Total Pageviews

Thursday, March 31, 2011

Ear Infections: To Treat or Not to Treat?

The View from the Office


     A brief history of ear infections (otitis media) is in order before going on to intelligently review the current state of the art. Once upon a time that a few of us still alive well remember, there were no antibiotics, and recurrent ear infections in children were a serious problem. Untreated, they could lead to mastoiditismeningitis, and even death. When antibiotics came along, the attitude was "Of course, we'll treat. This is a bad disease." And treatment worked. Mastoiditis became a rare problem. Meningitis became even more rare, especially after new vaccines. Ultimately, ear infections in children became a very benign and simple problem. For the last 50 years or so, there have been hundreds of studies comparing every new antibiotic made by a pharmaceutical company to the old traditional ones trying to show that the new one was better in some way--either it cured more cases or had fewer side effects. The general lesson we have learned from these studies is that the choice of antibiotic doesn't make much difference, so you just use the least expensive one.
     Then, a funny thing happened in the 1970s. Since otitis media was becoming a minor illness with just a few days of fussiness and moderate discomfort which would in the majority of cases go away even if it was not treated, European investigators started asking the question or whether you really need antibiotics at all for this newly less serious infection. The Netherlands pioneered this effort, and there it became standard policy NOT to treat ear infections with antibiotics at the first visit. At the first visit doctors would just recommend tylenol and analgesic drops (like Auralgan) in the ears. Then parents were given instructions that if symptoms were not much better by 3 days, they should return to get antibiotics. It turns out that this policy worked very well. The overall cure rates were the same as in the US, where antibiotics were being used routinely, and there were no increases in complications like mastoiditis.
     It took a while for this approach to drift over to the US, but in the 80s and early 90s there were a number of studies that compared antibiotic treatment of otitis media to the outcomes in children who were not treated with antibiotics. What these studies showed consistently is that there was a small, statistically significant, short-term benefit in the children who were treated with antibiotics. The precise benefit was one day less of symptoms (shorter duration of illness) in 1 out of 7 children treated. This was shocking, of course, to physicians who were trained to treat ear infections. Thus, despite the very clear literature, only a minority of physicians actually stopped prescribing antibiotics; old habits change hard. In my practice I have always preferred to share the evidence with the patients (in this case, the parents) and let them make their own decision. I neither urged nor discouraged antibiotic use. Instead I asked the parents if they would want to use antibiotics for their child for the sake of possibly (a 1 in 7 chance) having one day less of symptoms at the risk of a drug reaction, most commonly a rash, upset stomach, or diarrhea. In my experience about 75% of parents chose to use the antibiotic.

     Since the 1990s there have been very few studies of ear infections in children and absolutely no change in the bottom line--antibiotics confer a 1 in 7 chance of 1 day less of symptoms. That is why it is a noteworthy event that 2 recent studies have just been published in the New England Journal of Medicine on the treatment of ear infections in children--one in children less than 2 years of age in Pittsburgh PA, and the other in children aged 6 to 35 months in Finland. They both reach the same conclusion--that the benefits of antibiotic treatment are greater than has previously been estimated.

     Let's take a look at those two studies and see how convincing this conclusion is.

     In the under-2 years of age study, 291 children aged 6 to 23 months were diagnosed by experts using stringent criteria for the diagnosis of ear infection, and when an ear infection was diagnosed one group received a potent antibiotic (Augmentin) and the other group received a placebo. Among the children who received Augmentin (amoxicillin-calvulanate), 35% had initial resolution of symptoms by day 2, 61% by day 4, and 80% by day 7. This compared to rates of, 28% resolution by day 2, 54% resolution by day 4, and 74% resolution by day 7. These small differences were NOT statistically significant. For sustained relief of symptoms, the rates were 20% vs 14% at 2 days, 41% vs 36% at 4 days, and 67% vs 53% at 6 days. This result achieved borderline statistical significance (P value=0.04). Mean symptoms scores over the first 7 days were lower for the children treated with antibiotics than for those who received placebo (P=0.02). The rate of clinical failure--defined as the persistence of signs of acute infection on otoscopic examination--was also lower among the children treated with antibiotics than among those who received placebo: 4% vs 23% at or before the visit on day 4 or 5 (P < 0.001) and 16% vs 51% at or before the visit on day 10 to 12 (P < 0.001). 
     The second study randomized 319 children aged 6 to 35 months in Finland who were diagnosed by strict criteria as having ear infections to either placebo or the same antibiotic as above.  Treatment "failure" occurred in 18.5% of the children who received the antibiotic vs 44.9% of the children were received placebo (P < 0.001).  At 3 days after diagnosis, the failure rate was 13.7% in the antibiotic group vs. 25.3% in the placebo group. Overall, the antibiotic reduce the progression to treatment failure by 62%. Side-effects were much more common in the antibiotic group, and 47.8% of the treated children experienced diarrhea. The authors of this study comment, "Future studies should identify patients who may derive the greatest benefit, in order to minimize unnecessary antimicrobial treatment and the development of bacterial resistance."
      An editorialist reviewing these two studies concludes "Is acute otitis media a treatable disease? The investigators in Pittsburgh and Turku, Finland have provided the best data yet to answer the question, and the answer is yes; more young children with a certain diagnosis of acute otitis media recover more quickly when they are treated with an appropriate antimicrobial agent."

Fig 1: An acute ear infection: a very bulging tympanic membrane.

     To all this I have to say, "Not so fast!"  First, the authors used, as is appropriate for a formal study, a "strict" definition of an ear infection. In the Pittsburgh study, the criteria for a diagnosis of ear infection were:  (1) onset within 48 hours preceding the office visit; (2) a symptom assessment score of at least 3 on a scale of 0-14; the symptoms evaluated on a 3 point scale (none, a little, a lot) were: tugging on ear, crying, irritability, difficulty sleeping, diminished activity, diminished appetite, and fever. This is, in fact, admirably rigorous. The problem, however, is that out in the real world of general practice, primary care physicians do not do all this. Their history is very brief, no symptom scores are assessed, the ears are looked at very quickly, and lots of cases are diagnosed as ear infections that have no actual bulging of the tympanic membrane. What this means is that the group of patients being treated in ordinary offices is significantly different, probably with milder disease, than the patients included in the study. Thus we do not know if the conclusion from the formal study should apply to children with less severe illness.
     Clinical "failure" was strictly defined as either a lack of clinical improvement (and this is what parents really care about) or worsening of signs on otoscopic examination (which parents don't care about). My perspective as a practicing physician is that, if the child is not having any symptoms, I don't care what the ear drum looks like. I would never extend or repeat an antibiotic just because the ear drum look abnormal, whether moreso or not. What matters is how the patient is doing.
     Finally, both studies arbitrarily chose to use an advanced antibiotic (Augmentin). This is a powerful (probably more powerful than one needs) and effective antibiotic, but it causes a very high rate of gastrointestinal side-effects. In one studied it caused diarrhea in almost half of the children treated. This would mean that treatment is like trading one problem (an ear infection) for another (diarrhea), and it is hard to say which is worse. I can tell you which is messier. Certainly there is a need for additional studies, if we are going to making a recommendation to change general practice, to determine which antibiotic will cause the least side-effects while retaining most of the effectiveness. There are many good candidates.
     Thus in my opinion these studies don't change anything. It still comes down to a close call whether young children with mild ear infections should be treated. This decision should be made by the parents, not by the doctor. The doctor's role is continue to give parents the benefits of the latest information and help them to make a reasonable decision.
      Another strategy that has been well-defined as safe and effective in multiple studies is for the physician not to treat at the time of the first visit, but to give a prescription for an antibiotic to use if the symptoms become worse or do not resolve in 2-3 days. This was called a "delayed prescription" for an antibiotic. Only about 50% of parents given a "delayed prescription" actually get them filled, which means that many, many children get better all by themselves. This strategy significantly reduces the use of antibiotics and thus will lead to less emergence of antibiotic resistance among common bacteria. I use this strategy a lot.

References:  Hoberman A et al. (Pittsburgh) Treatment of acute otitis media in children under 2 years of age. NEJM 2011; 364:105-15.  Tahtinen PA et al. A placebo-controlled trial of antimicrobial treatment for acute otitis media. NEJM 2011; 364: 116-26. Klein JO. Is acute otitis media a treatable disease? (editorial) NEJM 364: 168-9.

Thursday, March 17, 2011

The Truth About Osteoporosis



    The primary predictive risk factor for osteoporosis is how old you are. One simple preventive, therefore, is not to grow old. If we're not interested in this strategy, what do we do?
    The most effective preventive strategy is to keep active and eat a good diet throughout life. Live a healthy lifestyle and generally you don't have to worry about problems like this. [See healthy lifestyle formula below.]

Smoking directly reduces bone strength and mineralization. 5 servings of brightly and multi-colored fruits and vegetables a day give you lots of extra calcium. Having a high body mass index actually protects you from osteoporosis, but leads to such an unpleasant assortment of other problems, it is not worth it. Exercise is absolutely essential both for a healthy life and for the prevention of osteoporosis. If you do all 5 steps of a healthy lifestyle, then you won't need to worry about osteoporosis when you're older. You just keep doing what you're doing.

     Well, you're older now, and you may not have done all that lifestyle stuff as regularly as you would have wished. What now?  The current national recommendation from the US Preventive Services Task Force (USPSTF) is to a risk assessment for osteoporosis at age 65 for women. There is insufficient evidence yet to recommend such screening for men. There are multiple ways of doing this. Getting a DEXA bone scan for bone density is the most popular (and the most lucrative for those who run the machines), but it is not the only way. I actually prefer something called the "Osteoporosis Risk Assessment Instrument"; you only have to answer 3 questions to calculate your risk. [Click on this link, Osteoporosis Risk Assessment Instrument,to calculate your own risk. You get 9 points if your age is between 64 to 74, and 15 points if your age is 75 or older; you also get 9 points if your weight is less than 60 kilograms or 132 pounds.]
     Now the website will say, if your score is 9 or greater, you should get a DEXA scan. I say, if your score is 9 or greater, then you should proceed to some reasonable treatment for osteoporosis. If you end up taking calcium, vitamin D, and getting more weight-bearing exercise and you don't have osteoporosis, you have really done yourself no harm. If you do have osteoporosis, then you're doing the right thing. I don't really see what the DEXA scan gets you other than the illusion that you know what's going on and what to do about it. The DEXA scan itself is not the criteria to use to decide whether to take a medicine like Fosamax. The occurrence of a fracture is the definitive criteria for that decision. Many will argue that it seems better to take the Fosamax before you get a fracture, and this is a perfectly reasonable leap of faith, but you will be acting beyond the limits of our current knowledge.
     Anyway, in my view the simple Osteoporosis Risk Assessment Instrument is a much, much simpler way of seeing if you should get serious about your risk of osteoporosis.  It is also a great deal cheaper than a DEXA scan. As you can see the major risk is age, followed by weight, and the third factor is whether you take estrogens for menopausal symptoms, which relatively few women do anymore.
     So, if you do have a high risk score, what you do you do about it. The primary treatment is--guess what? Exercise, calcium, and vitamin D. No secret here. The recommended amount of exercise is 22 minutes of weight-bearing activity (walking does fine) a day, 1000 mg of calcium a day, and at least 800 IU of vitamin D. The special medications (the most common one being Fosamax (alendronate) are not indicated unless you have already had a fracture from osteoporosis.

Some practical tips:
      1. A DEXA bone scan is not the only way to assess risk. A simple 3 question score (Osteoporosis Risk Assessment Instrument) will do the job more easily. Try it.
      2. There is no evidence that repeating a bone scan leads to any clinical benefit. The proven value of the test is a one-time thing only--it confirms that you have osteoporosis. It is clear from the studies that repeating the scan in less than 2 years leads to inaccurate results--either false reassurance or unnecessary worry. If the DEXA scan gets worse after 2 years, there's not much else to do. Just exercise, calcium, vitamin D, and Fosamax (or other bisphosphonate).
      3. Drugs for osteoporosis still have several controversial aspects.
                 a. They are clearly beneficial only for patients who have had prior fractures. In this case, they definitely reduce the rate of subsequent fractures.
                 b. We do not have any proven evidence of benefit from receiving treatment for more than 5 years. The studies haven't been performed for longer than this. There is some evidence of harm from prolonged treatment--primarily increased brittleness of the bones and a possible risk of a relatively rare complication, osteonecrosis of the jaw bone. It is quite reasonable just to stop this medication after 5 years of use; you have received most, if not all, of the benefit.
       4. The amount of calcium that is recommended is 800 to 1500 mg per day. You can get this in a single supplement tablet, but you can also get it naturally. The dark green leafy vegetables like kale have lots of calcium. One cup of kale is equivalent to a cup of whole milk in calcium content--about 400 mg.
       5. Vitamin D is the subject of increasing controversy. In recent years it has been learned that higher levels of vitamin D in the blood are associated with a reduced risk of heart disease and cancer, not just osteoporosis. What is not clear is whether giving a vitamin D supplement, of 800 to 2000 IU a day makes a difference. There are no studies confirming this, but it is widely expected to be helpful based on the basic science of human vitamin D metabolism. There are, of course, other ways to get vitamin D, of which regular exposure to sunlight is the best. You only need 10-15 minutes a day and not every day. 
       What is becoming clear is that around the world large numbers of people are deficient in vitamin D. In my last practice at Kaiser, I was routinely testing for vitamin D in all of my patients and found that about 20% of them were significantly deficient as the Kaiser laboratory defined the test (below 30 pcg/mL was considered deficient). What was really surprising is that a number of patients who were deficient were younger, had good diets, and exercised regularly. So what gives? A recent Institute of Medicine report suggests that we don't need to worry until the level is less than 20. Another problem, however, is that there is considerable variation from lab to lab in the way vitamin D levels are measured and reported. So what is considered deficient in one laboratory may be considered adequate in another. 
       There is enough controversy and uncertainty about the efficacy of routine screening for serum vitamin D levels that I no longer endorse it. What I do endorse, however, is routine supplementation for everyone with a multivitamin containing vitamin D, at least 800 IU per day for the average adult.

     6. Not all exercise is considered exercise from the perspective of preventing osteoporosis. This rather strange conclusion was brought to my attention by a patient in my practice here in Graeagle. He is a regular bicycle rider. He had heard that, since bicycle riding is not strictly weight-bearing, that it was ineffective in preventing osteoporosis, and he requested a DEXA bone scan for himself. I ordered it for him, expecting it to be fine, but it turns out he was right. He had osteoporosis. I did a search through the literature and found a number of well-substantiated reports confirming that intense bicycle riding does not prevent osteoporosisA similar problem may present itself to vigorous swimmers as well. The results suggest, in fact, that the more intense the bike riding, the greater the risk of osteoporosis (at least on the bone scan). Another factor that may be adding to the problem is that sweat contains a substantial amount of calcium; the more you sweat, the more you lose. You can lose up to 20 mg of calcium per hour through heavy sweating. Some clinical studies suggest that this effect is significant.
     Of course, my patient has never had a fracture and may never get one. He does not want to take the Fosamax medication, and it is not clear that he should. So he is left with going back to calcium (which he prefers to do through natural diet), vitamin D, and exercise. He should add some regular walking to his bike riding. 

     Who would have thought that a healthy person who is an avid bike-rider would need to worry about osteoporosis? We're still not really sure what all this means. It is not clear that he has any disease. It is clear that his bones look thinner than average on a DEXA scan. The real test of whether he has a disease or not is whether he experiences any clinical problem, and this has not happened yet. So we wait and see. The big question is what does he or you do in the meantime, while you're waiting. That's a personal decision.

Thursday, March 10, 2011

How To Take Care of Your Diabetes



     Diabetes is common, all too common. The first thing to say about it is that it can be prevented. The Healthy Lifestyle (Formula for Health) that I have previously described [see below] has been shown to prevent up to 93% of all cases of type 2 (adult-onset) diabetes. Now that's a bargain. No fuss, no mess. Think about it. If you already have type 2 diabetes, you can make it go away by changing to a healthy lifestyle.

     From a physician's point of view, diabetes is the most complicated disease we manage in primary care. There can be so many complications. Our job, and yours too, of course, is to prevent each and every complication. To achieve this we need teamwork--you and your physician working together.
    One of the things that makes diabetes so complicated is that there are so many experts out there who are publishing "guidelines" for an ideal world. The American Diabetes Association (ADA), for example, is a very well-intended organization which has done a lot of good work. They publish a set of guidelines ("Standards of Care") for diabetes based on the recommendations of experts, which make diabetes so complicated that no one could do it in the real world. They were apparently conceived for the world of specialists where they have a lot more time to manage their patients--an hour or more. In primary care we average only 15-20 minutes. The ADA recommended standards, if followed to the letter, would take on average about 2 hours per visit. I did a survey in a prior practice of mine in Pennsylvania in a rural setting (Hershey) among primary care physicians. It turns out that not one was following the published ADA guidelines--because they just didn't have the time. The reality, moreover, is that no one has ever done a study to see either if the specialists themselves are actually following the ADA "standards of care" or whether, if they do, it really makes a big difference in patient outcomes.

     Well, my prevailing principle in medical practice is to Keep It Simple. With that in mind, I have reduced the necessary steps for high-quality care of diabetic patients to 6 simple steps, which I make easy to remember by giving it the little memory clue the first six letters of the alphabet "ABCDEF". Here is all that you need to keep track of for your diabetes:

A = Hemoglobin A1c; this is the basic measure of sugar control in diabetes. It is a test that assesses your average glucose level for the past 3 months. The goal is to keep the hemoglobin A1c at 7.0% or below.

B = Blood Pressure;  Blood pressure control is extremely important in diabetes to prevent the development of renal failure. The goal is to keep your blood pressure averaging < 140/90 mm Hg.

C =  Cholesterol. The primary measure of cholesterol that is used for patients with diabetes is what we call your "bad" cholesterol or LDL cholesterol. For diabetic patients the goal is to keep your LDL below 100 mg/dL. It usually takes medication, a statin, to do this.

D = is for MDRD method of assessing kidney function. This is the only letter of our mnemonic that is not intuitive. The MDRD stands for the Modified Diet in Renal Disease study, which is where this method of assessing renal disease and its progression in diabetes was developed. The MDRD number is your estimated glomerular filtration rate (it may be easier to refer to  your kidney function as GFR)--i.e., how many milliliters of fluid can your kidneys filter every hour. The goal is for this number to be anywhere above 60. Most adults start with a normal GFR between 100-120. You won't really run into serious problems until it falls below 30, which is when you will want to consult a kidney specialist and start getting informed about dialysis options and procedures. As soon as it crosses below 60 you want to track it regularly. Some medication doses may have to be adjusted. The important thing to know is that kidney failure and the need for dialysis can be prevented. The secret is to keep good control of your blood pressure and monitor your renal function with the MDRD number.

E = eye checks by an ophthalmologist. You should have one at the time your diabetes is first diagnosed, and then every 2 years thereafter. This is to check for diabetic eye disease which is a major cause of blindness; it is preventable. Your ophthalmologist may suggest a different interval for follow-up checks ranging from every year to every 3 years. Your doctor needs to have a copy of the ophthalmologists latest report in his chart for you. You can help by asking your ophthalmologist to be sure to send your doctor a copy.

F = foot exams. A major complication of diabetes is loss of circulation and nerve function in your feet. This in turn can lead to repeated injury (since you won't feel any pain) and ultimately to difficult to treat foot ulcers, and finally, if these can't be controlled, to amputation of a part of your foot or leg. Your doctor should perform a good foot exam at least every 6 months looking for signs of severe fungus infections, bacterial infections, ulcers, or other sores or breaks in your skin. Just doing a good visual inspection of your feet on a regular basis has been shown to reduce the rate of amputations in diabetics by 50%.

     And that's it. It's really not all that complicated. There is absolutely no reason why you cannot track these 6 measures yourself. And, if it is not your doctor's usual practice to check any of these things, you can simply ask. If you are prepared and aware, you can insure that every thing that needs to be done is done. What you need, in a nutshell, is to ask for 3 blood tests--a hemoglobin A1c (should be checked every 3-6 months), a cholesterol panel, and a kidney function test (creatinine, which is how they calculate the MDRD number). You can check your own blood pressure at home; this is a really good idea. Then just ask your doctor to check your feet every 6 months and review with them when they received the last report from your eye doctor, whether you had any changes from diabetes in your retina, and when you are due for your next eye check up.

Thursday, March 3, 2011

Obesity Is Not the Problem

Obesity is Not the Problem.
A BMI > 30 is the Problem.

     People often come in to see me for care of their diseases. I routinely ask them what chronic medical problems they have, and they tell me all about their high blood pressure, diabetes, thyroid problem, and osteoporosis, etc. They usually don't think to mention the fact that they are significantly overweight. This is very understandable. Obesity is an unpleasant word to use about anyone. Yet our nation's economy depends heavily upon being able to sell junk food to almost everyone, with obesity as an obvious natural result. Therefore  I propose getting rid of the word obesity, at least as a medical term.
     The problems with it as a medical term are that it is too vague. The term "obesity" is generally used to mean someone is 20% or more overweight. Unfortunately, most people do not know their ideal weight, and, even if they did, it is no simple matter for most of us to multiple it by .2 and add it to our ideal weight in order to determine if we are obese. Who does that? Furthermore, some people are finicky and refer to themselves as overweight at a mere 10% over ideal body weight, while others at 30% over ideal body weight consider themselves normal because everyone else in their family is that way. "Normal" is relative after all. And, of course, in our society "obese" is a stigmatizing word that is used to attach a label to people as though they were all of the same nationality and ought to be blamed for a host of our country's ills. All of this is unhelpful.
      The good news is that obesity itself is not a disease, and its health hazards have been overstated. The trend in the medical profession has been away from classifying people as obese. Instead the clinical measure has become Body Mass Index (BMI). This number takes your weight (in kilograms as it turns out) and adjusts it for your height (in meters); the specific formula is: BMI= weight(kg) / height(meters)^2 (squared)
     There are a couple of really handy things about this number: (1) With the new electronic medical records that all health systems use, your weight and height can be automatically converted into this single number without anyone having to do any math; and (2) It turns out that there is a nice, simple dividing line for separating all those people whose weight, however much over ideal body weight it may be, is not a problem clinically from all the rest who have a significant, in fact, major medical problem.
     The magic number is 30 (kg/m^2). If your BMI is less than 30, your weight is not a medical problem. The experts define a normal BMI as between 18 and 25, but being over 25 is not associated with any significant increase in medical complications until you hit 30. A BMI > 30, however, is associated with significant increases in the risk of developing diabetes, high cholesterol, hypertension, heart disease, stroke, and dying. It is a real problem.
     Thus, when you come in to my office, I will always check your recorded height and weight to calculate your BMI. I will tell you if it is greater than 30, and I will record it in your chart as a medical problem, just as I do for hypertension and diabetes. And we will have a discussion about what you can confidently do to bring it back down under 30. We don't have to shoot for your perfect weight. We just have to get your BMI down under 30. This is a much easier goal to accomplish. For most people it can be achieved with an increase in exercise and conscious eating to lose around 10 pounds.

     Here's a handy little tool to calculate your own BMI. Let me know if it is over 30, and we can do something about it.