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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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Inflammation: Both Friend and Foe

A number of buzz-words appear repeatedly in health claims, such as natural, antioxidants, organic, and inflammation. Inflammation has been implicated in a number of chronic diseases, including diabetes, Parkinson’s, rheumatoid arthritis, allergies, atherosclerosis, and even cancer. Inflammation has been demonized, and is usually thought of as a bad thing. But it is not all bad.

In a study in Nature Medicine in September 2011, a research group led by Dr. Umut Ozcan at Children’s Hospital Boston (a teaching hospital affiliated with Harvard Medical School) reported that two proteins activated by inflammation are crucial to maintaining normal blood sugar levels in obese and diabetic mice. This could be the beginning of a new paradigm. Ozcan says:

This finding is completely contrary to the general dogma in the diabetes field that low-grade inflammation in obesity causes insulin resistance and type 2 diabetes. For 20 years, this inflammation has been seen as detrimental, whereas it is actually beneficial.

Increasing levels of these inflammatory signals might actually be therapeutic in diabetes and obesity. On the other hand, they might worsen inflammatory diseases like asthma and rheumatoid arthritis. Ozcan’s findings are intriguing and might eventually lead to new treatments, but there are no clinical applications as yet.

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Posted in: Basic Science, Herbs & Supplements, Nutrition

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Shilling for traditional Chinese medicine: Nature leaves its readers a lump of coal before Christmas

I’ve subscribed to Nature for many years now, even though I don’t always read it. Nature is one of the oldest and most respected scientific journals around. It’s been around since 1869 and is said to be the world’s most cited journal. What makes Nature unusual these days is that it’s one of the last of the remaining general science journals and one of the two that still publish original peer-reviewed research in a wide variety of scientific fields. Astronomy, physics, chemistry, medicine, biology, Nature publishes it all. The only other journal of its type that I can think of is Science, which also has a similar high impact factor. In any case, getting published in Nature is a big deal, one that can make a career. Believe it or not, I actually have a Nature publication. True, it’s from the 1990s, and, true, I’m only the fourth author, but it is a Nature publication. Ever since then, I keep telling myself that, one of these days, I’ll manage to find a way to be published again in Nature, although I realize that it’s looking increasingly unlikely that that will happen. Such is the power and cachet of Nature. It’s a name that has provided prestige to some of its spinoff journals, such as Nature Medicine, although of late Nature appears to have diluted the brand name beyond belief.

Nature sells out

All of the above is why I’m very, very disappointed in Nature for having dropped a huge lump of coal into the stockings of supporters of science-based medicine a mere three days before Christmas. Maybe its editors thought that it wouldn’t be noticed right before the holiday season. I don’t know. I do know that I noticed. Basically, Nature sold out to a Japanese pharmaceutical company, which, along with a research institute, bought a supplement in Nature that is in essence an advertorial for its point of view. Don’t believe me? Check out this acknowledgment of the sponsors published in the advertorial:
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Posted in: Herbs & Supplements, Medical Academia, Science and Medicine

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NCCAM Criticism from a Not-Quite-Opponent

The demographic of SBM readers are likely to remember the early Miller Lite beer television commercials where sports personalities debated as to whether the beverage “tastes great” or was “less filling.” In one classic version, New York Mets’ Marv Throneberry breaks the shouting match to level his decision: “I feel strongly both ways.”

My colleagues at Science-Based Medicine have generally been opposed completely to the existence of the NIH’s National Center for Complementary and Alternative Medicine (NCCAM). The primary objection is that the Center awards roughly $125 million per year in taxpayer dollars to studies that are generally not based on a strong scientific foundation or, in some cases, absolutely no scientific basis. On the other hand, the best NCCAM-supported studies have provided fruitful results, if not negative with regard to clinical outcomes.

The recent series of articles by Trine Tsouderos at the Chicago Tribune (1, 2, 3, 4) has reignited a national debate as to whether NCCAM is needed at all. After all, NCCAM was not because of science but because of politics, particularly the efforts of Senator Tom Harkin and Representative Dan Burton. And other NIH institutes, such as the National Cancer Institute, seem to do a much more rigorous and science-based job of funding studies of alternative cancer therapies through their unfortunately-named Office of Cancer Complementary and Alternative Medicine, or OCCAM.

In fact, I have long argued that if alternative therapies are to be investigated rigorously, they should be done so under each of the specific NIH institutes and centers (ICs) that have been established to focus on organ systems (National Institute of Diabetes and Digestive and Kidney Diseases; NIDDK) or a class of related disorders (National Institute on Drug Abuse; NIDA).

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Posted in: Herbs & Supplements, Science and the Media

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Vitamin B12 – The Energy Panacea?

Having spent many hours working in close proximity to a wall of vitamins, I’ve answered a lot of vitamin questions, and given a lot of recommendations. Before I can make a recommendation, I need to ask some questions of my own. My first is almost always, “Why do you want to take a vitamin?” The most common response I’m given is “insurance” – which usually means supplementation in the absence of any symptom or medical need. Running a close second is “I need more energy.” With some digging, the situation usually boils down to a perceived lack of energy compared to some prior period: last week, last year, or a decade ago. While I may identify possible medical issues as a result of these interviews (these are referred to a physician), I’m often faced with a patient with mild and non-specific descriptions of fatigue. And more often than not, they’ve already decided that they’re going to buy a multivitamin supplement. When it comes to boosting the energy levels, they’re often interested in a specific one: Vitamin B12 (cobalamin). So why does vitamin B12, among all the vitamins, have a halo of benefit for fatigue and energy levels? The answer is part science and a whole lot of marketing. (more…)

Posted in: Herbs & Supplements, Nutrition

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Pediatrics & “CAM” II: just wrong

In November, the journal Pediatrics published an entire supplement devoted to Pediatric Use of Complementary and Alternative Medicine: Legal, Ethical and Clinical Issues in Decision-Making. The authors purport to have “examined current legal, ethical, and clinical issues that arise when considering CAM use for children and identified where gaps remain in law and policy.” (S150) Their aim is to “illustrate the relevance and impact of identified [ethical, legal and clinical] guidelines and principles,” to recommend responses, identify issues needing further consideration, and thus “assist decision makers and act as a catalyst for policy development.” (S153)

Unfortunately, as we saw in Pediatrics & “CAM” I: the wrong solution, the authors’ solution for the “issues that arise when considering CAM use for children” consist, in the main, of placing a huge burden on the practicing physician to be knowledgeable about CAM, keep up with CAM research, educate patients about CAM, warn patients about CAM dangers, refer to CAM practitioners, ensure that CAM practitioners are properly educated, trained and credentialed, and so on.

Limit CAM? Not happening

Curiously absent are recommendations placing responsibility on those who profit from the sale of CAM products and services — the dietary supplement manufacturers, homeopaths, acupuncturists, and the like — whose actions are directly responsible for the deleterious effects on patients’ health detailed in the supplement articles and described in the earlier post.

Apparently the authors’ view is that there is no accommodation to CAM too onerous to ask the practicing physician or the patient to bear. Even though they plainly locate the problems they describe — a missed diagnosis, ineffective treatments, drug therapy interactions, poor advice — in the CAM services and products themselves, suggesting that these services and products be limited or eliminated never seems to cross their minds.

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Posted in: Acupuncture, Chiropractic, Herbs & Supplements, Homeopathy, Legal, Medical Ethics, Politics and Regulation, Vaccines

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Antioxidants and Exercise: More Harm Than Good?

Multivitamin supplementation has been getting a rough ride in the literature, as evidence emerges that routine supplementation for most is, at best, unnecessary. Some individual vitamins are earning their own unattractive risk/benefit profiles: Products like folic acid, calcium, and beta-carotene all seem inadvisable for routine supplementation in the absence of deficiency or medical indication. Vitamin E, already on the watch list,  looks increasingly problematic, with data recently published confirming the suspected association of supplementation with an elevated risk of prostate cancer.

Reading through the vitamin posts here at SBM, one issue comes through repeatedly: The danger of assuming therapeutic benefits in the absence of confirmatory evidence. Vitamin supplement have the patina of safety and of health, a feature that’s reinforced when you purchase them: You don’t need a prescription, you don’t get counseled on their use, and there isn’t a long list of frightening potential side effects to accompany the product. You can pull a bottle off the shelf, and take any dose you want. After all, how harmful can vitamins be when you can buy 5 pounds of vitamin C at a time, or vitamin E capsules in a 1000-pack?  But the research signals seem to be getting stronger, and most are pointing in the same direction: what we though we knew about antioxidants was based on simplistic hypotheses about nutrition and health. And while we thought we were doing ourselves good with antioxidant supplements, we may have been doing harm. (more…)

Posted in: Herbs & Supplements, Science and Medicine

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Pediatrics & “CAM” I: the wrong solution

Oh no!  Not again! The venerable medical journal Pediatrics devotes an entire supplement this month to Pediatric Use of Complementary and Alternative Medicine: Legal, Ethical, and Clinical Issues in Decision-Making.

We sense from the very first sentence that we are in familiar territory:

Rapid increases the use of complementary and alternative medicine (CAM) raise important legal, ethical, clinical, and policy issues. (S150)

“Rapid increases”? And evidence of these “rapid increases?” None cited.

We do, however, see the same shopworn reference to popularity deconstructed elsewhere on SBM. What we learned by actually examining “the large 2007 US survey” which purportedly “revealed that ~4 in 10 adults and 1 in 9 children and youth used CAM products or therapies within the previous year”(S150) is that

…most hard-core CAM modalities are used by a very small percentage of the population. Most are less than five percent. Only massage and manipulation are greater than 10 percent. These numbers are also not significantly different from 10 or 20 years ago — belying the claim that CAM use is increasing.

We also find this definition of “CAM”:

a broad domain of healing resources …other than those intrinsic to the politically dominant health system of a particular society or culture in a given historical period. (S150)

I’m not sure what it takes to become “intrinsic” to the “politically dominant” healthcare system. If it includes being legal, licensed or covered by public and/or private insurance, that would appear to disqualify dietary supplements, chiropractic, acupuncture, homeopathy, homeopathic products and naturopathy as “CAM” in some, or in some cases all, of the American states.

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Posted in: Acupuncture, Chiropractic, Herbs & Supplements, Homeopathy, Legal, Medical Ethics, Naturopathy, Politics and Regulation, Science and Medicine, Vaccines

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Collagen: An implausible supplement for joint pain

I’m one of those odd people that enjoys distance running. I end up spending a lot of time in the company of other runners. And when we’re not running, we’re usually griping about our running injuries. As the cohort that I run with ages, the injuries are getting more prevalent. Besides the acute conditions, the chronic problems are starting to appear. Our osteoarthritis years are here.

As the available pharmacist, I get a lot of questions about joint pain. What’s reassuring, I tell them, is that they shouldn’t blame running. Osteoarthritis is common — the most frequent cause of joint pain. For some, it starts in our twenties, and by our seventies, osteoarthritis is virtually certain. Regardless of your level of exercise, the passage of time means the classic osteoarthritis symptoms — joint pain and morning stiffness, that worsens over time.

Osteoarthritis progresses gradually. Blame biomechanics and biochemistry. It starts with a breakdown of the cartilage matrix. Stage 2 progresses to erosion of the cartilage and a release of collagen fragments. Stage 3 is a chronic inflammatory response. The goals of treatment are to reduce inflammation and pain, and stop progressive disease. There’s no drug therapy that’s been show to actually improve joint function. Reduce pain, or slow inflammation, yes. Analgesics, like Tylenol, and anti-inflammatories are mainstays. But repair damage? Sorry: you lose it, it’s gone. Chondrocytes don’t seem to be able to repair the overall matrix — which is made mainly of collagen. (more…)

Posted in: Herbs & Supplements, Nutrition

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Premature Claims for Neurotrophic Factors

Scientific medicine is not easy. By this point we have largely picked the low hanging fruit, and continued improvements are mostly incremental and hard won. In order to get the most out of our limited research dollars, and optimize medical practice with the safest and most effective treatments, we need to use all available scientific evidence in the proper way. That is the essence of SBM.

There are those, however, that misuse or abuse the scientific evidence — whether to promote an ideology, out of innocent ignorance, or for nefarious purposes. In order to be truly science-based a medical intervention should be plausible, or at least not implausible, based upon basic science evidence, and it should actually be safe and effective when tested in people. Therefore, medical practices can fail to be scientific for one of two broad reasons: they can be scientifically implausible, or they can lack proper clinical evidence for safety and efficacy (or even have evidence for lack of efficacy). Some modalities (like homeopathy) fail on both counts.

The more pernicious medical claims are those that seem highly plausible, that can be extrapolated from basic science, but simply lack adequate clinical evidence. Stem cell clinics are an example — they can easily dazzle desperate patients with scientific descriptions of how stem cells work, and even cite published basic-science papers showing the potential of this technology. But what they cannot do is provide clinical evidence that the specific intervention they are offering is safe and effective for the specific disease or condition they are treating.

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Posted in: Herbs & Supplements, Neuroscience/Mental Health, Science and Medicine

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