Clinical Trials

Archive for Clinical Trials

Reporting results from clinical trials is vital for science-based medicine

Real medicine is built on high quality data. That’s one lesson I learned through my rehabilitation as a former naturopath. I can assure you that this principle does not apply to naturopathy or any of the other types of alternative medicine, which are mostly based on anachronistic traditions, magical thinking, and poor academic integrity. I now know that real medicine incorporates any therapy scientifically demonstrated to be effective and safe, regardless of origin. Therapies that fail to demonstrate effectiveness remain alternative for good reason.

I made a sharp turn in my career when I realized this, but I was recently surprised to learn that a failure to respect the data can sometimes also characterize medicine. I’m not trying to fool anyone with an appeal to hypocrisy (often used by alternative medicine zealots to argue that their beliefs are somehow valid simply because medicine has problems). But I do want to draw attention to a problem with medical research, which has the potential to undermine science-based medicine and take us down the dark path of misinformed medicine — medicine based on incomplete data.


Most people probably don’t realize that a majority of clinical trials do not report their findings.[1–3] About half of trials conducted before 2007, before it was legally required to register and report clinical trials, have never been published.[4, 5] Even since stronger legal mandates were enacted, most clinical trials still are not registered or reported.[1–3] As a result, there is a huge amount of clinical data unknown to the medical community and not available to clinicians or patients.

This effectively means that medical decisions can be based on incomplete information, not only diminishing the effectiveness of treatments but also eroding the perceived plausibility of medical interventions over time. This is what Sense About Science’s AllTrials campaign is all about: ensuring that all clinical trials register and report results in a publicly-available database. I see it as an obvious and straightforward means to improve medicine. (more…)

Posted in: Clinical Trials, Ethics, Naturopathy, Politics and Regulation, Quality Improvement, Science and Medicine

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Curse Removal from the Annals. More Acupuncture Nonsense.

Pictured: Joshua Tree. Not pictured: My bleached bones.

Pictured: Joshua Tree. Not pictured: My bleached bones.  I hope.

A short post this week. Last weekend was a busy call weekend and as I type this I am heading for Palm Springs for a long weekend of hiking in the desert. If there is no entry in 14 days, look for my bleached bones somewhere in Joshua Tree.

Some observations about a recent article in the once-respected Annals of Internal Medicine, whose recent articles on acupuncture suggest their motto should be “The Annals: we have one too many ns.”

First there was, “Alexander Technique Lessons or Acupuncture Sessions for Persons With Chronic Neck Pain: A Randomized Trial,” and now “Acupuncture for Menopausal Hot Flashes: A Randomized Trial.”

Spinning yin deficiency

Why do the study? Why do any acupuncture study? Negative studies will not change practice. There are no reality-based reasons to think that acupuncture would be effective for any process. All the high quality studies show no efficacy. (more…)

Posted in: Acupuncture, Clinical Trials, Science and Medicine

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Is “harnessing the power of placebo” worthwhile to treat anything?

We frequently write about placebo effects here on Science-Based Medicine. The reason is simple. They are an important topic in medicine and, at least as importantly, understanding placebo effects is critical to understanding the exaggerated claims of advocates of “complementary and alternative medicine” (CAM), now more frequently called “integrative medicine” (i.e., integrating pseudoscience with science). Over the years, I (and, of course, others) have documented how CAM advocates have consistently moved the goalposts with respect to the efficacy of their pseudoscientific interventions. As larger and better-designed clinical trials have been done demonstrating that various CAM therapies without a basis in science—I’m distinguishing these from science-based modalities that have been co-opted and “rebranded” as CAM, such as exercise and nutrition—have no specific effects detectable above placebo effects, CAM advocates move the goalposts and claim that CAM works through the “power of placebo” and do their best to claim that “harnessing” that “power of placebo” is a justification to use their treatments. It turns out, however, that when placebo effects are examined rigorously there’s just not a lot of there there, so to speak. Results are underwhelming, and trying to “harness the power of placebo” without an intervention that actually impacts the pathophysiology of disease can even be dangerous. That’s not to say that learning to maximize placebo responses (whatever they are) while administering effective medical treatments isn’t important; rather, it’s to point out that, by themselves, placebo effects are not of much value.

Unfortunately, none of this has stopped what Steve Novella refers to as the “placebo narrative” from insinuating itself into lay discussions of medicine. That narrative proclaims in breathless terms (as Steve put it) the “surprising power of the placebo effect” without putting it into reasonable perspective or even really defining what is meant by “placebo effect.” First, as we have tried to explain time and time again here, there is no single “placebo effect.” There are placebo effects. Second, the only really correct reference to “the placebo response” or “placebo effect” is the outcome measured in the placebo arm of a clinical trial. The problem is that, all too often, discussions of placebo responses conflate the placebo effect measured in a clinical trial with all the other various placebo effects that add up to the response that is measured in that trial. Those effects include reporting biases, researcher biases, regression to the mean, conditioning, and many other components that contribute to what is measured in the outcome of a clinical trial. Another common misconception about placebo effects is that they are somehow “mind over matter,” that we can heal ourselves (or at least reduce our symptoms) through the power of will and mind. This is not true. Placebo effects are not the power of positive thinking.

Posted in: Acupuncture, Basic Science, Clinical Trials, Homeopathy, Science and the Media

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The fine line between quality improvement and medical research


As I’ve mentioned before, the single biggest difference between science-based medicine (SBM) and what I like to call pseudoscience-based medicine, namely the vast majority of what passes for “complementary and alternative medicine” (CAM) or “integrative medicine” is that SBM makes an active effort to improve. It seeks to improve efficacy of care by doing basic and clinical research. Then it seeks to improve the quality of care by applying the results of that research to patient care. Yes, the process is complicated and messy, and it frequently doesn’t progress as fast as we would like it to. Sometimes it goes down blind alleys or takes wrong turns, such as when a treatment is adopted too rapidly and determined later to be ineffective. Overall, however, improvement does occur, and it continues to occur. New treatments that work better are discovered. Old treatments that don’t work as well (or that don’t work at all) are abandoned.

There is, however a blurry line between what constitutes medical research and what constitutes quality improvement (QI). A couple of years ago, in one of those unexpected turns that a career can take, an opportunity presented itself for me to become co-director of a statewide quality improvement consortium for breast cancer care in my state. As I’ve alluded to before, it was a case of unexpectedly being in the right place at the right time, of seeing an opportunity and being willing to take it. How I ended up making quality improvement a large part of my career is unimportant. What is important is that it puts me in a unique position among all the other SBM contributors to discuss the interface between science and quality. (It’s also important that I lay down a disclaimer here that this post represents my opinion and my opinion alone; it does not represent the views of the QI with which I’m affiliated, my cancer center, or my university.) In particular, there are ethical considerations that are not obvious, apparently even to someone as brilliant as Steven Pinker, who Tweeted yesterday:

Posted in: Clinical Trials, Medical Ethics, Quality Improvement

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Is scientific peer review a “sacred cow” ready to be slaughtered?

Peer Review

I’ve frequently noted that one of the things most detested by quacks and promoters of pseudoscience is peer review. Creationists hate peer review. HIV/AIDS denialists hate it. Anti-vaccine cranks like those at Age of Autism hate it. Indeed, as a friend of mine, Mark Hoofnagle, pointed out several years ago, pseudoscientists and cranks of all stripes hate it. There’s a reason for that, of course, namely that it’s hard to pass peer review if you’re peddling pseudoscience, although, unfortunately, with the rise of “integrative medicine,” it’s nowhere near as difficult as it once was.

Be that as it may, peer review, the process by which scientific papers are evaluated by scientific “peers” to look for problems with the science and decide if the paper is appropriate for publication in a scientific journal, is a concept that dates back hundreds of years. However, for the most part, before the middle of the 20th century, the ultimate determination of whether a paper was appropriate for scientific publication was made by editors or editorial committees. Opinions of external reviewers were sometimes sought when deemed appropriate by journal editors, but by no means was this the practice for most manuscripts. Over the last six or seven decades, external peer review by scientists chosen by the journal editor evaluating a submission has become the standard. Similarly, decisions regarding whether or not to fund grant applications are now generally made by a panel of external reviewers. In the case of the NIH, these panels are called study sections and consist of scientists with expertise in the types of applications being referred to the study section for evaluation, along with (usually) a statistician or two and officials from the NIH who take care of organizing and running the meetings of the panel. The scientific members of a study section usually include “permanent” members, who are assigned to fixed terms on the study section, and ad hoc members, called in for one or a few meetings as needed and deemed necessary by the NIH.

Posted in: Basic Science, Clinical Trials, Science and Medicine

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Worshiping at the altar of the Cult of the Brave Maverick Doctor

Death of Cancer

One of my favorite television shows right now is The Knick, as I described before in a post about medical history. To give you an idea of how much I’m into The Knick, I’ll tell you that I signed up for Cinemax for three months just for that one show. (After its second season finale airs next Friday, I’ll drop Cinemax until next fall.) The reason why I’m bringing up The Knick (besides I love the show and need to bring it up at least once a year) is because an article by Malcolm Gladwell in The New Yorker entitled “Tough Medicine“, which is a commentary based on a new book on cancer by a veritable god of cancer research, Vincent T. DeVita, Jr., immediately resonated with a storyline in this season of The Knick. I haven’t yet read The Death of Cancer: After Fifty Years on the Front Lines of Medicine, a Pioneering Oncologist Reveals Why the War on Cancer Is Winnable–and How We Can Get There by Vincent T. DeVita and Elizabeth DeVita-Raeburn, but I want to. I can tell, though, that there will be parts of the book I find annoying just from Gladwell’s take on it, which approvingly describes DeVita as railing against the cautiousness and incremental nature of today’s cancer research. To give you an idea of where Gladwell’s coming from, I note that his article shows up in the title bar of my web browser not as “Tough Medicine” but rather “How To Cure Cancer”, even as the title on the web page itself remains “Tough Medicine”. On the other hand, the article does conclude with Gladwell demonstrating a better understanding of the disadvantages of what DeVita is proposing than it seems that he will in the beginning. In fact, it is Gladwell who is more reasonable than his subject, although he does appear share DeVita’s apparent assumption that potentially all cancer patients are savable if only we try hard enough. (more…)

Posted in: Cancer, Clinical Trials, History, Medical Ethics

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Influenza Eye Roll

Look!  A metaphor!

Look! A metaphor!

I don’t know the best metaphor. What comes around goes around. The more things change, the more they say the same. Sisyphus. Whack-A-Mole.

So what to do when the same old same old rears its head yet again? There are 2,545 posts on this blog, and I suppose I could just point to prior posts. But a blog entry that consists of links to prior posts would make the managing editor irritable. And we don’t want him irritable. Although those links are at the end of the post.

And WordPress is not a good format for reference material. I have trouble finding my own articles even when I know they exist and search for them using what I think are relevant terms.

It being the start of the flu season the same ole same ole nonsense is back about flu vaccines and influenza treatment. Influenza seasons vary, the nonsense does not. On the assumption that most of the readers of the post have no prior knowledge of what I have written on the topic, I thought I would tackle influenza yet again. (more…)

Posted in: Clinical Trials, Critical Thinking, Science and Medicine

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Misinterpreting TACT: No, Chelation Does Not Outperform Statins for Heart Disease

Chelation with intravenous EDTA (disodium ethylene diamine tetra-acetic acid) has long been used for heavy metal poisoning. It binds the metal ions and facilitates their excretion from the body. In recent years it has been used for many other indications that are not evidence-based, such as autism and coronary heart disease.

The Trial to Assess Chelation Therapy (TACT) was done to assess the effectiveness and safety of EDTA plus high-dose oral vitamins for preventing second heart attacks in patients who had already had one. An article on The People’s Pharmacy website portrays the study as strongly positive. The Graedons, authors of the website, claim that science supports the use of chelation. They report that for every 12 patients undergoing chelation, one heart attack will be prevented over a five-year period. They cite a 5-year NNT (number needed to treat) of 16 for statin therapy and they conclude that:

EDTA chelation outperformed statins because fewer people needed to receive treatment to achieve a desirable outcome.


Posted in: Clinical Trials, Science and Medicine

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Exercise and Memory

exercise-brainThere is no escaping the evidence that regular moderate exercise is associated with a host of medical benefits. Among those benefits are perhaps improved memory and cognition, and questionably a decreased risk of developing dementia.

The latest study to show this correlation involved younger and older adults who wore a step-monitor. The number of steps they took during the study interval was then correlated with their performance on neuropsychological testing. The researchers found that for the older adults, but not younger adults, more physical activity correlated with better overall cognitive performance, but especially for face-name recognition.

This is a small study, with 60 subjects total. Also, the study is correlational only. It is possible that healthier older adults are both more physically active and cognitively nimble, because of underlying biological fitness. More cognitively active older adults may also be more physically active – the lines of cause and effect are plausible in multiple ways. (more…)

Posted in: Clinical Trials, Neuroscience/Mental Health

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Acupuncture/TCPM Crapfest

Acupuncture needling

Look Ma! No gloves!

As I get older I get more grumpy. Issues that at one time I was rather sanguine about, now irritate the hell out of me. It is not like it was when I started practice. Information was hard to come by. Going through the Index Medicus, with the world’s tiniest font, wandering the stacks looking for papers, sending off for reprints, getting a precious Xerox (or even a mimeograph) of a classic paper from an attending.

You understood the value of eminence-based medicine, as it took a career to acquire and master the literature. You relied on the wisdom of old geezers like me who had decades of experience and reading.

That was then. Now? The world’s information is available almost instantaneously. You may not be able to master a new topic spending a day on Google and Pubmed, but you can acquire a reasonable understanding, especially of you have some background.

Because of Google and Pubmed, the only reasons for ignorance of your area of expertise in medicine are time, laziness, or stupidity. As a specialist, only time is an excuse. It is my job to keep up with infectious diseases, although with over 10,000 articles a year in ID, it is impossible to read everything. But if I have a question concerning patient care, I need to look it up. I have another blog whose raison d’être is looking up answers to the daily questions that arise in practice.

On the characteristics of a useful clinical trial

So the characteristics of a useful clinical trial are not hard to determine: Randomized, double blind, placebo controlled, adequately powered. Because you want to avoid spending time and money on a study only to end up with no useful conclusions. This is especially important with acupuncture where it not does matter what kind of acupuncture is used, if needles are used, where the needles are placed or even if you mime acupuncture or perform acupuncture on a rubber hand. The key features for success in acupuncture are belief that the patient is receiving acupuncture and that the patient believes the acupuncture will be effective. And the stronger the belief, the better the subjective response. (more…)

Posted in: Acupuncture, Clinical Trials, Traditional Chinese Medicine

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