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Archive for Clinical Trials

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…)

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

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Answering another criticism of science-based medicine

In the three and a half years that the Science-Based Medicine blog has existed, we contributors have come in for our share of criticism. Sometimes, the criticism is relatively mild; often it’s based on a misunderstanding of what SBM is; but sometimes it’s quite nasty. I can’t speak for the rest of the SBM crew on this, but I’ve gotten used to it. It comes with the territory, and there’s little to do about it other than to skim each criticism as it comes in to see if the author makes any valid points and, if he doesn’t, to ignore it and move on. Indeed, there’s enough criticism being flung our way that I rarely respond directly anymore. Exceptions tend to be egregious examples, incidents that spark real problems, such as when Age of Autism blogger and anti-vaccine activist Jake Crosby tried to paint me as being hopelessly in the thrall of big pharma, which resulted in the anti-vaccine horde who read that blog to try to get me fired by sending complaints to the Board of Governors at my university and the dean of my medical school. Other examples tend to be what I call “teachable moments,” in which the mistakes made in the criticism provide fodder for making a point about SBM versus alternative medicine, “complementary and alternative medicine” (CAM), or “integrative medicine” (IM)—or whatever the nom du jour is.

File this next one under the “teachable moment” variety of criticism directed at SBM.
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Posted in: Basic Science, Clinical Trials, Science and Medicine

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CAM: The Beer Goggles of Medicine

Pictured: A really delicious pair of beer goggles ready to be put in my face. I mean on my face.

Pictured: A really delicious pair of beer goggles ready to be put in my face. I mean on my face. Metaphored!

It is summer, the kids are off, and time to write dwindles in the face of sun and golf. Nonsense knows no season, and in my readings this week I came across the phrase “the undeniable power of the placebo.” I will do my best to deny that power at least three times before I crow my conclusion.

One of my first entries for SBM, back in the mists of time, was the Placebo Myth,1 where I argued that the placebo has no clinical effects, has clinically irrelevant alleged physiology and at most leads to a slight change in perception on the part of the patient that they have less pain. Essentially placebo does nothing. It has no power.

Two studies this month continue that argument: demonstrating that placebo has no practical benefit and the crowing in the media mistakenly trumpets that it does. Reporting on an article from Annals of Family Medicine, the headline on Medscape2 reads “Placebo Effects Modest in Treating the Common Cold.” How modest?
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Posted in: Clinical Trials, Science and Medicine

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Dummy Medicines, Dummy Doctors, and a Dummy Degree, Part 1: a Curious Editorial Choice for the New England Journal of Medicine

Background

This post concerns the recent article in the New England Journal of Medicine (NEJM) titled “Active Albuterol or Placebo, Sham Acupuncture, or No Intervention in Asthma.” It was ably reviewed by Dr. Gorski on Monday, so I will merely summarize its findings: of the three interventions used—inhaled albuterol (a bronchodilator), a placebo inhaler designed to mimic albuterol, or ‘sham acupuncture’—only albuterol resulted in a clinically important improvement of bronchial airflow; for that outcome the two sham treatments were equivalent to “no intervention.” For all three interventions, however, self-reported improvements were substantial and were much greater than self-reported improvements after “no intervention.” In other words, dummy treatments made the subjects (report that they) feel better, whereas real medicine not only made them feel better but actually made them better.

Before proceeding, let me offer a couple of caveats. First, the word “doctors” in the flippant title of this post refers mainly to two individuals: Daniel Moerman, PhD, the anthropologist who wrote the accompanying editorial, and Ted Kaptchuk, the Senior Author of the trial report. It does not refer to any of the other authors of the report. Second, I have no quarrel with the trial itself, which was quite good, or with the NEJM having published it, or even with most of the language in the article, save for the “spin” that Dr. Gorski has already discussed.

My quarrels are the same as those expressed by Drs. Gorski and Novella, and by all of us on the Placebo Panel at TAM. This post and the next will develop some of those points by considering the roles and opinions of Moerman and Kaptchuk, respectively.

A True Story

Late one night during the 1960s a friend and I, already in a cannabis-induced fog, wandered into a house that had been rented by one of his friends. There were about 8-10 ‘freaks’ there (the term was laudatory at the time); I didn’t know any of them. The air was thick with smoke of at least two varieties. After an uncertain interval I became aware of a guy who was having trouble breathing. He was sitting bolt upright in a chair, his hands on his knees, his mouth open, making wheezing sounds. He took short noisy breaths in, followed by what seemed to be very long breaths out, as though he was breathing through a straw. You could hear the wheezing in both directions. Others had also noticed that he was in distress; they tried to be helpful (“hey, man, ya want some water or somethin’?”), but he just shook his head. He couldn’t talk. My friend, who had asthma himself, announced that this guy was having an asthma attack and asked if he or anyone else had any asthma medicine. No one did.

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Posted in: Acupuncture, Cancer, Clinical Trials, Energy Medicine, Faith Healing & Spirituality, Health Fraud, Homeopathy, Medical Academia, Medical Ethics, Naturopathy, Pharmaceuticals, Public Health, Science and Medicine, Science and the Media

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Spin City: Using placebos to evaluate objective and subjective responses in asthma

As I type this, I’m on an airplane flying home from The Amazing Meeting 9 in Las Vegas. Sadly, I couldn’t stay for Sunday; my day job calls as I’ll be hosting a visiting professor. However, I can say—and with considerable justification, I believe—that out little portion of TAM mirrored the bigger picture in that it was a big success. Attendance at both our workshop on Thursday and our panel discussion on placebos on Saturday was fantastic, beyond our most optimistic expectations. There was also a bit of truly amazing serendipity that helped make our panel discussion on placebo medicine an even bigger success.

If there’s one thing about going away to a meeting, be it TAM or a professional meeting, it’s that it suddenly becomes very difficult for me to keep track of all the medical and blog stuff that I normally keep track of and nearly impossible to keep up with the medical literature. This is the likely explanation for why I had been unaware of a study published in the New England Journal of Medicine (NEJM) on Thursday that was so relevant to our discussion and illustrated out points so perfectly that it was hard to believe that some divine force didn’t give it to us in order to make our panel a total success.

Just kidding. It was TAM, after all. It was, however, embarrassing that I didn’t see the study until the morning of our panel, when Kimball Atwood showed it to me.

Before I get to the meat of this study and why it fit into our nefarious plans for world domination, (or at least the domination of medicine by science-based treatments), a brief recap of the panel discussion would seem to be in order. First, for the most part, we all more or less agreed that the term “placebo effect” is a misnomer and somewhat deceptive because it implies that there is a true physiologic effect caused by an inert intervention. “Placebo response” or “placebo responses” seemed to us a better term because what we are observing with a placebo is in reality a patient’s subjective response to thinking that he is having something active done having something done. In general, we do not see placebo responses resulting improvement in objective outcomes; i.e., prolonged survival in cancer. The relative contributions of components of this response, be they expectancy effects (if you expect to feel better you likely will feel better), conditioning, or one that is frequently dismissed or downplayed, namely artifacts of the design of randomized clinical trials and even subtle (or even not-so-subtle) biases in trial design. This issue of placebo responses being observed only in subjective patient-reported clinical outcomes (pain, anxiety, and the like) and not in objectively measured outcomes is an important one, and it is one that goes to the heart of the NEJM study that so serendipitously manifested itself to us. As Mark Crislip so humorously pointed out, the placebo response is the beer goggles of medicine (this is not a spoiler or stealing Mark’s line; several TAM attendees have already tweeted Mark’s line), and much of what is being observed are changes in the patient’s perception of his symptoms rather than true changes in the underlying pathophysiology. This study drove the point home better than we could.

Another point discussed by the panel is also quite relevant. As more and more studies demonstrate very convincingly that “complementary and alternative medicine” (CAM) or “integrative medicine” (IM) therapies do not produce improvements in symptoms greater than placebo. Moreover, multiple studies, including a famous NEJM meta-analysis and a recently updated Cochrane review, demonstrate, placebo responses probably do not constitute meaningful responses. In light of these findings, CAM apologists, driven by ideology rather than science and masters of spin, have begun to admit grudgingly that, yes, in essence their treatments are elaborate placebos. Not to be deterred, instead of simply concluding that their CAM interventions do not work, they’ve moved the goal posts and started to try to argue that it doesn’t matter that CAM effects are placebo effects because placebos are “powerful” and good and—oh, yes, by the way—there are a lot of treatments in science-based medicine that do little better than placebos. In other words, CAM advocates elevate the subjective above the objective and sell the subjective, and that’s exactly what they are doing with this study.
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Posted in: Acupuncture, Clinical Trials, Medical Ethics

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Update on Josephine Briggs and the NCCAM

Dr. Gorski is in the throes of grant-writing, so I’m filling in for him today by following up on a topic introduced a few months ago. It involves a key medical player in the U.S. government: Dr. Josephine Briggs, Director of the National Center for Complementary and Alternative Medicine (NCCAM).

Background

Steve Novella and I first encountered Dr. Briggs at the 2nd Yale Research Symposium on Complementary and Integrative Medicine in March, 2010. I reported here that she seemed well-meaning and pro-science but that she also seemed naive to the political realities of her office and to much of the content of “CAM” (as illustrated by her recommending the NCCAM website, which is full of misinformation; previously I’d noticed her unfortunate innocence of “acupuncture anesthesia,” which is to be expected of most academics but not of the CAM Explicator-in-Chief).

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Posted in: Clinical Trials, Health Fraud, Herbs & Supplements, Homeopathy, Naturopathy, Politics and Regulation, Science and Medicine, Vaccines

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