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Reiki: Fraudulent Misrepresentation

reiki-hands-pic

The Center for Integrative Medicine at the Cleveland Clinic sells reiki treatments (also here) to patients with cancer, fertility issues, Parkinson’s Disease and digestive problems, as well as other diseases and conditions. The Center’s website ad describes reiki as

a form of hands-on, natural healing that uses universal life force energy . . . [a] vital life force energy that flows through all living things. This gentle energy is limitless in abundance and is believed to be a spiritual form of energy. The Reiki practitioner is the conduit between you and the source of the universal life force energy. . . You may experience the energy as sensations such as heat, tingling, or pulsing where the practitioner places her hands on your body, or you may feel these sensations move through your body to other locations. This is the energy flowing into you.

This “universal life force energy” is described as having certain positive effects on one’s own energy, such as “energetically balancing” one physically, replenishing one’s supply of energy, improving distribution of that energy in the body, and dissolving “energy blockages.” It also increases one’s “vibrational frequencies,” although how these frequencies relate to one’s energy, or to anything else for that matter, is not made clear. (more…)

Posted in: Energy Medicine, Health Fraud, Homeopathy, Legal, Medical Ethics

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Prolotherapy

Prolotherapy is a treatment technique used for chronic myofascial pain, back pain, osteoarthritis, or sports injury. It involves repeated injections of dextrose solution or other irritating substances into the joint, tendon, or painful tissue in order to provoke a regenerative tissue response. Similar techniques have been used for about a century, but the first formal publication describing prolotherapy dates back to 1956, by Dr. George Hackett. He wrote:

Within the attachment of weakened ligaments and tendons to bone, the sensory nerves become overstimulated by abnormal tension to become not only the origin of specific local pain, but also definite areas of referred pain throughout the body to as far as the head, fingers and toes from specific relaxed ligaments and tendons.

Prolotherapy. A treatment to permanently strengthen the “weld” of disabled ligaments and tendons to bone by stimulating the production of new bone and fibrous tissue cells has been developed.

Initially the concept, referred to a sclerotherapy, was that the injections formed scar tissue to stabilize the joint, tendon, or ligament. The newer concept, called prolotherapy, is that the injections provoke the proliferation of tissue, allowing for limited regeneration. (more…)

Posted in: General

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Macular Degeneration and AREDS 2 Supplements

What AMD does to vision

What AMD does to vision

Four years ago I wrote about the premature marketing of a diet supplement for macular degeneration before the results of a trial to test it were available. Now that we know the results of that trial, a follow-up post is in order.

Age-related macular degeneration (AMD) is a leading cause of blindness. The incidence increases with age; it affects 10% of people by age 66-74 and 30% of people by age 75-85. There are known risk factors including genetics and smoking, but there is no effective prevention. There are multiple diet supplement products on the market that are advertised as “supporting eye health.” Some are based on evidence from randomized, controlled studies; but the advertising hype goes beyond the evidence and tends to mislead consumers. There is evidence that supplementation may slow the progression of moderate to severe AMD, but there is no evidence that supplements are effective in milder disease or for preventing AMD from developing in the first place. (more…)

Posted in: Clinical Trials, Herbs & Supplements

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“Integrative oncology”: The Trojan horse that is quackademic medicine infiltrates ASCO

OzCurtain

You might have noticed that I didn’t produce a post last week, something that’s unusual for me, given how prolific I have been in the blogosphere. One reason was personal. The other reason was that last weekend I was attending the annual meeting of the American Society of Clinical Oncology (ASCO) meeting in Chicago. I also must confess that, while I was there, I caused a bit of a stir on the meeting hashtag (#ASCO14) in the name of science-based medicine (SBM) on Twitter under my handle @gorskon. (What? You aren’t following me on Twitter? Get thee hence to my Twitter feed and add me. I’ll wait. Did you do it yet? Good. Now we can move on.) Of course, I know what you’re thinking: Cuddly, lovable me? Causing trouble? Making sure that I’ll almost certainly never be invited to be an official social media doc or to participate in panels on social media at ASCO, despite my extensive experience blogging, using Twitter, and just in general being a pain in the rear online to those who promote quackery and quackademic medicine? Perish the thought!

Of course, it was for just that reason that I was making a bit of a stir on Twitter. ASCO is one of the biggest (if not the biggest) and most organized oncology meetings out there, and there were several people considered “social media rock stars” in the world of oncology such as Mike Thompson, Deanna Attai, Matthew Katz, and Robert Miller live Tweeting the meeting, along with those viewed, correctly or incorrectly, as lesser lights, such as myself. In any case, on Sunday I noticed that a lot of people, including the official ASCO Twitter feed @ASCO, were Tweeting and re-Tweeting a link to this official story from ASCO, “Integrative Oncology Can Add Benefit to Traditional Cancer Treatments.” It was a description of a session that had been held on Saturday morning, Integrative Oncology: The Evidence Base, which, unfortunately, I had missed due to circumstances entirely beyond my control. Fortunately, however, ASCO is benevolent (not to mention that it also justifies the high cost of meeting registration) by providing immediate access to recordings of every major session, not to mention the slide sets used. If I couldn’t be there in person, at least I could cruise on over to the ASCO website and use my access to the 2014 virtual meeting to see what sort of quackademic medicine was being featured at ASCO. (more…)

Posted in: Acupuncture, Cancer, Medical Academia, Traditional Chinese Medicine

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VacciShield: Pixie dust for an imaginary threat

vaccishield

I know by now I shouldn’t be, but I am still amazed by how readily so many people buy into the seemingly endless array of bogus sCAM nostrums. Many are marketed and hawked for the treatment or prevention of diseases that are poorly managed by science-based medicine. There are countless examples of dietary supplements that are purported to effectively treat back and joint pains, depression, anxiety, autism, chronic pain, and chronic fatigue; the list goes on and on. The lure for these treatments is at least understandable and, although frustrated that scientific literacy and rational thought loses out, I empathize with the desire to believe in them. On the other end of the spectrum is the even more ethically corrupt substitution of safe and effective treatments with products that are not. I encountered what I find to be possibly the most frightening and dangerous example of this recently at my practice. A family new to the area called to schedule a routine health-maintenance visit for their 5-year-old daughter. When our nurse reviewed the medical records the mother had faxed over, she noted that the child was unimmunized and explained to her that she would need to begin catch-up vaccinations. The mother matter-of-factly stated that her daughter was actually fully vaccinated with a vaccine alternative. She had received a series of homeopathic vaccines from a naturopath. I am not going to discuss this egregious example of sCAM here, though it was addressed in previous SBM posts.1,2 Instead I’d like to focus on another part of the sCAM spectrum. Here lies a form of sCAM that, in some ways, is even more difficult for me to comprehend. These are products invented, marketed, and sold solely for the treatment or prevention of fictitious diseases or problems that exist only in the realm of fantasy. (more…)

Posted in: Herbs & Supplements, Medical Ethics, Naturopathy, Nutrition, Science and Medicine, Vaccines

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Don’t supplement users deserve consumer protection, too?

Canada's Parliament buildingThe Canadian Parliament, hypothetically protecting consumers since Confederation.

One of the most pervasive yet appealing health myths is the idea that natural equals safe. It’s a statement that’s repeated constantly by manufacturers of supplements and “natural” health products. It’s been the primary argument used, with considerable success, to give these products completely different regulatory structures than exist for drug products. Weaker regulation of supplements and natural health products has been a boon to manufacturers, but the same can’t be said for consumer protection. It’s effectively a buyer-beware marketplace in most parts of the world, with little accurate information available to consumers. But supplement manufacturers aren’t content with the minimal regulation that’s currently in place – they want health “freedom”. In this case, “freedom” means the right to sell any product, while being exempted from safety and regulatory requirements. New Canadian legislation is poised to raise safety standards for drugs and enhance the ability of regulators to recall dangerous products, yet consumers of natural health products are left behind. The legislation proposes to exempt anything considered a “natural health product”. This is not only bad public policy, but it has the potential to cause avoidable harm. After all, shouldn’t users of supplements and natural health products be entitled to the same safety and quality standards as those that use prescription drugs? If the supplement industry gets its way, the answer will be “no”. (There is an opportunity until June 10 for you to provide feedback on this legislation – see below.) (more…)

Posted in: Herbs & Supplements, Politics and Regulation, Science and Medicine

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Delaying Vaccines Not A Good Idea

AndEvil Mr. Vaccine and the consequences of vaccination.

There’s nothing like cold hard data to counteract opinion and propaganda. The anti-vaccine movement hit upon a clever marketing phrase with their “Too Many, Too Soon” campaign. Unfortunately, it is often difficult to capture the complexity and nuance of scientific data with a witty slogan, so such slogans tend to work better for those who don’t really care about such things as scientific data.

I’ll give it a try in any case: how about “too few, too late.” Or maybe, “A day late and an antigen short.”

OK, now you know why I’m not in the marketing business. So let’s talk about the actual scientific data.

The recommended vaccine schedule is not, it turns out, arbitrary or designed to maximize the profits of the vaccine industry. The Center for Disease Control (CDC) recommended vaccine schedule is designed to give children vaccines as soon as they need them and are old enough to handle them – maximizing benefit while minimizing risk. Booster shots are optimized to produce a sufficient antibody response for maximal protection. I don’t think anyone would argue that the schedule is perfect, but it is rational and evidence-based. (more…)

Posted in: Vaccines

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Forskolin: Here We Go Again

 Sisyphus and his endless task

Sisyphus and his endless task

My BMI is 21, but my e-mail and Facebook accounts must think I’m fat. I am constantly bombarded with messages about miracle weight loss solutions, and most of them are diet supplements featured on the Dr. Oz show. Back in December I wrote an article about Garcinia cambogia, Dr. Oz’s “newest, fastest fat buster.” I made this prediction: “I confidently expect another “miracle” to supplant Garcinia in the Land of Oz in the not-too-distant future.” I was right. The e-mails about Garcinia have recently been outnumbered by e-mails about a new Dr. Oz miracle weight loss supplement, forskolin. Actually, I think he discovered forskolin before he discovered Garcinia, but the forskolin propaganda seems to have reached a critical mass in the last few weeks.

The Land of Oz

A Dr. Oz episode on the “Rapid Belly Melt” aired a month ago, on May 5. He set fire to a paper representation of a fat belly to show how forskolin “works like a furnace inside your body.” The paper ignited, went up in flames, and revealed a non-flammable model of muscle tissue inside to show how forskolin burns fat, not muscle, and to illustrate how quickly it works. (more…)

Posted in: Herbs & Supplements

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Chiropractic Defense: Tempest in a Teapot

When Forbes.com published Steven Salzberg’s article “New Medicare Data Reveal Startling $496 million wasted on Chiropractors” (April 20, 2014), a flood of mail (more than 300 comments) from chiropractors and their patients provided a wealth of evidence that subluxation-based chiropractic is alive and well despite rejection by the scientific community. Pro-chiropractic comments laced with anti-medical rhetoric and ad hominem attacks, expressed with religious fervor, failed to distinguish between generic spinal manipulation (that can be useful in the treatment of mechanical-type back and spinal problems) and chiropractic adjustments used in an attempt to restore and maintain health by correcting vertebral subluxations. No distinction was made between a real, symptomatic orthopedic subluxation and an imaginary, asymptomatic chiropractic “vertebral subluxation complex,” neither of which has been shown to be a cause of bad health. While the chiropractic profession may have some justification for objecting to any suggestion that chiropractic treatment has no value whatsoever, especially in the case of mechanical-type back pain and other musculoskeletal problems, the tone and content of many of the comments by chiropractors provide good examples of why chiropractic is so often criticized by the scientific community.

A quote in the Forbes article, from my Science-Based Medicine article “Chiropractic: A Summary of Concerns,” brought this comment from a prominent chiropractor:

…Harriet Hall, Edzard Ernst, Jann Bellamy, and other current renowned medical bigots who attack all CAM providers but turn a blind eye to the dangers of the medical profession….Steven, your chiro critics are invalid—none of them are researchers or educators, but they are just disgruntled practitioners from yesteryear. Don’t get me started on the Science-Based guys who are just haters like you—Harriet Hall, Edzard Ernst, Jann Bellamy are renown medical bigots.

(more…)

Posted in: Chiropractic, History

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Of the Trial to Assess Chelation Therapy, Bayes, the NIH, and Human Studies Ethics

An experiment is ethical or not at its inception; it does not become ethical post hoc—ends do not justify means.
~ Henry K. Beecher

tact

A couple of weeks ago, Dr. Josephine Briggs, the Director of the National Center for Complementary and Alternative Medicine (NCCAM), posted a short essay on the NCCAM Research Blog touting the results of the Trial to Assess Chelation Therapy (TACT) (italics added):

The authors found that those receiving the active treatment clearly fared better than those receiving placebo. The accompanying editorial in the AHJ reminds readers about the value of equipoise and the need to “test our beliefs against evidence.”

Most physicians did not expect benefit from chelation treatment for cardiovascular disease. I readily admit, initially, I also did not expect we would find evidence that these treatments reduce heart attack, strokes, or death. So, the evidence of benefit coming from analyses of the TACT trial has been a surprise to many of us. The subgroup analyses are suggesting sizable benefit for diabetic patients—and also, importantly, no benefit for the non-diabetic patient. Clearly subgroup analyses, even if prespecified, do not give us the final answer. But it is also clear that more research is needed to test these important findings.

And TACT findings are indeed a reminder of the importance of retaining equipoise [sic], seeking further research aimed at replicating the findings, and neither accepting nor rejecting findings based on personal biases. The scientific process is designed to weed out our preconceived notions and replace them with evidence.

Dr. Briggs concluded:

So, TACT is a reminder—an open mind is at the center of the scientific method.

Dr. Briggs’s title was “Bayes’ Rule and Being Ready To Change Our Minds”, a reference to a recent editorial that had accompanied one of the TACT papers. That editorial, by Dr. Sanjay Kaul, a physician and statistician from UCLA, begins with this quotation:

Preconceived notions are the locks on the door to wisdom.
~ Merry Browne

Here is the relevant passage from Dr. Kaul’s editorial (italics added):

Sixth, it has been argued that the trial was unethical because there was no compelling clinical or preclinical evidence that chelation therapy has significant efficacy against atherosclerotic cardiovascular disease, and given that chelation therapy can cause harm, the risk was not minimal. A Bayesian analysis would not look kindly on the results because of the low prior probability of treatment effect (the so-called implausibility argument).6 This is an uncharitable (and unwarranted) interpretation of the data because previous systematic reviews concluded, “insufficient evidence to decide on the effectiveness or ineffectiveness of chelation therapy in improving clinical outcomes among people with atherosclerotic cardiovascular disease.” It is axiomatic that absence of evidence of efficacy is not the same as evidence of the absence of efficacy.

From a Bayesian perspective, the strength of evidence is often summarized using a Bayes factor, which is a measure of how well 2 competing hypotheses (the null and the alternate) predict the data. The Bayes factor and the corresponding strength of evidence for the primary end point result in TACT overall, and diabetic cohorts are shown in Table 1. The p-value of 0.035 for TACT overall cohort translates into a Bayes factor of 0.108, which means the evidence supports the null hypothesis ≈1/9th as strongly as it does the alternative. This reduces the null probability from 50% pretrial (justified by suspension of one’s belief in treatment effect) to 10% post-trial. Although this does not represent strong evidence against the null, it does reduce the level of skepticism surrounding chelation therapy. In the diabetic cohort, the nominal p-value of 0.0002 translates into a Bayes factor of 0.002 (1/500), which reduces the extremely skeptical prior null probability of 95% to 4% post- trial, indicating very strong evidence against the null.

In concluding, Dr. Kaul states:

Finally, TACT highlights the double standard when it comes to accepting inconvenient results not aligned with our preconceived notions on so-called dubious quack cures such as chelation…

Closed minds?

Dr. Kaul’s reference “6” above is to a lengthy article that we published in 2008 titled “Why the NIH Trial to Assess Chelation Therapy Should Be Abandoned”. So, it seems, both Drs. Briggs and Kaul were chastising us for our biased, preconceived beliefs about so-called dubious quack cures. Our minds were, apparently, not open. Let’s examine this contention. (more…)

Posted in: Clinical Trials, Health Fraud, Medical Academia, Medical Ethics, Politics and Regulation

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