Saturday, October 20, 2012

Look AHEAD trial stopped

Eat less, move more, have your heart attack on time!

With apologies for lack of any attention to the blog recently (which may be set to continue for some time) but this snippet just had to get passed on. This link from Karl:

http://www.theheart.org/article/1458351.do

More info here

http://www.nih.gov/news/health/oct2012/niddk-19.htm

And the glowing anticipation of success here from the planning stage:

https://www.lookaheadtrial.org/public/home.cfm

Pubmed gives a series of genuine success stories from the early days on all sorts of parameters. But the cardiovascular end points show how utterly useless these interventions are long term.

However the massive omission, from the quick look I've managed, is of any intention to report the all cause mortality. It seems very likely to me that more people died in the intervention group than in the usual care group, but p was > 0.05.

Call me a cynic, but I think they stopped the trial because they could see where that p number was heading. Has anyone seen a body count from anywhere in the trial?

Also, what might the outcome have been if the intervention group had been repeatedly bullied, harassed and indoctrinated to maintain a normoglycaemic, low grade ketogenic diet for 13.5 years? Say to an HbA1c of around 5%?

Ha ha ha bloody ha.

Peter

EDIT: Have started on the SCD1 k/o ob/ob mice. The thread WILL continue.

15 comments:

chintillo said...

I have never understood how insane is to put a person with hypertension to do cardiovascular exercise so they arteries will become more injured with a tension of 190/100 during 1 hour due to exercise and later having 2 or 3 hours with a 200 glucose post meal due their incipient diabetes.

How happy "recovery" for the cardiovascular system.

I think some "scientist" should do the recent Red Bull challenge but without the parachute.

Jack Kruse said...

You said, you could not find all cause mortality data for the stop. Not surprising to some of us. The trial was stopped because their hypothesis was being demolished. You and I both know it. But this post sfurther supports my concerns with RCT and so called evidence based medicine. The modern health care complex trump this brand of medicine. I loathe it. There is nothing more dangerous to modern humans than evidence based medicine and we all remain unaware of those pitfalls. Peter has touched on just that here.

I wrote very recently in my Brain Gut 14 blog this: The manner in which we ask questions is deeply flawed in medicine. Here is where the major causative factor lies in medicine that too few are talking about in research literature. You need to know it. Positive findings, whether they are good or bad for our biology, are twice as likely to be published as negative findings.

This dramatically skews the meaning of what the evidence is really showing us in medicine. It is at the core why people do not get better with evidence based practices and remain a medical annuity for the system. This is a cancer at the core evidence-based medicine today. When you become aware of what you do not know, it becomes easier to get to optimal. They key is for you to avoid those pitfalls before you access the healthcare system. Unfortunately, physicians are paid on this data and that is why it appears to many people that doctors just don’t get it. Many of us do get it, but if we step out of line we get punished by the system. That is how I feel about this Look Ahead nonsense. I am more cynical than Peter. I think the trial was ended because a current growth industry in healthcare might have been placed in peril if the trial continued.

Jane said...

I see the intervention arm included 'individual sessions with a nutritionist'. No wonder the trial failed. Conventional nutritionists talk utter nonsense. They live in the dark ages where everybody has iron deficiency or zinc deficiency or calcium deficiency, extremely unlikely in people eating meat and dairy products. The idea these people might have deficiencies of things removed from low-fat dairy or refined carbs never seems to enter their heads.

Tuck said...

Yeah, no kidding the diet wasn't working:

"Restriction of caloric intake is the primary method of achieving weight loss..."

"...The composition of the diet is structured to enhance glycemic control and to minimize cardiovascular risk factors. The recommended diet is based on guidelines of the ADA and National Cholesterol Education program and includes a maximum of 30% of total calories from total fat, a maximum of 10% of total calories from saturated fat, and a minimum of 15% of total calories from protein."

Let's do an alcholism intervention trial where the participants regularly consume alcohol. I wonder how that will turn out?

David Moss said...

@Tuck. It's very important for people with alcohol problems to regularly consume alcohol, every couple of hours, but particularly at breakfast, in order to maintain steady blood alcohol.

Stan (Heretic) said...

Peter, you beat me to it, I just noticed a writeup in the NYT about the study! It is also possible that something else may have gone badly wrong there. For one, reduction of the caloric intake by half over 11 years should have helped but it didn't! Unless their dietitians only reduced their fat and protein while kept all those "healthy" carbs in?

Jack K. - spot on! I would also add a comment that the worst disease of modern academics, especially medical, is not only a publication bias but an addiction! Addiction to being right!

Stan (Heretic)

karl said...

@Jack Kruse
Absolutely correct! The publish or perish grant machine needs to be stopped.

@Tuck and David Moss
You made me laugh out loud..

Re: Dietary advise - is there any evidence that scolding people to eat less actually works long term? - people just don't do it.

I did this diet - it is VERY hard to do and made me sick - even my fingernails got rippled and I would go to bed hungry as it was better then than when awake. I don't think they got many that really did this diet.

Low carb is troublesome - a pain when eating out - but quite livable for me..

Tony Mach said...

Here is the article for all you cheapstakes that can't afford a membership at "theheart.org"

http://webcache.googleusercontent.com/search?q=cache:1k9II8ZwOyMJ:www.theheart.org/article/1458351.do+&cd=1&hl=en&ct=clnk

From that website:
"In addition, early data showed that treadmill fitness levels, hemoglobin A1c levels, systolic and diastolic blood pressure, HDL-cholesterol levels, and triglyceride levels were all significantly improved among patients in the lifestyle-intervention arm when compared with the control group."

HDL-cholesterol improved!!!! And triglyceride levels improved!!!! And so did blood pressure!!!! Even "significantly"!!!! So it must be good!!!!!

With all these markers improved, who cares if it actually helps people. "Here, this piece of paper shows you have been a good boy."

Oh man, they are burying themselves under paradoxes and they carry on as if nothing was wrong.

Eva said...

"In addition, early data showed that treadmill fitness levels, hemoglobin A1c levels, systolic and diastolic blood pressure, HDL-cholesterol levels, and triglyceride levels were all significantly improved among patients in the lifestyle-intervention arm when compared with the control group."

That's rather interesting! Most of those things are good generally speaking. So makes me wonder what they were doing to counteract them. Was it more statins and grain and less saturated fat that did them in? Was the weight loss much? I guess if you exercise more and lose a tad of weight, that alone will account for most of those results. And exercise is not totally useless for weightloss, it's just not the panacea that many would have you believe. I do think that people who exercise more have less side effects with more glucose intake, because they do a better job of burning glycogen and so the body has a place to send more incoming glucose. Maybe all apparent improvements seen were the result only of exercise which is generally good for you I think all sides would agree (if not overdone of course). But exerise can be hard on the heart too if the heart is not getting the right support. Exercise can show rapid short term positive side effects, but the side effects of eating less saturated fat and more crap foods might accumulate more slowly but build up steam the longer it goes, eventually overcoming advantages of exercise. Just thinking out loud..

(and jeez, these prove you are not a robot tests are getting really hard. All I got was two fat black rectangles in the photo section. I have good eyes and I can't even GUESS what numbers or letters they might be!!!)

IanD said...

I complete 12 years as a T2 diabetic. I'm now 73 & fit, well & active.

During those 12 years I have personally conducted 2 diet/exercise routines:
DUK high starchy carb/low fat-sugar-salt, with regular exercise - mainly tennis. 8 years of that & I was becoming crippled & could not exercise. My active life was over - it was a painful struggle to get out of bed.

Then I found the http://www.diabetes.co.uk/forum, & switched to low carb, with fats as they come. 3 months & I was out of pain & playing tennis again, & 4 years on I am fit & well, & playing tennis at club standard still.

I have no intention of abandoning my low carb/high fat diet & exercise programme.


The surprise with the cited trial is that they continued so long before realising its futility.

Lowcarb team member said...

With the correct diet it would be normal to see massive reductions in HbA1c and vastly improved blood glucose control. Huge reductions in obesity, far better lipid counts and huge reductions in medication used. This has been proved countless times by lowcarbing diabetics, and they didn’t need 11 years and $220 million to find out a way to improve CVD. The good news we see on blogs and forums all over the world, counts for nothing with outfits like the NHS,DUK and the ADA, they call the good news reported ‘anecdotal’ they much prefer to accept the information received from big pharma and junk food companies. The fact that many of these outfits have been fined $billions for lying, bribery and corruption and falsifying drug trial evidence matters not a jot. Why, because the people we should be able to trust have sold out, and put money before peoples health and wellbeing. We need far more people like Bernstein, Wortman, Taubes, Kendrick, Briffa et al. They have the courage to stick their heads above the parapet, and refuse to be lackeys and yes men to stupidity and greed.

Eddie

Tony Mach said...

A study about the general population regarding cholesterol has been released. And same as in the AHEAD trial, one can in the population see the results of advise from doctors (starve yourself and do exercise): an LDL drop, but no noteworthy HDL rise.

"Along with a drop in total cholesterol, Margaret Carroll and her colleagues saw average LDL levels decline from 129 to 116 between the survey periods. HDL, or "good" cholesterol, rose slightly from 50.7 to 52.5, on average."

http://www.reuters.com/article/2012/10/16/us-cholesterol-idUSBRE89F1L420121016

Hurray! The numbers have changed!

And this is truly insane:

"As expected, the use of statins and other cholesterol-lowering medications increased among survey participants, from just over 3 percent to above 15 percent during the study period.

However, average cholesterol levels also fell among people who weren't on the medications, Carroll's team reported Tuesday in the Journal of the American Medical Association.

The most recent numbers suggest about one-quarter of adults age 45 and older in the U.S. are on a statin.
"

And look, another paradox! Their findings differ from the AHEAD trial!

"Danaei said the current findings support past research also showing average cholesterol is decreasing in the U.S., with a corresponding drop in heart disease."

And the "less-healthy" bit here is truly comical (if it weren't so sad):

"… substitution of vegetable oils for less-healthy trans fats …"

Sure, this is like "substitution of cocaine for less-healthy meth".

karl said...

@Tony Mach

Re Statins and reduced heart attacks - The problem is if they look at death by all causes - then statins don't do much.

There is a slight elevation of BG on statins that probably increases cancer a bit. Dying of cancer can be quite nasty.

I don't think statins work by lowering LDL - I think they work by lowering inflammation (I think CAD is an autoimmune disease for the most part )- BUT there are other ways to lower inflammation - and number one is keeping postprandial BG below 110..

Lowering LDL might be important for folks with E4/E4 or Familial hypercholesterolemia.

I'm more concerned with oxLDL levels that our doctors don't test for - but seems to correlate with BG levels.

David Isaak said...

The diet here was based on the infamous Food Pyramid--just less of it. If you want a good laugh (or cry), all of the instructional materials are posted here:

https://www.lookaheadtrial.org/public/dspMaterials.cfm

You have to scroll down quite a way to get to "Healthy Eating," but it's worth it: just a rehash of the crap you usually see on the side of a box of breakfast cereal.

cctw said...

the study showed decreased HB A1C, decreased blood pressure, decreased triglyceride levels, decreased ldl cholesterol and increased hdl levels...I never understood how someone can ignore the good in something