Earlier quoted context omitted.
I'm not trying to quibble, but am genuinely curious: What would a control group consist of? There were plenty of patients who didn't receive the trial program, at large in the general population. And it couldn't have been a blind study, because the patients knew what they were eating.
> What would a control group consist of? It would be an equivalent population who weren't asked to change their diets. There are multiple reasons the patients in this study might not be comparable to participants in other studies or to the general population. Age, gender, average disease severity all need to be controlled for. And if nothing else the simple fact the patient knows they're being monitored could have an…
A Way to Reverse Coronary Artery Disease? [pdf]
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Re: A Way to Reverse Coronary Artery Disease? [pdf]
#52Didn't Bill Clinton switch to a vegan diet to "manage" his heart disease? Think I saw it discussed on CNN. Here's a NYT article that I found on it: http://well.blogs.nytimes.com/2011/08/18/bill-clintons-vegan...
Re: A Way to Reverse Coronary Artery Disease? [pdf]
#531. The study was self-selected - we don't know to what degree. Did they place flyers in vegetarian recruiting grounds?
2. They explicitly state that they are not including 8 patients that experienced thrombotic or embolic events or had progression, blaming them on other factors. That may be the case, but it is not ok to exclude patients on that basis and report your adverse event as 1% due to that.
3. There is no marker of cardiac function provided in the study / we have no idea if the groups had similar baseline function.
This is a critical point because amongst the 'non-adherent' group there is one patient who underwent a heart transplant. A heart transplant is a very rare procedure and is only reserved for extremely severe heart failure. If a patient in a study eventually underwent a heart transplant, that patient very likely had horrific cardiac function at the beginning of the trial.
What is more telling is that such information could have been statistically provided very easily: They could have chosen to provide a summary of number of patients who had experienced infarcts; number of patients with aberrant ECG rhythms; number of patients on spironolactone (a medication reserved for use for late in heart failure); Left ventricular ejection fraction estimated from TTE; The list goes on.
Instead they provide only the sexes, 'symptom reduction', and adverse events.
In my opinion this study provides little more than anecdote that patients should switch entirely to a plant based diet, and at this point I would certainly not recommend a patient of mine to switch. However it should be studied in greater detail and it would be interesting if stronger evidence emerged.
Re: A Way to Reverse Coronary Artery Disease? [pdf]
#54Earlier quoted context omitted.
I'm not trying to quibble, but am genuinely curious: What would a control group consist of? There were plenty of patients who didn't receive the trial program, at large in the general population. And it couldn't have been a blind study, because the patients knew what they were eating.
> What would a control group consist of? It would be an equivalent population who weren't asked to change their diets. There are multiple reasons the patients in this study might not be comparable to participants in other studies or to the general population. Age, gender, average disease severity all need to be controlled for. And if nothing else the simple fact the patient knows they're being monitored could have an…
Which is actually an ethical quandary when you think about it. A doctor's ethics are really tested when he has to say to some patients "sure, I think you should change your diet and you'll probably die if you don't, but you're part of the control group!"
One more ethical (and still statistically somewhat interesting) way of administering such a study would be to bring in doctors advocating different sorts of diets. The Cleveland Clinic hasn't done such a thing but they probably could: they've got a group that advocates the rigid vegan diet and another that advocates the Mediterranean diet. Not as good as having a control group that continues to subsist on cheeseburgers and coke but it actually can test a few specific ideas, like the vegan claim.
Re: A Way to Reverse Coronary Artery Disease? [pdf]
#55Allow me to don my doctor hat and provide some comment here. I'll leave the statistical analysis to the mathematicians below. 1. The study was self-selected - we don't know to what degree. Did they place flyers in vegetarian recruiting grounds? 2. They explicitly state that they are not including 8 patients that experienced thrombotic or embolic events or had progression, blaming them on other factors. That may be th…
Re: A Way to Reverse Coronary Artery Disease? [pdf]
#561. No control group
2. Self reported dietary adherence
3. Obvious possibility of the healthy adherer effect (people who voluntarily present for interventions and are adherent to dietary changes will probably also exhibit other healthy behaviors like exercise, mood control, better sleep etc which introduces confounders.
4. No monitoring of medication adherence. Perhaps these people simply started taking their medications more regularly while in this program. Medication adherence among patients with CAD is notoriously terrible.
5. Possibility of sick stopper effect in their non-adherers (sickest people also most likely not to take their meds, precipitating worse outcomes).
6. They note that on average their patients lost 18 lbs; perhaps weight loss alone was responsible for their improvements
7. They exclude some of their sickest patients
8. They report symptom relief in adherent patients but don't mention what that means. Do they report less angina? Did they see plaque size reduction? If the former, you have introduced potential for placebo effect.
Re: A Way to Reverse Coronary Artery Disease? [pdf]
#57Earlier quoted context omitted.
Considering it states exactly that in the article in two places, I's say it's a safe assumption.
That quote is from the article, yes. But they repeatedly summarize the diet as "plant-based", rather than sugar-free and plant-based. What if the fact that they cut meat had absolutely no effect or even a negative one ? Would we be able to tell from this?
Re: A Way to Reverse Coronary Artery Disease? [pdf]
#58What was the rationale for excluding oils, nuts and avocados from the diet?
Re: A Way to Reverse Coronary Artery Disease? [pdf]
#59Earlier quoted context omitted.
Control and double blind studies are more important when the placebo effect and subjective outcomes are at play. Not necessary here. Everyone that follows a different diet would like to complain about that. You should have compared it to the paleo diet, or low-carb diet, or whatever. Show studies that those diets have similar effects and then they merit comparison. Self reporting is an issue, but this is not the only…
My friend, (a scientist) wants to develop a pill that "triggers" the placebo effect (lets face it, its as effective as many drugs). Could you test that?
Re: A Way to Reverse Coronary Artery Disease? [pdf]
#60My husband’s book, Prevent and Reverse Heart Disease is widely available. ‘ On his web site, dresselstyn.com you will find his counseling DVD for purchase
Or you may come to the Cleveland Clinic Wellness Institute for his monthly counseling seminar. Details available through his secretary Jackie at 216-448-8556.