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.
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…)
Acupuncture 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.
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:
- It is derived from the excrement of genetically modified E. coli bacteria
- Upon ingestion, it breaks down into aspartic acid, phenylalanine, methanol, formaldehyde, and formic acid.
- 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.
Like most people who grew up after April 22, 1970, I think it is important to be as environmentally responsible as possible. Like many I fail miserably much of the time, but at least I feel guilty about it. Recycling offers the opportunity to feel good about my environmental impact with little effort, since the garbage collection infrastructure in Portland makes recycling easy.
Some products are best extensively reprocessed before reused. Urine, as an example. There are proponents of topical and/or drinking urine as a treatment/cure for nearly any illnesses. The kidneys are mostly responsible for fluid and electrolyte balance and I realize that normal urine is mostly water, salts, urea and a smattering of other very dilute molecules. I have the urine tox screen to prove it. Urine is not a particularly noxious body fluid, but it is not high on my list of liquids to drink under normal circumstances.
Urine is mostly water but not an optimal source of water if it is your only source for fluids. Urine drinkers love to mention the occasional trapped earthquake victim who survives, in part, from drinking their own urine. For the first several days the urine would be dilute enough to keep people reasonably hydrated, as humans cannot concentrate urine as well as, say, a camel. So I can see where consuming urine for a short period of time would delay progressive dehydration and death. A couple days of drinking urine neat, shaken not stirred, would be harmless and, if there were no alternative sources of water, beneficial. I do suffer from the societal taboo that piss is icky, and for aesthetic reasons urine is not something I would want to consume, even when it is referred to as its more common designation ‘Coors Light’. (more…)
“I don’t want to give my child any drugs or chemicals for their ADHD,” says a parent. “Instead, I’m thinking about using caffeine. Sound strategy?”
It may be dispensed by a barista and not a pharmacist, and the unit sizes may be small, medium and large, but caffeine is a chemical and also a drug, just as much as methylphenidate (Ritalin) is. Caffeine is even sold as a drug — alone and in combination with other products. But I regularly speak with consumers who are instinctively resistant to what they perceive as drug therapy — they want “natural” options. Caffeinehas been touted as a viable alternative to prescription drugs for ADHD. But is caffeine a science-based treatment option? This question is a good one to illustrate the process of applying science-based thinking to an individual patient question. (more…)
It is an unfortunate truth that there is money in pseudoscience, particularly medical pseudoscience. Money both attracts charlatans and also funds their activities, which includes marketing pseudoscience and defending their claims from scientific scrutiny. In this way the game is rigged in favor of pseudoscience.
With0ut effective regulation, sites like ours are forced to play whack-a-mole with the medical pseudoscience du jour. The latest case in point is Titanium Ion Bands – which are just another version of the Power Balance bands that have been previously exposed as nonsense. The idea is that by wearing a small bracelet on one wrist you will experience improved athletic performance. This sounds impossible – because it is. But companies have successfully bamboozled enough of the public to rake in millions.
The marketing strategy is three-fold. First, get naive professional athletes to endorse the product. Second, give live demonstrations (deceptive parlor tricks) that convince the unsuspecting that something must be going on. And third, wow the scientifically illiterate with a confusing barrage of medical techno-babble. The combination is sadly effective.
Power Balance, for example, makes vague references to frequencies and energy as the explanation for how a little piece of rubber (with embedded holograms) can have any effect on human physiology. The company was eventually legally forced to admit: “”We admit that there is no credible scientific evidence that supports our claims.” The admission has not ended their sale, however.
As early as 2006, I used to be able to write monthly about US FDA warnings on erectile dysfunction supplements being found adulterated with prescription drugs such as sildenafil, the phosphodiesterase-5 inhibitor found in Viagra. These adulteration episodes raised the question of how many anecdotal reports of herbal products “working” had to do with them containing approved medicines.
So common was this practice that FDA created a site in 2008 that was dedicated to this problem: Hidden Risks of Erectile Dysfunction “Treatments” Sold Online. Indeed, these products were more commonly encountered from online retailers and not in health food stores. Other similar practices include bodybuilding supplement being spiked with anabolic steroids and weight loss supplements being adulterated with sibutramine (formerly Meridia), an anorectant removed from the market last year after showing increased incidence of heart attacks and stroke in patients with preexisting cardiovascular disease.
As most readers of the blog know, I am mostly an Infectious Disease doc. I spend my day diagnosing and treating infections and infectious complications. It is, as I have said before, a simple job. Me find bug, me kill bug, me go home. Kill bug. It is the key part of what I do everyday, and if there is karmic payback for the billions of microbial lives I have erased from the earth these past 25 years, my next life is not going to be so pleasant. I will probably come back as a rabbit in a syphilis lab.
It is always fun when my hobby, writing for SBM, crosses paths with my job. This month the Annals of Internal Medicine published “Oseltamivir Compared With the Chinese Traditional Therapy Maxingshigan–Yinqiaosan in the Treatment of H1N1 Influenza. A Randomized Trial.”
I though big pharma was good at coming up with names I do not know how to pronounce. If someone could provide a pronunciation guide in the comments, it would be ever so helpful, so I will not have to embarrass myself when this entry becomes a Quackcast. Dr. Hall wrote about this article on Tuesday, and I have avoided reading her post until this one is up, so there may be overlap in what is discussed. (more…)
During the early days of the 2009 H1N1 influenza A pandemic, the popular herbal formula maxingshigan–yinqiaosan was used widely by TCM practitioners to reduce symptoms. (It’s hard to pronounce and spell, so I’ll refer to it as M-Y.) A new study was done to test whether M-Y worked and to compare it to the prescription drug oseltamivir. It showed that M-Y did not work for the purpose it was being used for: it did not reduce symptoms, although it did reduce the duration of one sign, fever, allowing researchers to claim they had proved that it works as well as oseltamivir.
“Oseltamivir Compared With the Chinese Traditional Therapy: Maxingshigan–Yinqiaosan in the Treatment of H1N1 Influenza” by Wang et al. was published in the Annals of Internal Medicine earlier this month. The study was done in China, which is notorious for only publishing positive studies. Even if it were an impeccable study, we would have to wonder if other studies with unfavorable results had been “file-drawered.” It’s not impeccable; it’s seriously peccable.
It was randomized, prospective, and controlled; but not placebo controlled, because they couldn’t figure out how to prepare an adequate placebo control. They considered that including a no treatment group compensated for not using a placebo control, and that objective temperature measurement could be expected to get around any bias. It might not: the nurses who took the temperatures were blinded to the study, but the patients were not. It’s possible that those who knew they were getting M-Y might have believed in it and their bias might have somehow subtly influenced data gathering so that M-Y appeared more equivalent to oseltamivir than it actually was.
There are other problems besides the lack of blinding. (more…)