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Does massage therapy decrease inflammation and stimulate mitochondrial growth? An intriguing study oversold

If there’s one form of so-called “complementary and alternative medicine” (CAM) that I find more tolerable than most, it’s massage therapy. The reason, of course, is that, whatever else anyone claims about massage, there’s no doubt that it feels good. Indeed, I’ve sort of come around to Kimball Atwood’s way of thinking. Back when he and I were on a panel together at TAM9, Kimball said something somewhat surprising, namely that he’s not sure we even need to test massage in randomized clinical trials because we all know that it feels good and if it feels good it can certainly be helpful at the very least to improve patients’ quality of life. Unfortunately, there’s a lot of woo in massage these days, and massage therapists who buy into the woo aren’t satisfied with simply using the rationale that massage feels good to recommend it to patients. They just can’t resist going beyond that to infuse massage therapy with every bit as much woo as any chiropractor or acupuncturist infuses into his respective specialty. For instance, some of the claims for massage include:

  • Decreases muscle pain & tension.
  • Rejuvenates the body and mind and lifts the spirit.
  • Relieves anxiety, stress and tension.
  • Relaxes muscles.
  • Alleviates headaches.
  • Hastens healing.
  • Increases ranges of motion.
  • Facilitates removal of waste and inflammation by-products.
  • Stimulates the immune system.
  • Eases symptoms related to fibromyalgia.
  • Promotes relaxation and comfort.
  • Reduces nausea in pregnant women.
  • Accelerates weight gain in premature infants.
  • Helps premature infants become more active and aware.
  • Increases energy and alertness.
  • Enhances morale and attitude.

Of course, there’s little doubt that a good massage probably can relax muscles, promote relaxation and comfort (which seems like the same thing to me), and enhance morale and attitude. I’d even be willing to concede that massage, properly administered, can probably also alleviate headaches (tension headaches, anyway) and increase range of motion in joints. But facilitate the removal of waste and inflammation byproducts? Stimulate the immune system (the all-purpose meaningless claim)? Hasten healing? Not so much.

All too often massage therapists ruin a perfectly good massage by imposing pseudoscientific and quack claims on it, such as claims that they are stimulating acupressure points or their adoption of the language of “energy healing.” So it was with a bit of trepidation (but also more than a bit of interest) that I took a look at some links that readers sent me about a week ago (too late, alas, for me to write about this last Monday). These links were to news stories with titles like Scientists Uncover Why Massage Heals Sore Muscles and Massage Reduces Inflammation And Promotes Growth Of New Mitochondria Following Strenuous Exercise, Study Finds. My first impression, actually, was that this was somewhat counterintuitive in that one might predict that deep kneading of muscles might actually cause a bit of inflammation and that it’s the counterirritation effect that leads to the perceived reduction in the amount of pain. Yet, according to the press release issued by McMasters University, whose contents were mirrored in many news stories, a study claiming state-of-the-art methods is concluding that massage is reducing inflammation:
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Posted in: Basic Science, Clinical Trials, Science and the Media

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Does thinking make it so? CAM placebo fantasy versus scientific reality

Last week, I discussed a rather execrable study. Actually, the study itself wasn’t so execrable, at least not in its design, which was a fairly straightforward three-arm randomized clinical trial. Rather it was the interpretation of the study’s results that was execrable. In brief, the authors tested an “energy healing” modality known as “energy chelation” versus a placebo (sham “energy chelation”) and found, as is so often the case in studies of “complementary and alternative medicine” (CAM) or “integrative medicine” (IM) that both modalities did better than no treatment on the primary outcomes but that the “real” treatment (if one can call energy chelation “real treatment”) produced outcomes that were statistically indistinguishable from the “sham” treatment. Not surprisingly, the next move on the part of the researchers was to do a bunch of comparisons, and, as is so often the case (particularly when one fails to correct statistically for multiple comparisons), they found a couple of secondary endpoints with barely statistically significant differences and trumpeted them as meaning that their “energy chelation therapy” has “significant promise for reducing fatigue.” They then argued that the study was also ” designed to examine nonspecific and placebo elements that may drive responses.”

Which brings us to the “power” of placebo.

As I was contemplating what I wanted to discuss this week, I thought about the study that Drs. Coyne, Johansen, and I objected to, but then I also thought about Dr. Crislip’s post last week and post I did about a month ago in which I noticed how lately CAM apologists seem to be—shall we say?—retooling their message in the wake of negative trial after negative trial of their implausible treatments. Gone (mostly) are claims of powerful specific effects and efficacy from treatments such as various “energy healing” modalities, acupuncture, homeopathy, and the like themselves, to be replaced by claims that physicians should embrace CAM because it’s “harnessing the power of placebo” to produce “powerful mind-body healing.” It’s a powerful message that has sucked in people who normally would be considered skeptics, such as Michael Specter, who, as I described, apparently bought into the message sufficiently that when Ted Kaptchuk was making the media round right before the holidays he happily published a fairly credulous interview with him entitled, The Power of Nothing: Could Studying the Placebo Effect Change the Way We Think About Medicine? (My answer: Very likely no.) Even Ira Flatow of Science Friday fell hard for Kaptchuk’s message, declaring at the beginning of the interview that Kaptchuk’s irritable bowel syndrome study is evidence that “placebos work even when patients are in on the secret.” (It’s not.)

That skeptics and scientists find the idea that the mind has the power to heal the body, often referred to as “self-healing” or “mind-body healing,” so seductive should probably not be surprising. After all, who wouldn’t want to be able to cure themselves simply by willing it to be so? It’s a concept that, like so many concepts in CAM, goes far back into ancient times and stretches forward to today in ideas like The Secret, which goes quite a bit beyond the whole idea of “mind-body healing” or healing yourself because you wish it to be so, and declares that you can have virtually anything you want simply by thinking the right thoughts. In fact, to me it appears that the “powerful placebo” is being drafted in the service of supporting what are, at their core, mystical beliefs far more than science. I’d like to elaborate on that idea a bit more than I did last time I discussed this isssue, where I concluded by writing:

In the end, all too much of the rebranding of CAM as placebo and the selling of placebos as some sort of powerful “mind-body healing” strikes me as being much like The Secret, in which wishing makes it so.

Let’s take a look at just how far this goes.
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Posted in: Clinical Trials, Energy Medicine, Faith Healing & Spirituality, Religion

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What is Science?

Consider these statements:

…there is an evidence base for biofield therapies. (citing the Cochrane Review of Touch Therapies)

The larger issue is what constitutes “pseudoscience” and what information is worthy of dissemination to the public. Should the data from our well conducted, rigorous, randomized controlled trial [of 'biofield healing'] be dismissed because the mechanisms are unknown or because some scientists do not believe in the specific therapy?…Premature rejection of findings from rigorous randomized controlled trials are as big a threat to science as the continuation of falsehoods based on belief. Thus, as clinicians and scientists, our highest duty to patients should be to investigate promising solutions with high benefit/risk ratios, not to act as gatekeepers of information based on personal opinion.

–Jain et al, quoted here

Touch therapies may have a modest effect in pain relief. More studies on HT and Reiki in relieving pain are needed. More studies including children are also required to evaluate the effect of touch on children.

Touch Therapies are so-called as it is believed that the practitioners have touched the clients’ energy field.

It is believed this effect occurs by exerting energy to restore, energize, and balance the energy field disturbances using hands-on or hands-off techniques (Eden 1993). The underlying concept is that sickness and disease arise from imbalances in the vital energy field. However, the existence of the energy field of the human body has not been proven scientifically and thus the effect of such therapies, which are believed to exert an effect on one’s energy field, is controversial and lies in doubt.

—Cochrane Review of Touch Therapies, quoted here

 …

Science is advanced by an open mind that seeks knowledge, while acknowledging its current limits. Science does not make assertions about what cannot be true, simply because evidence that it is true has not yet been generated. Science does not mistake absence of evidence for evidence of absence. Science itself is fluid.

—David Katz

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.

—Ted Kaptchuk, quoted here.

 …It seems that the decision concerning acceptance of evidence (either in medicine or religion) ultimately reflects the beliefs of the person that exist before all arguments and observation.

 —Ted Kaptchuk, quoted here.

Together they betray a misunderstanding of science that is common not only to “CAM” apologists, but to many academic medical researchers. Let me explain. (more…)

Posted in: Basic Science, Book & movie reviews, Clinical Trials, Energy Medicine, Faith Healing & Spirituality, Homeopathy, Medical Academia, Science and Medicine

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Adventures in defending science-based medicine in cancer journals: Energy chelation

My co-bloggers and I have spent considerable time and effort over the last four years writing posts for this blog (and I for my not-so-super-secret other blog) bemoaning the infiltration of quackademic medicine into what once were bastions of evidence- and science-based medicine. We’ve discussed at considerable length reasons for why this steady infiltration of pseudoscience into medical academia has been occurring. Among other potential explanations, these reasons range from the ascendence of postmodernism in areas where it really doesn’t belong; to a change in our medical culture to a more “consumer”-oriented, “keep the customer satisfied”-sort of model in which patients are often referred to as “clients” or “customers”; to the corrosive influences of moneyed groups (such as the Bravewell Collaborative) and government agencies (such as the National Center for Complementary and Alternative medicine, a.k.a. NCCAM); to the equally corrosive influences of powerful woo-friendly legislators who use their position and influence to create such agencies (such as Senator Tom Harkin and Representative Dan Burton) and otherwise champion “complementary and alternative medicine” (CAM) and “integrative medicine” because they are true believers in quackery; to cynical legislators, like Senator Orrin Hatch, who champions such government programs supporting pseudoscience because he represents a state that is home to the largest concentration of supplement manufacturers in the United States and is consequently a master at bringing any initiative to regulate the supplement industry more tightly to a screeching halt.

As a result of our efforts and the need for a counterweight to the quackery that has infiltrated so much of academia, SBM has become fairly prominent in the medical blogosphere. Our traffic is good, and we have a number of “thought leaders” who regularly read what we write. We’ve even caught the attention of Dr. Josephine Briggs, director of NCCAM, and our founder Steve Novella was even invited to appear on The Dr. Oz Show for “balance.” All of this is something that we are justly proud of. On the other hand, I can’t help but keep things in perspective. While our traffic as a blog is quite respectable and we have become prominent in the skeptical and medical blogosphere and even, to some extent, in academia—we’re particularly gratified at the number of medical students who are regular readers—compared to the forces arrayed against SBM in academia and the media, we have to face facts: We are truly a tiny voice in the wilderness. For instance, we average around 9,000 to 16,000 visits a day. Compare that traffic to the many millions who used to watch Oprah Winfrey and still watch her protégé Dr. Oz or to health media and product empires of people like Andrew Weil and Deepak Chopra, and you get the idea.

All of this is why I started looking for opportunities to respond more directly to incursions of pseudoscience into medical academia. Occasional SBM contributor Peter Lipson provided me with just such an opportunity last summer when he sent me a link to a brain-meltingly bad study about the use of CAM in cancer that shows just how bad a study can be and still be published in what I used to consider a reasonably good cancer journal. I say “used to consider,” because the fact that this journal accepted a study this ludicrous indicates to me that its peer review is so broken that I now wonder about what else I’ve read in that journal that I should now discount as being too unreliable to take seriously. Maybe everything. I don’t know. What I do know is that seldom have I seen such a bad study in such a good cancer journal. Studies like the one about Tai Chi in fibromyalgia or placebo acupuncture applied to asthma don’t even come close.

Soon after this study appeared online ahead of print, James Coyne contacted me and asked me if I wanted to be co-author on a letter to the editor of the journal. Honored by Dr. Coyne’s request, I immediately said yes (of course), and together with Dr. Christoffer Johansen at the Survivorship Unit of the Danish Cancer Society, we submitted our letter to the editor. To my surprise, given the utter failure of past efforts to publish letters to the editor about studies of this sort, our letter was accepted for publication. Last week, the study in question saw print, and our letter was published online ahead of print, along with the response of the authors. All are instructive and, to me, show just what we are up against in trying to prevent pseudoscience from creeping into academia.
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Posted in: Cancer, Clinical Trials, Energy Medicine, Faith Healing & Spirituality, Medical Academia

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Reassessing whether low energy electromagnetic fields can have clinically relevant biological effects

It is with some trepidation that I write this, given that I realize this post might lead to charges that I’ve allowed myself to become so open-minded that my brains fell out, but I think the issues raised by what I’m about to discuss will make our readers think a bit—and perhaps spark some conversation. Because I’m in a bit of a contrarian mood, I’ll take that risk, although it’s possible I might end up with the proverbial egg on my face. As our regular readers know, the issue of the health effects of radiation from mobile phones has been a frequent topic of this blog. The reasons are obvious because fear mongering claims not based in science are frequently made in the lay press and in books (for example, Disconnect by Devra Davis) and, unfortunately, also by some physicians and scientists. Moreover, like homeopathy, the issue demands a discussion of prior probability and plausibility based on basic science alone, but the issues are a bit less clear-cut. Whereas the tenets of homeopathy clearly violate multiple laws of physics and chemistry, it is possible, albeit very unlikely, that radio waves might produce significant biological changes.

There’s also sometimes a maddening dogmatism on the part of some physicists that it’s “impossible” that long term exposure to radio waves could possibly cause cancer because such electromagnetic waves do not have anywhere near enough energy to cause ionization and thereby break chemical bonds. While it is certainly true that such radio waves can’t break chemical bonds and the likelihood that the radio waves from cell phones can cause cancer appears very low based solely on physics considerations, all too often the arguments made based on physics considerations alone use a simplistic understanding of cancer and carcinogenesis as their basis. It’s not for nothing that I have referred to such arguments as being based on a high school or freshman level of understanding about cancer—or just an outmoded understanding that prevailed a decade or two ago but today no longer does. Bernard Leikind, for instance, argued and famed skeptic Michael Shermer accepted that, because the radio waves used in cellular communications are too low energy to break chemical bonds and do not produce significant heating compared to other sources, “cell phones cannot damage living tissue or cause cancer.” Note the implicit assumption: That it is somehow necessary to “damage” living tissue in order to cause cancer. That’s an assumption that is arguably quite simplistic and ignores knowledge we’ve gained about epigenetics and how potential metabolic influences might cause cancer. Cancer is associated with characteristic cellular metabolic abnormalities, and determining which is responsible for the formation of cancer, metabolic abnormalities or gene mutations, has become a “chicken or the egg”-type of question.

I do not in any way believe that cell phone radiation actually is a cause of cancer because, unlike the case in homeopathy, where multiple well-established laws of physics would have to be overturned for homeopathy to work, I find the argument that a causation is “utterly impossible” far less persuasive than some physicists do when it comes to cell phone radiation and cancer. Even dismissing the “impossibility” argument, however, clearly such a link is at the very least incredibly implausible on physics considerations alone, as I have pointed out time and time again. Add to that the nearly completely negative epidemiological data in which only one group of researchers has been able to produce apparently “positive” studies, and my personal conclusion is that we probably already have enough data to reject a connection between radio waves and cancer and don’t need any more new large epidemiological studies; following up long term results on the ones already under way should be sufficient. That is not the same thing as arguing that radio waves have no significant biological effect, which is what, in essence, the argument from physics is based on. In fact, the inspiration for the rest of this post came from a meeting I had last week with a scientist and that scientist’s talk for our cancer center’s weekly Grand Rounds. What I learned did not demonstrate that cell phones cause cancer or even that they might cause cancer. Not even this scientist claimed his results were consistent with cell phone radiation causing cancer; in fact, he quite clearly stated they were not. However, what I learned from him cast some doubt (to me, at least) on the assumption that radio waves cannot have profound biological effects. In fact, ironically enough, this scientist is proposing the use of amplitude-modulated (AM) radio waves to treat cancer. I’m not yet convinced by any stretch of the imagination that this researcher is on to something, but his findings made me think about the perils and pitfalls of declaring something “impossible” solely on basic science considerations, because he has some very intriguing results that I can’t find a compelling reason to dismiss.

And, at least as of now, there’s no known physical mechanism that can explain his findings. Leaving aside the possibility of fraud or some sort of systematic bias that is not apparent in the methods sections of the papers I’m about to summarize, either he’s found something new and potentially promising, or he’s somehow very, very wrong.
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Posted in: Basic Science, Cancer, Clinical Trials

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NIH Director Francis Collins doesn’t understand the problem with CAM

As the sole cancer surgeon among our stable of Science-Based Medicine (SBM) bloggers, I’m probably the most irritated at the infiltration of pseudoscience into academia (or, as we sometimes like to call it, quackademic medicine) in the realm of cancer. Part of the reason, of course, is that cancer is so common and that the consequences of adding pseudoscience to cancer therapy are among the most devastating. Witness, for instance, the use of Gonzalez therapy to treat pancreatic cancer, a form of quackery that harms patients and resulted in incredibly unethical and disastrous clinical trial of Gonzalez quackery versus chemotherapy whose results were entirely predictable, given the lack of prior plausibility of the treatment: Gonzalez protocol patients did worse, with no evidence that the therapy impacted the natural history of the disease and the Gonzalez patients scoring lower on quality of life measures. Or look at what happens when patients with breast cancer choose quackery over science-based therapy.

I realize that “complementary and alternative medicine” (CAM) or, what quackademics like to call it now, “integrative medicine” (IM) is meant to refer to “integrating” alternative therapies into SBM or “complementing” SBM with a touch of the ol’ woo, but I could never manage to understand how “integrating” quackery with SBM would do anything but weaken the scientific foundation of medicine. Moreover, weakening those foundations would have more consequences than just “humanizing” medicine; weaker scientific standards would allow not just ancient quackery like traditional Chinese medicine (TCM) into academia, but it would also provide an opening for drug and device companies to promote their wares under less rigorous requirements for evidence. There’s also perhaps a touch of personal embarrassment involved. After all, oncology and cancer surgery tend to be specialties that are the most steeped in science. If I had to rank specialties for how science-based they are, I’d certainly put oncology near the top, which is why I tend to come down so hard on “integrative oncology” and, even worse, “naturopathic oncology.”

Consequently, I was doubly disturbed several months ago when I learned that the director of the National Institutes of Health, Francis Collins, had agreed to be the keynote speaker at the Eight International Society for Integrative Oncology Conference in Cleveland, OH. I say “doubly” disturbed because it disturbed me that Francis Collins would agree to speak at such a function and, perhaps even more, because the host institution was Case Western Reserve University, the institution where I both completed my surgery residency and my PhD in Physiology and Biophysics. Sadly, it now appears that my old stomping grounds at University Hospitals has been thoroughly infiltrated with quackademic medicine, as evidenced by this clinical trial of reiki for psoriasis that’s making the rounds of news services and the offering of acupuncture, reiki, and even reflexology at various UH facilities through the University Hospitals Connor Integrative Medicine Network. Let me tell you, there was none of this pseudoscience going on when I finished my residency there in 1996. Seeing it there now provokes a reaction in me not unlike Sylvester Junior’s reaction when his father Sylvester embarrasses him, particularly when I noted that the director of the CWRU Comprehensive Cancer Center, Dr. Stanton L. Gerson, was to give one of the keynote talks, entitled, “The Future of Integrative Oncology.” (Hint for those of you not familiar with classic Looney Tunes cartoons: A paper bag is involved.) I guess that by expressing my extreme disappointment and embarrassment that the institution where I learned to become a surgeon has during the last 15 years gone woo, I’ve probably just killed any opportunity I might have to work at the Case Comprehensive Cancer Center ever again. Oh, well, add it to the list, along with Beth Israel and my alma mater the University of Michigan.)

Back when I first learned about it, I thought about blogging the meeting, but without much concrete to go on, given the copious other SBM-related topics to blog about, all I could do was to write a critical open letter to Dr. Collins about his decision to accept the offer to be the keynote speaker at the Society for Integrative Oncology (SIO). Then yesterday I saw popping up in my e-mail a notice from the American Society of Clinical Oncology (ASCO), along with a link to a story in its publication The ASCO Post entitled NIH Director Calls for Rigorous Evaluation of Integrative Medicine to Provide Evidence of Efficacy.

Et tu, Dr. Collins?
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Posted in: Basic Science, Cancer, Clinical Trials, Politics and Regulation

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The New England Journal of Medicine Sinks a Bit Lower

I suppose it was bound to happen, but it still rankles. Here is the back cover of last week’s issue of the decreasingly prestigious New England Journal of Medicine:

 


Here’s the front cover:

It’s the 200th Anniversary issue, no less. Some might protest that ‘probiotics’—live bacteria of ‘good’ varieties, as far as the gut is concerned—aren’t all that implausible, and that there is some trial evidence that they help for some conditions. That’s true, but as is typically the case even for the somewhat plausible end of the “CAM” spectrum, the hype greatly surpasses the evidence. The abstract of the most recent systematic review that I could find for probiotic treatment of irritable bowel syndrome (IBS: symptoms and signs that best match the claims in the advertisement above) concluded:

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Posted in: Clinical Trials, Herbs & Supplements, History, Legal, Medical Ethics, Pharmaceuticals, Politics and Regulation, Science and Medicine, Science and the Media

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Tonsillectomy Indications and Complications

Tonsillectomy remains a common surgical procedure with over half a million cases in the US per year, the most common surgical procedure in children. The indications and effects of tonsillectomy remain a matter of research and debate, as is appropriate. It is also a subject of popular misinformation and alarmism.

A recent article by Seth Roberts raises many of the issues with tonsillectomy, but also reveals the pitfalls of non-experts trying to understand the clinical literature and the effects of bias on evaluating a complex medical question. Throughout the article Roberts displays a persistent bias toward downplaying the benefits and exaggerating the risks of tonsillectomy, while accusing the medical establishment of doing the exact opposite.  The purpose of this post is not to defend the practice of tonsillectomy but to review some of the relevant issues and explore how bias can affect an assessment of the evidence.

Indications for Tonsillectomy

Roberts tells the story of Rachael who was offered tonsillectomy for her son and so did some research on her own. She looked on Pubmed (a good place to start) and found a Cochrane review from 2009.

The Cochrane Review that Rachael found (“Tonsillectomy or adeno-tonsillectomy versus non-surgical treatment for chronic/recurrent acute tonsillitis”) was published in 2009. It describes four experiments that compared tonsillectomy to the care a sick child would otherwise receive. All four involved children like Rachael’s son, and all four had similar results: Tonsillectomies had only a small benefit. (Contrary to what Rachael was told.) During the year after random assignment to treatment — the point at which some children had their tonsils removed, other children did not — children whose tonsils were removed had one less sore throat than children who were not operated on (two instead of three for children like Rachael’s son).

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The rebranding of CAM as “harnessing the power of placebo”

If there’s one thing I’ve learned over the past seven years or so that I’ve been blogging, first at my other “super secret” (or, more accurately, super “not-so-secret”) blogging location, and then the four years I’ve been blogging here at Science-Based Medicine (SBM), it’s that the vast majority of “alternative medicine,” “complementary and alternative medicine” (CAM), and “integrative medicine” (IM) treatments (or whatever you want to call them) are nothing more than placebo medicine. True, there are exceptions, such as herbal treatments, mainly because they can contain chemicals in them that are active drugs, but any critical look at things like homeopathy (which is water), reiki (which is faith healing substituting Eastern mystical beliefs for Christianity), acupuncture (whose effects, when tested rigorously, are found to be nonspecific), or “energy healing” must conclude that any effects these modalities have are placebo effects or responses. Given writings on this topic by Steve Novella, Mark Crislip, Harriet Hall, Peter Lipson, myself, and others, this should be abundantly clear to readers of this blog, but, even so, it bears repeating. In fact, it probably can’t be repeated enough.

There was a time not so long ago when proponents of unscientific medicine tried very, very hard to argue that their nostrums have real effects on symptoms and disease above and beyond placebo effects. They would usually base such arguments on small, less rigorously designed clinical trials, mainly because, if there’s another thing I knew before from my medical education but that has been particularly reinforced in me since I started blogging, it’s that small clinical trials are very prone to false positives. Often they’d come up with some handwaving physiological or biological explanation, which, in the case of something like homeopathy, often violated the laws of chemistry and physics. Be that as it may, the larger and more rigorously designed the clinical trial, the less apparent effects become until, in the case of CAM therapies that do nothing (like homeopathy), they collapse into no effect detectable above that of placebo. Even so, there are often enough apparently “positive” clinical trials of water (homeopathy) that homeopaths can still cling to them as evidence that homeopathy works. Personally, I think that Kimball Atwood put it better when he cited a homeopath who said bluntly, “Either homeopathy works, or clinical trials don’t!” and concluded that, for highly implausible treatments like homeopathy, clinical trials as currently constituted under the paradigm of evidence-based, as opposed to science-based, medicine don’t work very well. Indeed, contrasting SBM with EBM has been a major theme of this blog over the last four years. In any case, for a long time, CAM enthusiasts argued that CAM really, really works, that it does better than placebo, just like real medicine.

Over the last few years, however, some CAM practitioners and quackademics have started to recognize that, no, when tested in rigorous clinical trials their nostrums really don’t have any detectable effects above and beyond that of placebo. A real scientist, when faced with such resoundingly negative results, would abandon such therapies as, by definition, a placebo therapy is a therapy that doesn’t do anything for the disease or condition being treated. CAM “scientists,” on the other hand, do not abandon therapies that have been demonstrated not to work. Instead, some of them have found a way to keep using such therapies. The way they justify that is to argue that placebo medicine is not just useful medicine but “powerful” medicine. Indeed, an article by Henry K. Beecher from 1955 referred to the “powerful placebo.” This construct allows them then to “rebrand” CAM unashamedly as “harnessing the power of placebo” as a way of defending its usefulness and relevance. In doing so, they like to ascribe magical powers to placebos, implying that placebos can do more than just decrease the perception of pain or other subjective symptoms but in fact can lead to objective improvements in a whole host of diseases and conditions. Some even go so far as to claim that there can be placebo effects without deception, citing a paper in which the investigators — you guessed it! — used deception to convince their patients that their placebos would relieve their symptoms. Increasingly, placebos are invoked as a means of “harnessing the power of the mind” over the body in order to relieve symptoms and cure disease in what at times seems like a magical mystery tour of the brain.

Part of what allows CAM practitioners to get away with this is that placebo effects are poorly understood even by most physicians and, not surprisingly, even more poorly understood by the public. Moreover, we all like to think that we have more control than we do over our bodies and, in particular, illnesses and symptoms, which is why the selling of placebo effects as a means of harnessing some innate hidden power we have to control our own bodies through the power of mind is so attractive to so many, including some scientists and physicians. Exhibit A is Ted Kaptchuk, the researcher from Harvard University responsible for spinning an interesting study of placebo effects in asthma into the invocation of the power of placebo. Kimball Atwood has written extensively about Kaptchuk recently, revealing his rather dubious background and arguments. More recently, however, Kaptchuk seems to be everywhere, appearing in articles and interviews, promoting just the argument I’m talking about, that CAM is a way of harnessing placebo effects, so much so that I felt it was time to take a look at this argument.

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

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Why Do We Really Need Clinical Trials?

A point I make over and over again when talking about new or alternative therapies that are not supported by good clinical trial evidence is that lower-level evidence, such as theoretical justifications, anecdotes, and pre-clinical research like in vitro studies and animal model testing, can only be suggestive, never reliable proof of safety or efficacy. It is necessary to begin evaluating a new therapy that does not yet have clinical evidence to support it by showing a plausible theory for why it might work and then moving on to demonstrate that it actually could work through pre-clinical research, which includes biochemistry, cell culture, and animal models. These sorts of supporting preclinical evidence are what we refer to when we refer to the “prior plausibility” of a clinical study. But this kind of evidence alone is not sufficient to support using the therapy in real patients except under experimental conditions, or when the urgency to intervene is great enough to balance the significant uncertainty about the effects of the intervention.

In support of this conclusion, we can consider the inherent unreliability of individual human judgments and all the many ways in which inadequately controlled research can mislead us. And we can reflect on how promising results in early trials often melt away when better, larger, more rigorous studies are done that better control for bias (the so-called Decline Effect). And it is not at all difficult to compile a large list of examples of the harm inadequately studied medical interventions can cause.

But what I’d like to do here is focus on a particularly good specific example of why thorough clinical trial evaluation of promising ideas is not just a nice extra to confirm what we already believe is true, it is the only way to genuinely know whether our treatments to more good than harm.

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

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