What is a 'randomized controlled trial', and why are the positive results of Hydroxychloroquine for Covid-19 greeted with skepticism?

Washington Examiner via MSN ^ | 09/18/2020 | David Hogberg

[SeekAndFind]

Once an obscure and highly technical term, it first entered common parlance when, in mid-March, President Trump suggested hydroxychloroquine as a possible treatment for COVID-19. Physicians and scientists said that randomized controlled trials involving the drug would be needed before we could know whether it was an effective treatment.

More recently, media coverage of a possible coronavirus vaccine has often mentioned the term, noting that vaccines must go through such trials before the Food and Drug Administration will approve them.

Indeed, it has become prominent in the news since the pandemic began. Typing the term into the search engine Google and selecting "News" will yield more than 146,000 results. A search of the Washington Examiner finds 20 articles using the term since March. We often write that it is "considered the gold standard in medical research."

But what, exactly, is a randomized controlled trial?

In summary, it is a scientific experiment in which patients are randomly assigned to receive either a specific treatment or a placebo. Sometimes, patients are assigned to a third group that receives the best available treatment that has been tested by previous research. That way, the new treatment can be compared to the most effective established treatment.

Ultimately, it will inform researchers about the efficacy and safety of a specific treatment. Researchers will be able to determine whether the treatment is more effective than no treatment or the best established treatment. They will also be able to better understand what side effects the treatment may have.

Assigning patients randomly enables researchers to eliminate certain sources of bias that could otherwise confound the results.

[gas_dr]

Actually that is either a prospective trial that is observational, or a retrospective observational study — both have some validity. But the ONLY way to quantify it is to perform an RCT

There are some things an RCT is unethical for — ie RCT on needing a parachute to jump out of an airplane — if randomized to the placebo group there would be 100% death. As for Ivermectin, there is excellent observational data for it, but nothing conclusive. Its a jump to state that it is unethical not to study the drug prospectively.

[circlecity]

Ok, how about ANY peer reviewed study showing the efficacy of cloth or paper masks. Because there are several showing they are ineffective.

[Jane Long]

So true!!

So sick of this career govt tool!!!

[gas_dr]

I absolutely do not disagree — I think masks are completely ineffective against virus (surgical and cloth). I was issued a P-100 as I deal with high risk exposures daily and so were all the frontline providers in my institution.

I was simply commenting on the fact that one could not have a RCT on mask use.

We do not disagree that the use of masks does little to reduce spread of disease outside of helping people remember not to touch their face with their hands, pick their nose, or put the fingers in the mouth.

Be well. This, too, shall pass.

[gas_dr]

I can complete the observational study on Fauci — he is pretty much a weasel.

[DugwayDuke]

gas_dr wrote: “It would be kind of hard to hold a doubly blinded RCT on mask wearing — for obvious reason. You can see who is in what group.”

Actually, it could be done if those conducting the study were kept from seeing the subjects.

[BDParrish]

I think I learned from you (was it Mom MD?) that the problem with all this is that COVID-19 is not virulent enough for this treatment to show undeniable quantifiable results. If more people were killed by this virus it would be easy to see the difference that a treatment makes.

The effect of bias on a treatment can be quantified and understood. In fact all bias need not be removed nor could it even be. We need to remove the effect of bias on the result or enough of the effect of it to see the actual result. (Please correct me.)

Did you see the study comparing relative risk of COVID-19 mortality with the relative risk of driving a car? Would the flubros want to see this?

"Population-level COVID-19 mortality risk for non-elderly individuals overall and for non-elderly individuals without underlying diseases in pandemic epicenters."

[poinq]

Yes its best to get a double blind, meaning both doctors and patients don’t know who gets the drug and who do not. And its best to get it randomized, meaning the groups are not in any way self selecting. But this critique was used to merely cast dispersions at HCQ because the tests were not perfect. They leave out the fact that the disease was so new, there was no time to run a “perfect” study. So they looked for evidence within the data they had. And in that data they found lots of evidence that HCQ works in lowering the deaths if the dose is normal and its taken as soon as symptoms start. In almost all of those studies there is a positive effect and in some there is no effect.

But almost all the antivirals including HCQ work about the same. However, Zinc and vitamin D also work as well. And the combination works best. There are some other vitamins and drugs that can help as well. But the combination of these three are extremely helpful in reducing the fatality and ICU rates to near zero.

And this fact which is known and understood by most doctors has changed the situation in a few ways. Firstly nurses and doctors have been using this formula for 6 months. Secondly the fatality rates have gone down significantly. Such that, if you see a fatality rate after June 1st it is far lower than before June 1st. Even in people 80+ the fatality rate goes from 30% in April down to 10% in August. And in those below 40 the fatality rate is below the flu or car accidents or even the fatality rate excepting Flu, Covid and car accidents. So just walking around is far more dangerous than getting Covid.

But getting back to HCQ, there are now some good studies that are both double blind and randomized that do show that HCQ works in reducing death. And now the blow back is that the studies are not big enough. But thats because the studies are ongoing and they will magically become valid right after the election.

[upsdriver]

Now, let us see the clinical controlled studies verifying the effectiveness of facemasks.

[silverleaf]

Tell that to the Doctor who knows only half his patients are going to receive the single 12 mg dose of scabies medicine that has in his observation helped 100% of covid patients.

http://covexit.com/professor-thomas-borody-interview-part-1/

Australian doctors can prescribe
http://covexit.com/australian-gps-can-legally-prescribe-ivermectin-triple-therapy-protocol-professor-borody/

Inadvertent double blind trial in Toronto nursing home, 100% prevention among 187 treated patients.
https://youtu.be/8XCYzpHBEkI

[norwaypinesavage]

"Physicians and scientists said that randomized controlled trials involving the drug would be needed before we could know whether it was an effective treatment."

Randomized controlled trials are indeed the gold standard WHEN YOU HAVE A MINIMAL AMOUNT OF DATA. There are now HUNDREDS OF THOUSANDS OF DATA POINTS that demonstrate that hydroxychloroquine, particularly when given early and supplemented with zinc and antibiotics, saves lives - thousands of them. Statistical analysis is irrelevant. Hydroxychloroquine works! The only people disputing that are politically motivated and not scientifically literate.

[va22030]

your moronic reply proves my point.

[fella]

NY ran a real world where wealthy and politically connected (plantation owners) were given the hydroxycloraquin protocol and the plebs were sent to nursing homes.

[SeekAndFind]

RE: NY ran a real world where wealthy and politically connected (plantation owners) were given the hydroxycloraquin protocol and the plebs were sent to nursing homes.

Can you provide the link please?

If it’s behind a paywall, can you summarize the result of the real world study for us?

[Mom MD]

Yup. masks are a political not a scientific construct.

[AppyPappy]

Because OrangeManBad.

[Mom MD]

wrong. We have had many medications that everyone “knew” worked that when the trials were done were actually harmful. look up xigris.

If the randomized trials show a clear survival benefit there is a way to unblind and release the results early

[Mom MD]

look up xigris. everyone knew it was saving lives except it was actually killing people

[RedStateRocker]

If it’s not a double-blind, randomized controlled trial, it’s bullshit; anyone who thinks otherwise is an ignoramus.

[silverleaf]

I looked it up
But I could only find that it was lab designed for a Big Pharma
On the other hand
Both Ivermectin and HCQ are FDA medications with decades of use including off label use by many docs in many countries
Both Listed by the WHO as among worlds safest drugs
Both are or were sold over the counter in many countries

I fail to see the comparison of that drug with a doc prescribing - or for some test purpose - during a pandemic- choosing to deny a potentially dying patient the off label use of a drug with decades of safe use. Which is Dr Borody’s point.