Back treatment for elderly no better than fake one

[Bob]

Back treatment for elderly no better than fake one

By STEPHANIE NANO, Associated Press Writer Stephanie Nano, Associated Press Writer
Wed Aug 5, 5:00 pm ET

NEW YORK – A common treatment that uses medical cement to fix cracks in the spinal bones of elderly people worked no better than a sham treatment, the first rigorous studies of the popular procedure reveal.

Pain and disability were virtually the same up to six months later, whether patients had a real treatment or a fake one.

Tens of thousands of Americans each year are treated with bone cement, especially older women with osteoporosis, some of them stooped and unable to stand up straight. The treatment is so widely believed to work that the researchers had a hard time getting patients to take part when it was explained that half of them would not get the real thing.

"All of us who do the procedure have seen apparently miraculous cures," said Dr. David F. Kallmes, a radiologist at the Mayo Clinic who led one of the studies. But he said there were also "miraculous cures" among those who got the fake treatments.

The researchers said it is yet another example of a medical procedure coming into wide use before good studies are done to show that it is safe and effective. Medicare pays $1,500 to $2,100 for the outpatient procedure.

Bone cement has long been approved for many medical uses, but this particular use had not been tested against a placebo procedure until now.

The findings, published in Thursday's New England Journal of Medicine, mean patients and doctors need to review the options together, wrote Dr. James N. Weinstein of Dartmouth Medical School in an accompanying editorial. "When best evidence suggests a tossup between treatment options and no benefit, informed patient choice is essential," he said.

About 750,000 Americans suffer painful compression fractures in the bones of the spine each year. Bone-thinning osteoporosis is the most common cause. The weakened bone collapses or cracks, sometimes causing debilitating pain, limiting mobility and resulting in a loss of height or a stooped posture.

Doctors usually try bed rest, painkillers and back braces before turning to vertebroplasty (pronounced vur-TEE-broh-plas-tee). During the procedure, hot bone cement is injected into the collapsed or cracked vertebra. The cement is thought to shore up or stabilize the compressed bone. There can be complications, including infection and leakage of the cement.

Bone cement was first used for spinal fractures in the U.S. in the 1990s, and Kallmes said it quickly became routine because there were few good options. The rate of Medicare-paid procedures nearly doubled from 2001 to 2005. Now there are about 80,000 procedures done in the United States each year, Kallmes said.

The Mayo-led study involved 131 patients at medical centers in the U.S., Britain and Australia. The second study enrolled 78 patients in Australia. The patients, mostly women with fractures from osteoporosis, were randomly assigned to get the cement injection or a fake treatment. On average, they were in their mid-70s.

Neither the patient nor the person who evaluated them knew which treatment they got.

All participants first got local anesthesia to numb their backs. For the fake treatment, doctors simulated the cement injection by pressing the back, tapping instruments and having the strong-smelling cement on hand.

The patients were questioned periodically afterward about their pain, mobility and other measures — up to six months in the Australian study and one month for the Mayo-led study. The results were similar in both tests.

"Both treatment groups improved, it's just that they improved by about the same amount," said study leader Dr. Rachelle Buchbinder of Cabrini Hospital in Melbourne, Australia.

The researchers do not know why people felt better, but suggest it could be due to the anesthesia, the placebo effect or that the fractures healed on their own over time. Kallmes said the procedure may work in a few patients, and that more research is needed to figure out who might benefit.

Kallmes, who's been doing the procedure for 15 years, said he has revamped his practice so that most patients are enrolled in new studies of the procedure. Buchbinder, who treats patients with back pain, said she no longer recommends it.

The Mayo-led study was funded by the National Institutes of Health; some of the researchers have received fees or grants from drug makers and medical equipment companies. The Australian study was also mostly government funded; a medical cement maker provided the cement and some funding.

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[nianfong]

acupuncture and herbs on the other hand, I bet would kick arthritis' ass.

[Swede]

There was an article in Acupunture Today about acupuncture vs. standard Western treatments for treating lower back pain. Can't recall all the details, but it was kinda bad. First, it seemed that all the acupucture patients did every treatment, but the Western methods were a) more voluntary and b) whatever the doctor and patient agreed upon, and therefore not all the same. But here was the crazy part: the acupuncture patients were split into three groups. Customized (acupuncturist makes diagnosis and makes treatment accordingly), standardized (most common points for treating lower back), and "simulated" (the poked patients with toothpicks inside the needle sleeves, no penetration, using same points as the standardized group). All three acupuncture groups were basically the same in the quality of results, and the haphazzard Western way lagged far behind. What suprised me was the way they interpreted the simulated acupuncture group performing as well as the other two groups--they said it is a sign that the actual mechanism by which acupunture works is still a mystery. Ok, I'll buy that, but in the interest of intellectual honesty, the phrase placebo effect might have fit nicely into the article, but what do I know?

[Bob]

Ted Kaptchuk, a doctor of traditional Chinese medicine now researching the placebo effect at Harvard Medical School, doesn't surf the web very often. He is surprised at what a complete stranger can know about him after a simple Google search.

"The web is amazing, isn't it? I don't use it enough," he says reading a web site detailing his history as a student activist in the '60s.

But his awe is short-lived. As he reads on, he runs into the all-too-familiar downside of information gleaned from the Internet.

"This is horrible! It's all a lie!" Kaptchuk exclaims. "I appointed Martin to that post; he didn't defeat me in an election!"

It's very like Kaptchuk to see both sides of technology. His philosopher's take on the placebo effect lies at the intersection of science and belief. SCIENTIFIC AMERICAN FRONTIERS asked Kaptchuk about his work and his thoughts on the art and science of healing.
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What were you like as a kid?

I was interested in science for a long time. In college, I studied religion and philosophy. Then I studied Chinese medicine in China and I came back and was a practitioner of Chinese medicine. When people became interested in alternative medicines, they asked me to help out at Harvard Medical School. I realized that in order to survive there, one had to become a scientist. So I became a scientist.



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Scientific perspective is so rational that it forgets that the passion and foibles of human beings are part of the dialogue and discourse of all ages.

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What are your research interests now?

I study placebo effects. I study acupuncture. I study alternative medicine. I'm mostly interested in the philosophy of medicine, history of medicine, history of science. I research to what extent the placebo effect is real: Is it an artifact of the way we do clinical trials? What's its duration? Its magnitude? Is it plastic? Can one vary it? In what illnesses does it apply?

Some of my research looks into what its mechanism is. Do we see what physiological pathways it takes? How does ritual get translated into physiology? Does acupuncture or herbal medicine have more efficacy than a placebo?

I'm not a proponent [of alternative medicine]. I actually am the same way anyone else is at [Harvard Medical School] - probably even more critical of those phenomena. I consider myself a scholar and a scientist. But I am unusual in that I am a practitioner and I have no problem being a practitioner. I don't know if it's me, my charisma, the placebo effect, or the needles or the herbs I give, but I don't have any problem with that.

Then my philosophic questions are: What are the scientific, moral and ethical implications of the placebo effect? Maybe this placebo effect is really what we should be doing here! In the Middle Ages, the pope said you couldn't visit Jewish doctors. That was an ethical judgement. Is that the same thing we say now, you can't get a placebo because it's a forbidden form of treatment? That it's not the outcome that matters, it's how it got done? That's an ethical judgement, too.

How are modern medicine and East Asian medicine similar?

They both try to take care of people; they both try to help people. They both use rational ideas - they don't use altered states of consciousness. They try to assess the situation using cognitive processes and they try to interpret what the situation is caused by. Then, they use material intervention - acupuncture or surgery or drugs. Both believe that the doctor/patient relationship is very important.


Kaptchuk practices acupuncture with success, but is it the needles or the ritual that helps his patients heal?
There are some inherent requirements of Chinese medicine that make a better doctor/patient relationship. You never want to treat just the finger or just the toe. You have to treat the person wherever the complaint resides. At that level, there is automatically a more integrated doctor/patient relationship. You're required to know about the person. It's not a conscious emphasis on the doctor/patient relationship, but it's part of the system that there's a more holistic approach.

How else would you say Chinese medicine is different from Western?

In modern medicine, you measure and isolate something, give it a precise numerical equivalent, quantify it. And East Asian medicine looks to the quality of the patient. It's a more artistic approach.

Modern medicine tries to quantify and privileges causality based on the smallest piece that you can reduce the question to. If you can find the germ, or the gene, or the metabolic chemistry, that's what they look for.



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I believe it is never too late. I never did anything with science until 1999-2000, and I'm on PBS now!

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The direction of Chinese medicine is the exact opposite.The emphasis is the context of the complaint. It's more macroscopic. What kind of patient is this? How does this person behave in his or her everyday life? In work life? What are their feelings and their sensibilities and their beliefs? If you have an eye problem, they ask you about your knees. If you have a knee problem, they ask you about your digestion. You can't interpret the knee unless you know how the person gets angry or doesn't get angry. Or how the person likes certain types of food, but not others.

To put it a different way, modern medicine is quantitative and traditional Chinese medicine is qualitative.

Hippocratic medicine was very similar to Chinese medicine, with the four humors and the four elements, and you balance them. Hippocrates didn't treat people; he treated the weather condition the person was in. If the person was bilious, that means that they were like a hot summer day and they were agitated and that's the issue that you had to treat no matter where the complaint was. If someone was phlegmatic, they were cold and lazy and didn't move around a lot and no matter what the complaint was - knees, eyes or digestion - you treated that quality. That's the same as Chinese medicine.

What is the relationship between alternative medicine and modern medicine in the United States today?

Until 10, 15 years ago, there was a tug-of-war. That's a polite way of describing an all - out attempt at destroying each other. What's happened is a realignment or armistice. I think people of both camps have realized that it's not to the patients' benefit that the providers of the same patient are ignorant of one another and even doing counterproductive things. So the patients demanded the cease-fire.



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How does ritual get translated into physiology?

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People have always been mistrustful of their doctors because no one medicine satisfies all the complaints that people have. For a short period, people thought modern medicine was wonderful and invincible, because the penicillin, antibiotics, some surgeries and cortisone drugs that came out after World War II really were wonder drugs. But, by and large, medicine - any medicine - can't alleviate all human suffering. But there will always be doctors around. Occasionally, they'll be liked, and occasionally, people will mistrust them. That's part of the human condition.

Human beings are the only animals that take pills. Humans are the only beings that see the possibility of things being very different. That applies to medicine and healthcare.

The first doctors were religious figures. The secularization and rationalization of healing - the removal of altered states of consciousness as a central feature of healing - that's what shamans and witchcraft do- is parallel to the rationalization of human self-understanding. Hippocratic medicine exactly parallels the rise of Greek philosophy and Chinese medicine exactly parallels the rise of Chinese philosophy.

How do you think science gets covered in the press?

There is a way that science purports to be objective and independent of preconception. The press is always confused because the scientists have this myth. And in fact, scientists contradict each other all the time. I think the problem is not the press, but that science has given itself its own religiosity of being objective.

But there is a very big gray zone on the edge of science, and the public demands clear answers on important questions. In fact, studies sometimes only cloud the gray zone. And sometimes what science thinks is an absolute clear zone becomes cloudy with more experimentation.

There's an element of mythos in science, and the press and the public are colluding with scientists in order to promote their priestly function in the secular world.

I don't have any problem with that. I think people have the right to religion, but they should be more clear about the fact that there's a lot of subjectivity in science - from the questions asked, to the interpretations of results.

What is it about the placebo effect that makes it so hard to study scientifically?

The idea of ritual is what science detests. The scientific revolution is about getting rid of culturally embedded behaviors, uncovering natural universals. A drug is a natural universal. Penicillin works in Africa or Asia. A ritual depends on belief, religion and imagination. Ritual is specific to culture. Placebo effect is presumably about the appearance of things, the belief in things, the ritual of things. There is something inherently unscientific about it.

It may be that ordinary people have demanded the investigation of alternative medicine. It may be that alternative medicines have demanded the placebo investigation. But I think that the NIH has really accelerated the placebo stuff. The big NIH conference on the placebo effect in 2000 was very important in initiating this conversation. NIH is a governmental bureaucratic institution, but it also really tries to be innovative and look into important questions.

You were an activist in your student days. Do you think of your work today as radical?

I think my work is radical in terms of science. But I try to abide by scientific rules. I try to be imaginative and innovative, potentially critical. I operate at the margins and I don't march with thousands of other scientists. But I work at the NIH and I fundraise for HMS. That's pretty straight. I still haven't cut my hair though.

Some people caution that the surge in alternative medicines signals the beginning of a non-scientific age. Do you think we are entering one?

I'm a scientist, but I can live with superstition. Scientific perspective is so rational that it forgets that the passion and foibles of human beings are part of the dialogue and discourse of all ages. I don't mean to say science is bad, but there's a hubris there that science has all the answers and you've just got to get rid of all the superstitious stuff and then we'd have a great world. I think we have to get rid of the arrogance and racism and intolerance and xenophobia, and that would be more important than getting the public to be purely rational.

Science's demand for privilege has to be negotiated, not automatic. There are a lot of reasons to be disappointed with science. In the same way, there are a lot of reasons to be really pleased with it. Getting rid of the arrogance will make people more appreciative of science, more than suppressing other tendencies with strict rationalism.

I think the NIH has every right and absolute responsibility to be absolutely scientific in everything it does because that's its job. But I can tolerate Haitian hoodoo medicine. Hmong refugees have a right to Hmong medicine. And I believe that Christians, Jews and Muslims have the right to pray to the creator of the universe and I don't object if my wife believes in astrology. I think patients have a right to that; I don't care whether it's scientific or not.

What career advice would you give to young scientists?

You really have to do what you love and what interests you. Also, I believe it is never too late. I never did anything with science until 1999-2000, and I'm on PBS now!

http://www.pbs.org/saf/1307/features/kaptchuk.htm

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Placebo and Healing Research


This multi-disciplinary program led by Ted Kaptchuk uses clinical trials, neuroimaging, historical, psychological, genetic, anthropological and health service studies to examine placebo effects. The program has an active bioethics component as well. Cathy Kerr, one of the investigators based at the Osher Research Center, is investigating neural processes underlying touch perception and bodily feelings. Learn more about her work by visiting www.osher.hms.harvard.edu/kerrlab.

http://www.osher.hms.harvard.edu/default.asp

Introduction


The Division for Research and Education in Complementary and Integrative Medical Therapies is a Harvard Medical School (HMS) program whose mission is to facilitate interdisciplinary and inter-institutional collaboration for purposes of 1) research evaluation of complementary and integrative medical therapies, 2) delivery of educational programs to the medical community and the public, and 3) the investigation of the design of sustainable models of complementary and integrative care delivery.



Full-time faculty, fellows, and staff of the Division are housed at the


Harvard Medical School Osher Research Center. The Research Center manages a portfolio of clinical trials and basic research investigations and offers continuing medical education courses for medical professionals through the Department of Continuing Education at HMS. The Division has a post-graduate research training program and is involved in the development of programs for residents and medical students. Division faculty, in conjunction with a team of complementary care providers and other healthcare providers, also investigate models of integrative care for various diseases and conditions.



The Division has an affiliated clinical program, the Osher Clinical Center for Complementary and Integrative Medical Therapies at Brigham and Women’s Hospital, a Harvard-Medical-School-affiliated teaching hospital. Information about this center is available at its own website which can also be reached by following the link at the top of this page.



Mission Statement


The mission of the Harvard Medical School Division for Research and Education in Complementary and Integrative Medical Therapies is to facilitate interdisciplinary and inter-institutional faculty collaboration for purposes of:

1.research evaluation of complementary and integrative medical therapies,
2.delivery of educational programs to the medical community and the public, and
3.investigation of the design of sustainable models of complementary and integrative care delivery in an academic setting.

[Bob]

If you are interested in the placebo effect here is a very informative clip on the study with regard to TCM:

http://vvi.onstreammedia.com/cgi-bin/vi ... pbssaf1307