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

- Rogue Medic

In Defense of No Improvement by Medic Madness – Part I

Thu, 13 Mar 2014 12:00:39 -0400 by
 

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.

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Footnotes:

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[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

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

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[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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[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]

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[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]

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[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]

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[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]

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[8] Straw man
Wikipedia
Article

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Filed Under: Cardiac Arrest, Critical Judgment, Evidence, Heresy, Placebo, Research

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

Thu, 19 Sep 2013 08:00:13 -0400 by
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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],

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Footnotes:

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[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

Free Full text from PubMed Central.

Real acupuncture was not any better than fake acupuncture.
 

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

 

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[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

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

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

 

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

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

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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Added 01-10-2019 – In going through some old sources, I have been making a few corrections and occasionally adding updated information, such as this more recent study showing that acupuncture is just a placebo –
 

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

Free Full Text in PDF format from carolinashealthcare.org
 

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

 

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Filed Under: Evidence, Heresy, Placebo, Spinal Immobilization

Placebo vs Belief vs Neither – Part III

Mon, 22 Aug 2011 06:30:27 -0400 by
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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.

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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.

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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.

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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.

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[youtube]HMGIbOGu8q0[/youtube]

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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.

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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.

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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.

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(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.

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Filed Under: 'Alternative' Medicine, Critical Judgment, Ethics, Heresy, Placebo, Unicorn Medicine
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