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Wednesday, June 29, 2011

Unprecedented. Experts decry Medtronic Studies.

From the New York Times. A few of my other posts on conflicts of interest in corporate research here, here,and here.
Spine Experts Repudiate Medtronic Studies
By BARRY MEIER and DUFF WILSON


In an extraordinary move, a group of spine specialists are publicly repudiating the research of other experts that has backed the widespread use of a Medtronic bone growth product. In a series of reports published in a medical journal on Tuesday, the specialists called the research misleading and biased.
The repudiation, appearing in a full issue of The Spine Journal devoted to the topic, represents a watershed in the long-running debate over conflicts of interest for the sponsorship of scientific studies by makers of drugs and medical devices. It is extremely rare for researchers to publicly chastise colleagues, and editors of leading medical journals said they could not recall an instance in which a publication had dedicated an entire issue for such a singular purpose.

Medtronic, the nation’s biggest maker of medical devices, has been facing intensifying scrutiny over its promotion of Infuse, the bone growth product at the center of the controversy. The bioengineered material is used primarily in spinal fusions, a procedure in which spinal vertebrae are joined to reduce back pain.

Infuse is used in about a quarter of the estimated 432,000 spinal fusions performed in this country each year. The articles published on Tuesday charge that researchers with financial ties to Medtronic overstated Infuse’s benefits and vastly understated its risks by claiming there were none.

“It harms patients to have biased and corrupted research published,” five doctors wrote in a joint editorial that accompanied the reports. “It harms patients to have unaccountable special interests permeate medical research.”

“The spine care field is currently at a precarious intersection of professionalism, morality and public safety,” Dr. Christopher M. Bono, editor of the special edition, said in a statement. “As physicians and journal editors, we felt an obligation to present a thorough examination of this controversial issue.”

It is too early to predict how the articles will affect the financial fortunes of Medtronic, which earned an estimated $900 million from Infuse in its most recent fiscal year. ..


Medtronic officials acknowledged in interviews that it was common for them to review studies of its products before publication. However, they sought to distance themselves from the content of the published reports, and said outside researchers, not the company, had determined the significance of data and how it should be presented. At the heart of the issue are potential side effects related to Infuse’s use that emerged during patient studies conducted about a decade ago by outside researchers with significant financial ties to Medtronic.

Medtronic, as required, reported that data to the F.D.A., and the agency considered the rate of those complications significant enough in some cases to require the company to list them on Infuse’s label. But in reporting on such studies in 13 medical journal articles published during the last decade, researchers whose studies were paid for by Medtronic maintained that Infuse’s use was not tied to any complications.
In one article released Tuesday, experts said those reports played down Infuse’s risks and slanted them to favor Infuse’s performance over a bone graft, the material traditionally used in a fusion. Those experts estimated that the incidence of adverse events in connection with Infuse’s use ranged from 10 to 50 percent, depending on how it was used.

Those side effects, they said, include male sterility, infection, bone loss and unwanted bone growth. A stronger version of Infuse, called Amplify, was recently rejected for approval by the F.D.A. because of concerns about possible cancer risks.

In 2008, the agency warned the public that it had received reports of life-threatening injuries associated with the use of Infuse in the cervical portion of the spine, a use that was not approved by the agency.

Dr. Eugene J. Carragee, editor of The Spine Journal, said he believed that Infuse was a valuable product for patients who were not candidates for a bone graft. But he added that the publication had undertaken the review because he and other experts hoped to cleanse the scientific record.

While Dr. Carragee said some researchers involved in the earlier reports were not influenced by links to Medtronic, he found it difficult to give those with major financial ties to the company such a pass. The median amount of Medtronic money received over time by researchers involved in some studies ranged from $12 million to $16 million, with most of that going to a few individuals, The Spine Journal estimated.
“A consistent number of people involved with these studies got extraordinary sums,” he said.


Tuesday’s articles added to an expanding number of studies pointing to serious side effects suffered by patients given Infuse. The journal also published an editorial by Dr. Charles L. Branch Jr., a Medtronic consultant, who said that the growing controversy over Infuse reflected a need to develop better ways to monitor and examine the off-label uses of medical products.

Infuse “appears to have been assigned the role of the poster child for all that is wrong with ‘off-label’ or physician-directed use of a novel beneficial technology,” wrote Dr. Branch, a neurosurgeon at the Wake Forest Baptist Medical Center in Winston-Salem, N.C.

Several researchers who were involved in the Medtronic-sponsored studies have defended their reports as scientifically sound and free of company influence, either directly or indirectly.

For example, one of them, Dr. Thomas A. Zdeblick of the University of Wisconsin, said that he did not have a “direct financial interest in the success of Infuse or Medtronic.” Over the years, Dr. Zdeblick has received over $20 million in royalty payments from Medtronic in connection with patents on devices, including one that is used with Infuse...


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Typical Patient who comes to my Acupuncture Clinic

I thought I might start to feature some case studies of some of my patients. This patient is particularly interesting. She is in her mid sixties and came in for help with Neuropathy of her feet. Her other problems include high cholesterol and high blood pressure. It turns out that the neuropathy was made much worse by Lipitor. She finally convinced her physician to discontinue it, and she was doing better but then he put her on another statin. Her neuropathy got so intense that she couldn't walk without a cane and was crying out from the pain. She stopped it and came into the clinic to see me.
I gave her treatment for stress and for the neuropathy in her feet. I saw her for the first time on a Thursday, and by the following Monday the pain in her feet was much improved, and her blood pressure had remained below 140 systolic and below 80 diastolic. She can walk without a cane now.
Of course it is hard to tell if the acupuncture helped or if it was tincture of time being off of the statin. Similarly with the blood pressure, it might have come down with the lessening of the pain in her feet.
I will continue to treat her for both problems, at least for awhile, and try to get her blood pressure low enough that she can consider cutting back on medications.
Interestingly, she had Clostridia dificil last year. A nasty life threatening type of colitis that is usually caused by antibiotics. And sure enough, she had been treated for 6 months with antibiotics for a bladder infection. She was also diagnosed with COPD because of a dry cough, when dry cough is a typical side effect of Lisinopril, something I've seen quite a bit in my clinic. The cough went away once she discontinued the Lisinopril, COPD, um, gone.
These are the types of medical histories that make people open to alternative medicine. First, do no harm.
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Monday, June 27, 2011

Peripheral Opioid Receptors in Electroacupuncture

This is a study that tries to specify which opioid receptors are involved in electroacupuncture's effectiveness in decreasing the Paw Pressure Threshold in rats. They use an irritant, carrageenan, which makes the joint hyperalgesic (more sensitive) and then measure how long it takes for the rat to pull away after pressure. The electroacupuncture effect lasts for many hours, so they injected the opiate antagonist at various times after the electroacupuncture.
Their findings suggest "that peripheral µ, d and ? receptors on peripheral nerve terminals are activated by EA, although there is a time difference among these activations."

Involvement of peripheral opioid receptors in electroacupuncture analgesia for carrageenan-induced hyperalgesia.


Department of Clinical Acupuncture and Moxibustion, Meiji University of Integrative Medicine, Nantan-shi, Kyoto, Japan. r_sekido@meiji-u.ac.jp
Taguchi R, Taguchi T, Kitakoji H.


Acupuncture is widely used to relieve pain; however, the mechanism underlying electroacupuncture analgesia (EAA) during inflammatory pain is unclear. We investigated whether endogenous peripheral opioid receptors participated in EAA during hyperalgesia elicited by carrageenan-induced inflammation. Moreover, we investigated which subtype of opioid receptor was involved in EAA. Carrageenan was subcutaneously administered by intraplanter (i.pl.) injection into the left hind paw. Nociceptive thresholds were measured using the paw pressure threshold (PPT). Rats received 3Hz electroacupuncture (EA) for 1h after carrageenan injection. The nonselective peripheral opioid receptor antagonist, naloxone methiodide, was administered by i.pl. injection of the inflamed paw 5min before EA. Also, animals received i.pl. or intravenous (i.v.) injection of selective antagonists against µ(D-Phe-Cys-Tyr-D-Trp-Orn-Thr-Pen-ThrNH2, CTOP), d(naltrindole, NTI), or ? (nor-Binaltorphimine, nor-BNI) opioid receptors 1h before EA. PPT decreased significantly 3h after carrageenan injection. EA resulted in significant increases of PPT, moreover, PPT elevations persisted for 9h after carrageenan injection. PPT elevations produced by EA were antagonized by local i.pl. injection of naloxone methiodide at 3 and 5h after cessation of EA. NTI, nor-BNI and CTOP blocked EAA from immediately, 1h, and 3h after EA cessation, respectively. The EAA in the inflamed paw could not be blocked by i.v. injection of NTI, nor-BNI and CTOP. These findings suggest that peripheral µ, d and ? receptors on peripheral nerve terminals are activated by EA, although there is a time difference among these activations.

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Lies, Damn Lies and Medical Science

In researching the Alternative Medicine Debate from yesterday, I came upon this article from the Atlantic from last November.

It is entitled,"Lies, Damn Lies, and Medical Science." And I'm sorry for the length of this post, but even at this length, there was more in the article I wanted to share. It concerns a Harvard trained, math whiz, named John Ioannidis. He has a lab in Greece and has devoted himself to carefully studying medical research and its claims and the ground breaking results have been met with some denials and blow back, but also with acceptance. He is one of the most sought after researchers in the world. The whole article is fascinating, and it would be great for readers interested in these controversies to read the whole thing. But I will excerpt some of the most parts I find the most interesting. First, do no harm... After reading this article, I certainly will reconsider some of the supplement recommendations I make in my clinic. They amount to certain vitamins, but still, if not necessary, best to skip them.



... Ioannidis, who had mostly been listening, delivered what felt like a coup de grâce: wasn’t it possible, he asked, that drug companies were carefully selecting the topics of their studies—for example, comparing their new drugs against those already known to be inferior to others on the market—so that they were ahead of the game even before the data juggling began? “Maybe sometimes it’s the questions that are biased, not the answers,” he said, flashing a friendly smile. Everyone nodded. Though the results of drug studies often make newspaper headlines, you have to wonder whether they prove anything at all. Indeed, given the breadth of the potential problems raised at the meeting, can any medical-research studies be trusted?

That question has been central to Ioannidis’s career. He’s what’s known as a meta-researcher, and he’s become one of the world’s foremost experts on the credibility of medical research. He and his team have shown, again and again, and in many different ways, that much of what biomedical researchers conclude in published studies—conclusions that doctors keep in mind when they prescribe antibiotics or blood-pressure medication, or when they advise us to consume more fiber or less meat, or when they recommend surgery for heart disease or back pain—is misleading, exaggerated, and often flat-out wrong. He charges that as much as 90 percent of the published medical information that doctors rely on is flawed. His work has been widely accepted by the medical community; it has been published in the field’s top journals, where it is heavily cited; and he is a big draw at conferences. Given this exposure, and the fact that his work broadly targets everyone else’s work in medicine, as well as everything that physicians do and all the health advice we get, Ioannidis may be one of the most influential scientists alive. Yet for all his influence, he worries that the field of medical research is so pervasively flawed, and so riddled with conflicts of interest, that it might be chronically resistant to change—or even to publicly admitting that there’s a problem.

...And sure enough, he goes on to suggest that an obsession with winning funding has gone a long way toward weakening the reliability of medical research.


... In poring over medical journals, he was struck by how many findings of all types were refuted by later findings. Of course, medical-science “never minds” are hardly secret. And they sometimes make headlines, as when in recent years large studies or growing consensuses of researchers concluded that mammograms, colonoscopies, and PSA tests are far less useful cancer-detection tools than we had been told; or when widely prescribed antidepressants such as Prozac, Zoloft, and Paxil were revealed to be no more effective than a placebo for most cases of depression; or when we learned that staying out of the sun entirely can actually increase cancer risks; or when we were told that the advice to drink lots of water during intense exercise was potentially fatal; or when, last April, we were informed that taking fish oil, exercising, and doing puzzles doesn’t really help fend off Alzheimer’s disease, as long claimed. Peer-reviewed studies have come to opposite conclusions on whether using cell phones can cause brain cancer, whether sleeping more than eight hours a night is healthful or dangerous, whether taking aspirin every day is more likely to save your life or cut it short, and whether routine angioplasty works better than pills to unclog heart arteries.

..Researchers headed into their studies wanting certain results—and, lo and behold, they were getting them. We think of the scientific process as being objective, rigorous, and even ruthless in separating out what is true from what we merely wish to be true, but in fact it’s easy to manipulate results, even unintentionally or unconsciously. “At every step in the process, there is room to distort results, a way to make a stronger claim or to select what is going to be concluded,” says Ioannidis. “There is an intellectual conflict of interest that pressures researchers to find whatever it is that is most likely to get them funded.”


In the late 1990s, Ioannidis set up a base at the University of Ioannina. He pulled together his team, which remains largely intact today, and started chipping away at the problem in a series of papers that pointed out specific ways certain studies were getting misleading results. Other meta-researchers were also starting to spotlight disturbingly high rates of error in the medical literature. But Ioannidis wanted to get the big picture across, and to do so with solid data, clear reasoning, and good statistical analysis. The project dragged on, until finally he retreated to the tiny island of Sikinos in the Aegean Sea, where he drew inspiration from the relatively primitive surroundings and the intellectual traditions they recalled. “A pervasive theme of ancient Greek literature is that you need to pursue the truth, no matter what the truth might be,” he says. In 2005, he unleashed two papers that challenged the foundations of medical research.

...Simply put, if you’re attracted to ideas that have a good chance of being wrong, and if you’re motivated to prove them right, and if you have a little wiggle room in how you assemble the evidence, you’ll probably succeed in proving wrong theories right. His model predicted, in different fields of medical research, rates of wrongness roughly corresponding to the observed rates at which findings were later convincingly refuted: 80 percent of non-randomized studies (by far the most common type) turn out to be wrong, as do 25 percent of supposedly gold-standard randomized trials, and as much as 10 percent of the platinum-standard large randomized trials. The article spelled out his belief that researchers were frequently manipulating data analyses, chasing career-advancing findings rather than good science, and even using the peer-review process—in which journals ask researchers to help decide which studies to publish—to suppress opposing views. “You can question some of the details of John’s calculations, but it’s hard to argue that the essential ideas aren’t absolutely correct,” says Doug Altman, an Oxford University researcher who directs the Centre for Statistics in Medicine.

Still, Ioannidis anticipated that the community might shrug off his findings: sure, a lot of dubious research makes it into journals, but we researchers and physicians know to ignore it and focus on the good stuff, so what’s the big deal? The other paper headed off that claim. He zoomed in on 49 of the most highly regarded research findings in medicine over the previous 13 years, as judged by the science community’s two standard measures: the papers had appeared in the journals most widely cited in research articles, and the 49 articles themselves were the most widely cited articles in these journals. These were articles that helped lead to the widespread popularity of treatments such as the use of hormone-replacement therapy for menopausal women, vitamin E to reduce the risk of heart disease, coronary stents to ward off heart attacks, and daily low-dose aspirin to control blood pressure and prevent heart attacks and strokes. Ioannidis was putting his contentions to the test not against run-of-the-mill research, or even merely well-accepted research, but against the absolute tip of the research pyramid. Of the 49 articles, 45 claimed to have uncovered effective interventions. Thirty-four of these claims had been retested, and 14 of these, or 41 percent, had been convincingly shown to be wrong or significantly exaggerated. If between a third and a half of the most acclaimed research in medicine was proving untrustworthy, the scope and impact of the problem were undeniable. That article was published in the Journal of the American Medical Association.



...Drug studies have the added corruptive force of financial conflict of interest. The exciting links between genes and various diseases and traits that are relentlessly hyped in the press for heralding miraculous around-the-corner treatments for everything from colon cancer to schizophrenia have in the past proved so vulnerable to error and distortion, Ioannidis has found, that in some cases you’d have done about as well by throwing darts at a chart of the genome. (These studies seem to have improved somewhat in recent years, but whether they will hold up or be useful in treatment are still open questions.) Vioxx, Zelnorm, and Baycol were among the widely prescribed drugs found to be safe and effective in large randomized controlled trials before the drugs were yanked from the market as unsafe or not so effective, or both.


But even for medicine’s most influential studies, the evidence sometimes remains surprisingly narrow. Of those 45 super-cited studies that Ioannidis focused on, 11 had never been retested. Perhaps worse, Ioannidis found that even when a research error is outed, it typically persists for years or even decades. He looked at three prominent health studies from the 1980s and 1990s that were each later soundly refuted, and discovered that researchers continued to cite the original results as correct more often than as flawed—in one case for at least 12 years after the results were discredited.

Doctors may notice that their patients don’t seem to fare as well with certain treatments as the literature would lead them to expect, but the field is appropriately conditioned to subjugate such anecdotal evidence to study findings. Yet much, perhaps even most, of what doctors do has never been formally put to the test in credible studies, given that the need to do so became obvious to the field only in the 1990s, leaving it playing catch-up with a century or more of non-evidence-based medicine, and contributing to Ioannidis’s shockingly high estimate of the degree to which medical knowledge is flawed. That we’re not routinely made seriously ill by this shortfall, he argues, is due largely to the fact that most medical interventions and advice don’t address life-and-death situations, but rather aim to leave us marginally healthier or less unhealthy, so we usually neither gain nor risk all that much.

Medical research is not especially plagued with wrongness. Other meta-research experts have confirmed that similar issues distort research in all fields of science, from physics to economics (where the highly regarded economists J. Bradford DeLong and Kevin Lang once showed how a remarkably consistent paucity of strong evidence in published economics studies made it unlikely that any of them were right). And needless to say, things only get worse when it comes to the pop expertise that endlessly spews at us from diet, relationship, investment, and parenting gurus and pundits. But we expect more of scientists, and especially of medical scientists, given that we believe we are staking our lives on their results. The public hardly recognizes how bad a bet this is. The medical community itself might still be largely oblivious to the scope of the problem, if Ioannidis hadn’t forced a confrontation when he published his studies in 2005.

...Rather, she’s concerned that, like many patients, he’ll end up with prescriptions for multiple drugs that will do little to help him, and may well harm him. “Usually what happens is that the doctor will ask for a suite of biochemical tests—liver fat, pancreas function, and so on,” she tells me. “The tests could turn up something, but they’re probably irrelevant. Just having a good talk with the patient and getting a close history is much more likely to tell me what’s wrong.” Of course, the doctors have all been trained to order these tests, she notes, and doing so is a lot quicker than a long bedside chat. They’re also trained to ply the patient with whatever drugs might help whack any errant test numbers back into line. What they’re not trained to do is to go back and look at the research papers that helped make these drugs the standard of care. “When you look the papers up, you often find the drugs didn’t even work better than a placebo. And no one tested how they worked in combination with the other drugs,” she says. “Just taking the patient off everything can improve their health right away.” But not only is checking out the research another time-consuming task, patients often don’t even like it when they’re taken off their drugs, she explains; they find their prescriptions reassuring.


In fact, the question of whether the problems with medical research should be broadcast to the public is a sticky one in the meta-research community. Already feeling that they’re fighting to keep patients from turning to alternative medical treatments such as homeopathy, or misdiagnosing themselves on the Internet, or simply neglecting medical treatment altogether, many researchers and physicians aren’t eager to provide even more reason to be skeptical of what doctors do—not to mention how public disenchantment with medicine could affect research funding. Ioannidis dismisses these concerns. “If we don’t tell the public about these problems, then we’re no better than nonscientists who falsely claim they can heal,” he says. “If the drugs don’t work and we’re not sure how to treat something, why should we claim differently? Some fear that there may be less funding because we stop claiming we can prove we have miraculous treatments. But if we can’t really provide those miracles, how long will we be able to fool the public anyway? The scientific enterprise is probably the most fantastic achievement in human history, but that doesn’t mean we have a right to overstate what we’re accomplishing.”

We could solve much of the wrongness problem, Ioannidis says, if the world simply stopped expecting scientists to be right. That’s because being wrong in science is fine, and even necessary—as long as scientists recognize that they blew it, report their mistake openly instead of disguising it as a success, and then move on to the next thing, until they come up with the very occasional genuine breakthrough. But as long as careers remain contingent on producing a stream of research that’s dressed up to seem more right than it is, scientists will keep delivering exactly that.

“Science is a noble endeavor, but it’s also a low-yield endeavor,” he says. “I’m not sure that more than a very small percentage of medical research is ever likely to lead to major improvements in clinical outcomes and quality of life. We should be very comfortable with that fact.”

This article available online at:

http://www.theatlantic.com/magazine/archive/2010/11/lies-damned-lies-and-medical-science/8269/

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Sunday, June 26, 2011

Another Alternative Medicine Critic Speaks

Here is the link to an article by David Colquhoun from Britain. It's called "America, the land of the Health Hucksters." I am not familiar with him, and he doesn't seem to be an MD, but he has very staunch opposition to alternative medicine practitioners. His criticisms seem to break down as follows.
1. Traditional Medicine can't cure everything, but that's no reason to adopt fairy tales. We need more research, not alternative medicine.
2. Big Pharma made mistakes and concealed negative data, but hey, no biggie.(Let's ignore those needless heart attacks from Vioxx, and teen suicides from Prozac, for example.) But it was scientists who discovered the bad studies, so no need to distrust the science or Big Pharma.
3. This paragraph, I simply must copy in its entirety because is so appalling, that I don't know where to start.
"I write from the perspective of someone who lives in a country that achieves health care for all its citizens at half the cost of the U.S. system, and gets better outcomes in life expectancy and infant mortality. The view from outside is that U.S. medicine rather resembles U.S. religion. It has been taken over by fundamentalists who are becoming very rich by persuading a gullible public to believe things that aren't true."
The U.S. is unique among developed nations in that we have for profit health care, that excludes many because of the cost. A majority of bankruptcies in this country are due to healthcare costs, and half of those actually had health insurance. So the religion in question is certainly not alternative medical practitioners, if there is a religion. The religion is for-profit-market-driven health care.
4. Placebo, placebo, placebo.
5. $2billion of taxpayer money for alternative medicine and not one useful treatment. Hookay. I thought he was all about research and the scientific method, and yet when a relatively tiny amount of money is appropriated to explore the bases of alternative practices, it is money ill spent. Does he have any idea how much money is spent on R and D in the pharmaceutical industry to produce drugs that don't work? Or drugs that make it to the market and then harm instead of help. Please.
6. "This is all very sad for a country that realized quite early that the interests of patients were best served by using treatments that had been shown to work." His own country's NICE now pays for acupuncture over other treatments for back pain because it has been shown to work.
7. Alternative Medicine is leading America down, like the decline and fall of the Roman Empire. Or are as bad as the torture allowed by Dick Cheney. (No. I'm not making these up. These are his arguments.) And why are we destroying America? Because of the vast amounts of money! Wow. Just wow. Hyperbole much?

So, in apologies for this long post I will limit my questions to Mr.Colquhoun, PhD. , er DR. Colquhoun, with just three questions.
1. Does he realize that just because alternative medicine is a Billion dollar business, that doesn't mean that individual practitioners make anything close to a billion dollars. Does he have any idea of the individual salary of an acupuncturist or chiropractor?
2. Is he even familiar with the NICE findings and their acceptance of acupuncture cited above?
3. What is in his mouth in the photo?? Is that really a cigarette?? I'll just leave it there...

(for more info on my practice link here...
)

Saturday, June 25, 2011

Acupuncture and Menopausal Symptoms

This study was cited in the most recent issue of Acupuncture Today. It compares acupuncture with sham acupuncture with symptoms, estrogen levels and FSH levels as outcome measures. I was not aware of it, and as a study it is pretty small, but I put it up for discussion's sake. Sara Calabro, LAc, reviewed the study. She also notes that in the U.K. there was a large study of over one million postmenopausal women looking at the risks of HRT (hormone replacement therapy.) Their findings show that women who took HRT in the early stages of menopause were at higher risk of developing breast cancer than those tho took it five or more years after menopause began. Of course, HRT has also been shown to increase heart problems, stroke and blood clots. So, we can hope that one day, acupuncture will be a first line recommendation for the symptoms of menopause, it's safe and many studies confirm that it is effective. Previous posts related to menopause are here and here. (For more information about my practice, please click here.)

Acupunct Med. 2011 Mar;29(1):27-31.

The effect of acupuncture on postmenopausal symptoms and reproductive hormones: a sham controlled clinical trial.
Sunay D, Ozdiken M, Arslan H, Seven A, Aral Y. Source Department of Family Medicine, Ministry of Health, Ankara Training and Research Hospital, Kiz kulesi sokak 3/5 Gaziosmanpasa Çankaya, Ankara, Turkey. didemsunay@gmail.c

Acupuncture is commonly used to treat menopausal symptoms and other gynaecological conditions. In this study, the authors aimed to investigate whether acupuncture has an effect on menopausal symptoms and to explore whether this effect is related to changes in hormone levels. Materials and methods A total of 53 postmenopausal women were alternately assigned into two treatment groups: acupuncture (n=27) and sham acupuncture (n=26). Menopausal symptoms were assessed using the Menopause Rating Scale (MRS). The serum oestradiol, follicular stimulating hormone (FSH) and luteinising hormone (LH) levels were measured at baseline and again after the first and last sessions. The Student t test was used for normally distributed data and the Wilcoxon signed rank test for not normally distributed data. The group differences in MRS scores were assessed using non-parametric Mann-Whitney U test.

RESULTS:

After treatment, total MRS, and the somatic and psychological subscale scores were significantly lower in the acupuncture group than the sham group (all p=0.001). The severity of hot flushes was found to be significantly decreased after treatment in acupuncture group (p=0.001). In the acupuncture group LH levels were lower and oestradiol levels were significantly higher than sham group (p=0.046 and p=0.045, respectively) after treatment, but there was no difference in FSH levels.

CONCLUSION:

Acupuncture was effective in reducing menopausal complaints when compared to sham acupuncture and can be considered as an alternative therapy in the treatment of menopausal symptoms.

Study exploring MRI of the hippocampus in depressed patients given electro acupuncture and Prozac

This study is a bit of a muddle, but because of the ubiquity of depression, I'll go ahead and post it here. The study design was to compare electro acupuncture with Prozac, versus Prozac alone, using MRI studies of the brain as the outcome measure, as well as the HAMD depression scale. In the EA group, the Cho/Cr ratio showed a significant difference before and after treatment, which also had a positive relevance with the HAMD scores before treatment.
Stress plays a significant role in depression and mood, so it may be the reduction in stress hormones that accounts for the hippocampal changes. (For more information about my practice, please click here.)

The relevance between symptoms and magnetic resonance imaging analysis of the hippocampus of depressed patients given electro-acupuncture combined with Fluoxetine intervention - A randomized, controlled trial.
Chin J Integr Med. 2011 Mar;17(3):190-9. Epub 2011 Feb 27.
Duan DM, Tu Y, Jiao S, Qin W.
Source

Department of Traditional Chinese Medicine of South Building, Chinese PLA General Hospital, Beijing, 100853, China. dongmei-d@hotmail.com



To probe the relevance between depressive symptoms and hippocampal volume and its metabolites detected by magnetic resonance imaging (MRI) in depressed patients who were given electro-acupuncture (EA) combined with Fluoxetine before and after treatment.
METHODS:

A randomized, controlled trial was conducted. A total of 75 cases of mild or moderate depression were randomly assigned to two groups: the EA group which received EA combined with Fluoxetine; the Fluoxetine group which received Fluoxetine only as the control. The 17-item Hamilton Scale for Depression (HAMD) was used to assess the depression level. The relevance between the changes of the hippocampal volume and its metabolites, including N-acetyl aspartate (NAA)/creatine (Cr) and choline containing compounds (Cho)/Cr, and the reduction rate of the HAMD score before and after treatment of the two groups were analyzed.
RESULTS:

At the end of the treatment, the therapeutic response rates were not statistically different between the two groups (73.53% for the Fluoxetine group and 83.33% for the EA group, respectively). Compared to that of the Fluoxetine group, a significant difference was shown in the EA group in the reduction rate of the HAMD scores (P<0.05). There was a negative correlation between the therapeutic effect and the HAMD scores before treatment in both groups of patients. There was no significant difference in the hippocampal volume before and after treatment. The NAA/Cr ratio of both groups increased after treatment, with the EA group increasing more. There was a negative correlation between the rate of change of the NAA/Cr after treatment and the HAMD scores before treatment in the two groups. In the Fluoxetine group, the Cho/Cr ratio showed no significant difference before and after treatment, which had no relevance with the HAMD scores before treatment either. Meanwhile, in the EA group, the Cho/Cr ratio showed a significant difference before and after treatment, which also had a positive relevance with the HAMD scores before treatment.
CONCLUSIONS:

There was a significant improvement in the hippocampal metabolites in depressed patients who treated by EA combined with Fluoxetine. Those differences showed relevance with the HAMD scores before treatment

Friday, June 24, 2011

Nice testimonial from a patient with allergies

Just for something different, I thought I'd share with you a testimonial from a patient I've been treating for allergic rhinitis. I received it yesterday and it hopefully speaks for itself. In this particular case, I started with acupuncture alone, and then added Astra Essence, an overall tonic with astragalus to strengthen the lung, as a daily tonic.

I developed allergies to cats and dogs about 30 years ago. I tried allergy shots for a year and they did not seem to help. When I went to friends' houses, I had to take a Zyrtec or Claritin, found that the pills did not always work and also found that they made me feel drowsy and a little off -- just when I'd most like to socialize. You're not supposed to drink when you take those medications, so wine with dinner was a problem.
Over the years, the allergies seemed to be getting worse. Feeling that this was all headed in the wrong direction, I wondered whether acupuncture could help when shots and pills had not. I didn't have much to lose. Dr. Sparrow's experience with her own allergies and acupuncture sounded promising and I liked the fact that she is a trained physician.
Dr. Sparrow has a great manner and is easy to talk to. She explained that the theory is that acupuncture and herbs can help to strengthen and balance your immune system. This made sense, because the medical research links allergies to immune system response.

Most importantly, the acupuncture and herbs are working for me. After just the first few treatments, I have been able to take no pills and still go comfortably to homes of friends with cats and dogs. After a year, it's even better. Dr. Sparrow advises not to challenge one's system too much, so I am still careful but I just don't have to be as careful (or drugged) as I was before. What a relief! As a side bonus, I have not had a cold or other illness in about a year (despite a heavy air travel schedule).
To give the blog readers a break from the academics and harangues about institutionalized medicine... For more information about my practice please click here.
If you have any questions or comments about this case or others please let me know in comments!


Wednesday, June 22, 2011

Acupuncture for High Blood Pressure

Here is the update for one of my patients being treated with acupuncture and herbal therapy for hypertension. He comes in once a month for treatment and takes Great Yin and Gastrodia Relieve Wind from Health concerns. His blood pressure has remained under control without medications. In addition, his constipation is gone (often a side effect of effective acupuncture treatment.)

Cholesterol Drugs (Statins) Linked With Diabetes Risk

Who could have predicted that a highly lucrative drug might turn out to have some unpredicted nasty side effects? I have posted before about statins, since I've seen cases in my clinic of people with new muscle aches and pains, or back pain, or shoulder pain, etc... that started when they started taking statins. The part that irks me the most is the wide spread and inflexible denial on the part of the medical community to scrutinize these drugs more closely. If you read through the article, you will notice how these findings, also, are summarily dismissed. I have posted about statins here. In the letter to the editor in the Economist (not mine) their dubious efficacy is mentioned here. (For more information about my practice please click here.)

Cholesterol Drugs Linked With Diabetes Risk
By TARA PARKER-POPE

Cholesterol-lowering drugs called statins, which have been shown to lower a person’s risk for heart attack, can also slightly increase a patient’s risk for developing diabetes, particularly at higher doses, new research shows.

The findings, based on new analyses of five clinical trials involving 32,752 patients, raise new questions about how much we really know about the long-term effects of statins, which are the most widely prescribed drugs in the United States. The focus on the link between statins and diabetes comes at a time when some medical experts and pharmaceutical companies have pushed to broaden the use of the drugs beyond the 40 million at-risk patients who already use them to healthy people who would take the drugs for prevention of heart disease.

Doctors cautioned that patients should not overreact to the diabetes news, saying that the increased diabetes risk is very small, and that the benefits of statin therapy still far outweigh any side effects.

“I don’t think it’s very clinically important,’’ said Dr. Steven E. Nissen, chairman of cardiology at the Cleveland Clinic, who consults with drug companies that make statins but requires his fees be donated to charity. “What I worry about here is that people will read this story and say, ‘I don’t want to get diabetes so I’m going to stop my statin,’ and then they have a heart attack.’’

Last year, the medical journal The Lancet published an analysis of major statin trials involving 90,000 patients that showed statin users had a 9 percent higher risk of developing diabetes than those who didn’t take statins. But questions remained about whether the effect was real or something that may have just been due to chance.

However, the latest analysis, published today in The Journal of the American Medical Association, makes the strongest case yet that statins can trigger diabetes in some people. The report focused on differences in diabetes risk among moderate-dose and high-dose statin users, and found that those taking high doses had a 12 percent higher risk of developing diabetes compared to moderate-dose users. That translates to a 20 percent overall increased risk of diabetes for high-dose statin users, compared to those who don’t take the drugs, according to the study’s senior author.

Even so, medical experts, including the study authors, argued that while more study is needed to understand the diabetes link, the increased risk doesn’t eclipse the strong health gains achieved with statins, which in some studies have reduced heart attack and stroke risk by half.

Based on the data in the study, a total of 498 people would need to take a statin before triggering one extra case of diabetes. By comparison, just 155 people would need to take a statin to prevent one heart attack.

“The net benefit favored the statins overall,’’ said Dr. Kausik Ray, professor of cardiovascular disease prevention at St. George’s University of London and senior author on the paper. Dr. Ray says he has consulted for drug companies that make statins.

Exactly how statins may increase diabetes risk isn’t entirely clear, though animal studies suggest that statins can increase muscle resistance to insulin, resulting in higher levels of circulating blood sugar. Dr. Kausik notes that the patients in the studies were diagnosed with diabetes because of elevated blood sugar levels, but that the long-term consequences of higher blood sugar levels triggered by statin use aren’t known.

“Diabetes is defined by blood glucose levels, but none of us are absolutely certain if this is going to carry the same risk as if you traditionally developed diabetes,’’ Dr. Kausik said.

In addition, Dr. Nissen says the statins don’t cause blood sugar to shoot up rapidly but instead can slightly elevate blood sugar enough to push borderline patients across the threshold into diabetes.

“It doesn’t take much to tip a few people over that boundary to the point where we call them diabetic,” said Dr. Nissen. “We can’t dismiss it, but I also don’t want to scare people who need these drugs. They are the best thing we’ve got going to prevent coronary disease events.”

Letter to the Economist

Just for the sake of completeness, I will post my letter to the Economist here. I didn't get it in in a timely fashion because of my last Spain trip in May, but I'll "publish" it here instead. It is in response to the Economist articles about Alternative Medicine, here and here.
Sir:I was amused and bemused by the full-throated condemnation of alternative medicine as no more than placebo in the May 21st Economist.. I can only address the acupuncture literature, since that is my area of interest and expertise. The author makes no mention whatsoever of the significant number of reputable acupuncture studies done on animals to delineate physiological pathways involved in acupuncture(no placebo there). Nor did he mention numerous fMRI studies done on acupuncture subjects, nor of the exhaustive studies performed on knee osteoarthritis nor of the extensive studies funded by the German insurance companies which lead to their including acupuncture as a covered benefit. Nor did he mention that the British NHS has recently included acupuncture as a first line treatment for back pain because “they want to fund only treatments that work.”
Placebos will always be with us both in traditional and alternative medicine, but without irony he mentions that fake surgery for the knee (it was actually arthroscopy) was no better than the real thing, but somehow never admits the obvious that surgery itself may be quite a powerful placebo. He also stated that Ernst, in debunking alternative medicine is addressing “a serious public-health problem.” “Conventional medicines must be safe and effective before licensed for sale.” In the last decade alone, Vioxx and Prozac, as the most egregious examples, were on the market for years and it took quite a bit of morbidity and mortality before the problems came to light or were even admitted.
There is nothing courageous, new, nor noteworthy in attacking alternative medicine. The fact is that acupuncture research is poorly funded, with no huge lobbying or industrial backing, since it is currently not easily scalable so remains unattractive to corporate interests. Admittedly, acupuncture’s mode of action has not been adequately explained and the results not yet entirely reproducible. The same could be said of some traditional modes of therapy. But patients seek safe treatment options, and vote with their feet. This fact alone seems to enrage some critics.


(For more information about my practice please click here.)

Tuesday, June 21, 2011

Head of Integrative Medicine at Scripps contributes to the Atlantic Debate

Though I would have to say that there hasn't been much coming from the other side on this "debate." Of course, I agree with the majority of commenters at the Atlantic, but it could be more balanced. I will excerpt a bit from Mimi Guarneri's contribution. (Notice the title of her article, ahem...) (For more information about my practice please click here.)
Mimi Guarneri, M.D. - Mimi Guarneri, M.D., is a clinical cardiologist and the founder of the Scripps Center for Integrative Medicine in La Jolla, California.
First, Do No Harm
By Mimi Guarneri, M.D.

Jun 21 2011, 8:00 AM ET 4



"Allopathic," or conventional, medicine excels in acute care. The "ill to the pill" mentality may be needed to fight an infection; surgery can be lifesaving. But allopathic medicine is not proactive; it is not focused on disease prevention and it has failed at chronic disease management. Allopathic medicine is focused on diagnosing disease after it has occurred, offering treatments based on surgery and pharmaceutical therapy.

As a board certified internist, cardiologist, and nuclear cardiologist, I recognize the value of the medicine I was taught at SUNY Downstate, Cornell, and New York University. But as a physician who practices the Hippocratic Oath -- "first do no harm" -- I have been compelled to seek out methods to heal my patients, relieve suffering, and prevent disease that are not part of the allopathic medicine paradigm...

Today the foundation of our medical pyramid is drugs and surgery. I believe the apex of the pyramid should be drugs and surgery and the foundation should be clean air, and water, nutrition, sleep, resiliency, and community.


I heartily agree with all of the above and would add that acupuncture offers the "resiliency" component of prevention. Clean water actually has contributed a huge amount to the 'Miracles of Modern Medicine" that the 20th Century enjoyed.
So why are we arguing over whether or not acupuncture is a placebo? We have three licensed acupuncturists and two physician acupuncturists at The Scripps Center for Integrative Medicine. I can cite patient after patient who has received benefit from our acupuncture program. And in regard to Dr. Salzberg's post, I have never seen a punctured lung or infection as a result of an acupuncture treatment. While I am sure complications can occur, they are certainly much less common than the hospital-acquired infections I saw as an interventional cardiologist.

The United States ranks 37th in the world in health outcomes and spends 2.6 trillion dollars per year on chronic disease management. The majority of this expense is attributed to seven chronic diseases -- all of which are preventable. Many of these diseases are man-made, the result of air pollution, high fructose corn syrup, and partially hydrogenated oils. The Interheart Study, which looked at 30,000 men and women in 52 countries, concluded that 90 percent of first heart attacks are completely preventable through lifestyle change. ..




The Atlantic, debate on Alternative Medicine

I hope everyone is following the discussion over at the Atlantic.

Friday, June 17, 2011

The Economist, "Think Yourself Better"

Here is another letter in rebuttal to the articles in the Economist. I would also direct you to my previous post about believing in treatments that don't work, but they make sense, dammit!

SIR – I have for years used acupuncture with good results, particularly in cases that have not responded to the medications and surgical procedures used in the Western medical canon. Acupuncture is practised by many physicians in the West and has been validated not only clinically but with double-blind studies. The method works, and our lack of understanding does not lessen its effect but underscores the inadequacy of our knowledge. While the placebo effect is an important phenomenon, it accompanies all forms of treatment, whether Western, Eastern, or otherwise.

Anthony Jahn
Professor of clinical otolaryngology
Columbia University
New York

(For more information about my practice please go to www.ksparrowmd.com)

Alternative Medicine Article from the Economist

Here is the link from a recent article from the Economist about Alternative Medicine. It takes a hostile attitude towards alternative medicine, of all varieties, decries the money patients will spend on it, and then chalks it all up to placebo. Sigh. The article doesn't differentiate between homeopathy, massage, yoga, acupuncture. Makes no mention of fMRI studies on acupuncture, nor the acupuncture research done on animals to demonstrate effects and the underlying physiology. I ended up writing a letter to the Editors, but way too late for admission into the magazine. But the the first letter in rebuttal to their articles I will copy in its entirety. He said it much better than I did. I may publish my letter in my blog in coming posts. (For more information about my practice, please click here.)
SIR – As a doctor who uses both conventional and complementary therapies in my practice, I read your leader on alternative medicine with interest (“There is no alternative”, May 21st). I agree with your assessment regarding the potential benefits of reforming the doctor-patient relationship, but I disagree entirely with your conclusion that alternative medicine is simply a sophisticated “placebo delivery service” that is “mostly quackery” and a “colossal waste of money”.

Too often heavily biased in-house scientific research performed by the medical industry for the purpose of demonstrating the supposed superiority of one medical product to another has been used by the industry to demonstrate a superiority to natural alternatives, which are less amenable to double-blind, placebo-controlled studies for technical reasons. More worryingly, such research is also used as a justification for the elimination of industrial medicine’s alternative competition by labelling alternative therapies as unfounded or even dangerous.

The growing popularity of alternatives to the drugs-and-surgery approach attests to an emerging awareness of the limitations of conventional medicine. The presence of alternative medicine in the medical marketplace provides more therapeutic options for patients and is an essential counterbalance that compels the medical industry to maintain its humanist foundations in the drive for corporate profits.

Dr Christopher Peine
Boise, Idaho

Thursday, June 16, 2011

The Triumph of New-Age Medicine

I must be the opposite of ADD. I've been deeply involved with some research issues, which I hope to blog about in the near future, and finally poked my head up to realize that I have sorely neglected my blog. I hope to post in the next few days on what I've been up to in the research arena, letters to The Economist, and other matters. But for now I'll leave you with this link to a new article in the Atlantic (click below on the title.) I've included one particular paragraph that emphasizes some topics that are familiar to followers of my blog.

The Triumph of New-Age Medicine

Unfortunately, the drugs we’ve thrown at these complex illnesses are by and large inadequate or worse, as has been thoroughly documented in the medical literature. The list of much-hyped and in some cases heavily prescribed drugs that have failed to do much to combat complex diseases, while presenting a real risk of horrific side effects, is a long one, including Avastin for cancer (blood clots, heart failure, and bowel perforation), Avandia for diabetes (heart attacks), and torcetrapib for heart disease (death). In many cases, the drugs used to treat the most-serious cancers add mere months to patients’ lives, often at significant cost to quality of life. No drug has proved safe and effective against Alzheimer’s, nor in combating obesity, which significantly raises the risk of all complex diseases. Even cholesterol-lowering statins, which once seemed one of the few nearly unqualified successes against complex disease, are now regarded as of questionable benefit in lowering the risk of a first heart attack, the use for which they are most widely prescribed. Surgery, widely enlisted against heart disease, is proving nearly as disappointing. Recent studies have shown heart-bypass surgery and the emplacement of stents to prop open arteries to be of surprisingly little help in extending the lives of most patients.


(For more information about my practice please go to www.ksparrowmd.com)