placebo still flaws me periodically. & it has had different definitions. i heart (<3) sham surgical trials (always the knee comes to mind); this one is new on me. incredible!
but if this is what it takes for us to tell the difference, just what is going on? how well has placebo been studied for actually directing of the bodies healing resources? i actually dont know. feel like i should. is it qualia Ltd? ill add it to the list. _JC
Keep up the good work. I’ve learned many things about critical appraisal and EBM based on this and your Medscape TWIC articles.
It would seem, after trials like Orbita and the early false hope of renal denervation studies, that sham control would be mandatory in trial design involving invasive procedures. Sadly, that does not yet seem to be the case.
OTOH, I would submit that the rigor of the control arm should be judged commensurately to the strength of the endpoints. I accept the benefit of TEER in primary and appropriately-selected secondary MR patients for that reason.
But no sham control, AND a benefit only in QOL? Well, that is a different story.
This seems to be close to standard operating procedure. Do a shoddy trial or study, massage the results to make the drug or procedure look good and it's off to the bank we go. How many millions of people were told by big pharma and the medical establishment that their lives could be saved, and ended up being sacrificed and even murdered over the last 40 years? Sorry, is that too harsh of a word? Is there a woke version of the word murder that is less up front and offensive? The snowflake definition maybe?
When I heard of it in 1988 I called by Duke Zoology prof, since it was based on Lizard hearts perfusing myocardium with sinusoids instead of coronary arteries. He was skeptical and so was I. However the LASER sometimes created neo vascularity on epicardial areas. I operated quite a few patients post TMR. Scarring was terrible.
How timely an article...how were the doctors fooled about this cardiac procedure? Oh please, can we expand into this COVID exercise with doctors stating falsehoods too..to their patients...a safe and effective “vaccine”...and that HCQ/ivermectin are BAD...How about...minimal addiction from those new strong opiate drugs several years ago. These are the days of the Big Pharma influences at the very top of the medical food chain...Congress and thru the FDA...political control most evident of the very people who treat US....more like medical political officers now. I greave for medicine of the past...where training was truly interested in a doctor-patient relationship built on trust...too many doctors still think this “vaccine” is safe and effective.
I remember having to cover the OR TEE service at Audubon hospital on occasion and finding myself involved in a bizarre procedure I had never encountered before. During these TMR procedures I was instructed to yell "hit" when micro bubbles appeared in the left ventricle. It seemed ridiculous that I was doing this and I was shocked that my colleagues were referring patients for the procedure.
At the same time we were running EECP beds, a noninvasive (but time-consuming) procedure for refractory angina which had little supportive evidence from placebo-controlled RCTS. But patients definitely felt better and studies to this today confirm this improvement which is likely due mostly to placebo effect (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7273423/)
Yes, subjective measures are a kind of evidence used in most medical studies that seek to understand symptomatology and the effect of their interventions.
How can you quantify that when "feel better" for me (someone that doesn't use novocaine if I have a cavity) to someone that takes medications like crazy for small issues??
Usually people use validated questionnaires. For example, the study at the center of this article (Leon et al.) used the Seattle Angina Questionnaire, which has been well validated to track symptom improvement by numerous research efforts.
Well with the way we've been bamboozled by doctors and pharma in the last 3 years I don't think I trust much that is published. Everyone seems to have an angle.. I mean just look WHO sponsors the study and that is a start!
Though I agree with you that the WHO has been basically fascist in their approach to the pandemic and many other issues previously as well, this doesn't mean everything they fund is inherently flawed. Your skepticism is warranted, however.
This is important. Distorting results of poorly conducted studies is occurring too frequently. I read and reread these studies with frustration. At first, I think it's me, not seeing how some "obvious" conclusion was reached based on weak or nonexistent support.
2 other things...
First: You said "I was baffled. Just weeks ago I had finished a top training program. During those years, I had moonlighted at a busy private cardiology group. I had never heard of TMR." Did you mean "weeks BEFORE"?
Second: Recently, I read where someone had commented their EP was recommending radiation treatment for atrial fibrillation that didn't respond to 2 ablation procedures and one surgical procedure. I found little information on using radiation. Apparently, there was one article that said it was superior to ablation when there are areas that "can't be reached" with ablation. But I saw no studies. Radiation can "cause" afib. Can you look into this and maybe do an article on the subject? As always, thanks.
If only vaccine manufacturers used actual placebo in their trials. Please correct me if I am wrong, but isn’t it common for them to use just the adjuvant, etc , but rarely what is considered pure placebo.
placebo still flaws me periodically. & it has had different definitions. i heart (<3) sham surgical trials (always the knee comes to mind); this one is new on me. incredible!
but if this is what it takes for us to tell the difference, just what is going on? how well has placebo been studied for actually directing of the bodies healing resources? i actually dont know. feel like i should. is it qualia Ltd? ill add it to the list. _JC
Keep up the good work. I’ve learned many things about critical appraisal and EBM based on this and your Medscape TWIC articles.
It would seem, after trials like Orbita and the early false hope of renal denervation studies, that sham control would be mandatory in trial design involving invasive procedures. Sadly, that does not yet seem to be the case.
OTOH, I would submit that the rigor of the control arm should be judged commensurately to the strength of the endpoints. I accept the benefit of TEER in primary and appropriately-selected secondary MR patients for that reason.
But no sham control, AND a benefit only in QOL? Well, that is a different story.
So very interesting. We are using some of these articles in our introduction to nursing research. The students love them.
This seems to be close to standard operating procedure. Do a shoddy trial or study, massage the results to make the drug or procedure look good and it's off to the bank we go. How many millions of people were told by big pharma and the medical establishment that their lives could be saved, and ended up being sacrificed and even murdered over the last 40 years? Sorry, is that too harsh of a word? Is there a woke version of the word murder that is less up front and offensive? The snowflake definition maybe?
Well said 👏🏽👏🏽👏🏽 no better descriptive term than that.
When I heard of it in 1988 I called by Duke Zoology prof, since it was based on Lizard hearts perfusing myocardium with sinusoids instead of coronary arteries. He was skeptical and so was I. However the LASER sometimes created neo vascularity on epicardial areas. I operated quite a few patients post TMR. Scarring was terrible.
How timely an article...how were the doctors fooled about this cardiac procedure? Oh please, can we expand into this COVID exercise with doctors stating falsehoods too..to their patients...a safe and effective “vaccine”...and that HCQ/ivermectin are BAD...How about...minimal addiction from those new strong opiate drugs several years ago. These are the days of the Big Pharma influences at the very top of the medical food chain...Congress and thru the FDA...political control most evident of the very people who treat US....more like medical political officers now. I greave for medicine of the past...where training was truly interested in a doctor-patient relationship built on trust...too many doctors still think this “vaccine” is safe and effective.
John,
I remember having to cover the OR TEE service at Audubon hospital on occasion and finding myself involved in a bizarre procedure I had never encountered before. During these TMR procedures I was instructed to yell "hit" when micro bubbles appeared in the left ventricle. It seemed ridiculous that I was doing this and I was shocked that my colleagues were referring patients for the procedure.
At the same time we were running EECP beds, a noninvasive (but time-consuming) procedure for refractory angina which had little supportive evidence from placebo-controlled RCTS. But patients definitely felt better and studies to this today confirm this improvement which is likely due mostly to placebo effect (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7273423/)
Anthony
So is "felt better" a scientific term now?
Yes, subjective measures are a kind of evidence used in most medical studies that seek to understand symptomatology and the effect of their interventions.
How can you quantify that when "feel better" for me (someone that doesn't use novocaine if I have a cavity) to someone that takes medications like crazy for small issues??
Usually people use validated questionnaires. For example, the study at the center of this article (Leon et al.) used the Seattle Angina Questionnaire, which has been well validated to track symptom improvement by numerous research efforts.
Well with the way we've been bamboozled by doctors and pharma in the last 3 years I don't think I trust much that is published. Everyone seems to have an angle.. I mean just look WHO sponsors the study and that is a start!
Though I agree with you that the WHO has been basically fascist in their approach to the pandemic and many other issues previously as well, this doesn't mean everything they fund is inherently flawed. Your skepticism is warranted, however.
This is important. Distorting results of poorly conducted studies is occurring too frequently. I read and reread these studies with frustration. At first, I think it's me, not seeing how some "obvious" conclusion was reached based on weak or nonexistent support.
2 other things...
First: You said "I was baffled. Just weeks ago I had finished a top training program. During those years, I had moonlighted at a busy private cardiology group. I had never heard of TMR." Did you mean "weeks BEFORE"?
Second: Recently, I read where someone had commented their EP was recommending radiation treatment for atrial fibrillation that didn't respond to 2 ablation procedures and one surgical procedure. I found little information on using radiation. Apparently, there was one article that said it was superior to ablation when there are areas that "can't be reached" with ablation. But I saw no studies. Radiation can "cause" afib. Can you look into this and maybe do an article on the subject? As always, thanks.
If only vaccine manufacturers used actual placebo in their trials. Please correct me if I am wrong, but isn’t it common for them to use just the adjuvant, etc , but rarely what is considered pure placebo.