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Twenty years ago I started my job as ‘Professor of Complementary Medicine’ at the University of Exeter and became a full-time researcher of all matters related to alternative medicine. One issue that was discussed endlessly during these early days was the question whether alternative medicine can be investigated scientifically. There were many vociferous proponents of the view that it was too subtle, too individualised, too special for that and that it defied science in principle. Alternative medicine, they claimed, needed an alternative to science to be validated. I spent my time arguing the opposite, of course, and today there finally seems to be a consensus that alternative medicine can and should be submitted to scientific tests much like any other branch of health care.
Looking back at those debates, I think it is rather obvious why apologists of alternative medicine were so vehement about opposing scientific investigations: they suspected, perhaps even knew, that the results of such research would be mostly negative. Once the anti-scientists saw that they were fighting a lost battle, they changed their tune and adopted science – well sort of: they became pseudo-scientists (‘if you cannot beat them, join them’). Their aim was to prevent disaster, namely the documentation of alternative medicine’s uselessness by scientists. Meanwhile many of these ‘anti-scientists turned pseudo-scientists’ have made rather surprising careers out of their cunning role-change; professorships at respectable universities have mushroomed. Yes, pseudo-scientists have splendid prospects these days in the realm of alternative medicine.
The term ‘pseudo-scientist’ as I understand it describes a person who thinks he/she knows the truth about his/her subject well before he/she has done the actual research. A pseudo-scientist is keen to understand the rules of science in order to corrupt science; he/she aims at using the tools of science not to test his/her assumptions and hypotheses, but to prove that his/her preconceived ideas were correct.
So, how does one become a top pseudo-scientist? During the last 20 years, I have observed some of the careers with interest and think I know how it is done. Here are nine lessons which, if followed rigorously, will lead to success (… oh yes, in case I again have someone thick enough to complain about me misleading my readers: THIS POST IS SLIGHTLY TONGUE IN CHEEK).
- Throw yourself into qualitative research. For instance, focus groups are a safe bet. This type of pseudo-research is not really difficult to do: you assemble about 5 -10 people, let them express their opinions, record them, extract from the diversity of views what you recognise as your own opinion and call it a ‘common theme’, write the whole thing up, and - BINGO! – you have a publication. The beauty of this approach is manifold: 1) you can repeat this exercise ad nauseam until your publication list is of respectable length; there are plenty of alternative medicine journals who will hurry to publish your pseudo-research; 2) you can manipulate your findings at will, for instance, by selecting your sample (if you recruit people outside a health food shop, for instance, and direct your group wisely, you will find everything alternative medicine journals love to print); 3) you will never produce a paper that displeases the likes of Prince Charles (this is more important than you may think: even pseudo-science needs a sponsor [or would that be a pseudo-sponsor?]).
- Conduct surveys. These are very popular and highly respected/publishable projects in alternative medicine – and they are almost as quick and easy as focus groups. Do not get deterred by the fact that thousands of very similar investigations are already available. If, for instance, there already is one describing the alternative medicine usage by leg-amputated police-men in North Devon, and you nevertheless feel the urge of going into this area, you can safely follow your instinct: do a survey of leg-amputated police men in North Devon with a medical history of diabetes. There are no limits, and as long as you conclude that your participants used a lot of alternative medicine, were very satisfied with it, did not experience any adverse effects, thought it was value for money, and would recommend it to their neighbour, you have secured another publication in an alternative medicine journal.
- Take a sociological, anthropological or psychological approach. How about studying, for example, the differences in worldviews, the different belief systems, the different ways of knowing, the different concepts about illness, the different expectations, the unique spiritual dimensions, the amazing views on holism – all in different cultures, settings or countries? Invariably, you will, of course, conclude that one truth is at least as good as the next. This will make you popular with all the post-modernists who use alternative medicine as a playground for getting a few publications out. This approach will allow you to travel extensively and generally have a good time. Your papers might not win you a Nobel prize, but one cannot have everything.
- Do a safety study. It could well be that, at one stage, your boss has a serious talk with you demanding that you start doing what (in his narrow mind) constitutes ‘real science’. He might be keen to get some brownie-points at the next RAE and could thus want you to actually test alternative treatments in terms of their safety and efficacy. Do not despair! Even then, there are plenty of possibilities to remain true to your pseudo-scientific principles. By now you are good at running surveys, and you could, for instance, take up your boss’ suggestion of studying the safety of your favourite alternative medicine with a survey of its users. You simply evaluate their experiences and opinions regarding adverse effects. But be careful, you are on somewhat thinner ice here; you don’t want to upset anyone by generating alarming findings. Make sure your sample is small enough for a false negative result, and that all participants are well-pleased with their alternative medicine. This might be merely a question of selecting your patients cleverly. The main thing is that your conclusion is positive. If you want to go the extra pseudo-scientific mile, mention in the discussion of your paper that your participants all felt that conventional drugs were very harmful.
- Publish case reports. If your boss insists you tackle the daunting issue of therapeutic efficacy, there is no reason to give up pseudo-science either. You can always find patients who happened to have recovered spectacularly well from a life-threatening disease after receiving your favourite form of alternative medicine. Once you have identified such a person, you write up her experience in much detail and call it a ‘case report’. It requires a little skill to brush over the fact that the patient also had lots of conventional treatments, or that her diagnosis was assumed but never properly verified. As a pseudo-scientist, you will have to learn how to discretely make such irritating details vanish so that, in the final paper, they are no longer recognisable. Once you are familiar with this methodology, you can try to find a couple more such cases and publish them as a ‘best case series’ – I can guarantee that you will be all other pseudo-scientists’ hero!
- Publish a case series. Your boss might point out, after you have published half a dozen such articles, that single cases are not really very conclusive. The antidote to this argument is simple: you do a large case series along the same lines. Here you can even show off your excellent statistical skills by calculating the statistical significance of the difference between the severity of the condition before the treatment and the one after it. As long as you show marked improvements, ignore all the many other factors involved in the outcome and conclude that these changes are undeniably the result of the treatment, you will be able to publish your paper without problems.
- Rig the study design. As your boss seems to be obsessed with the RAE and all that, he might one day insist you conduct what he narrow-mindedly calls a ‘proper’ study; in other words, you might be forced to bite the bullet and learn how to plan and run an RCT. As your particular alternative therapy is not really effective, this could lead to serious embarrassment in form of a negative result, something that must be avoided at all cost. I therefore recommend you join for a few months a research group that has a proven track record in doing RCTs of utterly useless treatments without ever failing to conclude that it is highly effective. There are several of those units both in the UK and elsewhere, and their expertise is remarkable. They will teach you how to incorporate all the right design features into your study without there being the slightest risk of generating a negative result. A particularly popular solution is to conduct what they call a ‘pragmatic’ trial, I suggest you focus on this splendid innovation that never fails to produce anything but cheerfully positive findings.
- Play with statistics until you get the desired result. It is hardly possible that this strategy fails – but once every blue moon, all precautions turn out to be in vain, and even the most cunningly designed study of your bogus therapy might deliver a negative result. This is a challenge to any pseudo-scientist, but you can master it, provided you don’t lose your head. In such a rare case I recommend to run as many different statistical tests as you can find; chances are that one of them will nevertheless produce something vaguely positive. If even this method fails (and it hardly ever does), you can always home in on the fact that, in your efficacy study of your bogus treatment, not a single patient died. Who would be able to doubt that this is a positive outcome? Stress it clearly, select it as the main feature of your conclusions, and thus make the more disappointing findings disappear.
- Create confirmatory studies that follow your rigged design and faulty statistics. Now that you are a fully-fledged pseudo-scientist who has produced one misleading or false positive result after the next, you may want a ‘proper’ confirmatory study of your pet-therapy. For this purpose run the same RCT over again, and again, and again. Eventually you want a meta-analysis of all RCTs ever published. As you are the only person who ever conducted studies on the bogus treatment in question, this should be quite easy: you pool the data of all your trials and, bob’s your uncle: a nice little summary of the totality of the data that shows beyond doubt that your therapy works. Now even your narrow-minded boss will be impressed.
These nine lessons can and should be modified to suit your particular situation, of course. Nothing here is written in stone. The one skill any pseudo-scientist must have is flexibility.
Every now and then, some smart arse is bound to attack you and claim that this is not rigorous science, that independent replications are required, that you are biased etc. etc. blah, blah, blah. Do not panic: either you ignore that person completely, or (in case there is a whole gang of nasty skeptics after you) you might just point out that:
- your work follows a new paradigm; the one of your critics is now obsolete,
- your detractors fail to understand the complexity of the subject and their comments merely reveal their ridiculous incompetence,
- your critics are less than impartial, in fact, most are bought by BIG PHARMA,
- you have a paper ‘in press’ that fully deals with all the criticism and explains how inappropriate it really is.
In closing, allow me a final word about publishing. There are hundreds of alternative medicine journals out there to chose from. They will love your papers because they are uncompromising promotional. These journals all have one thing in common: they are run by apologists of alternative medicine who abhor to read anything negative about alternative medicine. Consequently hardly a critical word about alternative medicine will ever appear in these journals. If you want to make double sure that your paper does not get criticised during the peer-review process (this would require a revision, and you don’t need extra work of that nature), you can suggest a friend for peer-reviewing it. In turn, you can offer to him/her that you do the same to him/her the next time he/she has an article to submit. This is how pseudo-scientists make sure that the body of pseudo-evidence for their pseudo-treatments is growing at a steady pace.
Dr. Ernst is a PM&R specialist and the author of 48 books and more than 1000 articles in the peer-reviewed medical literature. His most recent book, Trick or Treatment? Alternative Medicine on Trial is available from amazon. He blogs regularly at EdzardErnst.com and contributes occasionally to this blog.
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A Canadian study published today in the Annals of Internal Medicine suggests that about one third of new prescriptions (written by primary care physicians) are never filled. Over 15,000 patients were followed from 2006 to 2009. Prescription and patient characteristics were analyzed, though patients were not directly interviewed about their rationale for not filling their prescriptions.
In short, patients were less likely to fill a prescription if the treatment was expensive, but certain types of drug indications had consistently higher non-fill rates:
- Headache (51% not filled)
- Ischemic heart disease (51.3% not filled)
- Thyroid agents (49.4% not filled)
- Depression (36.8% not filled)
Overall, hormonal (especially Synthroid), ENT (especially Flonase), skin, and cardiovascular drugs (especially statins) had the highest non-fill rates.
As far as those prescriptions more likely to be filled, antibiotics (especially for urinary tract infections) ranked number one.
Trends towards prescription compliance were seen among older, healthier patients, and those who were switching medications within a class rather than starting an entirely new drug. Patients who received prescriptions from a doctor that they visited regularly (rather than a new provider) were also more likely to fill their prescriptions.
This study was not designed to elucidate the exact rationale behind prescription non-adherence, but I am willing to speculate about it. In my experience, patients are less likely to fill a prescription if a reasonable over-the-counter alternative is available (think headache or allergy relief). I also suspect that they are less likely to fill a prescription if they believe it won’t help them (skin cream) or isn’t treating a palpable symptom (statin therapy for dyslipidemia). Finally, patients are probably nervous about starting a medicine that could effect their metabolism or cognition (thyroid medication or anti-depressant) without a full explanation of the possible benefits and side effects.
I was surprised to see how compliant patients seem to be with antibiotic agents (at least, filling the initial prescriptions). Given the increasing rates of antibiotic resistance, this reinforces the need to limit prescriptions to those agents truly indicated, and to analyze bacterial sensitivities during the treatment process to optimize medical management.
My take home message from this study is that providers need to do a better job of explaining the reasoning behind new prescriptions (their necessity, consequences of non-compliance, and risk/benefit profiles) and reviewing the overall cost to the patient. If a cheaper, effective alternative is available (whether OTC or generic), we should consider prescribing it. Providers can likely improve medication compliance rates with a little patient education and price consciousness. Extra time should be spent with patients at higher risk for non-compliance due to their personal situation (age, degree of illness, income level) or if a specific drug with lower compliance rates is being introduced (Synthroid, statins, etc.) Regular follow up (especially with the same prescriber) to ensure that prescriptions are filled and taken as directed is also important.
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We’ve known for quite some time that weight loss can reduce the risk of developing insulin resistance and type 2 diabetes. However, a healthy diet alone (without weight loss) may also help to reduce risk. In a recent Spanish study (published in the Annals of Internal Medicine), 3,541 men and women ages 55-80 at risk for diabetes were followed for an average of 4.1 years. Those who ate a diet rich in fish, whole grains, fruits, vegetables, and olive oil were less likely to develop diabetes than those following other diets of similar caloric value.
This is interesting for a few reasons. First of all, it provides us with insight into the importance of what we eat (and not just how much we eat) for optimum health. When considering how to follow a Mediterranean diet, I think it might be easiest to focus on what is NOT on the menu, rather than what we need to add to our diet. Notice that the Mediterranean diet has very low sugar, refined carbohydrates, processed foods and animal fat (with the exception of fish oil). This is not a low carb or low fat diet. It is a low glycemic-index and unprocessed food diet.
Secondly, calorie-restriction alone may not be the optimal way to reduce the risk of developing type 2 diabetes. In the past we have focused primarily on fat loss for diabetes prevention – through calorie restriction and exercise. We’ve often heard that “a calorie is a calorie” and that folks can lose weight effectively on a low-carb, low-fat, or high protein diet. While it’s true that studies have been equivocal regarding the most effective type of diet for weight loss, and people have been able to lose weight on everything from a bacon and grapefruit to a cookie diet, a deeper look suggests that certain diets really are healthier for us in the long run.
Thirdly, what we eat can have a profound effect on our health, and food is an easily modifiable risk factor for illness. Unlike many diseases and conditions (such as type 1 diabetes and other autoimmune disorders) where we have little to no control over whether or not we contract them, it is exciting to know that a healthy diet is a powerful weapon against disease that does not rely on pharmaceutical products or medical interventions.
And finally, I found this study interesting because it confirms what I have noticed in my own life recently – that cutting out refined carbohydrates and sugars can have a very positive effect on body composition and overall health. I have always had a very difficult time with hunger during calorie restriction, and I finally realized that it had to do with being sensitive to blood sugar spikes and drops from too many refined carbs. Once I cut out all added sugars and white flours from my diet (replacing them with lean protein and whole grains) my chronic hunger resolved and I could settle in to a comfortable relationship with food without constantly battling the scale.
If you haven’t tried the Mediterranean diet, there’s no time like the present. While evidence suggests you’ll be healthier for it, my experience tells me you’ll feel a whole lot better too. Say goodbye to the food craving and hunger cycle, and hello to a new way of healthy eating that can be comfortably maintained for a lifetime.
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It is estimated that in seven years from now, half of all Americans will suffer from one or more chronic diseases, a majority of which are weight related. The American Medical Association recently declared that obesity itself is a disease. Obesity advocacy groups say that this move will lead to better health outcomes by providing more treatment options, preventative programs and education, as well as better reimbursement for treating individuals fighting obesity.
But what do patients need to know about weight loss? The good news is that a medically healthy weight does not require a very low percent body fat.
Weight loss for health – not for appearance – comes with a different (and in many cases much less demanding) set of recommendations. So for the purposes of this blog post, I’ll focus on key evidence-based advice for patients at risk for weight related disease…
1. You don’t need to lose that much weight to realize substantial health benefits.
A five to ten percent loss of body weight can lower risk for heart disease and other killers. For obese patients, even a modest weight reduction can have significant health benefits. An eleven pound reduction in weight leads to a fifty-eight percent decrease in the chance of developing diabetes. Even just losing two pounds reduces the risk of diabetes by sixteen percent.
2. Most people who succeed at losing weight (and keeping it off) do so with a combination of diet and exercise.
According to the National Weight Control Registry (NWCR) (a database of more than ten thousand Americans who have successfully kept at least 30 pounds off for a year or more):
- Ninety-eight percent of Registry participants report that they modified their food intake in some way to lose weight.
- Ninety-four percent increased their physical activity.
3. Walking is the most common form of exercise reported by successful weight loss subjects.
According to the NWCR, their study participants’ most frequently reported form of activity was walking. That’s not to say that other forms of activity (such as interval and strength training) aren’t an important part of a healthy lifestyle, but it is encouraging to know that brisk walking is a simple, affordable, and easily accessible place to start for most people.
4. Exercise itself (even without weight loss) is one of the most powerful preventive health interventions available.
Physical exercise has been shown to reduce blood pressure; decrease the risk for type 2 diabetes, strokes, certain types of cancer, and heart disease; improve arthritis symptoms and sleep disorders, and reduce erectile dysfunction, anxiety and depression. No pill or procedure can come close to providing all these amazing health benefits.
5. Diet is more important than exercise for shedding pounds of fat.
As I often tell my patients, “You can’t outrun your mouth.” Which means – you can eat far more calories in a short period of time than you can ever hope to burn with exercise. For this reason, diet plays a larger role in weight loss than exercise.
6. It’s more important to lose fat than to lose it by following a particular diet.
If diet is so important for losing weight, the next logical question is “Which diet is best?” Interestingly, the answer may be – whichever one you’ll stick to. Now, of course there are some diets that are more nutritionally sound than others – but the benefits of fat loss are so great, that health benefits are achieved even on relatively “unhealthy” diets. In a landmark diet comparison study, Michael Dansinger showed that study participants achieved similar benefits (such as improved cholesterol profiles, blood pressure, and inflammatory markers) from adhering to any of four vastly different diet regimes ranging from low fat, high carb to low carb, high fat.
7. The healthiest diets limit refined carbohydrate and animal fat intake, while maximizing fruit, vegetable, and healthy fats and protein.
I’ve just argued that a variety of diets work if you stick to them, and adherence is the key to fat loss, and even modest amounts of fat loss can have substantial health benefits. So does it really matter which diet you choose? In the long run, yes. Research has shown that there are some common nutritional principles that result in optimal health. The key ones are:
- Avoid refined carbohydrates as much as possible (such as sugar, fructose, and white flour/rice products). Unrefined carbs (such as whole grains, flax, oatmeal, brown rice, quinoa, berries, and cruciferous veggies) are an important part of a healthy diet.
- Avoid animal fats (trans fats). Healthy fats such as olive, fish and nut oils are preferable.
- Eat a diet rich in fiber, fruits and vegetables.
- Choose lean protein sources, including beans, eggs, chicken, fish, pork, yogurt, and fish.
- Limit alcohol intake and opt for water as your main source of hydration fluid.
8. Aim to lose 1 pound per week.
Cutting out approximately 500 calories from your daily caloric needs (established with a calorie calculator or by personal trial-and-error) is about as much as people can tolerate comfortably over periods of time. Diet adherence decreases as deficits exceed 500 calories per day.
9. The optimal, minimal amount of exercise for the average American adult is about one hour of moderate intensity exercise each day.
There is some disagreement on optimal exercise duration – some groups recommend half an hour per day (American College of Sports Medicine), others (such as the Institute of Medicine) a full hour. A review of the various positions and guidelines is available here. In terms of types of activity, there is general consensus that strength training twice a week should be added to moderate daily aerobic activity for best results.
10. You probably don’t need to take any vitamin or nutrition supplements.
Contrary to popular belief, most Americans (even with their sub-optimal eating habits) meet all of their basic dietary requirements with food intake. Non FDA-approved weight loss supplements have not been found to provide lasting benefits for weight loss and are generally ineffective and sometimes dangerous.
Weight loss drugs and surgical procedures may be effective last resorts for those who have failed to achieve results with diet and exercise. New prescription anti-obesity drugs and FDA-approved over-the-counter options are effective at helping patients shed extra pounds, but often come with unwanted side effects such as anal leakage and adverse cardiac events.
In conclusion, obesity underlies most of America’s chronic disease burden but can be reversed with modest weight loss through diet and exercise modifications. Patient adoption of long-term lifestyle changes are challenged by economic factors (e.g. healthy food “deserts” in inner cities), sedentary lifestyles, poor urban planning, excessive fast food and sugary beverage consumption, increasing portion sizes, and high tech conveniences that reduce energy expenditure, among other factors.
Patients are more likely to begin weight loss programs if recommended to do so by their physician, though studies suggest that they take advice more seriously if their physician is not overweight or obese herself. In our efforts to treat obesity, it may be especially important to lead by example.
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A recent, 358-person survey conducted by researchers at Yale University (and published in the International Journal of Obesity) suggested that patients may be less likely to follow the medical advice of overweight and obese physicians. Survey respondents were 57% female, 70% Caucasian, 51% had BMIs in the normal or underweight category (31% overweight and 17% obese), and were an average age of 37 years old.
Respondents rated overweight and obese physicians as less credible than normal weight doctors, and stated that they would be less likely to follow advice (including guidance about diet, exercise, smoking cessation, preventive health screenings, and medication compliance) from such physicians. Although credibility and trust scores differed between the hypothetical overweight and obese providers and normal weight colleagues, the respondents predicted less of a difference between them in terms of empathy and bedside manner. Respondents said they’d be more likely to switch physicians based on their weight alone. There was no less bias against overweight and obese physicians found in respondents who were themselves overweight or obese.
The study authors note that this survey is the first of its kind – assessing potential weight bias against physicians by patients of different weights. Previous studies (by Puhl, Heuer, and others) have documented weight bias against patients by physicians.
While the study has some significant limitations (such as the respondents being disproportionately Caucasian, thin, and female), I think it raises some interesting questions about weight bias and physicians’ ability to influence patients to adopt healthier lifestyles.
Considering the expansion of pay-for-performance measures (where physicians receive higher compensation from Medicare/Medicaid when their patients achieve certain health goals -such as improved blood sugar levels), being overweight or obese could reduce practice profit margins. If patients are less likely to follow advice from overweight or obese doctors, then it stands to reason that patients’ health outcomes could suffer along with the doctors’ income.
I’m certainly not suggesting that CMS monitor physician waist circumferences in an attempt to improve patient compliance with healthy lifestyle choices (Oh no, did I just give the bureaucrats a new regulatory idea?), but rather that physicians redouble their efforts to practice what they preach as part of a commitment to being good clinicians.
Some will say that the problem here is not expanding provider waistlines, but bias against the overweight and obese. While I agree that weight has little to do with intellectual competence, it does have to do with disease risk. Normalizing and destigmatizing unhealthiness is not the way to solve the weight bias problem. We know instinctively that carrying around a lot of extra pounds is damaging to our health. It’s important to show grace and kindness to one another as we join together on the same health journey – a struggle to make good lifestyle choices in a challenging environment that tempts us to eat poorly and cease exercising.
To doctors I say, let’s fight the good fight and model healthy behaviors to our patients. To patients I say, show grace to your doctors who carry extra pounds – don’t assume that they are less competent or knowledgeable because of a weight problem. And to thin, female, 30-something, Caucasian survey respondents I say – Wait till you hit menopause before you judge people who are overweight!