Even More Placebo Issues

This placebo study was reported on here and here. The results were somewhat surprising to me, that placebos worked even though the participants knew they were fake. I'm guessing now, but I wonder if the cultural ritual of taking pills is so powerful that the mere act of taking a pill, no matter its contents, encourages healing. And in the study, the participants were told that the "pills had been shown to be effective in clinical studies" even though they were inert. Which isn't the same as saying the pills are fake. Another observation is that it was canny of the researchers to use IBS, or "irritable bowel syndrome," since this condition is multi-factorial and subject to overall stress levels since there are so many nerve endings in the gut. It is also interesting that Ted Kaptchuk took on this study. He is an acupuncturist at Harvard and has done seminal work on the topic, authored "The Web That Has No Weaver," a basic explanation and text on acupuncture.
The acupuncture community, by necessity, is irrevocably involved in the discussion of placebo because our studies are scrutinized on every level for placebo bias. So I shouldn't be surprised that Kaptchuk would involve himself in this complicated topic. I would suggest, however, that all physicians should be interested in this topic given the poor track record of very popular and widely prescribed medications against placebo. (My next blog post will discuss the possible negative effects of cortisone injections for tendonitis, such as tennis elbow.)And there are many procedures which have never been challenged by a placebo procedure. And since the first tenet of the Hippocratic Oath is to do no harm, it is a phenomenon that deserves to be treated with respect.
The quote from Kaptchuk at the end of the article brings up questions, however.

“The magnitude of effect here is very large,” said the lead author, Dr. Ted J. Kaptchuk, a researcher at Beth Israel Deaconess Medical Center in Boston. The goal, he added, would be to develop a clinical strategy to use the placebo effect ethically, without lying to a patient.

Of course, we all want positive outcomes and would like to enhance any and all contributions to our therapeutic modality. But if one can't determine how much of any procedure IS actually placebo, it raises all sorts of questions for the practitioner, if not for the patient. If a large part of what the practitioner is doing is causing the patient to heal themselves, then it behooves them to do the safest option first, I would think. Then there's the whole other aspect of whether one would choose to practice a certain therapeutic modality if it really is all placebo. In my own case the answer would be an unequivocal "No." Of course there is some placebo in some patients when coming for acupuncture, but I suspect that there is much "nocebo" also. Nocebo is when the patients don't really think it will help, but will try anything. Fortunately, we know that acupuncture works on animals and babies, who aren't affected by placebo nor nocebo.

Here is the article from the NYTimes.

Perceptions: Positive Spin Adds to a Placebo’s Impact
By NICHOLAS BAKALAR

Can taking a placebo be effective even if the patient knows it is a placebo? A new report suggests the answer is yes.

In a study published online last week in the online journal PLoS One, researchers explained to 80 volunteers with irritable bowel syndrome that half of them would receive routine treatment and the other half would receive a placebo. They explained to all that this was an inert substance, like a sugar pill, that had been found to “produce significant improvement in I.B.S. symptoms through mind-body self-healing processes.” The patients, all treated with the same attention, warmth and empathy by the researchers, were then randomly assigned to get the pill or not.

At the end of three weeks, they tested all the patients with questionnaires assessing the level of their pain and other symptoms. The patients given the sugar pill — in a bottle clearly marked “placebo” — reported significantly better pain relief and greater reduction in the severity of other symptoms than those who got no pill. The authors speculate that the doctors’ communication of a positive outcome was one factor in the apparent effectiveness of the placebo.

“The magnitude of effect here is very large,” said the lead author, Dr. Ted J. Kaptchuk, a researcher at Beth Israel Deaconess Medical Center in Boston. The goal, he added, would be to develop a clinical strategy to use the placebo effect ethically, without lying to a patient.


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Do Cortisone Shots make Tendonitis Worse?

This blog post is about a study that was released in October reviewing more that 4 dozen studies on the efficacy of cortisone injections on tennis elbow. What they found was that the injections definitely helped with the short term pain, but prolonged the amount of time it took for the tendon to actually heal. They also discuss in this article the recent thinking on tendinopathies, that they may not actually be a condition of inflammation, rather of degeneration, or disease/fraying of the tendon. It made sense to give cortisone, which is a powerful anti-inflammatory to an inflamed tendon, but doesn't make sense with the current construct of frayed tendons. The cortisone probably leads to pain relief due to "neural receptor activation" but then interferes with healing long term. Physical Medicine and Rehab (PM and R) use saline injections in trigger points, so the mere injection with no active agent can be therapeutic, that we know. The PM and R folks also use "dry needling" which can be helpful, also, which is much more akin to acupuncture. Acupuncture has been shown to increase the circulation or blood flow to the affected area, by infrared studies, which is possibly why it helps with healing in the long term. This is the same reason that it can aggravate symptoms in the short term.


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October 27, 2010, 12:01 am
Phys Ed: Do Cortisone Shots Actually Make Things Worse?
By GRETCHEN REYNOLDS

In the late 1940s, the steroid cortisone, an anti-inflammatory drug, was first synthesized and hailed as a landmark. It soon became a safe, reliable means to treat the pain and inflammation associated with sports injuries (as well as other conditions). Cortisone shots became one of the preferred treatments for overuse injuries of tendons, like tennis elbow or an aching Achilles, which had been notoriously resistant to treatment. The shots were quite effective, providing rapid relief of pain.


Then came the earliest clinical trials, including one, published in 1954, that raised incipient doubts about cortisone’s powers. In that early experiment, more than half the patients who received a cortisone shot for tennis elbow or other tendon pain suffered a relapse of the injury within six months.

But that cautionary experiment and others didn’t slow the ascent of cortisone (also known as corticosteroids). It had such a magical, immediate effect against pain. Today cortisone shots remain a standard, much-requested treatment for tennis elbow and other tendon problems.

But a major new review article, published last Friday in The Lancet, should revive and intensify the doubts about cortisone’s efficacy. The review examined the results of nearly four dozen randomized trials, which enrolled thousands of people with tendon injuries, particularly tennis elbow, but also shoulder and Achilles-tendon pain. The reviewers determined that, for most of those who suffered from tennis elbow, cortisone injections did, as promised, bring fast and significant pain relief, compared with doing nothing or following a regimen of physical therapy. The pain relief could last for weeks.

But when the patients were re-examined at 6 and 12 months, the results were substantially different. Over all, people who received cortisone shots had a much lower rate of full recovery than those who did nothing or who underwent physical therapy. They also had a 63 percent higher risk of relapse than people who adopted the time-honored wait-and-see approach. The evidence for cortisone as a treatment for other aching tendons, like sore shoulders and Achilles-tendon pain, was slight and conflicting, the review found. But in terms of tennis elbow, the shots seemed to actually be counterproductive. As Bill Vicenzino, the chairman of sports physiotherapy at the University of Queensland in Australia and senior author of the review, said in an e-mail response to questions, “There is a tendency” among tennis-elbow sufferers “for the majority (70-90 percent) of those following a wait-and-see policy to get better” after six months to a year. But this is not the case for those getting cortisone shots, he wrote; they “tend to lag behind significantly at those time frames.” In other words, in some way, the cortisone shots impede full recovery, and compared with those adopting a wait-and-see policy, those getting the shots “are worse off.” Those people receiving multiple injections may be at particularly high risk for continuing damage. In one study that the researchers reviewed, “an average of four injections resulted in a 57 percent worse outcome when compared to one injection,” Dr. Vicenzino said.

Why cortisone shots should slow the healing of tennis elbow is a good question. An even better one, though, is why they help in the first place. For many years it was widely believed that tendon-overuse injuries were caused by inflammation, said Dr. Karim Khan, a professor at the School of Human Kinetics at the University of British Columbia and the co-author of a commentary in The Lancet accompanying the new review article. The injuries were, as a group, given the name tendinitis, since the suffix “-itis” means inflammation. Cortisone is an anti-inflammatory medication. Using it against an inflammation injury was logical.

But in the decades since, numerous studies have shown, persuasively, that these overuse injuries do not involve inflammation. When animal or human tissues from these types of injuries are examined, they do not contain the usual biochemical markers of inflammation. Instead, the injury seems to be degenerative. The fibers within the tendons fray. Today the injuries usually are referred to as tendinopathies, or diseased tendons.

Why then does a cortisone shot, an anti-inflammatory, work in the short term in noninflammatory injuries, providing undeniable if ephemeral pain relief? The injections seem to have “an effect on the neural receptors” involved in creating the pain in the sore tendon, Dr. Khan said. “They change the pain biology in the short term.” But, he said, cortisone shots do “not heal the structural damage” underlying the pain. Instead, they actually “impede the structural healing.”

Still, relief of pain might be a sufficient reason to champion the injections, if the pain “were severe,” Dr. Khan said. “But it’s not.” The pain associated with tendinopathies tends to fall somewhere around a 7 or so on a 10-point scale of pain. “It’s not insignificant, but it’s not kidney stones.”

So the question of whether cortisone shots still make sense as a treatment for tendinopathies, especially tennis elbow, depends, Dr. Khan said, on how you choose “to balance short-term pain relief versus the likelihood” of longer-term negative outcomes. In other words, is reducing soreness now worth an increased risk of delayed healing and possible relapse within the year?

Some people, including physicians, may decide that the answer remains yes. There will always be a longing for a magical pill, the quick fix, especially when the other widely accepted and studied alternatives for treating sore tendons are to do nothing or, more onerous to some people, to rigorously exercise the sore joint during physical therapy. But if he were to dispense advice based on his findings and that of his colleagues’ systematic review, Dr. Vicenzino said, he would suggest that athletes with tennis elbow (and possibly other tendinopathies) think not just once or twice about the wisdom of cortisone shots but “three or four times.”

Mammograms, the controversy continues

From last week's New York Times

An expert in breast cancer. Dr. Marisa Weiss, was diagnosed with breast cancer herself. This, is one of many anecdotal stories of early diagnosis leading to successful treatment after a mammogram. These stories abound and fuel the debate over the recently revised guidelines for mammography. The new guidelines stipulate that women with no risk factors do not need regular mammograms until age 50, and then every other year. I've done a few posts on the topic, here and here.

Dr. Marisa Weiss scheduled her mammogram this spring, just as she does every year. ..
Dr. Weiss, who soon learned that she had an invasive Stage 1 cancer in her left breast, is not just any physician. A radiation oncologist and a specialist in breast cancer, she founded a popular Web site, breastcancer.org, for women seeking comprehensive information about the disease, and she considers herself a woman with a mission...
A year ago, when a federal task force issued new guidelines relaxing the recommendations for mammography screening, Dr. Weiss was one of their fiercest critics. Mammograms aren’t perfect, she said at the time, but they save lives. Now she says one may have saved hers...
If Dr. Weiss had followed them, she might have skipped this year’s scan, giving the tumor more time to grow undetected; and if she had not had a trail of scans from her 40s, doctors would not have been able to compare the images and notice the tumor’s subtle emergence. (In fact, her risk is above average, because of her dense breast tissue and a family history. But she noted, “Most women who get breast cancer don’t have a family history — that’s a huge myth.”)...
Dr. Brawley says that on balance, mammography saves lives. But he notes that it misses some cancers, and that radiation from the scans will actually cause some cancers to develop.
In addition, some women will be called back repeatedly for additional procedures, scans and biopsies that ultimately rule out cancer but can be painful and anxiety-provoking. Mammograms also find some cancers that grow very slowly but look the same as any other cancerous tumor, leading to aggressive but unnecessary treatment..

.
The article goes on to say that the decision is still a personal one and though some primary care physicians have reduced the number of referrals for mammograms, the new guidelines have not had a big impact on mammogram scheduling nor insurance coverage. Of note, is that Dr. Weiss would have been in a higher risk group anyway, and would have received mammograms as per the previous recommendations.

The trend is disturbing to Dr. Weiss, who says she fears that radical changes in the way women live — earlier puberty, rising obesity and alcohol consumption, environmental pollution, long-term use of oral contraceptives, later childbearing and less breast-feeding — could lead to more breast cancer emerging at younger ages.

Dr. Weiss goes on to say,

“The thing is: every woman is at risk. And every woman needs to do everything she can to protect herself.”

Coincidentally, I went to see my OB/Gyn physician for a checkup, and she was diagnosed with breast cancer over a year ago. The cancer showed up 2 months after her mammogram when she noticed an asymmetric nipple and dimpling. So her mammogram missed it. There are no easy answers here, and I certainly hope we can get some insight and funding to find out the cause of increasing breast cancer rates.


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Immediate effects of acupuncture on strength performance

In this study, the researchers were looking for improvement of athletic performance after a single acupuncture treatment. This doesn't really fit into the Traditional Chinese Medicine array of uses for acupuncture, but it gives some heft to the observations of the NFL athletes cited in my previous post. Not that NFL athletes need any additional heft.
Following are a few exerpts from the abstract. We are again left with the conundrum of the verum acupuncture and the sham acupuncture both being effective, though the verum acupuncture more so.

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Immediate effects of acupuncture on strength performance: a randomized, controlled crossover trial. Eur J Appl Physiol. 2010 Sep;110(2):353-8. Epub 2010 May 25. Hübscher M, Vogt L, Ziebart T, Banzer W. Department of Sports Medicine, Goethe-University Frankfurt, Frankfurt, Germany. m.huebscher@sport.uni-frankfurt.de

The present study investigated the immediate efficacy of acupuncture compared to sham acupuncture and placebo laser acupuncture on strength performance. ..Assessment included bipedal drop jumps for maximum rebound height and quadriceps maximum isometric voluntary force (MIVF). ..Measurements were performed at baseline and immediately after treatment by a blinded investigator. ..The difference in the mean change in MIVF from baseline between acupuncture (46.6 N) and sham laser acupuncture (19.6 N) was statistically significant (p < style="font-style: italic; font-weight: bold;">The present study shows that a single acupuncture treatment was efficacious for improving isometric quadriceps strength in recreational athletes. These results might have implications not only for athletic performance enhancement, but also for rehabilitation programs aimed at restoring neuromuscular function.

HIV patients and Acupuncture

I just wanted to comment about this particular subset of patients. I see quite a few HIV positive patients for general "wellness," and I have to say that this is a most gratifying group to treat. The treatment plan usually consists of twice weekly visits initially to deal with specific problems and to get their immune systems optimized. I typically treat for stress and immune function in these patients, and then whatever other problems that they're faced with, eg sinusitis, tendonitis, lung problems and the like. If tolerated, an overall herbal formula with Astragalus is great for prevention of illness. Prevention is more than half the battle, especially when the patients have to travel a lot in planes (wow, do people get sick from planes...) After the initial series of about 4-6 visits, they usually come in once a month for treatment and to pick up herbs. What I've seen is that the acupuncture can help quite a bit with stress in these patients (of course that helps the immune system) and it keeps the number of ancillary infections, upper respiratory infections, diarrheal episodes etc... to a minimum. These are people who know their bodies and know their symptoms and can really attest to the benefits of the treatments, which is why it's so gratifying.


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HDL, "Good" Cholesterol May Lower Alzheimer Risk

At Columbia University’s Taub Institute for Research on Alzheimer’s Disease and the Aging Brain, they've done a study looking at Alzheimer risk and HDL, the "good" portion of cholesterol. If your HDL cholesterol is very high, this may be protective. In fact patients with high levels of HDL were less than half as likely to develop Alzheimer's Disease.

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‘Good’ Cholesterol May Lower Alzheimer’s Risk
By RONI CARYN RABIN

The people who reaped the benefit had very high HDL blood levels that exceeded 56 milligrams per deciliter of blood, the study reported. They developed 60 percent fewer cases of Alzheimer’s disease than people with the lowest HDL levels, of 38 milligrams or below...
But the HDL was only protective at extremely high levels, Dr. Reitz said. “It really only makes a difference if you’re higher than 56 [milliliters],” she said.

The report, published in the Archives of Neurology, is not the first to find that what’s good for the body may also good for the brain. Numerous studies have found that older people who walked the most were at lowest risk of developing vascular dementia, possibly because the regular exercise improves cerebral blood flow and lowers the risk of vascular disease.

Regular physical activity, in general, is believed to improve brain function, both by increasing blood flow to the brain and by stimulating the production of hormones and nerve growth factors involved in new nerve cell growth. Exercise also raises levels of “good” HDL cholesterol. Studies have found that animals that are kept physically active have better memories and more cells in their hippocampus, a part of the brain critical for memory. And exercise can help stave off or keep in check diseases like Type 2 diabetes, which increase the risk of developing dementia...

Some medications, like niacin and fibrates, may help raise HDL levels, Dr. Reitz said. But she recommends a Mediterranean diet rich in healthy fats from nuts, fish and olive oil, along with exercise, adding, “Aerobic exercise helps a lot.”

In a previous post, I discussed a study that looks at insulin resistance and acupuncture and how acupuncture can help with this aspect of metabolic syndrome and Type 2 diabetes. I hope it's not a stretch to think that acupuncture might help increase HDL cholesterol by increasing insulin sensitivity. Maybe it is a bit of a stretch, but for sure acupuncture can help to get you walking again if you have knee, back or hip pain!

Radiation Risk and Coronary CT Scans

During the presentation by Dr. Rita Redberg on Coronary Artery Disease during the "Controversies in Women's Health Conference" last week, she discussed the use of CT scans for screening and diagnosis of CAD. They are used to detect coronary calcium. She stated the astonishing fact that an estimated 1 in 270 women who have one of these scans at the age of 40 years will develop cancer from that CT!! She also said that based on CT scans done in 2007 alone there would be 30,000 cancers and 15000 excess deaths. She gave a horrific case study about a woman who was having abnormal chest pain that was unlikely to be angina. But, to reassure the patient, they did a coronary artery CT scan. They saw something suspicious and went to coronary cath. Her cath was normal without disease, but they dissected her Left Anterior Descending coronary artery and they had to go to emergency coronary artery bypass. She ended up with a heart transplant.
This underscores Dr. Redberg's admonition that less is more, and that "reassurance" is not sufficient reason to order a study. First do no harm.

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Calcium and PMS, or PMDD

I wanted to just mention another item or two from the UCSF "Controversies in Women's Health" Conference last week. For patients with PMDD, after the basic recommendations of decreasing salt, caffeine, sugar, sodium and alcohol, and increasing water, fresh fruit, and whole grains, getting exercise and reducing stress, (shouldn't we all?) they recommend Calcium supplementation. They found in a large multicenter study that 600mg twice a day, the equivalent of 2 "Tums" a day for three cycles improved symptoms in 55% of women by greater than 50%. Calcium relieved both emotional and physical symptoms. I'm glad to have something non-hormonal as an adjunct to herbs and acupuncture to offer patients with this difficult condition.

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Some sanity, at last, on Statins

I just attended the annual UCSF conference on Controversies in Women's Health. This conference is well done, in that it alerts practitioners to issues that are being discussed at the "Task Force" level. For example when I was at the conference 2 years ago I first heard about the mammography controversy, that the science was showing that there was no added benefit to mammography in younger women and that there were increased harms. Of course this caused a huge uproar in the subsequent two years. I won't go into the particulars of either side. But this was one of the first times I had actually been aware of the medical community admitting that there might be a downside to too much intervention.
This year, Professor Rita F. Redberg gave a thoughtful and informative talk on cardiovascular disease entitled "Prevention and Treatment of Cardiovascular Disease in Women:When is Less More?" Any readers of this blog know that this is an approach that I take seriously; to evaluate interventions carefully to make sure there is no harm being done, and to be highly suspicious of new, lucrative, and highly touted treatments. Dr. Redberg has a column in the Annals of Internal Medicine entitled "Less is More" and solicited contributions to the column via Deborah Grady, MD, section editor, Less is More, Annals of Internal Medicine. She asked specifically for cases, commentary, original investigation. What a great concept!
So as to the topic of Statins, I've been suspicious of them since the beginning because of the triad I just mentioned, new, lucrative and highly touted. My patients were coming in saying that their physicians were extremely enthusiastic about these medications, many even saying that they wished that they were in the water supply (!) (No worries, they probably are in our creeks and rivers by now, just like Prozac and antibiotics.) I also heard from patients that since they started taking them they had muscle problems and backaches. They were sure that they were from the statins, but their doctors insisted that they were fine. From Dr. Redberg's presentation, statins do cause muscle aches and pains, weakness, and memory loss. Her unequivocal position was that there is no data that statins reduce cardiac events or chronic heart disease mortality in women. Furthermore, there is no data that statins reduce all cause mortality in men or women.
She has a quote from one of her patients saying,

"Since stopping the Welchol, my leg muscle weakness has stoppend and I am able to walk down the stairs normally. I am also not experiencing memory loss. My thinking feels sharper."

First do no harm. Hopefully, with this latest consensus, people will feel more comfortable taking themselves off the statins, and physicians will not be so gung ho prescribing them. Dr. Redberg also said that cholesterol levels are clearly related to diet and physical activity, and it is unclear if the same benefits accrue via cholesterol lowering by medications.

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Good results with Acupuncture for a patient with High Blood Pressure

On a more anecdotal basis, I saw a patient today who has been coming to me for about 6 months to treat high blood pressure. He had no desire to take medications, and so was seeking some other alternatives. He is 67 and works in a stressful job as a taxi cab dispatcher. He had spent some time in Asia earlier in his working life so was open to acupuncture as an alternative.
He came twice weekly for 6 weeks and then weekly for 2 months. I treated him with classic points for decreasing rising yang, and also points that have been shown to calm the autonomic nervous system in studies, like sishencong and 6MC. We added daily herbal supplements in addition to the acupuncture treatments. In his particular case a Yin tonic was key. He now comes in once a month and has maintained his blood pressure in a healthy range. Here is a chart of his BP ( bit blurry, sorry!) It may not look super dramatic, but it's the difference between taking medications and not.

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Rethinking the Scientific Method from the New Yorker

The Truth Wears Off

This article from the most recent New Yorker looks at something called "the decline" effect. It is a phenomenon where an established result in science, or "fact" becomes less demonstrable over time. They give examples of antipsychotic medications,certain cognition effects and stents (ahem.) They mention several possible reasons for this effect. Wishful thinking on the part of researchers, for example. They cite acupuncture studies from 1990 to 2000 where all of the results from Asia were positive, when only 50% from the U.S. and Europe were positive. (This was obvious to anyone paying attention to the acupuncture literature at this time. I still ignore most of the studies out of Asia, China in particular.) Another possible explanation was just random chance that lead to the initial results that could not be reproduced.
The problem is, of course, that studies are very expensive! It's easy enough to call for more studies, but much more difficult to actually procure the money to pay for adequate studies. It was fortunate for the acupuncture community that the Insurance Companies in Germany were willing to pay for large enough studies to establish acupuncture efficacy for knee, hip and back pain. They did not discuss the corruption of studies by the drug companies as referenced in a previous post.

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ABSTRACT: ANNALS OF SCIENCE about the decline effect. On September 18, 2007, a few dozen neuroscientists, psychiatrists, and drug-company executives gathered in a hotel conference room in Brussels to hear some startling news. It had to do with a class of drugs known as atypical or second-generation antipsychotics, which came on the market in the early nineties. The therapeutic power of the drugs appeared to be steadily falling. A recent study showed an effect that was less than half of that documented in the first trials, in the early nineties. Before the effectiveness of a drug can be confirmed, it must be tested again and again. The test of replicability, as it’s known, is the foundation of modern research. It’s a safeguard
for the creep of subjectivity. But now all sorts of well-established, multiply confirmed findings have started to look increasingly uncertain. It’s as if our facts are losing their truth. This phenomenon doesn’t yet have an official name, but it’s occurring across a wide range of fields, from psychology to ecology. When Jonathan Schooler was a graduate student at the University of Washington, he discovered a surprising phenomenon having to do with language and memory that he called verbal overshadowing. While Schooler was publishing his results in journals, he noticed that it was proving difficult to replicate his earlier findings. Mentions psychologist Joseph Banks Rhine, who conducted several experiments dealing with E.S.P. In 2004, Schooler embarked on an imitation of Rhine’s research in an attempt to test the decline effect. The most likely explanation for the decline is an obvious one: regression to the mean. Yet the effect’s ubiquity seems to violate the laws of statistics. Describes Anders Møller’s discovery of the theory of fluctuating asymmetry in sexual selection. Mentions Leigh Simmons and Theodore Sterling. Biologist Michael Jennions argues that the decline effect is largely a product of publication bias. Biologist Richard Palmer suspects that an equally significant issue is the selective reporting of results—that is, the subtle omissions and unconscious misperceptions, as researchers struggle to make sense of their results. Mentions John Ioannidis. In the late nineteen-nineties, neuroscientist John Crabbe investigated the impact of unknown chance events on the test of replicability. The disturbing implication of his study is that a lot of extraordinary scientific data is nothing but noise. This suggests that the decline effect is actually a decline of illusion. Many scientific theories continue to be considered true even after failing numerous experimental tests. The decline effect is troubling because it reminds us how difficult it is to prove anything.

Read more http://www.newyorker.com/reporting/2010/12/13/101213fa_fact_lehrer?printable=true#ixzz17XfGb9b7

Big Money in Stents

Doctor Faces Suits Over Cardiac Stents By GARDINER HARRIS

This is an article about a busy cardiologist in Baltimore, who had inserted more than 30 cardiac stents in a single day, and is now facing charges that Dr. Midei “may have implanted 585 stents which were medically unnecessary” from 2007 to 2009. Medicare paid $3.8 million of the $6.6 million charged for those procedures in patients who did not need them.

The case has turned into a legal quagmire for Dr. Midei and St. Joseph, which have been sued by hundreds of patients who claim they received unnecessary implants. Some doctors say the case has revealed a level of inappropriate care that is more common than most patients know.

“What was going on in Baltimore is going on right now in every city in America,” said Dr. Steven Nissen, chief of cardiovascular medicine at the Cleveland Clinic, who said he routinely treats patients who have been given multiple unneeded stents. “We’re spending a fortune as a country on procedures that people don’t need.”


and

"A landmark 2007 study published in The New England Journal of Medicine showed that many patients given stents would fare just as well without them."


and

"Prosecutors, malpractice lawyers and state medical boards are only now waking up to the issue. The Texas Medical Board last month accused a widely known cardiologist in Austin of inserting unnecessary stents. In September, federal prosecutors accused a cardiologist in Salisbury, Md., of performing unnecessary stent surgeries, and last year a Louisiana doctor was sentenced to 10 years in prison for inserting unneeded stents."


and

"But far from questioning cardiologists who perform an unusually high number of stent procedures, many hospital executives celebrate these doctors because of the revenue they bring, which can be more than $10,000 per procedure."


and

Hospital patients expect their care to be based on medical need, not profits,” said Senator Max Baucus, Democrat of Montana and chairman of the Finance Committee. “Even more disconcerting is that this could be a sign of a larger national trend of wasteful medical device use.”

This is what happens when money can be made by procedures. You get more of them. And hope that no harm is done by them. Yeah right, what could possibly go wrong?
For those really interested, you can read more of the article below.

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A landmark 2007 study published in The New England Journal of Medicine showed that many patients given stents would fare just as well without them. Dr. Christopher J. White, president-elect of the Society for Cardiovascular Angiography and Interventions, said that inappropriate stenting was a problem, but a rare one. The federal Medicare program spent $3.5 billion last year on stent procedures.

Prosecutors, malpractice lawyers and state medical boards are only now waking up to the issue. The Texas Medical Board last month accused a widely known cardiologist in Austin of inserting unnecessary stents. In September, federal prosecutors accused a cardiologist in Salisbury, Md., of performing unnecessary stent surgeries, and last year a Louisiana doctor was sentenced to 10 years in prison for inserting unneeded stents.

J. Stephen Simms, a Baltimore lawyer who successfully pursued a federal whistle-blower lawsuit involving kickbacks for coronary procedures, said such cases were “the flavor of the month right now” with federal prosecutors.

Jay Miller, another Baltimore lawyer, said he was devoting his entire practice to unnecessary stent cases. “And I don’t think this is limited to just a few Maryland hospitals,” Mr. Miller said.

But far from questioning cardiologists who perform an unusually high number of stent procedures, many hospital executives celebrate these doctors because of the revenue they bring, which can be more than $10,000 per procedure.

“Hospital patients expect their care to be based on medical need, not profits,” said Senator Max Baucus, Democrat of Montana and chairman of the Finance Committee. “Even more disconcerting is that this could be a sign of a larger national trend of wasteful medical device use.”

Dr. Midei’s fall was as rapid as it was dramatic. In a June deposition for a lawsuit against him, he said: “I didn’t know what hit me. I was bewildered by what had happened.”

He had been one of the most sought-after clinicians in his region. Trained at Johns Hopkins University, he was a co-founder of MidAtlantic, a practice with dozens of cardiologists that controlled much of the cardiac business in Baltimore’s private hospitals. Dr. Midei was one of the practice’s stars. When MidAtlantic negotiated a $25 million merger with Union Hospital in 2007, the deal was contingent on his continued employment.

St. Joseph was so concerned about losing Dr. Midei’s business that the hospital offered a $1.2 million salary if he would leave MidAtlantic and join the hospital’s staff. When Dr. Midei agreed, the merger with Union collapsed, MidAtlantic sued, and the practice’s former chief executive vowed in a deposition to “spend the rest of my life trying to destroy him personally and professionally.”

In the June deposition, Dr. Midei estimated that in 2005 — before research revealed that many stents were unnecessary — he performed about 800 stent procedures. Instead of dropping in subsequent years, however, the number of stents Dr. Midei inserted rose to as many as 1,200 annually, he estimated. In a 2007 internal document, Abbott Laboratories ranked Dr. Midei’s use of stents behind only five other cardiologists in the Northeast, including those at hospitals four and five times St. Joseph’s size.

That sort of increase in volume was an obvious red flag, said Dr. William E. Boden, clinical chief of the division of cardiovascular medicine at the University of Buffalo and an author of the 2007 stent study. “For him to have this brisk increase over those years is really unusual,” Dr. Boden said.

In stable patients, stents should be used only if X-rays show that most of the artery is blocked, and the patient has symptoms like frequent chest pain. Stent procedures can, in rare cases, cause bleeding, stroke or a heart attack. Once a stent is placed, it can result in a life-threatening clot that emerges weeks to months later. Stent patients must spend a year or more taking blood-thinning medications, which have their own risks.

In April 2009, a patient of Dr. Midei’s who was also a St. Joseph employee complained that he had received an unneeded stent and that many other patients had as well. The hospital engaged a panel of experts who reviewed 1,878 cases from January 2007 to May 2009 and found that 585 patients might have received unnecessary stents.

When asked to review the cases himself, Dr. Midei found far less blockage than he had initially, according to the Maryland Board of Physicians. The hospital suspended his privileges and eventually sent letters to all 585 patients. Hundreds of lawsuits against Dr. Midei and St. Joseph followed, including from patients treated well before January 2007.

Abbott responded to the controversy by hiring Dr. Midei as a consultant. “It’s the right thing to do because he helped us so many times over the years,” an Abbott executive wrote in a January e-mail cited in the Senate report.

The company sent Dr. Midei to Japan, but news of the controversy made his duties impossible, and he flew home. After one particularly critical story in The Baltimore Sun, David C. Pacitti, an Abbott executive, wrote in an e-mail, “Someone needs to take this writer out and kick his ass!”

Edward Chaid, 68, a semiretired general contractor from Timonium, Md., is among those who have sued. Five years ago, Mr. Chaid decided to get his first physical examination in decades. Just to be safe, his doctor sent him for a cardiac stress test at MidAtlantic, which revealed a small “squiggle” of concern, Mr. Chaid said. He was sent to Dr. Midei to get his arteries X-rayed, and he emerged from the procedure with two stents.

“Dr. Midei said: ‘You sure are lucky. You had 90 percent blockage.’ And the nurse said, ‘Oh yeah, you were blocked in your widow-maker.’ And I said: ‘Thank God. I guess I’m really lucky you got it when you did,’ ” Mr. Chaid said in an interview.

Five years later, another doctor concluded that Mr. Chaid’s blockage had been minimal. “I was really shocked,” Mr. Chaid said. “I’m from a generation where doctors are thought very highly of.”

But Mr. Snyder, Dr. Midei’s lawyer, said that his client’s care had been entirely appropriate, that doctors often interpret X-rays differently and that St. Joseph was using him as a scapegoat. A Web site created by friends of Dr. Midei lists dozens of testimonials like this one: “Plain and simple, Dr. Midei saved my life.”

Metabolic Syndrome and Heart Rate Variability (HRV)

This study is related to my last post concerning acupuncture and metabolic syndrome and insulin resistance in that acupuncture can enhance HRV so may help with Insulin resistance and its relationship to metabolic syndrome. Because the ANS (autonomic nervous system) decrease has been associated with a higher risk of sudden cardiovascular and cerebrovascular disease. So they explored the relationship between ANS control of the cardiovascular system and metabolic syndrome. In this study they looked at short term HRV (5 minutes) and long term (overnight and 24 hour sessions) in relation to metabolic syndrome status, high-density lipoprotein cholesterol (HDL-C), and waist circumference. Both nighttime and 24-h HRV showed closer associations with metabolic syndrome than did short-term HRV.

(To read more about acupuncture and my practice, please click here.)

Metabolic Syndrome and Short-Term and Long-Term Heart Rate Variability in Elderly Free of Clinical Cardiovascular Disease: The PROOF Study.
Assoumou HG, Pichot V, Barthelemy JC, Dauphinot V, Celle S, Gosse P, Kossovsky M, Gaspoz JM, Roche F.
Rejuvenation Res. 2010 Sep 6
University Hospital and Jean Monnet University , Pres Lyon, Saint-Etienne, France .
Abstract Objective: Autonomic nervous system (ANS) activity decrease has been associated with a higher risk of sudden cardiovascular and cerebrovascular disease. Thus, we explored the relationship between ANS control of the cardiovascular system and metabolic syndrome. Methods: We analyzed the relationship with both short-term and long-term heart rate variability (HRV) and metabolic syndrome in the cross-sectional PROgnostic indicator OF cardiovascular and cerebrovascular events (PROOF) cohort study of 1,011 elderly subjects recruited amongst the inhabitants of the city of Saint Etienne, France, aged 65.6 +/- 0.8 years at the inclusion date. Physical examination included measurements of height, weight, systolic and diastolic blood pressure, waist circumference, and biological parameters. HRV variables were measured over 5-min, nighttime, and 24-h periods using Holter monitoring. Results: After adjustment for current type 2 diabetes, depression, and smoking, we found that metabolic syndrome status, high-density lipoprotein cholesterol (HDL-C), and waist circumference were significantly (p < 0.05) associated with total power, very-low frequency, low-frequency/high-frequency (LF/HF) ratio, and normalized LF. HDL-C and metabolic syndrome status were significantly associated with decreased long-term HRV variables. Both nighttime and 24-h HRV showed closer associations with metabolic syndrome than did short-term HRV (5-min). Metabolic syndrome severity was associated with a decrease in both the long-term and short-term HRV variables. Conclusions: ANS control alteration of the cardiovascular system was more pronounced when evaluated by long-term than short-term HRV recordings, particularly in women.

Acupuncturist for the NFL players

One of my patients brought me this article from the New York Times Sports Section. It's about an acupuncturist who is devoted to 3 or 4 NFL teams and works 96 hours a week to keep them in good shape for their upcoming games. She uses a combination of a sort of massage and Japanese Style acupuncture, at times using as many as 130 needles. Tough guys!! But it's great to see acupuncture becoming more and more mainstream.

(To read more about acupuncture and my practice, please click here.)

Acupuncture: is it effective for treatment of insulin resistance?

Acupuncture: is it effective for treatment of insulin resistance?
Diabetes Obes Metab. 2010 Jul;12(7):555-69.
Liang F, Koya D.Department of Endocrinology & Metabolism, Kanazawa Medical University, Ishikawa, Japan.

This study out of Japan looks at the literature concerning acupuncture and conditions related to Insulin Resistance and concludes that acupuncture might very well improve insulin sensitivity, though, of course, calls for better, controlled, studies. This review analyses 234 English publications listed on the PubMed database between 1979 and 2009 on the effectiveness of acupuncture as a treatment for IR.
A few quotes

"Insulin resistance (IR) is closely associated with obesity, type 2 diabetes mellitus (T2DM), hypertension, polycystic ovary syndrome (PCOS), non-alcohol fatty liver diseases (NAFLD) and metabolic syndrome and is also a risk factor for serious diseases such as cardiovascular diseases. Pharmacological treatments available for IR are limited by drug adverse effects."

" Numerous experimental studies have demonstrated that acupuncture can correct various metabolic disorders such as hyperglycemia, overweight, hyperphagia, hyperlipidemia, inflammation, altered activity of the sympathetic nervous system and insulin signal defect, all of which contribute to the development of IR. In addition, acupuncture has the potential to improve insulin sensitivity."

(To read more about acupuncture and my practice, please click here.)