment on people without permission and without collecting the data that would allow us to learn from the experiment.

Many of those who habitually practised blood-letting as a daily means of cure in the last generation were careful and shrewd observers, as is shown bytheir writings; and it seems scarcely possible that such men should have been utterly mistaken in assigning advantages to this powerful means of modifying vital actions. It would be more reasonable to conclude that the advantages must be very great to have blinded their eyes to the accompanying evils.[2]

When was this written?

 

1871.

 

But this paper, written thousands of years after we started using this treatment, was still defending blood-letting. The author was saying –

Don’t throw the baby out with the bathwater.

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

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

2. It diminished swelling. . . . .

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

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

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

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

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

8. . . . venesection would cause hamorrhages to cease.[2]

That is a lot of misleading evidence of benefit, but these are just surrogate endpoints.

We harm patients because we think that surrogate endpoint studies are good enough to make a dangerous treatment the standard of care. We are fools.

Look – it’s scientific.[3]

 


Points for blood-letting. Image credit.

Thousands of years later, in spite of repeated evidence of harm, this doctor (and many others) were still defending blood-letting.

It was found out that, if no patients were bled at all, more recovered than if all those were bled who had the collection of symptoms whose union gave certain names to diseases seen by experience often to justify vensection.[2]

How long will it take to get rid of spinal immobilization?

How long will it take to get rid of epinephrine for cardiac arrest?

How long will it take to get rid of amiodarone for cardiac arrest?

How long will it take to start studying NTG (NiTroGlycerin) for cardiac arrest?[4]

Without evidence of safety and efficacy, we must limit treatments to controlled trials.

Defined either by a symptomatic or an anatomical nomenclature, every class of disease, in which bleeding was put through the test of experience, was injured by it.[2]

 

every class of disease was injured by it.

 

How little would it take for many doctors to return to this discredited traditional treatment?

Emptying the veins is, in point of fact, abnormally clearing the way for an abnormally weakened blood-stream; and there must be cases in which that will constitute the turning-point of life or death.[2]

In spite of evidence of harm, blood-letting is still being defended as probably beneficial for something –

We just need to find the disease that isn’t made worse by this discredited traditional treatment!

The treatment is too good to get rid of.

The problem is not with the treatment, but with finding the right patients to inflict the treatment on.

Is this any way to treat patients?

Is this any different from harming patients with spinal immobilization?

Footnotes:

[1] ?

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

[3] Scientific – It’s just a catchphrase
Rogue Medic
Sat, 21 Jan 2012
Article

[4] High dose nitroglycerin treatment in a patient with cardiac arrest: a case report.
Guglin M, Postler G.
J Med Case Reports. 2009 Aug 10;3:8782.
PMID: 19830240 [PubMed – in process]

Free Full Text from PubMed Central . . . . . Free Full Text PDF from PubMed Central

Hemochromatosis is one illness for which removing blood, in order to remove the excess iron the body retains, is useful. That does not mean that we should look for illnesses to treat with discredited traditional treatments.

.

Comments

  1. That study is thought-provoking at the very least. A couple of things:

    1. Epi and Amio, according to the paper, were still used in accordance with current (as of 2009) ACLS protocols before introducing NTG. In each one of these cases, NTG was the drug of last resort. Understanding that there were 22 subjects (and 9 died regardless), and considering this is the only study I’ve read (I wasn’t aware of NTG being used in this manner until I read the post), it would appear to give some traction to your views regarding Epi and Amio use. That said, continuous compressions must never be overlooked. I know this is obvious – at least by now it should be – but the reminder is always worth seeing.

    2. You know me well enough, I think, to know that I’m not satisfied unless I know WHY something happens. And this is no different; I would like very much to know why this works. I’m not asking if you understand why it works. I’m just saying that I would simply like to know more. And I would like to see more studies done. If I run across anything else in literature I will share it.

    Thanks for posting the link.

    • Walt,

      That study is thought-provoking at the very least. A couple of things:

      1. Epi and Amio, according to the paper, were still used in accordance with current (as of 2009) ACLS protocols before introducing NTG. In each one of these cases, NTG was the drug of last resort. Understanding that there were 22 subjects (and 9 died regardless), and considering this is the only study I’ve read (I wasn’t aware of NTG being used in this manner until I read the post), it would appear to give some traction to your views regarding Epi and Amio use. That said, continuous compressions must never be overlooked. I know this is obvious – at least by now it should be – but the reminder is always worth seeing.

      Dr. Guglin has been trying to get a study done, but apparently the IRBs have been stating that there needs to be a lot of animal research done first. As if NTG could be more dangerous than epinephrine, or amiodarone, or lidocaine.

      Yes. More research is needed, but it is not being done because of an apparent misguided attempt to protect patients.

      What are we protecting them from – something that might actually improve survival?

      2. You know me well enough, I think, to know that I’m not satisfied unless I know WHY something happens. And this is no different; I would like very much to know why this works. I’m not asking if you understand why it works. I’m just saying that I would simply like to know more. And I would like to see more studies done. If I run across anything else in literature I will share it.

      Thanks for posting the link.

      Epinephrine seems to get the heart beating again, just as a shot of cocaine would be expected to.

      Stimulants stimulate.

      What is more likely to be beneficial is something that counters the negative effects of stimulus. The heart is likely to have stopped because of too much stimulus. Giving more may make it beat again, for a little while, but it is no way a good solution.

      Decreasing afterload is likely to make the heart beat more efficiently, once it does beat again. Of course, that is just a guess about an treatment that is not adequately studied.

      .

  2. There’s a pattern to be found somewhere in here. Being a true American, my first thought is who REALLY benefits from keeping the myths active?

    My Hippie roots dictate I look for the Grand Boogeyman — the Corporation and its money — but as I get older and think I’m wiser, I have to say it goes deeper than that: Human Beings are Hope Fiends!

    Blood-letting stuck around for an awful long time, hopefully longer than the illusion of the efficacy of Epinephrine will. But don’t you think the same forces are at work here?

    The people will buy in to whatever offers them hope. As long as they believe in it, it will be used.

    It doesn’t have to be backed by science.

    It doesn’t have to be written up by reputable journals.

    All that needs to happen is that word goes around that “This may help!” between friends, associates and lovers; essentially, other people.

    And Physicians are people who are in the business of providing hope for other people. Unless something outrageous and incontrovertible happens, they’ll cling to what they believe is right. If any therapy or intervention worked for them in the past, that’s where their faith stays until GROSSLY proven otherwise, Experience shows, it’s hard to shake the comfort of the “known”..

    The fact that I KNOW I brought the dead back to life with BiCarb, Epi and ZAP! repeated over and over makes it hard for me to see drug administration in Cardiac Arrest through any other filter. Even though, quite some time ago the best knowledge of medicine made available was shown to betray me.

    For every group that provides “proof” something is not working, another group is proving the other guys have missed something, extending the period of doubt but doing nothing to provide a definitive answer.

    Case in point: I was sure you would have seen this and reflected on it:

    http://www.ems1.com/cardiac-care/articles/1225970-Prove-it-Epinephrine-administration-improves-outcome-following-cardiac-arrest/

    The article states “However, we can say with 95% confidence that the true odds of achieving ROSC in the field for patients who receive epinephrine are between 2.0 and 5.6 times greater. In addition, the odds of surviving long enough or admission to the hospital were almost two and a-half times greater if the patients received epinephrine in the field.

    However, both of these data points are secondary outcome measures, which are useful for informational purposes only.”

    That’s enough information to make many in EMS “feel” there’s still hope in Epinephrine use and continuing its use.

    Makes me wonder about those “little things” we may have missed when it comes to blood-letting!

    My point is that all of this is a very HUMAN thing, subject to as much application of science as it does on the insistence on the belief in magic.

    • firetender,

      There’s a pattern to be found somewhere in here. Being a true American, my first thought is who REALLY benefits from keeping the myths active?

      My Hippie roots dictate I look for the Grand Boogeyman — the Corporation and its money — but as I get older and think I’m wiser, I have to say it goes deeper than that: Human Beings are Hope Fiends!

      Never attribute to malice that which is adequately explained by stupidity.Hanlon’s Razor.

      Blood-letting stuck around for an awful long time, hopefully longer than the illusion of the efficacy of Epinephrine will. But don’t you think the same forces are at work here?

      The people will buy in to whatever offers them hope. As long as they believe in it, it will be used.

      It doesn’t have to be backed by science.

      It doesn’t have to be written up by reputable journals.

      All that needs to happen is that word goes around that “This may help!” between friends, associates and lovers; essentially, other people.

      And that is why I do not differentiate among treatments that have no basis in evidence.

      They are equally useless. Without evidence of benefit, the only reasonable approach is to assume that there is more harm than benefit.

      And Physicians are people who are in the business of providing hope for other people. Unless something outrageous and incontrovertible happens, they’ll cling to what they believe is right. If any therapy or intervention worked for them in the past, that’s where their faith stays until GROSSLY proven otherwise, Experience shows, it’s hard to shake the comfort of the “known”..

      There is no known in anecdote.

      There is only assumed in anecdote.

      There is only the illusion of knowledge.

      The fact that I KNOW I brought the dead back to life with BiCarb, Epi and ZAP! repeated over and over makes it hard for me to see drug administration in Cardiac Arrest through any other filter. Even though, quite some time ago the best knowledge of medicine made available was shown to betray me.

      You believed that you brought back the patient for specific reasons, because people you trusted told you that they believed these were the reasons.

      That was not science.

      There were no studies to demonstrate that these treatments improved survival. There was only extrapolation of expert opinion, based on mouse, rat, dog, and pig studies. That is not the level of science to base a treatment on. that is the level of science to form a hypothesis for a human safety study. Then the human safety study is used to justify a larger human study. Usually this will only be of a surrogate endpoint, such as ROSC (Return Of Spontaneous Circulation). That should be followed by a survival study – at least survival to discharge, but longer is better. After all, nobody wants to survive to discharge, only to die before they get home. That is not the goal.

      For every group that provides “proof” something is not working, another group is proving the other guys have missed something, extending the period of doubt but doing nothing to provide a definitive answer.

      Case in point: I was sure you would have seen this and reflected on it:

      http://www.ems1.com/cardiac-care/articles/1225970-Prove-it-Epinephrine-administration-improves-outcome-following-cardiac-arrest/

      They are not creating any doubt. The study makes it clear that the survival never reached statistical significance. This was because of the politicians interfering in the study.

      The article states “However, we can say with 95% confidence that the true odds of achieving ROSC in the field for patients who receive epinephrine are between 2.0 and 5.6 times greater. In addition, the odds of surviving long enough or admission to the hospital were almost two and a-half times greater if the patients received epinephrine in the field.

      However, both of these data points are secondary outcome measures, which are useful for informational purposes only.”

      That’s enough information to make many in EMS “feel” there’s still hope in Epinephrine use and continuing its use.

      Yes, that will encourage the ignorant, who do not see any difference between being able to leave the hospital alive and just getting a pulse back, maybe keeping that pulse until arriving at the hospital, but never waking up before their heart stops pumping adrenaline (epinephrine).

      The best survival in that study was only 4%. That is not something that should be a goal in the treatment of cardiac arrest. 4% is not an example to set for others.

      Makes me wonder about those “little things” we may have missed when it comes to blood-letting!

      Why would you wonder about some purely imaginary benefit?

      What evidence do you have that anything has been missed?

      My point is that all of this is a very HUMAN thing, subject to as much application of science as it does on the insistence on the belief in magic.

      It does appear to be very human to expect magic to work, but magic is only an illusion. Make only works at misleading people.

      The abuse of patients with treatments not based on evidence is human, but it is not ethical and it is not science.

      .

  3. …forgot to mention that even though that particular article reflects that the value of the study to EMS providors is negligible because of flaws in its execution, it concludes with:

    “Epinephrine MAY have value for patients in cardiac arrest. At this point, the medical community is still unclear on what that value might be.”

    (Emphasis theirs!)

    That’s enough hope for some people to make sure you’ll be on the anti-epinephrine soapbox for quite some time Rogue. I suppose if science weren’t such a human endeavor, even I would have more faith in it!

    • firetender,

      …forgot to mention that even though that particular article reflects that the value of the study to EMS providors is negligible because of flaws in its execution, it concludes with:

      “Epinephrine MAY have value for patients in cardiac arrest. At this point, the medical community is still unclear on what that value might be.”

      (Emphasis theirs!)

      I forgot to mention that I already responded to that article (a couple of days ago), to the misleading coverage of the same article by JournalWatch (a month ago), and in one of my posts (about a month ago). I will have to write something more detailed, but this does not change anything. There is still no evidence that epinephrine improves survival from cardiac arrest.

      A much better study is –

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

      I covered this in Does Epinephrine Improve Survival from Cardiac Arrest.

      Guess what?

      In the hospital, the patients who received epinephrine were dying at a much higher rate than the patients who did not receive epinephrine.

      That’s enough hope for some people to make sure you’ll be on the anti-epinephrine soapbox for quite some time Rogue. I suppose if science weren’t such a human endeavor, even I would have more faith in it!

      Science is a means for people to minimize their biases in examining the world. Not all scientists are good at minimizing biases.

      Nothing else works anywhere near as well.

      .

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