If Your Diabetes Is Out of Control, Go See Your Family Doc Every 2wks!

I try to call a spade a spade.  I've pointed out colleagues who perform colonoscopies too frequently and place unnecessary coronary stents.  I've also pointed out areas for savings in our insurance system and in our government (stop paying benefits to the deceased! and reign in legislatures' ability to plump up their retirement benefits in ways that you & I can't do).  Earlier this month, two authors concluded that primary care physicians in the United States, including family physicians like myself, are paid too much relative to other countries and are thus driving up the cost of healthcare (conveniently, the reporters underplayed the point that primary care in the States is way underpaid relative to specialty care in comparison to those other countries - but that's another battle for another time).

So just how do I jack up the cost of healthcare?  By seeing more patients!  Really?  At $40-50 per visit? Even at $100/visit, I'd be seeing patients 24/7 in order to approximate the cost of just one (unnecessary) procedure running into the tens of thousands of dollars.  Can you tell I'm not very happy about how we've moved away from prevention and towards treatment after the fact?  Don't get me wrong.  I love being a family physician.  I've truly been blessed with this opportunity such that I wouldn't trade this profession for any other.  I just don't care for our dysfunctional sickcare system.

But I digress.  What I wanted to point out is a study published this week in Archives of Internal Medicine whereby patients with diabetes who are seen more frequently (every 1-2wks) have their cardiovascular risk factors brought under control much more quickly than those seen every 3-6mo.  The authors arrived at their conclusion after evaluating patient charts for over 26,000 patients w/poorly controlled diabetes, dyslipidemia & hypertension followed for 9 years.  The patients seen most frequently were able to reach goal blood pressure, cholesterol & hemoglobin A1c in weeks-to-months as opposed to months-to-years.

So, would you rather pay your family physician $40-50 per visit for a few weeks-to-months to get your health optimized or would you rather pay a specialist to emergently place a stent in your heart or bypass an artery for $50,000.  Which brings up that healthcare conundrum once more:  quick, great, inexpensive - which two adjectives do you want to describe your healthcare because you can't have all three at the same time (at least not w/our current system) unless you put in the effort like a Biggest Loser.

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Tight Sugar Control Might Not Help Cognitive Function

When the facts change, I change my mind.  What do you do, sir? - John Maynard Keynes

Wow!  I'm going to go out on a limb here but I believe that ACCORD (Action to Control Cardiovascular Risk in Diabetes) is going to be this decade's WHI (Women's Health Initiative).  If you'll recall, back in 2002, WHI turned on its head the then prevailing wisdom with regards to estrogen replacement therapy.  Since ACCORD was initially published back in 2008 (I guess I can't read a calendar), it's done the same with regards to tight control of cardiovascular risk factors in diabetics.  Intensive control of blood pressure, cholesterol and even glucose didn't positively impact mortality and other clinical outcomes.  If anything, tight glucose control actually increased mortality in the population studied (older patients w/long standing diabetes).

The latest salvo was published online yesterday in Lancet Neurology concluding that intensive glucose lowering did not improve cognitive outcomes (although it did positively impact total brain volume).  In the MIND (Memory in Diabetes) subset of ACCORD, the authors followed 2,977 participants who'd already been randomized to various treatment protocols as per ACCORD.  After 40 months, there was no difference in cognitive function between intensive glucose control vs standard measures.  Sure it's nice to have a bigger brain, but it's the function of the mass that matters.

Worse yet, as noted in previous analyses, total mortality was increased in the intensively treated group.  No benefit.  Greater risk.  Looks like we need to individualize our treatment goals rather than use the same cookie cutter to drive everyone down towards a hemoglobin A1c <6.

The Times They Are a-Changin' - Bob Dylan

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Biggest Losers Improve Their CIMT & Other Cardiovascular Risk Factors

If it seems like I'm catching up on my reading, that's because I am.  And thanks to a colleague who pointed out a study published online this summer looking at the health of the competitors in NBC's Biggest Loser TV series.  As most of you are well aware, the participants in the show are all morbidly obese.  They are then brought together to compete via intense exercise ~3hrs/d & moderate caloric restriction (never less than 70% resting metabolic rate in a 30:45:25 ratio of protein:carbohydrate:fat.

As any regular viewer of the show knows, these men & women (average 32yo) are usually able to lose at least 100 pounds, most of which is body fat, over the 7 months of filming.  The authors demonstrated a dramatic improvement in cardiovascular risk factors, both traditional & novel, from baseline to post-competition.  For instance, systolic & diastolic blood pressures dropped by 16mm Hg & 15mm Hg, respectively, from pre-hypertensive down to normal.  Glucose, Hemoglobin A1c & insulin dropped by 20mg/dL, 0.64 & 5mIU/mL respectively, from pre-diabetic down to normal.  With exercise, HDL increased by almost 14mg/dL, from just barely normal to almost optimal.

More importantly, the participants were able to decrease by ~25% their carotid intima media thickness (CIMT) rather dramatically in such a short period of time.  This implies that subclinical atherosclerosis is, in fact, reversible, at least in those who are willing to put in the effort.  Granted, the short duration of the TV series doesn't allow for observation of any improvement in clinical outcomes, eg cardiovascular events and/or mortality. However, the correlation between serum/plasma improvements and physiological measures, eg CIMT, gives us all hope, assuming we can put in the effort the participants did.

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Saw Palmetto Doesn't Improve Prostate Symptoms

One of the inevitable challenges men face as we grow older (besides erectile dysfunction) is benign prostate hypertrophy (BPH), eg an enlarged prostate, such that we have urgency, frequency, difficulty fully emptying our bladder, starting and/or stopping our stream, poor sleep from frequent nocturnal awakenings to empty our bladder.

There are two pharmaceutical classes to fix the issue.  One uses alpha blockers to relax the prostate capsule.  The other uses 5 alpha reductase inhibitors to shrink the prostate. The former takes effect in days to weeks but does run the risk of floppy iris syndrome (so go see your ophthalmologist to check for cataracts ready for surgery prior to starting) while the latter takes months (and has been linked to lower risk of prostate cancer but higher grade if/when diagnosed).  The latter also upsets the balance of testosterone byproducts such that less is converted into dihydrotestosterone (which allows for more hair) and more is converted into estradiol (which may decrease sex drive and also lead to erectile dysfunction).

Given the issues associated with prevailing pharmaceutical options, it's not surprising that many men would rather try herbal & dietary nutraceuticals, most commonly saw palmetto.  However, in a randomized, double-blind, placebo-controlled tudy just published in today's Journal of the American Medical Association, the authors found no benefit from even higher than normal dosing.  Specifically, the authors randomized 369 men w/moderately symptomatic BPH to 320mg/d of saw palmetto vs placebo x 24wks.  At that time, the dose was increased to 2/d and at 48 weeks, it was increased yet again to 3/d for the last 24wks of the study.  Unfortunately, there was no improvement compared to placebo at any time using the validated American Urological Association's Prostate Symptom Score.

Previous findings published in February 2006 in the New England Journal of Medicine came to a similar conclusion at just 320mg/d dose alone.  Even the dietary supplement industry gave kudos to the study design and quality of supplement used.  They could not explain the unexpected results either which tells me that these findings are probably close to the truth than they'd like to admit.  With that said, if you want to believe in it or at least try something before succumbing to Big Pharma, go ahead.  Just remember that there is no 3rd party oversight such that you aren't guaranteed the same quality, potency & lack of contamination as the product used in this study.

Of course, if all else fails, there's always surgery.  Seriously!  I'd just suggest taking it a step at a time w/your family physician before crossing the doorway to the urologist.

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More Testosterone is Good for Erectile Dysfunction

For many men who suffer from erectile dysfunction, the class of phosphodiesterase 5 (PDE5) inhibitors is a God send.  No more pumps.  No more injections.  No more intra-urethral suppositories.  Discrete, relatively quick acting & long lasting (latter two depending upon the drug).  However, not all men respond adequately (if at all) to this miracle drug.

It turns out that this lack of response may be due to (relatively) low levels of testosterone.  In a small study published online last month, the authors (supported by the manufacturers naturally) gave testosterone-naive patients Testim brand of topical testosterone or switched those on non-Testim testosterone to Testim w/resultant improvement in erectile function in both situations in accordance with final testosterone levels (average 500 =/- 248ng/dL).

With that said, we should notice that no controls were performed as this was not a randomized, double-blind, placebo-controlled trial, but rather an analysis of the manufacturer's patient registry.  So perhaps these hypogonadal non-responders to PDE5 inhibitors might have reported an improvement in their erectile function w/any other form or brand of testosterone.  Or perhaps they just needed to bump their testosterone levels high enough for their individual physiology (given the wide range of levels at study end).

Regardless, I think that it's imperative that when presented w/someone complaining of erectile dysfunction, rather than reflexively reaching for the little blue pill, we take a look at the bigger picture:  overall health, eg diabetes, heart disease, hypertension, depression, etc; medication side effects, eg blood pressure lowering drugs, antidepressants, etc; mental & emotional factors, eg relationship w/partner, family & friends, financial stability or lack thereof, other stressors, etc.   

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Fluke or Trend: Coffee vs Depression

Remember the scene in the recent remake of The Green Hornet where Kato makes Britt Reid a proper cuppa joe?  The debate over risk:benefit ratio of coffee wages on.  Recent salvos have demonstrated an associated benefit to coffee consumption with regards to stroke, prostate cancer & breast cancer.  To add fuel to the fire, in a study published yesterday in Archives of Internal Medicine, the authors found a link between coffee consumption and depression in women.  More specifically, they found no association between decaffeinated coffee and depression.

The authors followed 50,739 women (average 63yo) for 10 years in the Nurses' Health Study.  All were depression-free at baseline in order to participate in this particular analysis.  Coffee consumption was then evaluated as part of a validated food questionnaire every 4 years.  Compared to those who drank less than a cup of coffee/week, those who drank 2-3 cups/d had 15% lower risk of depression while those who drank 4-5 cups/d had 20% lower risk.  Those who drank decaffeinated coffee showed no association w/depression.

As always, epidemiological observational studies are perfect for developing hypotheses but add no evidence to demonstrating cause & effect.  In other words, while the BBC is willing to state that "Coffee may prevent depression", this study really does nothing of the sort.  In fact, as others noted, perhaps depressed women decided against drinking caffeinated coffee because too much caffeine makes them jittery & anxious and leads to insomnia.  At the very least, we can be clear that it's probably not so much the coffee as much as it is the caffeine, which means that perhaps caffeinated tea and gasp! even soft drinks & energy shots, maybe even dark chocolate, might have a similar effect.  I can't wait to see that research and how far the pendulum swings!

By the way, if you can remember back to last Friday's post regarding the link between depression and stroke, this study goes a long way towards explaining the link between coffee and stroke . . . Yes, it's tenuous at best, but still it's an interesting possibility!

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Never Be The First To Prescribe And Never Be The Last

Never be the first to prescribe a new drug and never be the last.  Why?  Aren't new(er) drugs better?  Not always!  Sure, they're at least just as good (they have to be in order to get passed) as their older competitors and sometimes even better.  But by dint of being new, we don't have the same safety data that we do w/our older drugs.  Remember, better the devil you know than the devil you don't know.  I use this bit of introduction to bring to light a study published earlier this summer (I can't read everything, you know!) in a journal I don't usually peruse, in which exenatide (sold as Byetta) and sitagliptin (sold as Januvia & Janumet) were linked to pancreatic cancer.

Exenatide was approved over 6 years ago as a revolutionary new way to control sugars in patients with diabetes.  As a side note, it's derived from the saliva of the gila monster. Both exenatide & sitagliptin are incretins,  members of a new class of drugs (both oral and injectable) that help maintain glucose homeostasis.  Besides being a daily injectable medication, exenatide's major downfall has been an increase risk for pancreatitis, which was first noted approximately 4 years ago by the Food & Drug Administration.  I suppose this was tempered by an association with weight loss (which encouraged off-label use), most likely due to pronounced nausea, vomiting & anorexia.

These points were highlighted & debated during the recent European Association for the Study of Diabetes meeting last week.  More importantly, as pointed out in the accompanying editorial, while exenatide was approved based upon its ability to lower Hemoglobin A1c, there have been no studies demonstrating any clinically relevant outcomes.  Similarly, while we have studies demonstrating how well niacin raises HDL, we have none demonstrating a decrease in cardiovascular events, much less mortality, unlike their older competitors.

Which brings me back to the beginning.  Never be the first, but never be the last, either.

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What Do You Do About Atypical Femur Fractures?

Earlier this month, I had the privilege to lecture about osteoporosis at the annual Scientific Assembly of our American Academy of Family Physicians.  While osteoporosis is a bread & butter topic for geriatricians and family physicians who take care of large numbers of elders, our pharmaceutical armamentarium has been thrown into disarray by the recent findings of atypical femur fractures associated with bisphosphonate use.

The strength of the evidence, including its association with osteonecrosis of the jaw and possible esophageal+gastric cancer, is such that two of the Food & Drug Administration's advisory committees recently recommended that bisphosphonates be given for a finite period of time rather than the previous lifetime method.  Unfortunately, the committees were unable to arrive at a conclusion as to the duration of time for bisphosphonate use.

However, be that as it may, it's too late for the women who've already sustained an atypical femur fracture, as well as the ones who will, in all probability, develop one over the next several years given their length of use.  The big question is what do we have to offer these women?  In a study published in this month's Journal of Clinical Endocrinology & Metabolism, the authors demonstrated that strontium ranelate and teriparatide can heal these atypical femur fractures, even if they have been in a state of non-union for a year!  

Well, perhaps "study" isn't quite the right word since this was more a case report of 3 women who had sustained atypical femur fractures and did not heal until being adminstered either strontium ranelate or teriparatide.  In a related case report published earlier this summer in the same journal, the authors were able to help heal the atypical stress fracture sustained in a patient on alendronate for 13 years.  It should be noted that she was deficient in vitamin D which was subsequently rapidly repleted.

The point is to offer hope to women who've sustained rare atypical fractures while attempting to prevent the much more common osteoporotic hip fractures.  While the future will lead to more therapies, we need to practice now based upon the evidence before us, not what might be.

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Weakness in legs, listing to the side, falling due to these symptoms. does not seem to be stroke - any ideas?

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Mood Affects Stroke Risk

Observational studies are intriguing concepts.  They give us information linking A to B, but they tell us nothing of whether A causes B or vice versa or perhaps it's just a coincidence.  Luckily, most observational studies give us some clue as to directionality (unlike the chicken & egg conundrum) but it could still be happenstance.

Recently, studies have been published concluding that healthier lifestyles, white-fleshed fruits & vegetables, dark chocolate & high intensity exercise are associated with lower risk of stroke.  I suppose there's always the possibility that some other factor coincident with these factors is the true reason for the decrease in stroke risk.  But somehow I doubt it.  After all, these choices are all reported by healthier people.

But what about our mood?  In a meta-analysis and systematic review published in the Journal of the American Medical Association this week, the authors evaluated 28 prospective studies, including 317,540 cohorts & 8,478 cases of stroke during a 2-29 year follow up, and concluded that depression is associated with an increase risk of total, ischemic & fatal stroke.  Clearly, one could expect to become depressed after suffering a stroke.  However, the participants in these studies were stroke-free at baseline, such that only their moods differentiated one from the other, and thus their risk for stroke later on.

This study of studies builds upon other studies that have arrived at similar conclusions.  In fact, another trial, published last month, came to a similar conclusion after following 80,574 women, stroke-free at baseline, for 6 years in the Nurses' Health Study.

However, the tough part of the job is now set in front of us as we need to figure out the direction of this association.  I say this because one way to prove causation is to treat depression and look for a lower rate of stroke.  Only time will tell as we gather more information.  In the meantime, we should still aggressively treat & manage our depressed patients, not just to remission, but to recovery, so that they can see the rainbow at the end of the tunnel, regardless of whether this affects their stroke risk.

Lifestyle Affects Stroke Risk

About a month ago, we learned that lifestyle affects our mortality.  Earlier this month, we learned that lifestyle affects diabetes risk.  Two days ago, we learned that lifestyle affects erectile function.  Three days ago, we learned that eating white-fleshed fruits & vegetables is associated with a lower risk of stroke.  Well, timing is everything.  In a study published early online last week in the Archives of Internal Medicine, the authors noted a strong association between lifestyle and total, ischemic & hemorrhagic strokes.

Specifically, the authors followed 36,686 Finnish participants for over 13yrs as part of the World Health Organization (WHO) MONitoring trends and determinants of CArdiovascular disease (MONICA) study.  Five cross-sectional surveys were performed in 6 geographically distinct areas in 1982, 1987, 1992, 1997 & 2002.  While the participants were 25-65yo at the start of the study, the average age was actually in the 40s, such that younger participants (avg 41yo) engaged in more healthy lifestyles than older participants (avg 49yo).

The lifestyles analyzed were smoking, body mass index (BMI), physical activity, vegetable consumption & alcohol consumption.  The healthiest lifestyle consisted of never smoking, BMI <25kg/m2, moderate or high physical activity, vegetable consumption >3 times/wk, and alcohol consumption <210g/wk for men & <140g/wk for women.  Unhealthy lifestyles were the opposite of the above such that the factors were considered essentially dichotomous, with a minimum score of zero and maximum of 5.  

Regardless of the specific lifestyle, the greater the number of healthy ones, the lower one's risk for total, ischemic & hemorrhagic strokes.  Granted, those participants with the highest number of healthy lifestyles also had the lowest blood pressures, cholesterol & history of diabetes, and highest education, in a graded fashion.  They also tended to be younger.  But the association between lifestyle & stroke risk remained even after taking these variables into account.

The bottom line?  We truly control our health destiny.