Lap Band - Not the Band-Aid You Want?

Laparoscopic adjustable gastric banding, more commonly known as lap band (which Allergan markets as their trademarked LAP-BAND adjustable gastric banding system), has flourished over the last several years, as evidenced by all the billboards I saw while driving in Southern California last week.

As we attempt to deal w/our nation's obesity, those who are in dire straights w/body mass index (BMI) >40kg/m2 and w/o obesity related health problems and those w/BMI >35kg/m2 w/obesity-related health problems qualify for surgery.  In fact, the FDA just approved decreasing the lower limit to just 30kg/m2 in those w/obesity-related health problems this past month based upon a review of 12-24 month data from a prospective 5 year study.

Ironically, in a study published last month in the Archives of Surgery, the long term outcomes from laparoscopic adjustable banding performed between 1994 & 1997 in Europe where the authors started performing these surgeries in 1992 were not so wonderful during the follow up period approximately 12 years after surgery.  In fact, close to a third of the patients experienced band erosion and close to half required removal of the band.  

Granted the study was small w/only 151 consecutive patients followed, of whom only 82 responded to questions.  Furthermore, tremendous experience has been gained since the beginning close to 2 decades ago with over 300,00 patients enrolled in the BOLD database with over 12,000 patients being added monthly per Allergan.  However, results from this 10 year trial won't be available until 2017 at the earliest.  

In the meantime, I should point out that in Europe (where we often look for advanced medicines & surgical procedures now available years before reaching our shores), there has been a shift away from lap bands since 2004 towards the more traditional gastric bypass.  As noted above, this is quite opposite our national experience where Allergan expects to make $220-240M this year.

And just what are those obesity related health problems?  Cancer, diabetes, high blood pressure, heartburn, heart disease, osteoarthritis (typically hips & knees), sleep apnea, stroke, and more.  This also assumes that the patient has failed all reasonable attempts at medical therapy, eg diet & exercise.  But if you think about, the participants of NBC's Biggest Loser are able to lose just as much weight as those who have surgery.  All they (we) have to do is change our lifestyle.  Something easier said than done for most of us.

You Can't Win A Fight With Your Wife - Part 2

As I mentioned yesterday, some people are going to believe what they want to believe, no matter the proof.  Just like the fact that I'll never win an argument or battle w/my wife.  But having said that, I must now turn the other cheek, at least with regards to vitamin D.  Little did I realize while working in a vitamin D research lab as a pre-med student many moons ago that I would find vitamin D so fascinating and important (sorry! the truth comes out) almost 3 decades later.  While I am not an expert, I am quite the proponent of getting enough vitamin D and checking/reaching optimal levels.

So I was quite disappointed in the Institute of Medicine's recommendations released last November.  In an editorial published in the New England Journal of Medicine last week, it turns out that for non-bone related indications, members of the IOM considered the existing evidence as inconsistent & inconclusive.  Remember that all the current evidence linking vitamin D levels to cancer, cognitive function, heart disease, and infections is observational in nature.  This data is only able to demonstrate an association.

On the other hand, the data linking vitamin D to falls & osteoporotic fractures is consistent & defnitive, having been derived from cause & effect studies, typically randomized, double-blind, placebo-controlled studies.  Which is why the authors agreed upon 20ng/mL as adequate for bone health looking at PTH response.  But when 20-30ng/mL is considered insufficient by Quest Diagnostics, 30-100ng/mL is considered the normal reference range by Quest, and toxicity is manifest only at levels significantly above 100ng/mL, I can't rationally explain why I want to push vitamin D levels closer to 100ng/mL and farther from 30ng/mL (but, of course, without exceeding 100ng/mL) except to think of a grading system.  So yes, I'm one of those who speak with a forked tongue.

But I can think that I can make a reasonable justification in that some vitamin D is necessary for bone health as long as I don't push beyond the upper limit of normal.  On the other hand, when it comes to vaccinations, I find it impossible to come up with a reasonable justification not to get vaccinated (unless one is allergic), especially since those who go unvaccinated expose not only themselves but others to risk of some infectious disease.

Maybe a better analogy is to consider hormone therapy for menopausal women.  Current randomized, double-blind, placebo-controlled evidence warrants giving estrogen + progesterone for symptomatic vasomotor instability at the lowest dose for the shortest period of time, but not for prevention of heart disease or cognitive decline, while observational & laboratory data suggest other potential indications.

I guess what I'm trying to say is that if you want to do something based upon observational data, try to have some cause & effect data supporting your decision, too.

You Can't Win A Fight With Your Wife

My wife & I have been married for over 17 years now and over the years, I've learned that I have a better chance of winning the MegaMillions lottery than I have of winning an argument with her.  I tell my residents & fellows the same thing when it comes to dealing w/(demented) patients who are hallucinating or delusional.  You can never convince these patients that their perception isn't reality.

It turns out there are folks who feel so strongly about something that no amount of science will convince them otherwise.  Granted, we haven't always done a good job explaining the difference between the various types of scientific studies that appear to toss the truth around back and forth.  Some days, coffee is good for you; other days, it's not.  I don't blame them.  But on the other hand, all the existing data tells us that vaccines don't cause autism.  But try to convince the parents of a child who was diagnosed w/autism spectrum disorder soon after his/her vaccination, thanks in no small part to Dr. Andrew Wakefield, who has since been discredited by Britain's General Medical Council and whose fraud has been exposed in a 3 part series authored by Brian Deer as published in the British Medical Journal (part 1, 2 & 3).

So it was with great interest that I read the comments posted at www.USAToday.com regarding a study just published in the New England Journal of Medicine that concludes that fish consumption does not affect mercury levels nor does said mercury levels affect heart disease, stroke & mortality risk.  As of the time that I write this post, none of the 23 individuals who posted a comment believed in the conclusion, most pointing to hidden collusion from an obvious agenda - convincing patients to eat more fish.

Well, let me toss in my 2 cents and let's ignore this study, even though "mercury is a toxin", as one individual posted, and others are (rightly) more concerned about its neurotoxic effects.  Most, if not all, studies looking at the relationship between fish consumption and heart disease (without considering mercury) conclude that more (fish) is better.  Likewise, with most, if not all, studies regarding cognitive function & dementing illnesses - more fish means less (cognitive decline).  In none of these studies has there been any demonstration of harm (besides the occasional fishbone, I suppose).  So I look at this study as superfluous but supportive.  But then again, I eat fish (even had sushi last night).  I doubt that I'll ever be able to convince my colleague to do so.

Magic Pill Prevents Diabetes! Part 2

As a follow up to last Thursday's rant about magic pill(s) to prevent diabetes, I wanted to delve further into exploring the risks associated with pioglitazone, especially since it's pharmaceutical competitor, rosiglitazone, has been linked to increase risk of adverse cardiac events (both are known to increase one's risk for heart failure exacerbations plus both are linked to greater fracture risk) and an earlier version, troglitazone, was pulled off the market due to risk of liver issues.

Now, medically speaking, I tend to lump things together, rather than split them apart.  Of course, the pharmaceutical companies don't like this as they want their product to stand out as superior to the rest.  But given a number of otherwise similar products, I tend to choose the least expensive, generic version that gives me equivalent results.

But let's think about this the other way around.  Let's say that there are 2 drugs, neither one of which is risk-free, sharing some side effects in common (weight gain, edema, heart failure, and fracture risk), but one of which has a significantly greater risk of say bad cardiac outcomes.  While it has not been been demonstrated via randomized, double blind, placebo controlled studies, let's say for arguments sake that all the observational data point toward a significant difference in terms of these cardiac outcomes.  Given this summary, wouldn't you split, rather than lump, and choose the drug with the lower risk profile?

As if you couldn't tell, I was referring to pioglitazone & rosiglitazone.  And in a quirk of fate or perhaps just serendipity, a systematic review & meta-analysis of 16 observational studies involving over 810,000 uses of TZDs (both pioglitazone & rosiglitazone) was just published in the British Medical Journal concluding that the latter drug was associated with a statistically significant greater risk for heart attacks, heart failure & mortality, compared to those who received the former.

So if you're looking for a magic pill w/o side effects that will prevent diabetes, keep looking.  It doesn't exist yet. But if lifestyle modification isn't in the books for you, last Thursday's review offers hope with pioglitazone assuming that you are not risk adverse.  But in one of those rare situations, I wouldn't substitute its competitor, rosiglitazone, even if it were offered to me for free.

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Are You 50 Years Old? Get Your Zostavax Shot!

A good deal of family medicine is focused on prevention, which is different from screening.  In an ideal world, we prevent (all) diseases & illnesses before they manifest themselves.  This is primary prevention.  For instance, washing  hands helps prevent spread of the common cold and other communicable diseases.  So does wearing condoms (well, the latter, anyway).

Most of the time when we speak of screening, we're talking about looking for disease at an early stage where we have better chances of effecting a cure (this is secondary prevention).  For instance, when a patient turns 50 years old, assuming no other risk factors, we typically recommend a screening colonoscopy, looking for pre-cancerous polyps.  And at any visit, we ask about tobacco use, hoping to find those who do and convince them to stop before it's too late, eg Alzheimer's disease, cancer, COPD, erectile dysfunction, stroke, etc.

I mention this because the Food & Drug Administration just (yesterday) approved the use of Zostavax vaccine to prevent shingles starting in those 50 years and older.  If Zostavax sounds familiar, it's because it's already approved (since 2006) for use in anyone 60 years and up.  In fact, a recent study demonstrated a 45% relative risk reduction in shingles in those who received the vaccine compared to those who didn't.  Only 152 individuals needed to receive the vaccination in order to prevent a single case of shingles.  And a major reason to prevent shingles is to minimize the risk of complications, eg post-herpetic neuralgia, a debilitating chronic pain state.

Given that most family physicians and internists are overworked, I'd suggest you bring up this topic and request your immunization rather than risk developing shingles while waiting for your doc to find out about this new indication.  And while you're at it, don't forget to ask for your screening colonoscopy!

Magic Pill Prevents Diabetes!

I read about magic, breakthru pills on the Internet everyday.  Marketing ploys tout all natural, 100% organic, dietary supplements, as if natural & organic equal safe.  Think about this.  Would you wipe your ass w/poison oak or poison ivy?  No?  But it's natural!  Would you snort a line of cocaine, inject some heroin or smoke some marijuana just because no antibiotics & fertilizers were used in their production?  Thought not.  Well, most of you, anyway!

Diabetes, especially the common Type 2 version associated w/being overweight & obese, is becoming a real big problem, pun intended.  We've known how to fix this (prevent diabetes) at least since 2002 - stop stuffing our faces & get off our butts.  However, that's easier said than done.  Most of us are still waiting for that magic pill that will cure everything w/o causing any side effects.

Back in 2002, the Diabetes Prevention Program (DPP) concluded in a randomized study over close to 3 years that lifestyle modification reduced one's risk of developing diabetes by 58% while taking the medicine, metformin, reduced one's risk by 31%, compared to doing neither.  Statistically speaking, these two interventions were considered equivalent.  But I suspect that due to a history of concern over the risk of lactic acidosis as well as its known GI side effects, metformin never gained traction, although some physicians do prescribe it in just such a fashion.

As as you know, inertia trumps lifestyle modification hands down.  Over the next 10 years of follow up after conclusion of the randomized portion of DPP, as published in the Lancet, the total risk of developing diabetes was still lower in those who changed their lifestyle.

Well, for those of you waiting for that magic pill, I'm happy to report that a study published today in the New England Journal of Medicine concluded that pioglitazone reduced the risk of becoming diabetic in a randomized, double-blind, placebo-controlled 2.4 year study 602 patients w/impaired glucose tolerance.  Those who received pioglitazone noted statistically significant lower fasting glucose, HgbA1c (running 3 month average of sugar control), diastolic blood pressure (bottom number), and rate of carotid intima-media thickening (less is good), as well as higher HDL cholesterol (the good kind).

Down sides?  You should monitor your liver function while taking this drug.  And those taking pioglitazone were more likely to suffer from weight gain and edema (fluid retention), both well known side effects.  This particular study was too small & too short to shed any light on the recent revelation of increased risk of fractures & heart failure in those taking pioglitazone.

What about taking both?  After all, we've been treating diabetics with this 1-2 punch for years and there's even a combination pill available, Actoplus Met.  So if you're really not inclined to change your lifestyle and just want to pop a pill to prevent diabetes, I suppose you could have your cake and eat it, too.  Just be sure you don't already have kidney disease and heart failure - and as always, talk it over w/your family physician about whether it's worth the risk or not.  But if you want a risk free solution, stop stuffing your face and get off your ass!  By the way, this study was sponsored by the manufacturers of pioglitazone . . .

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Goldilocks & Activity (Physical & Sexual)

Remember Goldilocks?  She wanted everything just right.  Size of her chair, temperature of her porridge, and firmness of her bed.  Something like that, right?  She didn't like extremes, whether too little or too much of anything.  In reading my posts, I'm sure you've gathered that I believe in the Goldilocks theory of medicine, whereby many of the measurable parameters need to be made just so for optimal health & wellbeing, as opposed to settling for just good enough.

I thought about this some more when I read a study just published in JAMA this week about physical & sexual activity.  It turns out that infrequent or episodic activity, whether physical or sexual in nature, could serve as a trigger for a heart attack or even sudden cardiac death (SCD), more than doubling, even quadrupling one's (relative) risk.  However, to put it into proper perspective, that extra hour of activity is estimated to account for just 2-3 additional heart attacks per 10,000 person-years & 1 more SCD per 10,000 person-years.

On the other hand, habituating oneself to regular activity was associated with the expected 30-45% decrease (relative) risk of cardiac events.  I can hear it now.  Gee, honey, the doctor says we have to have sex regularly to prevent me from having a heart attack.

Fish Consumption vs Macular Degeneration

Don't ask me why, but a heart attack doesn't scare me.  However, the thought of having a stroke gives me the willies.  Luckily, eating more non-fried fatty fish can lower our stroke risk, as can a host of other lifestyle modifications.  It turns out that going blind is another condition that sends shivers down my spine since I'm so dependent upon my eyesight (aren't we all?).  The good news is that the Archives of Ophthalmology released a study this week demonstrating an association between more fish (oil) consumption and lower risk for age-related macular degeneration (ARMD) in women.

The authors followed 38,022 women in the Women's Healthy Initiative study for 10 years after completion of a detailed food-frequency questionnaire.  All participants were free of ARMD at baseline.  Those in the highest tertile of docosahexanoic acid (DHA) consumption (230mg/d) had a 38% lower risk of developing ARMD compared to those in the lowest tertile.  For eicosapentaenoic acid (EPA), those in the highest tertile of consumption (100mg/d) had a 34% lower risk compared to those in the lower tertile of consumption.

In real world terms, for those of us who don't like (can't) read the small print on the side of bottles of Fish Oil supplement, eating at least 1 serving of fish a week was associated with 42% lower risk of ARMD compared to those who ate less than a serving of fish a month.

I know that some are concerned about the possibility of heavy metal & mercury poisoning from fish (oil), but given all the benefit vs the extremely low theoretical risk, I'll eat my fish (and take my fish oil).  And visit my sister-in-law, the optometrist, every year.

Environment vs Heart Attacks & Strokes

As noted in USA Today last month, authors in the Lancet published a review of 36 studies looking for external & environmental triggers of myocardial infarctions, something beyond the usual blood pressure, cholesterol & sugar analysis.  They concluded that the use of cocaine had the greatest risk of triggering a heart attack in any given individual but that exposure to air pollution & traffic, while of dramatically lower risk, was likely to cause more heart attacks simply because we live in an industrialized world but relatively fewer people use cocaine.

Well, it's not like most of us can just pick up from the city and move out into the country to avoid a heart attack.  Besides, while the absolute numbers might be large, the absolute risk of having a heart attack due to air pollution and traffic is still quite small.  So the headline is a great way to draw readership but doesn't really offer much reason to change anything for you & me.

Now, we've all known that air pollution can trigger & aggravate asthma and other breathing conditions.  But despite the study above, I wasn't convinced that where we choose to live makes that much of an impact to most of us.  So ironically, I found a study this week published in the European Heart Journal where the authors concluded that residential road traffic noise was associated with an increase risk of stroke in our retirees.

The authors analyzed data from 57,053 participants over 13 years and uncovered 1,881 initial diagnoses of stroke, which they then linked back to exposure to traffic noise and air pollution.  Via statistics, they assigned 27% higher risk of stroke to those older than 64.5 years of age with no significant change in risk for those less than 64.5 years old.

Asthma, heart attacks, and now strokes.  I guess that explains the real estate adage, "location, location, location!"  So on second thought, maybe it might not be a bad idea to reconsider that job offer to relocate (to a less populated area).  And if you're about to retire and collect that gold watch at 65 years old, moving out to the country might actually be good for your health.

RIP Nate Dogg 1969-2011

I don't claim to follow rap or hip-hop but Nathaniel D. Hale, better known as Nate Dogg, passed away yesterday at age 41.  No details were given regarding cause of death but USA Today did report that he had suffered strokes in 2007 & 2008.  In fact, he suffered his first stroke at 38 years old and his second at 39 years old, only to die 3 years later.  Now, I don't know about you, but despite being a geriatrician, I think of stroke as being a condition of the elderly.  Not that it's any less painful in our (grand)parents generation, but to lose a talent with so many more years to offer us is truly sad.  We can't prevent all strokes, but we can certainly minimize our risk if we adopt healthier lifestyles, at the risk of putting out a shameless self-plug.  Let's do our best to maintain our ability to complete our life goals.  And let's not leave this Earth prematurely.

Starbucks Might Prevent Strokes

Remember the old Folgers coffee jingle?  "The best part of wakin' up is Folgers in your cup".  I guess it's been replaced by Starbucks since I can't recall the last time I heard that phrase but see Starbucks at just about every street corner.  Well, it turns out that a cup of joe in the morning might not be such a bad idea, at least not if you're a woman.

In a study just published in Stroke, the authors followed 34,670 women without any history of heart disease or cancer for 10+years.  After taking into the account the usual suspects, eg age, alcohol, blood pressure, body mass index, cholesterol, diabetes, smoking, etc, they concluded that daily coffee consumption was associated with a lower risk of total stroke (by 22%), cerebral infarction (by 25%) & subarachnoid hemorrhage (by 23%), but not intracerebral hemorrhage, compared to those who drank a different morning beverage.

As always, please note that while these findings are statistically significant (and clinically significant, at least for me, any time you can reduce stroke risk), they are still associative in nature.  There has yet to be a demonstration of cause & effect.  On the other hand, these findings are consistent with those published in March 2009 regarding the 83,076 women in the Nurses' Health Study, so there does appear to be a trend towards benefit in women.

However, in all fairness, I should point out that a smaller study of both men & women published in November 2010 concluded that drinking coffee sporadically, rather than regularly, transiently increased one's risk of ischemic stroke.

The moral of today's story?  If you're a woman, you can drink your java at the nearest coffeehouse every day without worrying about stroke risk, but if you're a man, you might want to reconsider.  In either case, I don't think those other sugary, fatty drinks are going to do any of us any good health-wise.

Caught Between A Rock And A Hard Place - Part 2

Men tend to be rather self-conscious when it comes to hair loss (I suppose women are, too).  That explains the proliferation of haircare products advertised to help regrow hair or hide its loss.  There's also a growing number of hair transplant surgeons to step in when pharmaceuticals fail.  And just what are these medications?

The most commonly used drugs to minimize hair loss (male pattern hair loss or androgenetic alopecia) are minoxidil (sold as Rogaine) and finasteride (sold as Propecia & Proscar).  The latter is a 5 alpha reductase inhibitor (5ARI) which also includes dutasteride (sold as Avodart).  Both finasteride & dutasteride are also used to shrink the prostate in those men suffering from benign prostate hyperplasia by inhibiting the breakdown of testosterone (T) via 5 alpha reductase into dihydrotestosterone (DHT).

So now that that's all clear, it's been known for some time that both finasteride & dutasteride also increase one's risk of erectile dysfunction, loss of libido (sex drive), and gynecomastia (male breast development).  The percentage of affected varies depending upon the study but is usually stated as up to 8.1% in the product insert for both Propecia & Proscar, and up to 7.6% for Avodart.  Previously, this was thought to be transient and reversible.

However, in an article published in USA Today, there are now reports that the sexual side effects may not be reversible after all!  In a study published this month in the Journal of Sexual Medicine, the authors reviewed the available data in the literature surrounding the use of these 5ARIs and noted that a subset of men reported prolonged adverse sexual side effects, even after discontinuation of the medicine.

So are we doomed to choosing btwn hair loss +/- prostate enlargement vs erectile dysfunction +/- gynecomastia?  It turns out that there's a physiologic rationale for the side effects:  estradiol (E2)!  Think of T as the fulcrum upon which the seesaw of DHT & E2 are balanced on opposite ends - E2 is the other breakdown of T via aromatase.  Sorry, I can't avoid the biochemistry.  Anyway, the seesaw is typically flat & level in someone not taking any medicine.  Now, imagine the seesaw in someone taking a 5ARI.  What happens as DHT decreases?  E2 increases, right?  And when there's too much E2, one develops erectile dysfunction & gynecomastia.

So I always recommend checking E2 in addition to DHT in those patients for whom I prescribe a 5ARI.  And in those who develop either erectile dysfunction or gynecomastia, one can consider an aromatase inhibitor if stopping the 5ARI either doesn't work or isn't an option.  So don't give up hope.  Ask your physician to check your hormone levels.  And perhaps you can get yourself out from between that rock & hard place.

Mediterranean Diet vs Metabolic Syndrome

I thought I'd start out this week just the same way I ended last week, looking for trends.  It turns out that some authors published a meta-analysis released this week in the Journal of the American College of Cardiology looking over 50 original studies involving 534,906 participants and came to the same conclusion as others in the past:  adherence to the Mediterranean diet is associated with a lower risk of metabolic syndrome.

Furthermore, when study types were broken down into epidemiological/observational & clinical trials, both demonstrated a protective effect on the individual components of metabolic syndrome, eg waist circumference, HDL, triglycerides, blood pressure, and glucose.

Now, I don't have access to all 50 studies.  But in my personal library, I found studies published in September 2004 and December 2008, both with general findings similar to that above.  The point of this is that changing one's diet/nutrition/lifestyle is a relatively inexpensive means to manage costs associated with the end-stage outcome of metabolic syndrome, eg obesity, heart disease, diabetes, and stroke.  The year is still new.  Set an example for your patients.  Commit yourself to a better, healthier you!

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Cheers! Let's Drink for Cognitive Function!

In the movie industry, sequels to successful films are a common way to garner more revenue.  So I find it ironic that this is the 3rd post this week that's a follow up to another post that I've written about recently, this time regarding alcohol and heart disease.  In this particular variation on the alcohol theme, authors recently concluded that low-to-moderate consumption of alcohol is associated with a lower risk of dementia.

More specifically, the authors followed 3,202 participants over 3 years via detailed assessments of alcohol consumption and Structured Interview for Diagnosis of Dementia of Alzheimer type, Multi-infarct Dementia and Dementia of other Etiology.  Mood disorder was assessed via the short version of the Geriatric Depression Scale.  They also evaluated functional ability via the an 8 item scale of the Instrumental Activities of Daily Living.  

The biggest question always raised in these types of studies is whether the specific form of alcohol matters.  In other words, does it matter whether someone drinks beer mostly, or wine mostly, or mixed drinks mostly.  It turns out that regardless of the type of alcohol consumed, the risk of dementia is lower compared to teetotalers.

Do recall that this is an observational study, demonstrating only an association.  It is not a randomized, double blind, placebo controlled study that demonstrates causation.  More importantly, those who drank low-to-moderate amounts of alcohol also tended to be healthier, both physically & mentally.  So who wants to volunteer for the study of causation as a follow up to this study of association?

In the meantime, it's always good to know that this study's findings are not a fluke but merely confirm similar conclusions published 4 years ago and again just 3 years ago in a systematic review of the literature.

Smoking Cigarettes Increases Risk of Breast Cancer - Part 2

"It's deja vu all over again." Yogi Berra

As a follow up to yesterday's introduction about searching for trends in medicine, I coincidentally managed to stumble upon another gem published last week in the British Medical Journal demonstrating yet again (remember my January 27th post?) a link between smoking, both active & passive, and breast cancer in postmenopausal women.

This time, the authors followed for 10 years the 79,990 women in the Women's Health Initiative Observational Study and concluded that, compared to women who had never smoked, former smokers had a 9% higher risk of breast cancer, whereas current smokers had a 16% higher risk.  In fact, the highest risk for breast cancer was found in those who had smoked for 50 years or more compared to those who had never smoked.  

Amongst never smokers, those with the most passive exposure had a 32% greater risk of developing breast cancer compared to those without such exposure.  So just what constitutes excessive passive exposure?  Ten or more years during childhood, 20 or more years as an adult at home, and/or 10 or more years as an adult at work.  In particular, the last qualification has some very significant public health & legislative implications, even in our fair city, where just about anything goes.

Cannabis Use: Is It Really Safe? Part 2

I believe in trends, not fads.  So unless the first study suggesting a change in management is really strong (statistically significant, causative data rather than just associative, in a similar population, looking at clinical outcomes that matter rather than just disease risk markers), I tend to wait for follow up studies with similar findings.  In science, we've been burned too many times by some remarkable & miraculous discovery, only to find out later that the results were conjured, as no one else has been able to corroborate the outcome.  In medicine, we say "Never be the first, but never be the last".

Along those lines, when I stumbled upon an article in the USA Today over the weekend, I thought I had managed to trump them but as I read further into the article, I realized that the tables had been turned.  Instead, I had missed an article published in the British Medical Journal last week and was looking at more evidence linking cannabis to psychosis (remember my post from two weeks ago?).

The authors had followed a cohort of 1923 individuals over a decade and noted that, in those participants without baseline history of psychosis (or psychotic symptoms) and no admitted cannabis use ever, initial use of cannabis over the ensuing 3 years almost doubled the risk of psychosis during the next 8+ years.

As a family physician & geriatrician, not a psychiatrist, I find it compelling that I have now found 5 studies published in reputable journals over the last 4 years linking cannabis to psychosis (not to mention a number of other health conditions).  Maybe it's time we took another look at this billion dollar industry.

Part 3
Part 1

Caught Between A Rock And A Hard Place

Non-steroidal anti-inflammatory drugs (NSAIDs) are used commonly without much second thought.  They're widely available over-the-counter without prescription at just half the prescription strength.

Members of this class include naprosyn, ibuprofen, and ubiquitous aspirin, amongst others.  We know that taking aspirin daily can prevent heart attacks & strokes in those at risk, in exchange for a small but greater risk of bleeding in the stomach & brain.  All NSAIDs, while quite useful for pain relief and potentially for fever control, can also wreck havoc with the kidneys in addition to irritating the stomach.

As of last week, we can now add erectile dysfunction to the growing list of side effects as published in the Journal of Urology.  The authors evaluated 80,966 men between 45 and 69 years old and divided them based upon NSAID use (both self-reported & by pharmacy data).  After allowing for the usual adjustments, eg age, chronic conditions, etc, NSAID use was associated with 38% higher risk of erectile dysfunction.

So where do we go from here?  Remember that this study is observational in nature.  It can only prove association, not cause & effect.  It's good for generating hypotheses but not for demonstrating proof.  Therefore, if you need to take your NSAID, continue to do so.  But the best piece of advice is to discuss this study with your family physician in order to understand its implications for you.

Oh, and in case you're wondering, similar findings were published in May 2006.

Diabetes = Dying 6 Years Earlier

Diabetes is not kind to the body but can it kill you?  After all, high sugars can cause blindness, kidney failure, amputations, heart attacks & strokes (any of which might make you wish you were dead).  Well, in a study published last week in the New England Journal of Medicine, the authors reviewed the cause of death in 123,205 persons out of 820, 900 participants in 97 trials, and after excluding those w/baseline vascular disease & adjusting for age, sex, tobacco use, and body mass index, they concluded that diabetes more than doubled one's risk of death from vascular causes, eg heart attacks, strokes & peripheral vascular disease, compared to those without diabetes.

While the increase in vascular risk was expected (though perhaps not the extent), I was surprised to find that diabetes also increased all-cause mortality by 80% compared to those without diabetes.  Furthermore, diabetics had a 25% greater risk of dying from liver, pancreas, ovary, colorectum, lung, bladder, and breast cancer compared to their non-diabetic brethen.  

Even after adjusting for blood pressure, cholesterol, inflammation & kidney function, diabetics had a great chance of dying from kidney disease, liver disease & other digestive disorders, pneumonia & other infectious diseases, mental & nervous system disorders, intentional self-harm, and chronic obstructive pulmonary disease.  

After running through all the statistics, the authors concluded that a 50 year old man w/diabetes would live 6 years less than his counterpart without diabetes.  So go find out your fasting glucose because every 18mg/dL above 100mg/dL was associated with 10% higher risk of death from any cause, eg all-cause mortality, the Holy Grail of outcome studies.  Every 18mg/dL above 100mg/dL increased cancer deaths by 5%, vascular deaths by 13%, and other causes of death by 10%.  

The take-home point?  Do whatever you can to avoid developing diabetes.  Change your eating habits & your level of physical activity.  Get rid of that paunch.  Work with your family physician so that you can live a long & fulfilling life.

Hospice & Palliative Care for Prostate Cancer

As a follow up to yesterday's discussion about the last 6 months of life in those with heart failure, the Archives of Internal Medicine also published a study looking at the use of hospice in men dying of prostate cancer between 1992 and 2005.

The good news is that just over half (54%) were enrolled in hospice.  The bad news, the average length of stay prior to death was just 24 days while one in four enrolled within seven days of passing.  So yes, the message is getting out to offer palliative care but it's not getting through early enough.

As physicians, we are trained to save lives.  So we continue to offer medications, therapies, and surgeries, even when faced with certain death, because to do otherwise would be to admit defeat.  It's time that patients, families & physicians realize and admit that death cannot be defeated.

Despite what you may read or hear about immortality moving within our grasp, that is not the case.  So to encourage thinking otherwise is disingenuous for everyone involved. Instead, even as we first attempt a cure, we should also be just as focused on offering palliative care to counter all the symptoms and side effects of said therapy.

And we should initiate a discussion as to when to focus less on cure and more on caring, with the possibility of transitioning to a hospice facility when the staff there can do the most good in preparing the patient and family for one of life's certainty.  As noted two weeks ago, there are studies that demonstrate higher quality of life and prolonged survival in those patients who elect hospice care over narrowed focused continued attempts at cure.

Hospice & Palliative Care for Heart Failure

Heart disease remains the number one killer of both men & women in the US.  However, not everyone dies a quick & sudden death from a massive heart attack or dysrhythmic collapse.  Instead, due to the modern miracles of medicine, many suffer for an inordinate number of years with damaged hearts leading to heart failure while one in four die within the first year after the diagnosis is first made and one in three die within a year of hospitalization for heart failure.  In fact, heart failure accounts (at least partially) for one in eight deaths.

Given the grim statistics above, it's imperative that we start talking to our patients about their goals and their desires for (specific) treatment soon after, if not immediately upon, diagnosis so that even as we work to mitigate the complications of heart failure, we can also palliate the symptoms in a fashion consistent with the patient and family's desire.

Towards that end, two studies were published last month looking at the cost of care during the last six months of life in the US and in Canada over the past decade or so.  Given our general love of the care offered by our neighbor to the north to all her citizens, it's surprising to me that there were more similarities than differences.  Surely, the way medicine is practiced has changed during this same period of time, something documented in both studies.  But importantly, only one in three in the US died in the hospital with hospice use increasing over this period of time, coincident with a surge in the number of hospitals with palliative care programs.

We're not there yet.  We're still not optimally caring for our dying, once it's clear that death is imminent in the next 6 months or so.  But we're slowly getting better.

Prostate Cancer Patients Can Still Take Their Testosterone Therapy!

While doing some research looking for studies on testosterone, I stumbled upon a gem, a diamond in the rough, really, that was published online last month in the Journal of Urology, in which the authors concluded that in patients with untreated prostate cancer, testosterone supplementation does not lead to cancer progression.

This is quite an amazing turnaround in thinking in a very short amount of time if you follow medical literature.  If you'll recall, Huggins received the Nobel Prize in Medicine for discovering that castration (surgically reducing testosterone levels) would allow men w/metastatic prostate cancer to live just a bit longer.  Thus, we all concluded that testosterone had to be the cause of prostate cancer, ignoring the obvious fact that testosterone levels are highest in adolescence whereas prostate cancer is a condition of the aged when testosterone reaches a nadir.

Only recently has literature been published concluding that testosterone is not the cause of prostate cancer and that perhaps, there might be another reason for this malignancy.  And last year, the AHA, ACS & AUA came together in a statement to address the cardiovascular risk associated with (hormonal) androgen deprivation therapy.

We used to think of the prostate simply as analogous to charcoal briquets fresh from the store w/testosterone equivalent to the lighter fluid.  In essence, we were waiting for a spark to ignite a conflagration, analogous to trying to find the (still unknown) factor that converts normal prostate into cancerous prostate.

Now, we have a more complicated picture, the saturation model, whereby a prostate cancer needs a fixed amount of testosterone, albeit very low, such that (surgical or chemical) castration might be beneficial by completely depriving the prostate of any and all testosterone.  However, any more testosterone above that level means nothing to the cancer.

And in fact, that's what the authors found in 13 hypogonadal men (average age 59 years old) who chose active surveillance for their Gleason score 6 (in twelve and 7 in one) and elected testosterone therapy that almost tripled their baseline total testosterone from 238ng/dL up to 664ng/dL on average without any statistically significant change in PSA over 1-8 years of follow up.  Amazingly enough, no cancer was found in half the patients upon repeat biopsy.  There was no progression of disease in any of these men, neither local or distant during the time observed.

Let's be clear.  I'm not advocating that all men w/prostate cancer receive testosterone therapy.  But rather than routinely withhold therapy that can provide clinical benefit, we now have the basis to have an intelligent conversation about risk vs benefit.  In some men with low grade, localized disease who are clinically symptomatic of low testosterone, supplementation might make sense if they are interested in active surveillance anyway.

Heartburn & Magnesium: What's the Link?

Back in the day, in the dark ages of peptic ulcer disease, we didn't have much to offer those who suffered from heartburn and ulcers.  Heck, we didn't even know why it happened.  We put it off to stress and scoffed at the idea that an infection might increase one's risk substantially.

Then we developed H2 blockers, such as Pepcid and Zantac (not to be confused w/Xanax, a cousin of Valium, the addicting anti-anxiety drug).  At first, like most drugs, these were only available by prescription only.  However, they soon made over-the-counter.  But these medications weren't completely successful.

So we then developed the proton-pump-inhibitor class, a revolution in stomach acid control.  Who doesn't know of the purple pill (not to be confused with the blue pill used for a completely unrelated purpose) that brought relief to so many sufferers.  Similarly, this drug was originally only available by prescription.  But over the last several years, half-strength versions have made it over-the-counter.

And therein lies the problem.  Because these medications are so efficacious in controlling heartburn symptoms and because they are so easily obtained these days, many patients are taking them without medical supervision.  Of course, no one remembers to tell their family physician about all those pesky over-the-counter medications and herbal supplements that they're taking, especially the natural & organic ones since they must be good for you, right?

Well, we've recently learned, to the contrary, that we do have to be concerned about long-term use of PPIs.  For instance, PPIs have been associated with osteoporotic fractures because they make it difficult to absorb calcium carbonate, the most common form of calcium supplement, due to their acid suppressing properties.  More recently, PPI use has been associated with an increase risk of pneumonia, both in the community and in the hospital, whether on the ward or postoperatively.  Worse, PPI use has recently been linked to an increase risk of dangerous diarrhea due to Clostridium difficile.  And, PPI use has also been linked to higher risk of recurrent heart attacks due despite the use of anti-platelet drugs such as clpidogrel & prasugrel.

With all that background, guess what?  In an announcement yesterday from the FDA, PPIs were declared to decrease magnesium absorption to such a degree that long term use can cause hypomagnesemia (low magnesium) leading to muscle spasm (tetany), irregular heartbeat (dysrhythmia), and convulsions (seizures), of which the latter two can result in death.

So we've just been warned to check magnesium levels prior to starting PPIs in those expected to be taking this for a long period of time (more than 1 year).  We should also check magnesium in those who are also taking digoxin, diuretics (water pills), and any other drugs that can, in and of themselves, cause low magnesium, prior to starting PPIs.  

In 2009, 21 million patients obtained prescription-strength PPIs and took them for an average of 6 months, whereas prolonged period of time is considered more than a year.  Compare that to the millions of patients who take OTC PPIs without supervision.  It's doubtful that they stop after 14 days and don't repeat more than 2 times (3 total) each year.  After all, if it works and the heartburn is gone, why stop?  Especially if it comes back again?  Plus it's cheaper to take this OTC medication than to seek medical attention.  And there's no time loss waiting in the doctor's office reading months old magazines.

My point is this.  Whether you're taking a prescription PPI, eg Aciphex, Dexilant, Nexium, Prevacid, Prilosec, or Zegerid, or an OTC PPI, eg Prevacid 24HR, Prilosec OTC, or Zegerid OTC, ask your family physician to consider checking your magnesium level.  And by the way, consider switching from calcium carbonate to calcium citrate.

Heart Disease in Women: What Not To Do

Finally, in the American Heart Association's latest guideline & recommendations, they also developed a short list of those interventions that are not useful/effective and/or may cause harm, rather than prevent heart disease in women.  Obviously, some of these recommendations are rather controversial.  Maybe not so obvious, unless you've been reading my recent rants, all these recommendations are subject to change in the future once new information comes out suggesting not so much a fad (outlier), but rather a trend in another direction.

For those older than 65 years of age, aspirin may be useful in the otherwise healthy once blood pressure is controlled.  But, routine aspirin is not recommended to prevent heart attacks in healthy women <65 years old due to the greater risk of bleeding in the brain or from the intestinal tract.  Now, this is where you need to read closely, because the AHA then slips in the recommendation that aspirin may be reasonable for women <65 years old, if they want to prevent an ischemic stroke.

While I agree this seems somewhat two-faced and clearly very confusing, current scientific literature points to the use of aspirin as being effective at preventing strokes in young women (<65 years old) but ineffective in preventing heart attacks in the same age group.  Balance your stroke risk against your risk for bleeding in the brain and/or stomach, and clearly it's now an individual decision, not the broad stroke of the paintbrush that we're used to using.

While proven to prevent spinal tube defects, the AHA states that folic acid has not been proven to prevent heart disease when used in isolation or in combination with vitamins B6 & B12.  They also conclude that the preponderance of evidence shows that antioxidant vitamin supplements, eg vitamin E, C & beta carotene, have no demonstrable benefit for the 1o & 2o prevention of heart disease in women.

And while hormone therapy, including selective estrogen-receptor modulators, are useful in treating debilitating menopausal symptoms, the AHA concluded that they should not be used solely for the 1o & 2o prevention of heart disease in women.  If you've been following my posts, you'll realize that this recommendation is not without controversy.  But again, I reserve the right to change my mind when confronted with new evidence to the contrary.  So even as we strive to practice cost-effective, evidence-based medicine, let's be sure that we bend & sway with the winds of change.

Heart Disease in Women: Risk Factor Goals

In the American Heart Association's latest recommendations to prevent heart disease in women, they summarized several risk factor goals that all family physicians should know by heart (pun intended) but which may not be clear to the women in our lives.  And if you don't know where you're supposed to go, how will you get there, right?

So be sure you know your blood pressure.  It's not enough to be told "it's good" or "it's normal".  You need to know how good or how normal.  AHA acknowledges the goal of an optimal blood pressure of <120/80mm Hg be obtained & maintained via lifestyle interventions.

Medication should be started when blood pressure is >140/90mm Hg (or >130/80mm Hg in those with chronic kidney disease and/or diabetes).  If the women in your life doesn't like the side effects of any particular blood pressure medication, make sure she addresses her concerns with her family physician.  In this day & age, given all the various options available to us, there is no reason (aside from cost) that someone should have to suffer from medication side effects.  This is a situation where the pound of cure should really be weightless (free of side effects).

The women in our lives also need to know their cholesterol numbers.  Again, good enough really isn't.  Specifically, the AHA acknowledges the following optimal goals: LDL <100mg/dL, HDL >50mg/dL, triglycerides <150mg/dL, and non-HDL (total cholesterol minus HDL) <130mg/dL in all women via lifestyle interventions.

Where I disagree with the AHA (and NCEP ATPIII) is their stratification as to when to start medication.  They approach this from a public health perspective (in order to ration care & save money).  However, when I meet with someone, we develop a plan specific to their needs & goals, rather than accepting a good enough attitude that comes from treating groups, rather than individuals, in order to save money for society.

AHA notes that niacin or fibrates can be used when HDL is low (<50mg/dL) or non-HDL is high (>130mg/dL) but only in high risk women after their LDL goal is reached.  High risk women are those with known heart disease or whose risk is calculated to be >20% over the next 10 years.  This can be derived via the Framingham Risk Calculator and the Reynolds Risk Score.

Finally, while the AHA did not discuss body composition, they did recommend using lifestyle interventions to reach a goal waist <35 inch and appropriate body weight such that body mass index is <25kg/m2.