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Studying Placebo Effects

ResearchBlogging.orgMeasuring placebo effects (often misleadingly referred to as the placebo effect – singular) is a part of standard clinical trial design, because they need to be distinguished from the physiological effects of the treatment under study. Rarely, however, are placebo effects the actual target being measured, but such is the case with a new study published in the most recent edition of the British Medical Journal (BMJ) – Components of placebo effect: randomised controlled trial in patients with irritable bowel syndrome. (Here is a summary if you cannot access the article directly.)

Dr. Ted Kaptchuk et.al. studied the response to various placebo treatments in 262 adults with irritable bowel syndrome (IBS). The three groups were designed to address three major categories of placebo effects: 1) response to the process of being assessed and observed, 2) response to being given a placebo treatment, and 3) response to the patient-practitioner relationship. These types of placebo effects were represented by three treatment arms: 1) observation alone, 2) placebo acupuncture, 3) placebo acupuncture plus an “augmented” practitioner-patient relationship – with added “warmth, attention, and confidence.”

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Posted in: Clinical Trials, Science and Medicine

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SPECT Scans at the Amen Clinic – A New Phrenology?

Phrenology was a 19th century pseudoscience that claimed to associate brain areas with specific personality traits. It was based on palpating bumps on the skull and was totally bogus. New brain imaging procedures are giving us real insights into brain function in health and disease. They are still blunt instruments, and it is easy and tempting to over-interpret what we are seeing. In his book The New Phrenology William Uttal warns that “the excitement of these new research tools can lead to a neuroreductionist wild goose chase” and that we must be careful not to succumb to new versions of the old phrenology.

The Amen Clinics, founded by Daniel G. Amen, MD, offer SPECT (single photon emission computed tomography) scans to help diagnose and manage conditions such as attention deficit disorders (ADD), mood disorders, anxiety and panic disorders, autistic spectrum disorders, obsessive compulsive disorder (OCD), substance abuse, toxic exposure, brain trauma, memory problems, temper problems, and relationship and marital struggles.

The scans generate colored pictures of the brain that show “areas of your brain that work well, areas that work too hard, and areas that do not work enough.” They do not actually provide a diagnosis, but “must be placed in the context of a person’s life, including their personal history and mental state.” “The goal of treatment is to balance brain function, such as calm the overactive areas and enhance the underactive ones.” (more…)

Posted in: Medical Ethics, Neuroscience/Mental Health, Science and Medicine

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Colon “cleanses”: A load of you know what…

Death begins in the colon.

Perhaps you’ve heard this little bit of “alternative medicine” wisdom. Oddly enough, I had never heard it until well after I had become a surgeon (although my first thought upon hearing it was that it would make a killer name for a rock band or a blog). That’s when I began encountering claims that seemed to indicate that constipation was the most evil thing in the world, something that must be avoided at all costs. Naturally, I wondered just what the heck was meant by this bit of “wisdom.” What, I wondered, was it based on? What, I wondered, was the purpose of it? To answer this question, recently I decided to go back and review what people say about colon health:

Have you ever considered this simple question: Are you clean inside?

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Posted in: Science and Medicine, Surgical Procedures

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Charlie Woo TV

Some of us received the announcement a week ago of the Bravewell Collaborative’s planned conference on “Integrative Medicine” co-sponsored with the National Academies’ Institute of Medicine, to take place in February, 2009.  (Note: I like to cap slogans and commercial trademarks and such and enclose them in quotation marks. Especially when the terms have no consensus meaning or are intended to obscure and confuse. ) 

Several of us may blog on the announcement. I want to emphasize a few points that struck me as revealing.  

The announcement also listed Friday’s Charlie Rose Pub TV interview program with Harvey Fineberg, MD, President of the “IOM,” Christy Mack, wife of the CEO of Morgan Stanley and the ideologue behind Bravewell and the project, and Ralph Snyderman, ubiquitous former dean of Duke University Medical School now vagabond “CAM” promoter and fund raiser. 

First off was a significant disclosure. Charlie Rose had been married at one time to Christy Mack’s sister, and Christy and he were still dear friends. As if disclosure is enough to help a viewer distinguish between facts and views obscured by a haze of politeness, appreciation, and gooey mutual stroking.

So much for  investigative, penetrating, and revealing journalism.

Snyderman, whose school was recipient also of large Templeton Foundation grants to ivestigate significance of spirituality and religion in “healing” revealed that he at one time was one of those straight arrow physicians who treated disease (instead of a person.) Until he experienced some of “the techniques” – unspecified – himself. In typical testimonial phrasing, he found it wondrous that something as intangible as hope could help heal. (Some of us also find that wondrous – even dubiousl.)  And then the tried and trite criticisms of docs being too involved in details (like what works and how to use it) and losing sight of the “whole person.”  ”Health is a value and one can have impact…” Eyes roll at such platitudinous and vacuous language.

If that were not enough, Fineberg demonstrated his deep knowledge of “Integrative Medicine” by telling the difference between “healing” and “curing,” and his democratic outlook by wanting to test any methods that works – regardless of the origin. David G’s blog the other day and Kim Atwood’s previous words discussed that issue, which still befuddles the NCCAM, which seems to test anything whether it contains molecules or not, and whether the idea generated in a crucible of observation and experimentation, or descended in a 2 AM drug-induced revelation.  He then used artemisinin (for resistant malaria) to illustrate the potential mining of miraculous natural drugs from traditional Chinese Medicine. I assume he assumed that TCM practitioners had  had been using it for malaria for centuries…despite the fact that there was no description of infectious diseases in TCM. Finding artemisinin for malaria was a product of extraction and purification from plants, known as modern pharmacology.

Christy Mack tried to introduce new concepts, explaining that one of her new aims is to empower the patient to heal oneself…That is not only decades old, but a word-linkage that, as with all esoteric ideation , means a lot to her and her co-believers, but little to the uninitiated.  Another concept was for each person to make a personal health plan for one’s life.  Can’t I do that now if I want? Seems I already did, then chance and nature intervened…

When Snyderman let slip the term, “CAM”, Mack jumped in saying, “Integrative Medicine” is not “CAM”.  Here was a clue to the joining of these otherwise poorly fitting edges of “IM” and the “IOM.”   We just won’t talk about those inconvenient absurdities that “IOM” might shrink from. My take is that Mack and ”CAM” advocacates want the blessings of as many System organizations as possible to fill their “CAM” CV as prelude to legitimization, licensing, and insurance reimbursement.  “CAM” practitioners are using the Bravewell as internediary to using “IOM.” Morgan Stanley money being an efficient lubricant. Simple.

So “IOM,” in exchange for more $?millions as it did for the NCCAM committee, sells itself and its merit badge for ”CAM”‘s  CV sash.  Fair exchange in this capitalist system, yes?  Seems that the only factor nissing in this exchange that keeps it from illegality is a sexual act. The Quiet Revolution moves on. 

Personal note: In 1993 when I awoke from 3 weeks of post-op unconsciousness in the ICU, the first things I recalled were on the overhead TV: the NCAA basketball finals, the Waco cult building complex on fire, and Charlie Rose interviewing another talking head with that ominous blacked-out background. The Quiet Revolution moves on as the Nightmare recurs. �

Posted in: Faith Healing & Spirituality, Health Fraud, Medical Academia, Science and Medicine, Science and the Media

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On the ethics of clinical trials of homeopathy in Third World countries

ResearchBlogging.orgI’m on the record multiple times as saying that I reject the entire concept and nomenclature of “alternative medicine” as being distinct from “conventional” medicine as a false dichotomy, when in reality there should be just “medicine.” Indeed, if there is one major theme to which this blog is dedicated it’s that medicine should be as much as possible science-based, a concept that takes into account not just clinical trials, which are prone to all sorts of false-positive results in the case of modalities that have no plausibility from a scientific perspective. In essence, I advocate treating “alternative” medicine the same as “conventional” medicine subjecting it to the same scientific process to determine whether it has efficacy or not, after which medicine that is effective is retained and used and medicine that fails the test is discarded. Where it comes from, the “alternative” or the “conventional” medical realm, matters little to me. All that matters is that it is based on sound science and that it has been demonstrated to have efficacy significantly greater than that of a placebo.

Given that, you’d think I’d be all in favor of subjecting alternative medicine, be it woo or more credible, to rigorous scientific testing. In many cases, you’d be right. My sole caveat is that, when testing alt-med, priority should be given to modalities that have at least a modicum of scientific plausibility, even if a bit tenuous. Herbal remedies would thus be at the front of my line to be tested, while obvious woo whose core principle on which it is based is so utterly ridiculous and scientifically implausible (like homeopathy, for instance) would be relegated to the back of line, if it’s ever tested at all. More implausible modalities that might work (albeit by a method that has nothing to do with the “life energy” manipulation that is claimed for it) like acupuncture would be somewhere in the middle. It’s a matter of resource prioritization, in which it makes little sense to test blatant woo before more plausible therapies are examined. Indeed, it’s arguable whether blatant woo like homeopathy should even have resources wasted testing it at all, given its extreme scientific improbability. Finally, regardless of what modality is being tested in scientific and/or clinical trials, it has to be done according to the highest ethical standards, on adults fully cognizant of or able to be taught about the questions being asked, the issues involved, and the potential risks who are thus able to give truly informed consent.
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Posted in: Homeopathy, Medical Ethics, Public Health, Science and Medicine

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My Woo: A Confession

It’s a case of mind over matter. I have no mind but it doesn’t seem to matter.
— George Burns

I should be working on my taxes. Instead, I’ll dwell on the other, more pleasant, inevitability.

Its been a bad couple of months for death. Everyone dies, and people often die of infection, but the flu season has been busy and with the MRSA lurking in the community, I have seen too many young die who should have otherwise survived their influenza.

I spend most of my professional day working in an acute care hospital, and most people in the hospital die of something. They die when their heart or lungs or liver or brain or some combination sustain more damage than can be compensated for. People live within fairly narrow operational parameters and when those parameters are exceeded for any length of time, they die. It is never a surprise when people die due to organ failure past the point of return or support. That is the cause of death in most of the patients I see.

Sometimes, and not very often, people die of nothing in particular. They just die. You get an autopsy, and there does not appear to be any single event that caused the death, nor does the sum of the underlying diseases seem to have lead to death. Usually it is the advanced elderly who just die. There reaches a point where the organism shuts down. I once had a patient die as I walked into the room on rounds. He looked at me and then died. He had many medical problems, but none that should have killed him, and his blood work on the day of death was normal and his autopsy had no clue as to why he died. Creepy. I like to have a definitive cause of death, but I do not always get one.

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Posted in: Science and Medicine

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Airborne Settles Case On False Advertising

The story of Airborne – a popular supplement marketed as an “herbal health formula that boosts your immune system to help your body combat germs” – is representative of what is wrong with the supplement industry and how it is regulated in the US. Recently the company that sells Airborne – Airborne Health, Inc – agreed to pay $23.3 million to refund consumers who purchased the product (if they have proof of purchase). This was to settle a class-action law suit brought by the Center for Science in the Public Interest (CSPI) and others claiming false advertising. In the settlement the company did not admit any wrongdoing. While this can be viewed as a minor victory for science-based medicine, it actually highlights the many deficiencies in the system.

For background, Airborne was launched in 1999 as a supplement designed to ward off the common cold. It has been extremely successful, due largely to its slick packaging, a clever slogan that it was developed by a school teacher, and promotion by Oprah Winfrey. The Airborne brand of products has expanded, including pixie powder for children, Airborne seasonal, Airborne Jr., Airborne on-the-go, and others. Advertising urged users to take Airborne at the first sign of a cold or as a preventive treatment if about to enter a germ-filled area, like an airplane. They also cited a “scientific” study that demonstrated Airborne is effective.

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Posted in: Herbs & Supplements, Science and Medicine

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The Business of Being Born

One of our readers asked for a critique of the movie “The Business of Being Born.” I guess my sex and specialty make me the best qualified to comment. I delivered over 200 babies as a family physician. I had two babies of my own (at age 37 and 39), one with intervention (forceps) and one 9-pounder who almost “fell” out before the obstetrician was ready.

“The Business of Being Born” is a movie about midwives, home births, and hospital births in America. It’s a sort of kinder, gentler “Sicko” with onscreen births, gooey, bloody newborns and fat naked women. The message of the movie is that for an uncomplicated pregnancy, natural home births with midwives are better and safer than medicalized hospital births with obstetricians. It’s strong on sound bites, emotional appeals, and superficial arguments, but weak on substance, depth, and scientific evidence for its claims.
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Posted in: Science and Medicine, Science and the Media

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When impressive science fails to impress patients

One of the greatest challenges in medicine can sometimes be to convince patients that the results of scientific and medical research apply to them, or, at the very least, to explain how such results apply. One of the reasons that medicine based not on science or evidence fluorishes is because it can be so hard to explain to patients why a particular intervention is viewed as effective. My co-blogger Steve Novella wrote about some of the fallibilities of human perception that lead to perceiving correlations and treatment effectiveness where there are none. R. Robert Bausell wrote about the same thing in his recent book Snake Oil Science. While it is undoubtedly true that people tend to pay more attention to anecdotes than to studies and statistics, there is also another reason why doctors often have problems convincing patients of the value of health interventions, and that’s the difference in perception and how we value different kinds of evidence.

A couple of years ago, I came across an article that explains this gulf between how those of us trying to practice science- and evidence-based medicine perceive the world and how most human beings not trained in medicine or science perceive it. The article, which was published in 2006 in the New York Times and written by Dr. Abigail Zuker, proposed one reason why this might be, beginning with a discussion with her mother in which she tries to convince her of the benefit of exercise, even in the elderly, a concept that her mother would have none of and dismissed contemptuously:

“Studies,” she says, dripping scorn. “Don’t give me studies. Look at Tee. Look at all the exercise she did. She never stopped exercising. Look what happened to her.”

End of discussion. Tee, her old friend and contemporary, took physical fitness seriously, and wound up bedbound in a nursing home, felled by osteoporosis and strokes, while my mother, who has not broken a sweat in the last 60 years, still totters around on ever-thinning pins. So much for exercise. So much for studies. So much for modern clinical medicine, based on the randomized allocation of treatment and placebo. All that beautiful science, stymied by the single, incontrovertible, inescapable image of Tee, the one who exercised but grew hunched and crippled anyway.

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Posted in: Clinical Trials, Public Health, Science and Medicine

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Where Are We Going?

Where is it all headed? Medicine on another threshold. Allow me to present several previously unconnected news articles that illuminate the serious problem we face in today’s increasingly scientifically rootless world.

Who are scientific medicine’s friends; on whom can we rely for support of reason and common sense, unbiased approaches to funding, unbiased efficacy evaluation, fair law enforcement, and a return to the logical world of decades ago? The private insurance industry is taking it in the gut, while Pharma receives the repeated jabs. Corrupt administrations run off with hundreds of millions, inadequately punished for the degree of misbehavior. Academicians, no longer squeaky clean, unwilling to keep house on big-money grant recipients while tolerating massive private consulting fees. Schools infiltrated by mindless relativism satisfy the lowest academic levels despite the revolutionary changes in biology and massive knowledge base new MDs have to apply.

Just in 2 weeks a number of seemingly unrelated developments in the news got one to thinkin’, …there aren’t any to trust anymore. The government agencies are just as bad. Start with the FDA. Steve Barrett’s Consumer Health Digest Quackwatch.com has been trying to reassess the status of one or more quackery proponents and practitioners. One of his routes is the examination of FDA records of enforcement and warning letters to violators. From CHD of 3/11/08:

FDA “hides” old warning letters. The FDA Web site has made several changes that greatly decrease the visibility of warning letters about products and safety violations. Letters issued before January 2007 have been moved into a new directory so that all incoming links to them from other sites have been broken. This directory is also coded so that search engines cannot index its contents. Searching for warning letters on the FDA site is difficult because (a) the newer and older letters have to be searched separately, (b) the search page for pre-2007 pages in not easy to find. (c) letters are moved to the archive folder at irregular intervals, and (d) many of the older letters are in PDF format, which means that they will be found only if the searcher uses specific keywords. The agency as become extremely slow in responding to Freedom of Information Act requests. In August 2005, Dr. Barrett asked for a document related to a warning letter. If one exists, finding it would take only a few minutes. Barrett’s Congressman has asked twice for the document, and FDA staff members have phoned Barrett four times during the past year to find out whether he still wants it. But it still has not come. Bloomberg News has reported that in May 2007, the agency had 20,365 unfilled requests, including 1,924 that were more than three years old and that the the number of workers filling requests has been cut even though the backlog had been steadily rising. [Blum J. (more…)

Posted in: Politics and Regulation, Science and Medicine, Vaccines

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