Clinical Trials

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Dummy Medicine, Dummy Doctors, and a Dummy Degree, Part 2.2: Harvard Medical School and the Curious Case of Ted Kaptchuk, OMD (cont. again)

“Strong Medicine”: Ted Kaptchuk and the Powerful Placebo

At the beginning of the first edition of The Web that has no Weaver, published in 1983, author Ted Kaptchuk portended his eventual academic interest in the placebo:

A story is told in China about a peasant who had worked as a maintenance man in a newly established Western missionary hospital. When he retired to his remote home village, he took with him some hypodermic needles and lots of antibiotics. He put up a shingle, and whenever someone came to him with a fever, he injected the patient with the wonder drugs. A remarkable percentage of these people got well, despite the fact that this practitioner of Western medicine knew next to nothing about what he was doing. In the West today, much of what passes for Chinese medicine is not very different from the so-called Western medicine practiced by this Chinese peasant. Out of a complex medical system, only the bare essentials of acupuncture technique have reached the West. Patients often get well from such treatment because acupuncture, like Western antibiotics, is strong medicine.

Other than to wonder if Kaptchuk had watched too many cowboy ‘n’ Native American movies as a kid, when I first read that passage I barely blinked. Although the Chinese peasant may have occasionally treated someone infected with a bacterium susceptible to his antibiotic, most people will get well no matter what you do, because most illnesses are self-limited. Most people feel better even sooner if they think that someone with special expertise is taking care of them. If you want to call those phenomena the “placebo effect,” in the colloquial sense of the term, fine. That, I supposed, was what Kaptchuk meant by “strong medicine.”

Turns out I was mistaken. Let’s briefly follow Kaptchuk’s career path after 1983. In the 2000 edition of The Web, he wrote:

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Posted in: Acupuncture, Basic Science, Book & movie reviews, Chiropractic, Clinical Trials, Homeopathy, Medical Academia, Science and Medicine

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The Prostrate Placebo

I seem to be writing a lot about the urinary tract this month. Just coincidence, I assure you. As I slide into old age, medical issues that were once only of cursory interest for a young whippersnapper have increasing potential to be directly applicable to grumpy old geezers. Like benign prostatic hypertrophy (BPH). I am heading into an age where I may have to start paying attention to my prostate (not prostrate, as it is so often pronounced, although an infection of the former certainly can make you the latter), so articles that in former days I would have ignored, I read. JAMA this month has what should be the nail in the coffin of saw palmetto, demonstrating that the herb has no efficacy in the treatment of symptoms of BPH: Effect of increasing doses of saw palmetto extract on lower urinary tract symptoms: a randomized trial.

It demonstrated that compared to placebo, saw palmetto did nothing. There have been multiple studies in the past with the more or less the usual arc of clinical studies of CAM products: better designed trials showing decreasing efficacy, until excellent studies show no effect. There is the usual meta analysis or two, where all the suboptimal studies are lumped together, the authors bemoan the quality of the data, and proceed to draw conclusions from the garbage anyway. GIGO.

The NEJM study from 2006 demonstrated that saw palmetto was no better than placebo but it was suggested that perhaps the dose of saw palmetto was not high enough or that the patients were not treated long enough to demonstrate an effect, and the JAMA study hoped to remedy that defect. (more…)

Posted in: Clinical Trials, Herbs & Supplements, Science and Medicine

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The wrong way to “open up” clinical trials

Science-based medicine rests on twin pillars that are utterly essential to the development of treatments that are safe and efficacious. Both of these pillars depend on science, but in different ways. The first of these is, of course, the basic science that provides the hypotheses to test about the mechanisms behind the diseases and malfunctions that plague the human body. This basic science suggests ways of either correcting or alleviating these malfunctions in order to alleviate symptoms and prevent morbidity and mortality and how to improve health to increase quality and quantity of life. Another critical aspect of basic science is that it also provides scientists with an estimate of the plausibility of various proposed interventions, treatments and cures designed to treat disease and improve health. For example, if a proposed remedy relies upon ideas that do not jibe with some of the most well-established laws in science, such as homeopathy, the concepts behind which violate multiple laws of physics and chemistry, it’s a very safe bet that that particular treatment will not work and that we should test something else. Of course, the raison d’être of this blog derives from the unfortunate fact that in today’s medicine this is not the case and we are wasting incredible amounts of time, money, and lost opportunities in order to pursue the scientific equivalent of fairy dust as though it represented a promising breakthrough that will save medicine, even though much of it is based on prescientific thinking and mysticism. Examples include homeopathy, reiki, therapeutic touch, acupuncture, and much of traditional Chinese medicine and Ayurveda, all of which have managed to attach themselves to medical academia like kudzu.

Of course, basic science alone is not enough. Humans are incredibly complex organisms, and what we consider to be an adequate understanding of disease won’t always result in an efficacious treatment, no matter how good the science is. Note that this is not the same thing as saying that utter implausibility from a scientific basis (as is the case with homeopathy) doesn’t mean a treatment won’t work. When a proposed treatment relies on claiming “memory” for water that doesn’t exist or postulates the existence of a “life energy” that no scientific instrument can detect and the ability to manipulate that life energy that no scientist can prove, it’s a pretty safe bet that that treatment is a pair of fetid dingo’s kidneys. Outside of these sorts of cases, though, clinical trials and epidemiological studies are the second pillar of science-based medicine, in particular clinical trials, which is where the “rubber hits the road,” so to speak. In clinical trials, we take observations from the laboratory that have led to treatments and test them in humans. The idea is to test for both safety and efficacy and then to begin to figure out which patients are most likely to benefit from the new treatment.
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Posted in: Clinical Trials, Science and Medicine

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Understanding and Treating Colic

Parenting an infant can be totally overwhelming. One of the earliest challenge many face is learning to deal with periods of intractable crying. I often speak with sleep deprived parents when they’re looking for something — anything — to stop their baby from crying. They’ve typically been told by friends of family that their baby must have “colic” and they’ve come to the pharmacy, looking for a treatment. Colic is common, affecting up to 40% of babies in the few months of life.

While distressing, colic is a diagnosis of exclusion — that it, it is given only after other causes have been ruled out (hunger, pain, fatigue, etc.). The most common definition for colic is fussing or crying for more than 3 hours per day, more than 3 days per week, for more than 3 weeks. These criteria, first proposed by Morris Wessel in 1954, continue to be used today. However, scientific evidence to explain the cause is lacking. Ideas proposed include:

  • changes in gastrointestinal bacteria/flora
  • food allergies
  • lactose intolerance
  • excess gas in stomach
  • cramping or indigestion
  • intolerance to substances in the breast milk
  • behavioural issues secondary to parenting factors

Despite its intensity, colic resolves on its own with no interventions. By three months of age, colic has resolved in 60% of infants. By four months, it’s 90%. It sounds harmless and short-lived, but colic’s ability to induce stress in parents cannot be overstated. Parents may be angry, frustrated, depressed, exhausted, or just feel guilty, ascribing their baby’s cries to some parenting fault. (more…)

Posted in: Clinical Trials, Pharmaceuticals, Science and Medicine

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Seven Deadly Medical Hypotheses revisited

Back in February, Mark Crislip and I both deconstructed an article written by Dr. Reynold Spector that appeared in the March/April issue of Skeptical Inquirer (SI), the flagship publication for the Committee for Skeptical Inquiry (CSI). The article was entitled Seven Deadly Medical Hypotheses, and, contrary to the usual standard of articles published in SI, it used a panoply of spin, bad arguments, and, yes, misinformation to paint a picture of seven horrifically deadly “medical hypotheses,” most of which, even if the reader accepted Dr. Spector’s arguments at face value in a worst case scenario, weren’t actually all that deadly at all, with the alleged deadliness of the others being in dispute. In addition, Dr. Spector painted a picture of medical science that is not nearly rigorous enough. While we at SBM would probably agree that much of medical science is insufficiently rigorous, given how so-called “complementary and alternative medicine” (CAM) or “integrative medicine” (IM) has found a prominent place in medical practice in all too many academic and private medical centers, Dr. Spector got it so wrong that he wasn’t even wrong when he conflated preliminary, hypothesis-generating studies with the big, randomized, phase III clinical trials necessary to achieve FDA approval for a new drug or device. This latest article by Dr. Spector seemed to be of a piece with his previous article in the January/February 2010 issue of SI entitled The War on Cancer A Progress Report for Skeptics, which was so negative in its assessment of scientific progress against cancer that for a moment I was wondering if I were reading NaturalNews.com or Mercola.com.

Unfortunately, Seven Deadly Medical Hypotheses itself is not yet online on the CSI website; so readers without a subscription to SI cannot at the present time judge for themselves whether Mark and I were too harsh on Dr. Spector, but our criticisms, along with that of SBM partner-in-crime Harriet Hall, did have an impact. Seemingly genuinely stunned at the level of criticism leveled at an article published in SI, SI’s editor Kendrick Frazier, to his credit, invited several responses to Dr. Spector’s article, which Harriet Hall, Mark Crislip, Carol Tavris, Avrum Bluming, and I eagerly provided. These letters were originally scheduled to be published a couple of issues ago, along with Dr. Spector’s response. Unfortunately, publishing in dead tree media being what it is, Harriet Hall and I were disappointed to find that the latest issue of SI still didn’t contain our rebuttals. Fortunately, Mr. Frazier has posted this material online for your edification, although, again, I wish he had also published the original article as well.
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Posted in: Cancer, Clinical Trials, Science and Medicine

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The Annals of Internal Medicine Qualifies for Fail Blog.

As most readers of the blog know, I am mostly an Infectious Disease doc. I spend my day diagnosing and treating infections and infectious complications. It is, as I have said before, a simple job. Me find bug, me kill bug, me go home. Kill bug. It is the key part of what I do everyday, and if there is karmic payback for the billions of microbial lives I have erased from the earth these past 25 years, my next life is not going to be so pleasant. I will probably come back as a rabbit in a syphilis lab.

It is always fun when my hobby, writing for SBM, crosses paths with my job. This month the Annals of Internal Medicine published “Oseltamivir Compared With the Chinese Traditional Therapy Maxingshigan–Yinqiaosan in the Treatment of H1N1 Influenza. A Randomized Trial.”

I though big pharma was good at coming up with names I do not know how to pronounce. If someone could provide a pronunciation guide in the comments, it would be ever so helpful, so I will not have to embarrass myself when this entry becomes a Quackcast. Dr. Hall wrote about this article on Tuesday, and I have avoided reading her post until this one is up, so there may be overlap in what is discussed. (more…)

Posted in: Basic Science, Clinical Trials, Herbs & Supplements, Science and Medicine

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When a “scientific study” is neither

There is quite a bit of art to the practice of medicine: knowing how to get and to give information to a patient, how to create a sense of worry without creating a feeling of panic, how to use the best available science to help them maintain or return to health.  Underlying all of the art is the science: what blood pressure is likely to be harmful in a particular patient?  What can I offer to mitigate this harm?  This science is developed over years by observation and systematic study.  We have a very good idea of what blood pressure levels are optimal to prevent heart attacks in various populations.  These data are hard-won.  It has taken decades and it continues.

If a researcher were to discover a promising, new blood pressure intervention, they would have a long way to go from bench to bedside.  They would have to prove as well as possible that it is safe and effective—and from a science-based medicine perspective, that it is even plausible.  If the discovery is a drug that relaxes blood vessels, or a type of exercise, we have good reason to believe it might work and can go on to figuring out if it does work.  If the intervention is wearing plaid every day, we have little reason to think this would be effective, and it probably isn’t worth the time and cost of looking into it.

The well-respected journal Cancer has just wasted space in the study of wearing plaid.  Well, not really; it’s worse than that.  The article is called, “Complementary medicine for fatigue and cortisol variability in breast cancer survivors: A Randomized Controlled Trial.”  There is nothing that isn’t wrong with this study, and if it weren’t published in a major journal, it might even be light comedy.

Tragedy wins the day, however, because cancer is a big deal, and I don’t like it when people mess around with cancer.
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Posted in: Clinical Trials, Energy Medicine

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Dummy Medicine, Dummy Doctors, and a Dummy Degree, Part 2.0: Harvard Medical School and the Curious Case of Ted Kaptchuk, OMD

Review

The recent albuterol vs. placebo trial reported in the New England Journal of Medicine (NEJM) found that experimental subjects with asthma experienced substantial, measured improvements in lung function after inhaling albuterol, but not after inhaling placebo, undergoing sham acupuncture, or “no treatment.” It also found that the same subjects reported having felt substantially improved after either albuterol or each of the two sham treatments, but not after “no treatment.” Anthropologist Daniel Moerman, in an accompanying editorial, wrote, “the authors conclude that the patient reports were ‘unreliable,’ since they reported improvement when there was none”—precisely as any rational clinician or biomedical scientist would have concluded.

In Part 1 of this blog we saw that Moerman took issue with that conclusion. He argued, with just a bit of hedging, that the subjects’ perceptions of improvement were more important than objective measures of their lung function. I wondered how the NEJM editors had chosen someone whose bibliography predicted such an anti-medical opinion. I doubted that Editor-in-Chief Jeffrey Drazen, an expert in the pathophysiology of asthma, had ever heard of Moerman. I suggested, in a way that probably appeared facetious, that Ted Kaptchuk, the senior author of the asthma report, might have recommended him. (more…)

Posted in: Acupuncture, Chiropractic, Clinical Trials, Health Fraud, Herbs & Supplements, History, Medical Academia, Medical Ethics, Naturopathy, Pharmaceuticals, Science and Medicine, Science and the Media

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Revisiting Daniel Moerman and “placebo effects”

About three weeks ago, ironically enough, right around the time of TAM 9, the New England Journal of Medicine (NEJM) inadvertently provided us in the form of a new study on asthma and placebo effects not only material for our discussion panel on placebo effects but material for multiple posts, including one by me, one by Kimball Atwood, and one by Peter Lipson, the latter two of whom tried to point out that the sorts of uses of these results could result in patients dying. Meanwhile, Mark Crislip, in his ever-inimitable fashion, discussed the study as well, using it to liken complementary and alternative medicine (CAM) as the “beer goggles of medicine,” a line I totally plan on stealing. The study itself, we all agreed, was actually pretty well done. What it showed is that in asthma a patient’s subjective assessment of how well he’s doing is a poor guide to how well his lungs are actually doing from an objective, functional standpoint. For the most part, the authors came to this conclusion as well, although their hedging and hawing over their results made almost palpable their disappointment that their chosen placebos utterly failed to produce anything resembling an objective response improving lung function as measured by changes (or lack thereof) in FEV1.

In actuality, where most of our criticism landed, and landed hard—deservedly, in my opinion—was on the accompanying editorial, written by Dr. Daniel Moerman, an emeritus professor of anthropology at the University of Michigan-Dearborn. There was a time when I thought that anthropologists might have a lot to tell us about how we practice medicine, and maybe they actually do. Unfortunately, my opinion in this matter has been considerably soured by much of what I’ve read when anthropologists try to dabble in medicine. Recently, I became aware that Moerman appeared on the Clinical Conversations podcast around the time his editorial was published, and, even though the podcast is less than 18 minutes long, Moerman’s appearance in the podcast provides a rich vein of material to mine regarding what, exactly, placebo effects are or are not, not to mention evidence that Dr. Moerman appears to like to make like Humpty-Dumpty in this passage:
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Posted in: Acupuncture, Basic Science, Clinical Trials, Neuroscience/Mental Health, Science and the Media

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Belief in Echinacea

Note: The study discussed here has also been covered by Mark Crislip. I wrote this before his article was published, so please forgive any repetition. I approached it from a different angle; and anyway, if something is worth saying once it’s probably worth saying twice.

Echinacea purpurea

Echinacea purpurea, or purple coneflowers – not a cure for the common cold.

Is Echinacea effective for preventing and treating the common cold or is it just a placebo? My interpretation of the evidence is that Echinacea does little or nothing for the common cold. Initial reports were favorable, but were followed by four highly-credible negative trials in major medical journals. A Cochrane systematic review was typically wishy-washy. The Natural Medicines Comprehensive Database rates it as only “possibly effective” commenting that:

Clinical studies and meta-analyses show that taking some Echinacea preparations can modestly reduce cold symptom severity and duration, possibly by about 10% to 30%; however, this level of symptom reduction might not be clinically meaningful for some patients. Several other clinical studies found no benefit from Echinacea preparations for reducing cold symptoms in adults or children…

A review on the common cold in American Family Physician stated that Echinacea is not recommended as a treatment.

I have a friend who believes in Echinacea. She says for the last several years she has taken Echinacea at the first hint of a cold, and she hasn’t developed a single cold in all that time. I told her that if that was valid evidence that it worked, I had just as valid evidence that it didn’t. For the last several years I have been careful not to take Echinacea at the first hint of a cold, and I haven’t had a single cold in all that time either. So I could claim that not taking Echinacea is an effective cold preventive! I thought my “evidence” cancelled out hers; she said we would just have to agree to disagree.

A recent study looked at the effect of belief on response to Echinacea and dummy pills. “Placebo Effects and the Common Cold: A Randomized Controlled Trial” was published by Barrett et al. in the Annals of Family Medicine. (more…)

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