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Pursued by Protandim Proselytizers

I’m fed up! In August 2009 I wrote about Protandim, pointing out that it’s not supported by good evidence. I thought I had made myself clear; but apparently I had only made myself a target. True believers have deluged the Internet with attacks on my article, calling it mere “opinion,” ignoring its main points, and denigrating me personally. I have ignored the Internet attacks, but I’m beginning to feel personally harassed: I have lost count of the e-mails I have received from Protandim enthusiasts trying to convince me that it works and that I should change my mind. I’ve spent hours trying to explain my reasoning in e-mails, and it’s becoming a repetitive chore, so I am writing this so that next time I get an e-mail inquiry I can simply forward this link.

What Is In It?

Protandim is a mixture of milk thistle, bacopa extract, ashwagandha, green tea extract, and turmeric extract (all of which, incidentally, can be purchased individually at much lower cost).

What Do They Claim It Does?

As described on Wikipedia:

The manufacturers of Protandim claim the product can indirectly increase antioxidant activity by up-regulating endogenous antioxidant factors such as the enzymes superoxide dismutase (SOD) and catalase, as well as the tripeptide glutathione, and by activation of theNrf2 pathway.

Nrf2 is a transcription factor that upregulates the expression of various genes that may regulate oxidative stress. Drugs to target that pathway might have benefits for diseases that are caused or exacerbated by oxidative stress. Such drugs are investigational at this point, but the makers of Protandim have skipped the investigational stage and are marketing a product that they think is effective for almost every ailment known to man and that they are promoting as an anti-aging supplement.

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Posted in: Herbs & Supplements

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Steve Jobs’ cancer and pushing the limits of science-based medicine

Editor’s note: There is an update to this post.

An Apple fanboy contemplates computers and mortality

I’m a bit of an Apple fanboy and admit it freely. My history with Apple products goes way back to the early 1980s, when one of my housemates at college had an Apple IIe, which I would sometimes use for writing, gaming, and various other applications. Indeed, I remember one of the first “bloody” battle games for the IIe. It was called The Bilestoad and involved either taking on the computer or another opponent with battle axes in combat that basically involved hacking each other’s limbs off, complete with chunky, low-resolution blood and gore. (You youngsters out there will be highly amused at the gameplay here.) Of course, it’s amazing that nothing’s changed when it comes to computer games except the quality of graphics. Be that as it may, this same roommate was one of the first students to get a hold of the new Macintosh when it was released in early 1984. I really liked it right from the start but only got to play with it occasionally for a few months. After using a Macintosh SE to do a research project during my last year of medical school, I have used the Macintosh platform more or less exclusively, and the first computer I purchased with my own money was a Mac LC back in 1990 or 1991. Today, I have multiple Apple products, including my MacBook Air, my iPhone, and my old school iPod Classic, among others. Oddly enough, I do not have an iPad, but that’s probably only a matter of time, awaiting software that lets me do actual work on it.

All of this is my typical long-winded way of explaining why I was immensely saddened when I learned of Steve Jobs’ death last week. Ever since speculation started to swirl about his health back 2004 and then again in 2008, capped off by the revelation that he had undergone a liver transplant for a rare form of pancreatic cancer in 2009, I feared the worst. Last week, the end finally came. However, there is much to learn relevant to the themes of this blog in examining the strange and unusual case of Steve Jobs. Now, after his death five days ago, which coincidentally came a mere day after the launch of iCloud and the iPhone 4S, it occurs to me that it would be worthwhile to try to synthesize what we know about Jobs’ battle with cancer and then to discuss the use (and misuse) of his story. Of course, this is a difficult thing to do because Jobs was notoriously secretive and I can only rely on what has been published in the media, some of which is conflicting and all of which lacks sufficient detail to come to any definite conclusions, but I will try, hoping that the upcoming release of his biography by Walter Isaacson in couple of weeks might answer some of the questions I still have remaining, given that Isaacson followed Jobs through his battle with cancer and was given unprecedented access to Jobs and those close to him.

In the meantime, I speculate. I hope my speculations are sufficiently educated as not to be shown to be completely wrong, but they are speculations nonetheless.
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Posted in: Cancer, Medical Ethics, Nutrition, Science and the Media, Surgical Procedures

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The Prostrate Placebo

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

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

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

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

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Legislative Alchemy III: Acupuncture

legislative-alchemy-imageAcupuncture is typically depicted as sticking needles at various points on the body prescribed (inconsistently, it turns out) by charts indicating purported “meridians” through which “qi” flows in the human, or animal, body. However, from one of the many SBM posts on acupuncture, this one by Dr. Novella , we in fact know that:

the consensus of the best clinical studies on acupuncture show that there is no specific effect of sticking needles into acupuncture points. Choosing random points works just as well, as does poking the skin with toothpicks rather than penetrating the skin with a needle to elicit the alleged “de qi”. The most parsimonious interpretation of the evidence is that the needles (i.e. acupuncture itself) are superfluous — any perceived benefit comes from the therapeutic interaction. This has been directly studied, and the evidence suggests that the way to maximize the subjective effects from the ritual of acupuncture is to enhance the interaction with the practitioner, and has nothing to do with the acupuncture itself. Acupuncture is a clear example of selling a specific procedure based entirely on non-specific effects from the therapeutic interaction — a good bedside manner and some hopeful encouragement.”

Unfortunately, those who draft state legislation do not read SBM. They should. If they did, they wouldn’t be enacting acupuncture practice acts. But they do.

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Posted in: Acupuncture, Herbs & Supplements, Legal, Politics and Regulation

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Statistical Errors in Mainstream Journals

While we frequently on SBM target the worst abuses of science in medicine, it’s important to recognize that doing rigorous science is complex and mainstream scientists often fall short of the ideal. In fact, one of the advantages of exploring pseudoscience in medicine is developing a sensitive detector for errors in logic, method, and analysis. Many of the errors we point out in so-called “alternative” medicine also crop up elsewhere in medicine – although usually to a much less degree.

It is not uncommon, for example, for a paper to fail to adjust for multiple analysis – if you compare many variables you have to take that into consideration when doing the statistical analysis otherwise the probability of a chance correlation will be increased.

I discussed just yesterday on NeuroLogica the misapplication of meta-analysis – in this case to the question of whether or not CCSVI correlates with multiple sclerosis. I find this very common in the literature, essentially a failure to appreciate the limits of this particular analysis tool.

Another example comes recently from the journal Nature Neuroscience (an article I learned about from Ben Goldacre over at the Bad Science blog). Erroneous analyses of interactions in neuroscience: a problem of significance investigates the frequency of a subtle but important statistical error in high profile neuroscience journals.

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Posted in: Neuroscience/Mental Health, Science and Medicine

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Artificial Sweeteners: Is Aspartame Safe?

Note: This was originally published as a “SkepDoc” column in Skeptic magazine under the title “Aspartame: Safe Sweetener or Perilous Poison?” and is reprinted here with the kind permission of Michael Shermer. There are other artificial sweeteners not specifically addressed here, but as far as I know there are no convincing health concerns about any of them, just this same kind of hype and fearmongering based on animal studies and speculation with no validation from human clinical studies.


Aspartame is a low calorie sugar substitute marketed under brand names like Equal and Nutrasweet. It is a combination of two amino acids: L-aspartic acid and L-phenylalanine. It is available as individual packets for adding to foods and it is a component of many diet soft drinks and other reduced-calorie foods. Depending on who you listen to, it is either a safe aid to weight loss and diabetes control or it is evil incarnate, a deadly poison that is devastating the health of consumers.

A reader sent me an ad from his local newspaper that recommended using stevia instead of aspartame and made these startling claims about aspartame:

  1. It is derived from the excrement of genetically modified E. coli bacteria
  2. Upon ingestion, it breaks down into aspartic acid, phenylalanine, methanol, formaldehyde, and formic acid.
  3. It accounts for over 75% of the adverse reactions to food additives reported to the FDA each year including seizures, migraines, dizzinesss, nausea, muscle spasms, weight gain, depression, fatigue, irritability, heart palpitations, breathing difficulties, anxiety, tinnitus, schizophrenia and death.

Let’s look at those claims one by one.
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Posted in: Herbs & Supplements, Nutrition

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The wrong way to “open up” clinical trials

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

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

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Understanding and Treating Colic

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

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

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

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

Posted in: Clinical Trials, Pharmaceuticals, Science and Medicine

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Does Weight Matter?

Determining the net health effects of independent factors can be tricky, especially when those factors cannot be controlled for in experimental studies. For things like body mass index (BMI) we must rely on observational data and triangulate with multiple studies to isolate the contributions from BMI. But it can be done.

The data, however, are likely to be complex and noisy, and therefore there is plenty of opportunity for ideology to trump objectivity in interpreting the data. There are those who, for whatever reason, deny that we are having an obesity epidemic in the West, and those who deny the health implications of being overweight as an independent factor.

BMI

The terms overweight and obesity have had various definitions in the past, but in recent years the various health organizations have settled on consensus operational definitions (for obvious practical reasons). Their definition relates to body mass index, which is a person’s weight in kilograms (kg) divided by their height in meters (m) squared.

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Posted in: Public Health

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Benedetti on Placebos

There has been an ongoing debate about placebos on SBM, both in the articles and in the comments. What does it mean that a treatment has been shown to be “no better than placebo?”  If our goal is for patients to feel better and they feel better with placebos, why not prescribe them? Do placebos actually do anything useful? What can science tell us about why a patient might report diminished pain after taking an inert sugar pill? The subject is complex and prone to misconceptions. A recent podcast interview offers a breakthrough in understanding.

On her Brain Science Podcast Dr. Ginger Campbell interviewed Dr. Fabrizio Benedetti, a physician and clinical neurophysiologist who is one of the world’s leading researchers on the neurobiology of placebos. A transcript of the interview [PDF] is available on her website for those who prefer reading to listening. The information Dr. Benedetti presents and the expanded remarks by Dr. Campbell after the interview go a long way towards explaining the placebo phenomenon and its consequences for clinical medicine. Dr. Campbell also includes a handy list of references. I’ll try to provide a summary of the main points, but I recommend reading or listening to the original.

A common misconception is that the response to placebos is a purely subjective psychological response involving only the cortical level of the brain; but evidence is accumulating that real, measurable, objective subcortical neurophysiologic phenomena are involved. One of the first hints was a 1978 study showing that the placebo response to pain could be blocked by naloxone, a narcotic antagonist drug, indicating that the placebo must have actually caused an increase in endogenous opioids. (more…)

Posted in: Basic Science, Neuroscience/Mental Health

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