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Archive for Herbs & Supplements

New Dietary Ingredient (NDI) rules planned for the supplement industry

A rumble of discontent is being heard across the dietary supplement industry since a draft guidance document was published last month by the US Food and Drug Administration. In response to the FDA Food Safety Modernization Act signed into law in January by President Obama, the FDA was required to produce a documents requiring dietary supplement and foods companies to submit safety information on any new dietary ingredient (NDI) placed into products after 1994.

The guidance document is open for comments from industry but, when issued, a final rule will require dietary supplement products to file a claim of a New Dietary Ingredient (NDI) for any supplement component that was not part of the diet before 1994. What seems to be riling up the industry is that any change in supplement composition after 1994 will require filing of a NDI disclosure. That is, if you as a manufacturer add more DHA to your fish oil supplement, you have to file a NDI notification.

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Posted in: Herbs & Supplements, Legal

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Belief in Echinacea

Note: The study discussed here has also been covered by Mark Crislip. I wrote this before his article was published, so please forgive any repetition. I approached it from a different angle; and anyway, if something is worth saying once it’s probably worth saying twice.

 

Is Echinacea effective for preventing and treating the common cold or is it just a placebo? My interpretation of the evidence is that Echinacea does little or nothing for the common cold. Initial reports were favorable, but were followed by four highly credible negative trials in major medical journals. A Cochrane systematic review was typically wishy-washy  The Natural Medicines Comprehensive Database rates it as only “possibly effective” commenting that

Clinical studies and meta-analyses show that taking some Echinacea preparations can modestly reduce cold symptom severity and duration, possibly by about 10% to 30%; however, this level of symptom reduction might not be clinically meaningful for some patients. Several other clinical studies found no benefit from Echinacea preparations for reducing cold symptoms in adults or children…

A review on the common cold in American Family Physician stated that Echinacea is not recommended as a treatment.

I have a friend who believes in Echinacea. She says for the last several years she has taken Echinacea at the first hint of a cold, and she hasn’t developed a single cold in all that time. I told her that if that was valid evidence that it worked, I had just as valid evidence that it didn’t. For the last several years I have been careful not to take Echinacea at the first hint of a cold, and I haven’t had a single cold in all that time either. So I could claim that not taking Echinacea is an effective cold preventive! I thought my “evidence” cancelled out hers; she said we would just have to agree to disagree.

A recent study looked at the effect of belief on response to Echinacea and dummy pills. “Placebo Effects and the Common Cold: A Randomized Controlled Trial” was published by Barrett et al. in the Annals of Family Medicine(more…)

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

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Honey

I cram for TAM, and, combined with other commitments, not the least of which is that it is finally sunny and warm in Portland, after a year that has resembled All the Summer in a Day,  which leads to a relatively short post.  There are just so many hours in a day and if possible those days need to be spent in the sun.

In my first year in practice I was sitting on a nursing station writing a note when a patient started howling in pain.  Further investigation revealed that the patient had a chronic, open surgical wound and the (old) surgeon had ordered sugar poured into the wound as part of wound care.  The cafeteria mistakenly sent up salt, and a metaphor became reality.  It did pique my interest in both sugar and honey for wound care,  an area where you have to be careful not to fall prey to all the errors in CAM thinking: a reliance on anecdotes, using suboptimal studies as evidence, mistaking a gobbet of basic science as a meaningful clinical application, and not realizing the warping effect of confirmation bias.

That being said, I have suggested honey and sugar for years for patients, and many patients with prior refractory wounds had healing.  And what are the three most dangerous words in medicine?  In my experience.  I have recommended honey less in the era of the wound vac, but there are not an insignificant number of people with insufficient financial resources who cannot afford even simple wound care supplies. Many  of the ointments, creams and special bandages for wound care costs too much.  Patients also like honey as it is natural (people do love to fall for the naturalistic fallacy) and inexpensive, and I always tell patients that the data is iffy, but not stupid. (more…)

Posted in: Herbs & Supplements, Science and Medicine, Surgical Procedures

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Scientific evidence for synergy in a botanical product

So, you’re curious about herbal medicine. Is there any truth to this stuff?

Uncle Howie tells you that he read in the National Enquirer about an herb that has better antibacterial effects on cuts and scrapes than Neosporin ointment — never mind that Neosporin is composed of three different antibiotics that come originally from bacteria themselves.

So you set out on a quest to purchase some of this herb, known colloquially as goldenseal. When you go to your local Whole Hippie Dump-a-Load-of-Cash Emporium you find goldenseal alright, in about twenty different forms. On one side of the aisle are containers with loose, crushed up leaves and roots that look like medical marijuana. On a shelf, you find see-through capsules that seem to contain a powdered version of the herb. Down the aisle a bit you find boxes of blister-packs containing a proprietary extract of free-range goldenseal from the Appalachians harvested under moonlight by bare-breasted virgins. The same company also makes an ointment, allegedly procured the same way.

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Posted in: Basic Science, Herbs & Supplements

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Update on Josephine Briggs and the NCCAM

Dr. Gorski is in the throes of grant-writing, so I’m filling in for him today by following up on a topic introduced a few months ago. It involves a key medical player in the U.S. government: Dr. Josephine Briggs, Director of the National Center for Complementary and Alternative Medicine (NCCAM).

Background

Steve Novella and I first encountered Dr. Briggs at the 2nd Yale Research Symposium on Complementary and Integrative Medicine in March, 2010. I reported here that she seemed well-meaning and pro-science but that she also seemed naive to the political realities of her office and to much of the content of “CAM” (as illustrated by her recommending the NCCAM website, which is full of misinformation; previously I’d noticed her unfortunate innocence of “acupuncture anesthesia,” which is to be expected of most academics but not of the CAM Explicator-in-Chief).

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Posted in: Clinical Trials, Health Fraud, Herbs & Supplements, Homeopathy, Naturopathy, Politics and Regulation, Science and Medicine, Vaccines

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Utah Senator Orrin Hatch: A pit bull in defense of the supplement industry

Editor’s note: This weekend was truly NIH grant crunch time. I have to get my final version of my R01 to our university’s grants office by Tuesday, or it might not get uploaded by the July 5 deadline. (Funny how electronic submission, which was supposed to make applicants’ lives easier, seems to have made them harder.) Consequently, I decided to take a few minutes and spiff up a post I did not long ago for my other blog and use it here, mainly because it is particularly relevant to our usual SBM topics. I’ll be back next time with something new.

The weakness and ineffectiveness of the law in the U.S. regulating dietary supplements has been a frequent topic here on Science-Based Medicine, including the continued failure of efforts to address the serious shortcomings of current law and the illogic at its very heart. Indeed, over the last decade or so that I’ve paid attention to relevant issues regarding supplements continually amazed at how much supplement manufacturers can get away with and for how long. For example, one of the most recent atrocities against science occurred when Boyd Haley, disgraced chemistry professor at the University of Kentucky and prominent member of the mercury militia wing of the anti-vaccine movement, tried to sell an industrial chelator as a dietary supplement to treat autistic children. True, that was too much even for the underfunded, undermanned FDA to ignore, but it was amazing how long he got away with it. Apparently it takes someone trying to market a chemical compound that can’t by any stretch of the imagination be characterized as a “nutrient” or “food” to be so obviously against even the travesty of a mockery of a sham of a law regulating supplements (the Dietary Supplement Health and Education Act of 1994, or the DSHEA) that the FDA could take action.

Of course, here at SBM, we’ve written numerous posts on the shortcomings of the DSHEA. Basically, this law created a new class of regulated entities known as dietary supplements and liberalized the sorts of information that supplement manufacturers could transmit to the public. The result has been this:

It [the DSHEA] also expanded the types of products that could be marketed as “supplements.” The most logical definition of “dietary supplement” would be something that supplies one or more essential nutrients missing from the diet. DSHEA went far beyond this to include vitamins; minerals; herbs or other botanicals; amino acids; other dietary substances to supplement the diet by increasing dietary intake; and any concentrate, metabolite, constituent, extract, or combination of any such ingredients. Although many such products (particularly herbs) are marketed for their alleged preventive or therapeutic effects, the 1994 law has made it difficult or impossible for the FDA to regulate them as drugs. Since its passage, even hormones, such as DHEA and melatonin, are being hawked as supplements.

One might wonder how such a bad law could survive for so long (seventeen years now), but it has its defenders. One man, in particular, defends the DSHEA against all regulatory threats, foreign and domestic. His name is Senator Orrin Hatch (R-UT), and he was just the subject of a writeup in the New York Times last week referring to him as a “natural ally” of the supplement industry:
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Posted in: Herbs & Supplements, Pharmaceuticals, Politics and Regulation

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“CAM” Education in Medical Schools—A Critical Opportunity Missed

Mea culpa to the max. I completely forgot that today is my day to post on SBM, so I’m going to have to cheat a little. Here is a link to a recent article by yours truly that appeared on Virtual Mentor, an online ethics journal published by the AMA with major input from medical students. Note that I didn’t write the initial scenario; that was provided to me for my comments. The contents for the entire issue, titled “Complementary and Alternative Therapies—Medicine’s Response,” are here. Check out some of the other contributors (I was unaware of who they would be when I agreed to write my piece).

Posted in: Acupuncture, Basic Science, Chiropractic, Energy Medicine, Herbs & Supplements, History, Homeopathy, Medical Academia, Medical Ethics, Science and Medicine

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Failed Flaxseed and Bad News Brownies

Well, it’s been a tough month for herbs since my last monthly soiree here at SBM.

Just last week at the American Society for Clinical Oncology (ASCO) meeting, a group out of the Mayo Clinic presented data from a study showing that a well-characterized flaxseed extract was ineffective against hot flashes in postmenopausal women. But as Steve Novella noted here earlier this week, negative clinical trials data on supplements rarely influence the behavior of those who continue to advocate for their herbal use.

Flaxseed, known to contain phytoestrogen compounds such as secoisolariciresinol diglucoside (SDG) and enterolactone, has been purported to relieve hot flashes.

But I think the hypothesis was flawed in the first place: while these compounds bind the estrogen receptor, they have largely been shown to be estrogen receptor modulators that act in a negative manner. Work from the group of Dr. Lillian Thompson at the University of Toronto has repeatedly shown in an estrogen-dependent animal model of human breast cancer that flaxseed components act in a predominantly anti-estrogenic manner. One might suspect that hot flashes would be made worse by flaxseed, although this was not the case in the study presented as ASCO.

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Posted in: Cancer, Clinical Trials, Herbs & Supplements

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Black Cohosh and Hot Flashes

Black Cohosh, an herbal “supplement” (i.e. unregulated drug) remains popular for the treatment of hot flashes and other autonomic symptoms resulting from menopause. This product is yet another good example of the double standard that the supplement industry and ideological promoters are allowed to employ.

The NCCAM website gives this summary:

Black cohosh, a member of the buttercup family, is a plant native to North America. It has a history of use for rheumatism (arthritis and muscle pain) but has been used more recently to treat hot flashes, night sweats, vaginal dryness, and other symptoms that can occur during menopause.

While the information is available if you look through the links below, their summary makes no mention of the fact that their own studies show black cohosh is ineffective. In their “at a glance” summary they characterize the scientific evidence as “mixed.”

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Posted in: Herbs & Supplements

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Oil of Oregano

Paradoxically, the less evidence that exists to support the use of of a treatment, the more passionate its supporters seem to be. I learned this early in my career as a pharmacist. One pharmacy I worked at did a steady business in essential oils. And king of the oils was oil of oregano. Not only were there several different brands of the basic oil, they were different forms, including capsules, creams and even nasal sprays. Not aware of any therapeutic benefits, I would ask customers what they were using it for. I rarely heard the same condition described: skin infections, athlete’s foot, head lice, colds, sore throats, “parasites”, “yeasts”, diabetes, allergies and ringworm were apparently no match against the judicious use of oregano oil. Intrigued, I took a closer look.

Long before our scientific understanding of bacteria and antimicrobials, infected wounds were packed with different products in an attempt to minimize the odour, and hopefully speed healing. It’s likely that someone happened upon a fragrant herb and discovered that it seemed to help treat wounds (or at least, cover some of the smell). Given there have been some amazing drugs with powerful effects that have emerged from natural products, it’s certainly plausible that oil of oregano could have biological and therapeutic effects. Oregano (Origanum vulgare) leaves contain a wide variety of chemical compounds, including leanolic acids, ursolic acids, and phenolic glycosides. Phenolic compounds make up to 71% of the oil. Carvacrol, thymol, cymene, and terpinine and are found in oregano leaves and do appear to have biological effects. It’s these chemicals that are proposed to be the parts with beneficial effects.

The claims made by one manufacturer are unambiguous:

Oreganol P73 is the most powerful germ killer with scientifically proven results against almost every virus, bacteria, parasite, and fungi. The complexity of the phytochemical matrix in Oreganol P73 possesses a broad spectrum of antimicrobial properties that are safe for prolonged use. The oil can be used topically and internally. Oreganol P73 is the medicine chest in a bottle, especially since it is proven never to harm the internal organs, even when used daily for health maintenance.

So if we accept the manufacturer’s claims at face value, there should be evidence demonstrating oregano oil is both safe and effective when used internally and externally. There is apparently also adequate long-term safety data to demonstrate that it can be safely used on a daily basis.
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Posted in: Herbs & Supplements

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