Health for life

A study due in the upcoming July 15 issue of the American Heart Association journal Circulation will be reporting that: ¹

"Greater adherence to the prudent pattern [of eating] may reduce the risk of cardiovascular and total mortality, whereas greater adherence to the Western pattern may increase the risk among initially healthy women."

What did the researchers define as a "prudent pattern"?

"High prudent pattern scores represented high intakes of vegetables, fruit, legumes, fish, poultry, and whole grains, whereas high Western pattern scores lected high intakes of red meat, processed meat, ined grains, French fries, and sweets/desserts."

It was a large prospective evaluation of the diets of 72,113 women who participated in the Nurses Health Study. They were followed for 18 years.

The prudent diet reduced risk of cardiovascular death by 28% when compared to the Western diet. It reduced risk of all-cause death by 17%.

The Western diet increased risk of cardiovascular death by 22%, cancer death by 16%, and all-cause death by 21%.

These findings are similar to those reported earlier this year in the same journal.² In that study, the diets of 9,514 participants of the ARIC cohort (Atherosclerosis Risk in Communities study) were evaluated over the course of 9 years. Those men or women who ate a Western pattern - high in meat and fried foods - had a higher risk of developing metabolic syndrome. Metabolic syndrome is a constellation of risk factors for heart disease. These include insulin resistance, diabetes, hypertension, high blood lipids, high uric acid levels, and obesity - especially weight carried around the waist.

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¹ Dietary Patterns And Risk Of Mortality From Cardiovascular Disease, Cancer, And All Causes In A Prospective Cohort Of Women, Circulation, 2008

² Dietary Intake And The Development Of The Metabolic Syndrome. The Atherosclerosis Risk In Communities Study, Circulation, 2008

A cure for diabetes?

Mrs. Jones (name changed) was obese. Her weight remained persistently high despite education and entreaties about diet and exercise. She hated taking all those medications. She dreaded bathing suits.

And then.... she had bariatric surgery. She shed pounds faster than Supreme Court justices spanking a health insurance mandate. Instead of having a corpulent and unhealthy patient, the Disease Management Care Blog had a svelte and healthy patient.

Based on witnessing first hand patient transformations like this, the DMCB knows that bariatric surgery for obesity works.

Despite clinical anecdotes, however, obesity surgery skeptics have pointed out that the evidence has been marred by the lack of any prospective randomized clinical trials. Looking backwards at outcomes data cant rule out the possibility that something else was going on to account for the surgerys apparent success. Most of all, this includes self-selection bias where patients, who are destined to independently do well, select surgery. By leaving assignment to chance, docs and patients are out of the decision-making. This randomization helps researchers be more confident that the surgery, and nothing else, accounts for any observed outcomes.

Enter the New England Journal of Medicine, which published the results from two landmark prospective and randomized trials that compared obesity surgery to conservative medical management:

1. Geltrude Mingrone and colleagues screened 72 and then randomly assigned 60 diabetic persons with a BMI of 35 to either a) conventional medical therapy (targeting an A1c of 7% using a multidisciplinary team with visits every 3 months for a year and then one additional visit at two years) or b) gastric bypass or c) biliopancreatic diversion.  The study occurred at Romes Catholic University. Follow-up lasted two years. At the end of the study, 56 patients data were available for analysis. 15 of the 20 patients who had gastric bypass, 19 of the 20 patients who had the diversion and zero of the medically treated patients were off diabetes medications and had normal blood glucoses. As expected, surgery resulted in a whopping decrease in the BMI down to approximately 29.  In contrast the mean BMI was 43 in the medically treated group. Two patients had the surgical complications of hernia and obstruction

2. Philip Schauer and colleagues screened 218 patients and randomly assigned 150 diabetic obese persons with BMIs ranging from 27 to 43 to either a) medical therapy (life style counseling, weight management home glucose monitoring and medications with diabetes specialist clinic visits every three months that targeted an A1c of 6%) or b) "Roux en Y" bypass or c) sleeve gastrectomy. The study occurred at Cleveland Clinic. Follow-up lasted one year and 140 patients data were available for analysis. 5 of 41 patients in the medical therapy group vs. 21 in the 50 assigned to gastric bypass and 18 of 49 who had the sleeve achieved the A1c of 6%. Whats more, most of the surgery patients who achieved the targeted A1c were off all diabetes medications.  As expected, the surgery groups decreased their BMI down to the 26-27 range, while the medically treated patients BMI remained essentially unchanged.  In contrast to Rome, there was a wider range of complications that included 4 reoperations and 1 patient that developed a gastrointestinal leak with peritonitis.

Based on these data plus less pristine studies, its clinical experience and common sense, the DMCB is convinced that bariatric surgery works. These two studies are an important step forward in building the case for the use of this approach in persons with obesity and diabetes.

That being said, there is still room for some skepticism. That lingering doubt could be enough for a commercial insurer to limit coverage. It may be enough to prompt a PCP to recommend that an obese patient with diabetes should still hold off on surgery a bit longer. It may be enough for patients and families to wait another year until there are more confirmatory studies.

Heres why:

1. The studies were not "blinded." The purpose of "blinding" is to keep patients and doctors from being swayed by a "placebo effect." While thats intuitively silly, there is a possibility that having abdominal surgery made those patients believe they were going to lose weight and be cured of diabetes. After all, sham surgery has been known to help angina chest pains.

2. The studies are not necessarily "generalizable." Both studies were conducted by teams of surgeons from single institutions. While we can take Rome and Clevelands word for it, we dont know if obesity surgery done at Bumkinvilles Our Mother of Holy Deficit Hospital will have the same success and low rates of complications.

3. Speaking of complications, both studies were not adequately "powered" to fully assess mishap rates. While there were small single digit differences in the rates of complications, the small numbers may not tell the whole story. Having more patients enrolled in these studies would have increased the ability to meaningfully quantify all the possible bad outcomes.  That was one of the lessons of the Vioxx catastrophe.

4. Last but not least, the success of the surgery may have been inflated by the relatively poor performance of the non-surgical comparison groups. We know very little about the "intensity" of the medical treatment, other than they had the benefit of accessing a multidisciplinary clinic every three months. Population health management experts know that lifestyle change requires an intense program that includes engagement in a personalized and multidimensional care plan that includes far more frequent in-person and telephonic coaching. We dont know if the medical therapy group achieved this level of excellence.

Despite these limitations, however, the DMCB is more convinced that, for patients in whom nothing else works, bariatric surgery can reverse diabetes.

Many brain-training companies tout the scientific backing of their products – the laboratory studies that reveal how their programs improve your brainpower. But according to a new report, most intervention studies like these have a critical flaw: They do not adequately account for the placebo effect.

The new analysis appears in the journal Perspectives on Psychological Science.

The results of psychological interventions, like medical ones, must be compared to improvements in a control condition, said University of Illinois psychology professor Daniel Simons, who co-wrote the article with Walter Boot, Cary Stothart and Cassie Stutts, of Florida State University. In a clinical trial for a new drug, some participants receive a pill with the critical ingredients, and others receive an identical-looking pill that is inert – a placebo. Because participants cannot tell which they received, people in each condition should be equally likely to expect improvements.

In contrast, for most psychology interventions, participants know whats in their "pill," Simons said.

"Its not possible to use a brain-training program for 10 hours without knowing the type of training you received," he said. "People can form expectations for what will improve based on their experiences with the training tasks, and the existence of differences in expectations between people in treatment and control groups potentially undermines any claim that improvements were due to the treatment itself. Not one of the studies cited by the brain-training companies looks at differing expectations between the groups."

Merely having an "active control group," one that does something for the same amount of time as the treatment group, does not protect against the placebo effect, Simons said. A treatment group that completes an intensive memory-training regimen might expect improved performance on other cognitive tasks assessing memory. A control group that does crossword puzzles or watches DVDs for the same amount of time likely wont expect the same amount of improvement on the same tasks, he said.

"These problems are not limited to brain-training studies," Simons said. "They hold true for almost all intervention studies."

To illustrate the pervasiveness of this problem, the researchers examined expectations for improvement in studies of the effect of playing action video games on measures of perception and attention.

"Such studies find greater improvements in performance on attention and perception tasks after training with action video games than after training with non-action games for the same amount of time," Boot said. "However, even with this sort of active control condition, these interventions still are at risk for differential placebo effects."

The researchers measured expectations in two survey studies involving 200 participants each. Participants watched either a short video of an action game ("Unreal Tournament") or one of the games commonly used as controls in these studies ("Tetris" or "The Sims"). They then read descriptions of the cognitive tests used in the studies, watched short videos of the tests, and answered questions about whether they thought their performance on the tests would improve as a result of training on the video game they had viewed.

The results showed that expectations for improvement were greater for the action-game group than for the control games on exactly the same tests that showed bigger improvements for action-game training in the intervention studies. In fact, the pattern of expected improvements exactly matched actual improvements seen in video game intervention studies, the researchers found.

"If expectations for improvement align perfectly with the actual improvements, then any claim that the treatment was effective is premature," Simons said. "Researchers must first eliminate differences in expectations across conditions."

"Even though participants in psychology interventions typically know the nature of their intervention – you cant play a video game without knowing the game youre playing – there are steps researchers can take to ensure that the advantages of the treatment group are not due to expectations," Boot said.

For example, researchers can mislead participants as to the expected benefits of a particular intervention, giving those in the control group higher expectations for improvement than those in the treatment group. Researchers also can assess expectations generated by treatments in a separate sample of participants to ensure that expectations do not differ between intervention and control treatments.

"Although placebo effects can be helpful as well, we need to know what causes improvements in an intervention," Simons said. "We dont want to recommend new therapies, change school curricula, or encourage the elderly to buy brain-training games if the benefits are just due to expectations for improvement. Only by using better active controls that equate for expectations can we draw definitive conclusions about the effectiveness of any intervention."

Since 1977, there has been a 70% increase in caffeine consumption among children and adolescents. Whether it is coffee, tea, soda, or energy drinks, our children are consuming more of it. One well documented effect of caffeine is improved cognitive performance on certain tasks. However, scientists also hypothesize that habitual caffeine use may lead to greater neural rewards if the caffeine drinker were to consume illicit drugs.

To add more to the research base regarding caffeines effect on cognition in children and teens, Jennifer Temple, PhD, University at Buffalo, recently investigated with graduate student Adam Graczyk whether male and female children perform differently on 5 separate tasks in response to caffeine. Using a sample size of 96 children and adolescents, they measured developmental and gender differences in subjects who were given caffeine or placebo and then put through memory tests, reaction time tests, and color-word tasks. The results showed that caffeine increased the number correct in the memory tests, and that females had more correct responses than males in simple reaction time and color-word tasks. There were also differences across the menstrual cycle in the females.

According to Temple, "This is the first study in children and adolescents to report sex differences in responses to caffeine on cognitive tasks as well as different responses according to the girls menstrual cycles. It suggests that if we look at caffeine as a model for illicit drugs, men and women respond differently because of circulating steroid hormones. Moving forward, this could be helpful in developing treatments for drug addictions based on gender." This poster will be presented at the American Society for Nutritions scientific sessions at Experimental Biology.

This study was funded by NIDA grant RO1 DA030386 and by the Gender Institute at the University at Buffalo.

Caffeine Pairing: A Potential New Way to Eat Your Veggies?

In a separate study addressing caffeine, Temple along with her PhD student Leah Panek wanted to find out whether pairing a flavored food (in this case yogurt) with caffeine consumption would increase ones perceived likeability of that food.

They tested whether a caffeinated beverage paired with a novel flavored yogurt would increase perence for that yogurt compared with placebo. A total of 68 men and women ages 18-50 were randomized to receive a beverage containing placebo or caffeine and then consumed a low energy density yogurt or high energy density yogurt. The flavors were not typical of yogurt in order to avoid any taste perences in place prior to the study; they included almond, maple, peppermint, pumpkin pie, raspberry-lemon, strawberry coconut, and savory (cumin).

Results showed that after rating and ranking the seven yogurts over 4 days, yogurt liking increased over time, with the yogurt paired with caffeine liked more than yogurt paired with placebo.

"Next wed like to do the same experiment with fruits and vegetables, in order to capitalize on the fact that people already consume caffeine," Temple said.

Imagine if you could learn to love the one vegetable you hate by administering caffeine!