0 More on Al Lewis Book Why No One Believes the Numbers

Remember the DMCBs reviews (here and here) of Al Lewis book Why No One Believes the Numbers?  The DMCB cant either, which is why you may want to check out this review by Christobel Selecky over at the excellent DMCB sister blog, The Doctor Weighs In.  Its worthwhile reading, especially since Ms. Selecky was the CEO of the star crossed disease management company LifeMasters. She knows of what she speaks and has the scars to prove it.

The DMCB finds her 6th paragraph slightly off topic but worthy of further discussion. Say what you like about the "evidence" supporting disease management, but lets at least be consistent and apply the same high standard to the patient centered medical home, the electronic health record and accountable care organizations.  Patients deserve nothing less.

0 Aggressive Insulin Treatment vs Pills for Diabetes with Athersclerotic Disease No Difference in Outcomes

When doctors and their patients review the treatment options for diabetes mellitus, a common question is "Why mess around?" If the blood glucose, thanks to a relative lack of the hormone "insulin," is "high," shouldnt the more "natural," tighter and physiologic answer be... insulin? While there are pills that can lower blood glucose levels and patients detest shots, its unclear if the long term clinical, economic and quality-of-life outcomes favor one approach (oral medications) over another (insulin).

The Disease Management Care Blog thinks that these are the issues that were explored by the important, international and huge multi-center "ORIGIN" Study.  The results have just been published by the New England Journal.

Over 12,000 persons over age 50 years with

1) impaired glucose control or "pre" diabetes (more on this topic here), or

2) just-diagnosed diabetes or,

3) well-controlled diabetes (A1c less than 8 to 9%) on no or just one oral medication

and

4) established heart or atherosclerotic vascular disease

were randomly assigned to insulin glargine (with dosing that aimed for a normal blood glucose of 95 mg.%) or usual care (that relied on physician judgement and local guidelines). 

After one year, 50% of the insulin group hit their targeted blood glucose level and their median A1c (a measure of average blood glucose control over time) was 5.9%.  The usual care group achieved a median glucose level of 123 mg.% and after one year the A1c was 6.2%.  The difference in A1cs persisted over the remainder of the study (Table here)

The mean age of the participants was 63 years with an impressive median follow-up of 6 years that yielded outcome results on 99% of the participants.

Results?  No difference in heart attacks or kidney disease.

When cardiovascular death, nonfatal heart attack, non-fatal stroke were combined, the incidence was the same in both groups - about 3% per year.  There was no difference in kidney outcomes including deterioration in function or need for dialysis.  Hospitalization rates for any cause were the same in both groups.  There was an isolated difference involving angina that, in the DMCBs mind, may have been a statistical fluke.  You can look at the outcomes for yourself here.

There was one important difference.  Among the 1456 persons without formal diabetes (the "impaired" group - see above), persons given the insulin were less likely to progress to a formal diagnosis of diabetes (25% vs. 31%).  Unfortunately, they paid a price, because they had a higher rate of insulin-induced low blood sugar reactions (an incidence of 17 vs. 5 per 100 person-years).

Based on these results, the DMCB thinks:

1. Turning to insulin treatment early in the course of pre or diabetes treatment for persons with heart disease doesnt appear to offer any important difference in macrovascular (heart attack and stroke) disease or kidney disease outcomes. However, thats only true among patients who have achieved an A1c below 7%.  (The DMCB cant figure out what happened to the patients with a baseline A1c in the 8% to 9% range who didnt get to an A1c below 7 - did insulin help them?)

2. Whats more, its possible that driving an A1c lower - once its below 7% - doesnt offer any additional outcomes advantage.

3.  While early insulin supplementation may prevent the "burn out" of the insulin-producing cells of the pancreas, the price for that is a higher incidence of low blood sugar reactions.  Even though this "cure" of diabetes may seem like a big deal, why bother if theres no difference in survivorship?

4. As the population health management service providers discuss care planning with their patients with diabetes and heart disease, the topic of early aggressive insulin may come up.  Heres an answer to that question.

5. If accountable or risk-assuming organizations believe that early aggressive insulin treatment will lower the direct costs attributable to heart disease among their patients and enrollees with diabetes, the answer is no.

That out-of-ate but compelling image is from a 2003 HHS website on why Prevention Makes Common Cents

0 No evidence drugs vitamins supplements help prevent cognitive decline in healthy older adults

A review of published research has found no evidence that drugs, herbal products or vitamin supplements help prevent cognitive decline in healthy older adults.

The review, conducted at St. Michaels Hospital, found some evidence that mental exercises, such as computerized memory training programs, might help.

"This review provides some evidence to help clinicians and their patients address what strategies might prevent cognitive decline," said Dr. Raza Naqvi, a University of Toronto resident and lead author of the review.

The issue is of particular importance given that mild cognitive impairment affects 10 to 25 per cent of people over age 70. Mild cognitive impairment is characterized by reduced memory, judgment, and decision-making skills compared to someone of a similar age, but not enough to interfere with daily activities.

The annual rate of decline into dementia, such as Alzheimers disease, is about 10 per cent. Given that rate and the aging population, its estimated the number of Canadians with dementia will double to more than 1 million in the next 25 years.

Researchers including Dr. Sharon Straus, head of the Knowledge Translation Program at St. Michaels, reviewed 32 randomized clinical trials involving about 25,000 patients.

They found no strong evidence for pharmacologic treatments such as cholinesterase inhibitors that were developed to improve the effectiveness of acetylcholine, a chemical messenger that assists memory, thought and judgment.

Nor was there strong evidence that herbal supplements such as gingko improved cognitive functions or vitamins and fatty acids such as vitamin B6 or omega-3 fatty acids.

Some studies on estrogen actually indicated an increase in cognitive decline and dementia.

Evidence on the value of physical exercise, such as strength-training, was weak.

The strongest evidence was for the value of mental exercises such as computerized training programs or intensive one-on-one personal cognitive training in memory, reasoning, or speed of processing.

Dr. Naqvi said future studies should address the impact of cognitive training on the prevention of cognitive decline.

"We encourage researchers to consider easily accessible tools such as crossword puzzles and sudoko that have not been rigorously studied," he said. "The studies in this review that assessed cognitive exercises used exercises that were both labour- and resource-intensive, and thus may not be applicable to most of our patients."

0 Pregnant No more Smoke for Baby Health

Pregnant women who stop smoking with the habit during pregnancy gave birth to healthy children, and with the same weight as those of mothers who do not smoke. This goes on from a study of Nick Macklon University of Southampton (UK) at the European Society of Human Reproduction and Embryology meeting in Stockholm (Sweden), indicating that the negative effects of smoking, the baby on the way, you can "Cancel" if you quit the habit during pregnancy.

Decreased birth weight is the most common effect of smoking during pregnancy, which in some cases. Risk of preterm birth and disorders related to the development of the brain Mothers who smoke, the researchers said, have always been encouraged to give up smoking again and became pregnant, although until now there was little evidence that the object could have positive effects on the unborn child in the last minute.

The result comes from a study of 50 000 pregnant women from the University Medical Centre in Southampton from 2002 to 2010 were followed, the researchers identified seven groups of women - Non smoking, who for more than a year to before conception closing, which was less than a year before conception, which was confirmed after the pregnancy stopped, further comprising up to 10 cigarettes a day, between 10 and 20 per day, more than 20 stops per day -. and are the data collected, the parameters of the newborn

After adjusting the results for other factors known that the properties of the baby at birth - gestational age, weight and age of the mother and the socio-economic class - the researchers found that children whose mothers had stopped smoking during the period " periconceptional "- or the time when they thought they were pregnant or as soon as pregnancy is confirmed - they were was born with a birth weight were significantly higher in children who smoke whose mothers continue, and similar to the offspring of women who never even smoked. "Not only was birth weight is much higher than among children of mothers who had to continue to smoke, was - explained Macklon - but we also have found that babies born the same gestational age and the same head circumference than those achieved by women had never smoked.