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

- Rogue Medic

Does the parachute study prove that research doesn’t matter? Part III

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

Continuing from Part II, which looked at the way the satirical parachute paper misrepresents EBM (Evidence-Based Medicine), but that is expected from satire. You could also provide a great defense of blood-letting as the best medicine using satire.

In the comments to Does the parachute study prove that research doesn’t matter? Part I is the following from Kevin –
 

After claiming to know what he is writing about, Kevin finishes with this –
 

As a reminder, there is not level 1 evidence that oxygen works during an acute heart attack either. That is because we do not withhold it from anyone to study it in randomized fashion due to ethical concerns and assumptions made from non-level 1 evidence.

 

What does Kevin mean by level 1?

There have been some studies of oxygen. It is unethical to not study the drug oxygen.
 

3D Isolated Oxygen Tank


Image credit.
 

For example, there was a study of One hundred percent oxygen in the treatment of acute myocardial infarction and severe angina pectoris in JAMA (Journal of the American Medical Association) way back in 1950.

If oxygen is so much better than room air for heart attack patients, the patients receiving 100% oxygen should have dramatically better outcomes than patients receiving room air by mask in this double-blinded study. The results were not statistically significant, but patients receiving 100% oxygen did not do as well as the patients receiving room air by mask.[1]

Hypoxic patients were treated with oxygen, rather than enrolled in the study, because the study looked at treating heart attack, rather than treating hypoxia. Whether we should treat hypoxia without symptoms is also a different question.

Kevin’s comment was written in September, which is ironically when the paper Oxygen Therapy in Suspected Acute Myocardial Infarction was published. We have stopped using blood-letting to treat patients, even though withholding blood-letting used to be considered just as unethical.
 

CONCLUSIONS: Routine use of supplemental oxygen in patients with suspected myocardial infarction who did not have hypoxemia was not found to reduce 1-year all-cause mortality.[2]

 

The evil scientists did not uphold dogma? Burn the heretics.

The acronym for the study reflects the addiction to continuing questionable treatments, which must not be questioned. DETO2X.

Have competent people condemned this research as unethical?

I have not looked at any of the other medical research blogs, but you should go ahead and read them (listen to the podcasts, watch the videos) and see what they write. Tell me if anyone condemns the research. Don’t quote Gwyneth Paltrow or Dr. Oz, but competent science bloggers.

The actual dogma was to give oxygen to heart attack patients, so is routine oxygen for heart attack just another case of harming patients with tradition?

What does Cochrane tell us?
 

Authors’ conclusions There is no evidence from randomised controlled trials to support the routine use of inhaled oxygen in people with AMI, and we cannot rule out a harmful effect. Given the uncertainty surrounding the effect of oxygen therapy on all-cause mortality and on other outcomes critical for clinical decision, well-conducted, high quality randomised controlled trials are urgently required to inform guidelines in order to give definitive recommendations about the routine use of oxygen in AMI.[3]

 

well-conducted, high quality randomised controlled trials are urgently required

The purpose of research is to learn what is effective and what is safe. We should only be using treatments that are both effective and safe outside of well-controlled trials.

We have been harming too many patients with treatments that should never have been used outside of well-controlled trials.

We need to stop trying to make treatments look better than they are.

We need to stop coming up with rationalizations for hurting patients.

We need higher standards.

 

I have also written about EBM and the parachute paper in these posts –

Does the parachute study prove that research doesn’t matter? Part I – Wed, 22 Aug 2012

Common Sense vs. Evidence – Thu, 28 Mar 2013

The Parachute Study as an Objection to Studying Ventilations in Cardiac Arrest – Mon, 08 Apr 2013

Do we know that these treatments do not help? – Mon, 15 Apr 2013

Why Ignoring Evidence Based Medicine Kills Patients – Fri, 28 Jun 2013

JAMA Opinion Article in Support of Anecdote-Based Medicine – Thu, 28 Nov 2013

Why US EMS will never get to sit at the adult table – The Appeal to Authority – Sun, 04 May 2014

Natural Alternatives to the EpiPen, Because We Believe in Parachutes – Wed, 23 Dec 2015

Does the parachute study prove that research doesn’t matter? Part II – Thu, 30 Nov 2017

Footnotes:

[1] One hundred percent oxygen in the treatment of acute myocardial infarction and severe angina pectoris.
RUSSEK HI, REGAN FD, NAEGELE CF.
J Am Med Assoc. 1950 Sep 30;144(5):373-5. No abstract available.
PMID: 14774103 [PubMed – indexed for MEDLINE]

[2] Oxygen Therapy in Suspected Acute Myocardial Infarction.
Hofmann R, James SK, Jernberg T, Lindahl B, Erlinge D, Witt N, Arefalk G, Frick M, Alfredsson J, Nilsson L, Ravn-Fischer A, Omerovic E, Kellerth T, Sparv D, Ekelund U, Linder R, Ekström M, Lauermann J, Haaga U, Pernow J, Östlund O, Herlitz J, Svensson L; DETO2X–SWEDEHEART Investigators.
N Engl J Med. 2017 Sep 28;377(13):1240-1249. doi: 10.1056/NEJMoa1706222. Epub 2017 Aug 28.
PMID: 28844200

[3] Oxygen therapy for acute myocardial infarction.
Cabello JB, Burls A, Emparanza JI, Bayliss SE, Quinn T.
Cochrane Database Syst Rev. 2016 Dec 19;12:CD007160. doi: 10.1002/14651858.CD007160.pub4. Review.
PMID: 27991651

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