August 20th, 2009 by Steve Novella, M.D. in Better Health Network, Quackery Exposed
Tags: CAM, Complementary And Alternative Medicine, Placebo, Placebo Effect, Placebo Medicine
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It is my contention that terms such as “complementary and alternative medicine” and “integrative medicine” exist for two primary purposes. The first is marketing – they are an attempt at rebranding methods that do not meet the usual standards of unqualified “medicine”. The second is a very deliberate and often calculating attempt at creating a double standard.
We already have a standard of care within medicine, and although its application is imperfect its principles are clear – the best available scientific evidence should be used to determine that medical interventions meet a minimum standard of safety and effectiveness. Regulations have largely (although also imperfectly) reflected that principle, as have academia, publishing standards, professional organizations, licensing boards, and product regulation.
With the creation of the new brand of medicine (CAM and integrative) came the opportunity to change the rules of science and medicine to create an alternative standard, one tailor made for those modalities that do not meet existing scientific and even ethical standards for medicine. This manifests in many ways – the NCCAM was created so that these modalities would have an alternate standard for garnering federal dollars for research. Many states now have “health care freedom laws” which create a separate standard of care (actually an elimination of the standard of care) for self-proclaimed “alternative” practices.
But perhaps the most insidious and damaging double-standard that is being advocated under the banner of CAM is a separate standard of scientific research itself. The normal rules of research that have evolved over the last few centuries are being subtly altered or discarded, with clever newspeak. It is a way for proponents to choose their evidence, rather than having the evidence decide what works and what does not work. We saw this strategy at play with the recent acupuncture study for back pain that clearly showed acupuncture was no more effective than placebo acupuncture. Proponents (propagated by an uncritical media) turned scientific logic on its head by interpreting this result as indicating that placebo acupuncture must work also (if only we could figure out how, they unconvincingly mused).
We see this strategy at work also with the use of so-called “pragmatic” studies – a rebranding of “unblinded” studies. This is a way to choose their evidence – in this case, poorly controlled unblinded studies that are more likely to reflect the bias of the researchers and therefore give them a result that they like. This is their reaction to well-designed placebo controlled trials that show their preferred modality does not work.
Another strategy is to change the meaning of the concept of placebo effects. This one was ready-made, and most people grossly misunderstand the nature of “the” placebo effect. One of my first articles for SBM was about the placebo effect because this concept is so criticial to science-based medicine. To summarize – the placebo effect is really many effects. It is everything other than a physiological response to the treatment. It is not all a real effect of mind-over-matter – it includes every bias and artifact of observation as well. It includes things like subjects reporting they feel better to the researcher because they want the treatment to work and they want to please the authority figure, who also wants the treatment to work and may be encouraging the perception of benefit.
It is most important to understand how the term “placebo effect” is used in the context of a controlled clinical trial. Scientific methodology is about controlling variables – because we want to know which variables work and which ones do not. In any clinical scenario there are a multitude of variables that may affect the outcome or the perception of the outcome. Therefore a well-designed study maximally controls all the variables – ideally so that the one variable of interest (the treatment) is completely isolated. This is accomplished in a number of ways. One method is randomization – randomly assigning subjects to the various treatment and placebo arms of a clinical trial. Randomization combined with sufficiently large trial size (number of subjects) results in all variables not specifically controlled for averaging out among the various arms. Another way to look at is that randomization prevents systematic biases in who gets treated and who gets a placebo from affecting the results.
Another method of controlling variables is the double-blind placebo control. Ideally one group of subjects will receive the treatment being studied while another group will receive a treatment that is identical in every way except that it is inert (i.e. it controls for all possible variables and isolated the one variable of interest – the treatment). Both the subject and the examiner are blinded to which is which to control for psychological effects. In order to conclude that the treatment “works” those subject receiving the active treatment must do statistically significantly better than those receiving the placebo. If the activity of the treatment was the only variable, then we can confidently conclude it was responsible for the improvement.
I know this is all very basic, but it is these very basic concepts that are being challenged by proponents of so-called CAM. They are trying to say the the effect measured in the placebo arm of such studies is a real effect, something valuable and alone is sufficient to justify the treatment. This philosophy has been termed by critics “placebo medicine” and is just the latest attempt at creating a double standard. But the claim is utterly ignorant of the scientific nature of the placebo effect. It is a method of controlling for biases, artifacts, and variables (known and unknown) – it is not a real effect.
There may be some non-specific therapeutic effects mixed into placebo effects. For example, people who are being studied tend to take better care of themselves and are more compliant with treatments (because they are being watched). They may also feel better as a result of the positive attention from a health care provider – old-fashioned good bedside manner. These are some of the variables being controlled for. But it is scientifically absurd to argue that they justify an ineffective treatment. But that is exactly what CAM proponents are doing.
The latest manifestation of this strategy is a report put out in the UK by The Kings Fund – a health policy charity. They put together a committee to examine how the UK can find evidence to support CAM therapies. They are not interested in figuring out “if” such treatments work, but rather how they can show “that” they work. They report:
Explaining the need for different types of research when assessing complementary practice, Professor Dame Carol Black said: ‘It has become widely accepted that a stronger evidence base is needed if we are to reach a better understanding of complementary practices and ensure greater confidence in their clinical and cost effectiveness. The challenge is to develop methods of research that allow us to assess the value of an approach that seeks to integrate the physical intervention, the personal context in which it is given, and non-specific effects that together comprise a particular therapy.’
Got that? We need new kinds of research (read “double standard”) in order to demonstrate the value of these special CAM practices. The reason that we need to find new ways to demonstrate their value is because they fail under the accepted scientific methods. The last sentence is just a fancy way of saying that placebo effects should count as real effects.
It further says:
‘As long as findings from research can provide confidence in the positive effect of the physical intervention at the heart of the treatment, then any added benefit brought by the therapeutic relationship and the context for treatment should count as part of the treatment effect,’ the report says.
‘For complementary therapies such a holistic approach to effectiveness should be adopted by bodies such as NICE, when comparing cost-effectiveness across a range of treatments.’
The “physical intervention at the heart of the treatment” is functionally the same thing as – non-specific placebo effects. They want to take a “holistic” approach to evidence (another useful marketing brand), meaning they get to decide what the evidence means. George Orwell would be proud.
As usual, Edzard Ernst (the go to expert for the media) gets it exactly right. He is quoted as saying:
‘This is the introduction of double standards through the back door.’
‘In this case we might as well allow an ineffective medication on the market, because it too will have a placebo effect.’
That latter point is a favorite of mine as well. Whenever CAM proponents try to change the rules of science to suit their needs, I invite my r
*This blog post was originally published at Science-Based Medicine*
August 19th, 2009 by Gwenn Schurgin O'Keeffe, M.D. in Better Health Network, Health Tips
Tags: Child-Proofing, Geriatrics, Pediatrics, Pills, Safety
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If you are a family with kids and have grandparents or great grandparents alive, you likely enjoy visiting with your relatives from time to time. While your small children may not always get much out of these visits, especially while very young, they do wonders for our older relatives who so enjoy visits from family and delight in seeing us become parents and expand our families.
I remember vividly visiting my grandparents as they aged, as a child, a teen, a young adult and when I became a parent with my own infants and toddlers. I recall well their delight…and the vivid images of their aging lives: durable medical equipment like canes and walkers in the corner of the room. And, the kitchen counter with rows of medication bottles that made the counter appear like the pharmacist’s counter at the local pharmacy. Given all of my grandparents had arthritis towards the end of their lives, none of those bottles had child-resistant tops.
Whether at home, an assisted care facility or a nursing home, the issue I worry about with small kids are floors and medications. Even if someone is handing an older person their medication, a pill can fall to the floor without being noticed and later found by a toddling child who mistakes it for a piece of candy. That’s what happened last week when 15 month old boy found a shiny pink pill on the floor of his grandmother’s house and didn’t think twice about tossing it in his mouth. Thankfully, it was bitter so he spit most of it out but it was a blood pressure medication so we had to given him activated charcoal, a lot of it, and then observe him in the emergency room for 6 hours.
This story had a happy ending but could have been a disaster had it been a different type of pill or a higher dose, or a group of pills. It’s very, very important that we all take a moment to think about the pill safety of our older relatives – for their sake and the sake of the small children in their lives. In addition to products that can help dispense pills more safely, making sure floors are clean before visits and supervising kids during visits are essential.
As an aside, the moral to this story can be extended to hotels and homes we may visit that we are not as familiar with. Pills can easily fall out of pockets, purses and luggage. When traveling anywhere with small kids, get on the ground and look under beds, chairs, sofas, pillows and be sure there are not any pills or other small items that we wouldn’t want our small children, or even older children, to touch, or worse – eat!
BTW, can you find the pill in this picture? Hint: it’s blue.
See On The Edge Of Something blog for the “before” shots showing the pill in a spoon on the floor.
Not so easy, huh? Unless, of course, you are a very small child with the eye sight of a falcon and live close to the ground routinely. Now do you get the point?
*This blog post was originally published at Dr. Gwenn Is In*
August 19th, 2009 by Nancy Brown, Ph.D. in Better Health Network, Opinion
Tags: Depressed Parents, Depression, Mental Health, Pediatrics, teens
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Teens living with a depressed parent need information and support. The inclination of most people living with someone who is depressed is to take on responsibility for the ill parent and other family members.
Life is difficult for anyone living with a depressed parent. The daily home life is complex – with little consistency, irregular habits, plans made at the last minute, little consideration for each person’s wishes or desires, and there is usually a huge decrease in communication. The depressed parent withdraws from the family and the teens are left to manage on their own, creating feelings of loneliness.
Teens are not likely to realize how much their life has changed, or how serious the depression is and need adults who see the changes to bring them to the attention of the family, medical and emotional professionals. Even if the depression lifts for a period, everyone in the family will likely be anxious about when it will returns.
I believe that all health care professionals are ethically responsible to help teens avoid the responsibility and loneliness associated with living with a depressed parent. As mentioned in a previous post, there are also many resources for those parents who are willing to admit the depression, as well.
This post, Teens Who Live With A Depressed Parent, was originally published on
Healthine.com by Nancy Brown, Ph.D..
August 19th, 2009 by Toni Brayer, M.D. in Better Health Network, Opinion, True Stories
Tags: Fix Medicare, Healthcare reform, Internal Medicine, Letter, Medicare, Obama, Paperwork, Primary Care, Red Tape
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Dear President Obama,
I am in favor of Health Care Reform and I agree with you that universal coverage and eliminating the abuses that both patients and doctors have suffered at the whim of the for-profit insurance industry must be curtailed.
But I also want you to fix Medicare. Medicare is so bureaucratic that expanding it in its current form would be the death knell for primary care physicians and many community hospitals. The arcane methods of reimbursement, the ever expanding diagnosis codes, the excessive documentation rules and the poor payment to “cognitive, diagnosing, talking” physicians makes the idea of expansion untenable.
May I give you one small example, Mr. President? I moved my medical office in April. Six weeks before the move I notified Medicare of my pending change of address and filled out 22 pages of forms. Yes, Mr. Commander in Chief…22 pages for a change of address. It is now mid-August and I still do not have the “approval” for my address change.
I continue to care for my Medicare patients and they are a handful. Older folks have quite a number of medical issues, you see, and sometimes it takes 1/2 hour just to go over their medications and try to understand how their condition has changed. That is before I even begin to examine them and explain tests, treatment and coordinate their care. Despite the fact that I care for these patients, according the Medicare rules, I cannot submit a bill to Medicare because they have not approved my change of office address.
I have spent countless hours on the phone with Medicare and have sent additional documentation that they requested. I send the forms and information “overnight, registered” because a documented trail is needed to avoid having to start over at the beginning again and again. I was even required to send a signature from my “bank officer” and a utility bill from the office. Mr President, I don’t have a close relationship with a bank officer so this required a bank visit and took time away from caring for patients…but I certainly did comply.
I am still waiting to hear from Medicare. At my last call they said they had not received yet another document, but when I gave them the post office tracking number, they said it was received after all. They could not tell me when or if they will accept my address change.
I have bills stacking up since April and I just found out that they will not accept them if they are over 30 days old. I have cared for patients for 5 months and will not receive any reimbursement from Medicare. The rules state I cannot bill the patient or their supplemental Medicare insurance either.
Believe me, Mr. President, I commend you for taking on such a huge task. Please also know that Medicare reform is needed along with health care reform.
A loyal American ,
Internal Medicine (aka: primary care) physician
*This blog post was originally published at EverythingHealth*
August 18th, 2009 by Paul Auerbach, M.D. in Better Health Network
Tags: Cantimer, Dehydration, Emergency Medicine, Outdoor Medicine, Saliva Test, Salivary Osmolality, Spit, Technology, wilderness medicine
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I’m often asked about technologies that are amenable to research applied in outdoor or wilderness settings. A company called Cantimer has developed and made available one of these technologies.
Cantimer is a privately–held, development–stage company commercializing a patented, proprietary, sensor technology platform based on a convergence of micro electromechanical systems (MEMS) technology and advanced polymer science. According to the website, the Company’s first commercial product will be an innovative, hand–held device for non-invasive measurement and monitoring of human hydration status from the osmolality of saliva.
This past October (2008), there was a press release issued by the Company. To paraphrase:
“Cantimer, Inc. Delivers First Alpha Instruments for Real-Time, Non-Invasive, Incident-Scene Assessment of Dehydration in Firefighters
Devices to be used for field testing in structural fire environments and search and rescue operations.
Cantimer, Inc. announced that it has shipped ten alpha instruments for real-time, non-invasive assessment of human hydration to the U.S. Government’s Technical Support Working Group (TSWG). The units will be used for incident-scene assessment of dehydration in firefighters. Dr. Christina Baxter, from TSWG, commented, ‘The focus over the last several months has been on laboratory work that adds to the body of knowledge regarding salivary osmolality as a useful measure of human hydration or dehydration status. That work has gone very well. We are now looking forward to using these new devices for actual field testing in structural firefighting or search and rescue operations – with more of an emphasis on implementation, ergonomics and the user experience.’
Maintaining an optimal level of hydration is a major health concern for firefighters and other emergency scene first responders. Progressive acute dehydration associated with physical exertion in heat-stressed environments significantly increases the risks of temperature-related health problems, with resulting losses of productivity and, in some cases, death. It has been shown that fluid losses of as little as 2% of total body weight (3.5 pounds in a normally 175 pound individual) can lead to noticeable compromises in physical and cognitive performance.
Dehydration and resulting temperature-related health problems among firefighters are preventable through adequate on-scene hydration management. Cantimer’s devices, incorporating the Company’s proprietary sensing technology, enable convenient, field-deployable, real-time measurement, and therefore management, of hydration status from an easily-obtained sample of saliva.
Although easy to treat if identified early, dehydration is a pervasive condition that contributes to a large number of preventable hospitalizations in the U.S. every year. Cantimer believes that the availability of a hand-held device that aims to make it as easy to determine a person’s state of hydration as it is to take their body temperature will have significant benefits, not only for the health and safety of firefighters and other first-responders, but for military personnel, athletes at all levels, the elderly, the very young and those suffering from a wide range of medical conditions.”
The wilderness and outdoor medicine literature is replete with opinions and arguments about conditions predisposing to dehydration and the determination of hydration status. We presume dehydration in the field by clinical diagnosis (e.g., signs and symptoms), but do not generally deploy an actual quantifiable measurement to determine its presence. So, with the advent of the technology espoused by Cantimer, we may finally have a convenient tool with which to begin to diagnose, as opposed to predict, dehydration, during virtually any activity for which the physical environment will allow its use. This will hopefully also allow us to test different hydration/rehydration strategies, including various fluids, electrolyte concentrations, and so forth.
This post, Spit Test To Determine Hydration Status, was originally published on
Healthine.com by Paul Auerbach, M.D..
