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Wear and tear on the knee joints creates pain for up to 40% of Americans over age 45. There are plenty of over-the-counter (OTC) and prescription (Rx) osteoarthritis treatments available, but how effective are they relative to one another? A new meta-analysis published by the Annals of Internal Medicine may shed some light on this important question. After 3 months of the following treatments, here is how they compared to one another in terms of power to reduce pain, starting with strongest first:
#1. Knee injection with gel (Rx hyaluronic acid)
#2. Knee injection with steroid (Rx corticosteroid)
#3. Diclofenac (Voltaren – Rx oral NSAID)
#4. Ibuprofen (Motrin – OTC oral NSAID)
#5. Naproxen (Alleve – OTC oral NSAID)
#6. Celecoxib (Celebrex – Rx NSAID)
#7. Knee injection with saline solution (placebo injection)
#8. Acetaminophen (Tylenol – OTC Synthetic nonopiate derivative of p-aminophenol)
#9. Oral placebo (Sugar Pill)
I found this rank order list interesting for a few reasons. First of all, acetaminophen and celecoxib appear to be less effective than I had believed. Second, placebos may be demonstrably more effective the more invasive they are (injecting saline into the knee works better than acetaminophen, and significantly better than sugar pills). Third, injection of a cushion gel fluid is surprisingly effective, especially since its mechanism of action has little to do with direct reduction of inflammation (the cornerstone of most arthritis therapies). Perhaps mechanical treatments for pain have been underutilized? And finally, first line therapy with acetaminophen is not clinically superior to placebo.
There are several caveats to this information, of course. First of all, arthritis pain treatments must be customized to the individual and their unique tolerances and risk profiles. Mild pain need not be treated with medicines that carry higher risks (such as joint infection or gastrointestinal bleeding), and advanced arthritis sufferers may benefit from “jumping the line” and starting with stronger medicines. The study is limited in that treatments were only compared over a 3 month trial period, and we cannot be certain that the patient populations were substantially similar as the comparative effectiveness was calculated.
That being said, this study will influence my practice. I will likely lean towards recommending more effective therapies with my future patients, including careful consideration of injections and diclofenac for moderate to severe OA, and ibuprofen/naproxen for mild to moderate OA, while shying away from celecoxib and acetaminophen altogether. And as we already know, glucosamine and chondroitin have been convincingly shown to be no better than placebo, so save your money on those pills. The racket is expected to blossom into a $20 billion dollar industry by 2020 if we don’t curb our appetite for expensive placebos.
In conclusion, the elephant in the room is that weight loss and exercise are still the very best treatments for knee osteoarthritis. Check out the American Academy of Orthopedic Surgery’s recent list of evidence-based recommendations for the treatment of knee arthritis for more information about the full spectrum of treatment options.
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A Cost Effective Fitness Band
In a new study published in the Annals of Internal Medicine, researchers found that overweight and obese patients who used a popular smart phone app (MyFitnessPal) did not lose significant weight after a 6 month trial period. The randomized controlled trial is the first of its kind to demonstrate that well-liked mobile apps may be ineffective for most users.
Two hundred and twelve racially diverse (73% female) patients treated at two UCLA primary care clinics were enrolled in the study. All indicated that they were interested in losing weight and 79% who completed the study indicated that they were “somewhat” or “completely” satisfied with the app, while 92% reported that they’d recommend it to a friend.
Unfortunately, as pleased as the subjects were with the app, there was no statistically significant difference in weight loss between the intervention and control groups. On average, the MyFitnessPal users lost 0.66 lbs in 6 months.
The authors note:
“Most participants rarely used the app after the first month of the study… Given these results it may not be worth a clinician’s time to prescribe MyFitnessPal to every overweight patient with a smart phone… Our analysis did not show any demographic covariates to be important predictors of app use.”
This study serves as a reminder that “popular” and “effective” do not always go hand-in-hand when it comes to weight loss interventions. While mHealth apps are expected to earn $26 billion by 2017, one is left to wonder if this money will be well spent or if we’ll all be “somewhat to completely satisfied” with the apps without anything medically significant to show for it?
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I have spent many blog hours bemoaning the inadequate communication going on in hospitals today. Thanks to authors of a new study published in the New England Journal of Medicine, I have more objective data for my ranting. A prospective intervention study conducted at 9 academic children’s hospitals (and involving 10,740 patients over 18 months) revealed that requiring resident physicians to adopt a formal “hand off” process at shift change resulted in a 30% reduction of medical errors.
What was the intervention exactly? Details are available via mail order from the folks at Boston Children’s Hospital. It may take me a few weeks to get my hands on the curriculum (which was supported by a grant from the Department of Health and Human Services). I’m not sure how complex the new handoff initiative is in practice (or if it’s something that could be replicated without government-approved formality) but one thing is certain: disciplined physician communication saves lives.
I myself (without a grant from HHS or a NEJM study to back my assertions – ahem) proposed a set of comprehensive communication practices that can help to reduce medical errors in the hospital. My list involves more than peer hand-offs, but also nursing communication, EMR documentation strategies, and reliance on pharmacists for medication reconciliation and review. It is more than just an information exchange protocol for shift-changes, it is a lifestyle choice.
I applaud the I-PASS Handoff Study for its rigorous, evidence-based approach to implementing communication interventions among pediatric residents in children’s hospitals. I am stunned by how effective this one intervention has been – but a part of me is saddened that we practically had to mandate the obvious before it got done. What will it take for physicians to adopt safer communications strategies for inpatient care? I’m guessing that for many of us, it will involve enrollment in a workshop with hospital administration-driven requirements for participation.
For others of us – regular communication with staff, patients, and peers already defines our medical practice. But because (apparently?) we are not in the majority, we’ll just carry on our instinctual carefulness and wait for the rest to catch up. At least now we know that there is a path forward regarding improving communication skills and transfer of patient information. If we have to force doctors to look up from their iPhones and sit around a table and speak to one another – then so be it. The process may improve our lives while it saves those of our patients.
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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.