Module i: overview of complementary & alternative medicine

Complementary and Alternative Medicine Online Continuing Education Series NCCAM CHAPTER I: OVERVIEW OF COMPLEMENTARY AND ALTERNATIVE
Let’s drill down and talk a little more about some of the approaches, some of the potential hazards, and some of the opportunities. I’m going to go back to those CAM domains again; I mentioned 5 of them, and you have the wheel in the upper left. I’m going to talk about biologically based systems and begin with a discussion of vitamins and minerals. Most of us have adequate amounts of vitamins and minerals in our diet. Not all of us. In the developing world, few have adequate amounts. And we know that health requires adequate amounts. There remains some disagreement as to what constitutes adequate amounts, but there’s no disagreement that vitamins and minerals are important for people who are malnourished and may be important even for some people who aren’t. Here’s one piece of data that’s fairly strong, although it’s still controversial. It was published in the Journal of the American Medical Association in 2002 from Switzerland. It was a study of individuals who have already had a heart attack, asking whether taking a placebo, a sugar pill, or a supplement consisting of folic acid, vitamin B6, and vitamin B12 reduced their likelihood in the subsequent year of getting a second heart attack. This slide suggests that the supplements did reduce the likelihood. So more vitamins and minerals are necessary if you’re deficient. Maybe they’re healthful, but we know that too much of a good thing, in any aspect of life, is not good. On the left, you’ll see some hazards of excess amounts of vitamin A. They’re associated with birth defects, liver abnormalities, and thinning bones. Too much vitamin E. There was a study done in China published in 1993, suggesting that vitamin E and some other vitamins reduced rates of gastrointestinal cancers. But there were some larger studies in Scandinavia focusing down that showed that smokers who had extra doses of vitamin E, the alpha- tocopherol form, actually had a statistically higher rate. So the assumption that some is good, more is better, needs to be questioned. Complementary and Alternative Medicine Online Continuing Education Series NCCAM What about special diets? How many of you have heard of the Atkins diet? Okay, I should ask the question a different way. Any of you not heard of the Atkins diet? One person in the back was brave enough to raise her hand. So Dr. Atkins believed, contrary to conventional wisdom and medical opinion, that a very high-fat diet helps you lose weight faster and does not increase fats in the bloodstream. That really doesn’t sit well with us who have tried to tell our patients that we’re taking too much fat in our diet, which we are, which is in part a reason for the epidemic of obesity today. But we and other institutes co-funded a study, and we are now taking a lead in a follow-up study, published in the venerable New England Journal of Medicine 6 months ago, that showed that for at least 6 months, individuals on the Atkins diet lost weight faster than individuals on a conventional, lower calorie diet. By the end of 1 year, it was a little hard to sustain the Atkins diet, they crept up a little bit. Our purpose in follow-up studies is to ask, over a longer time frame in a larger number of individuals, can you sustain this weight loss, and does the lipid profile in the blood change. In this study, the lipid profile was not worse on the Atkins diet, but we’ll see with longer term therapies. Let’s move from vitamins and diets to something a little more complicated , not that diets aren’t. That’s the issue of herbal supplements. In the Journal of the American Medical Association in 2002, there was a major survey conducted in over 2500 people, out of Boston University, which showed that these are the 10 most commonly used herbals and supplements. I’m sure all of you are familiar with at least a few of these. Ginseng, ginkgo biloba—we can’t pronounce all of them. Allium sativum, or garlic. Okay, it’s good on pizza; maybe more is good for you. This survey told us why patients are using these supplements; 16% of people said “because I think it’s good for me.” There are more specific reasons; 7% of the patients said “I’m taking it because of my joints” and so on. You can see the list. We have a host of approaches, a host of supplements, a host or reasons, and a host of obligations to study these approaches. I mentioned that the Internet is a source of information. It can be a source of useful information. I recommend several NIH Web sites, including our own, that I’ll cite at the end of our talk. I recommend, as well, that you look at the Internet as a vehicle for misinformation. There was a study published, again, in the Journal of the American Medical Association just a few months Complementary and Alternative Medicine Online Continuing Education Series NCCAM ago that surveyed and found 338 different Web sites that were selling 8 of the most common herbal products, like on that list I just showed you; 88% of these sites made health claims. It’s a complex fact of how herbal supplements are regulated in the U.S. today that they can be sold, but they can’t make a health claim. So 88% of these Web sites are actually doing something illegal, but it’s a little difficult to police even though the Federal Trade Commission and the FDA get together to do so. Fifty-five percent of these sites said that their approach would treat, prevent, or cure a specific disease. It’s one thing to say this herb is a natural form of Viagra. That has a certain cache in the
marketplace today. It’s another thing to have a patient who’s victim to cancer, who’s desperate, feel that they need to place their hope and their remaining disposable income So I talked about some of the beginning challenges of herbs, and now there are a few others that I’m going to talk about. I mentioned that the safety is assumed but not proven. The products are not standardized, and some of these are contaminated. Let me give you one piece of data in this chart on the right that was published by one of our grantees a couple of years ago that looked at a whole series, all the available variations in a health food store shelf of ginseng products. And what I’m showing you in this graph is the percentage content in the bottle of what the bottle said was in it. This one had 1/9 of what the label said it had. This had 3 times as much. If you were going to buy an aspirin, you’d have a good bet that there was close to 325 mg of acetylsalicylic acid in that compressed tablet. With ginseng, it might be 30 mg; it might be 1000 mg. How do you make health decisions when you don’t know? Some herbs, as I indicated, cause side effects and can be toxic and cause allergic reactions or interactions with drugs. An important issue is what you’re giving up to take the herb. So let’s look at one of the most controversial current herbal products, ephedra, marketed for athletic performance and weight loss. The major current use of this product is in combination with caffeine. You should know that ephedra evolved in China as a short-term treatment for congestion, for colds, and ephedrine and pseudoephedrine (Sudafed), are the drugs purified from it that were shown to be the active ingredients. But in attempting to emulate venerable ancient practices, we’re losing the tradition, and we’re not using it the way the Chinese said 500 years ago it should be Complementary and Alternative Medicine Online Continuing Education Series NCCAM used. We’re using it long term and in different ways. We lead to this kind of headline about the death of a famous major league player and controversy in industry and academia, in public venues, and in the halls of Congress about ephedra-containing Let’s move ahead and talk about an herb where there’s some positive promise rather than problems. I’m going to talk about ginkgo biloba, and I’ll begin with this little cartoon on the left that some of you might have seen last year in the Washington Post. There was a study, published out of Massachusetts, showing that ginkgo biloba did not improve memory in individuals who already had normal memories. So this cartoon from Toles is really great. It shows a court scene. The prosecuting attorney is saying, “Don’t remember the outrageous claims you made for herbal remedies, huh? Well, perhaps this will refresh your memory.” And the defendant then says, “Well, actually, no. Ginkgo biloba won’t.” But the reality is there’s a whole series of studies suggesting that ginkgo extracts may slow decline of memory as we age. The data were sufficient for us to enlist, in partnership with 3 of our sister NIH institutes, 3076 otherwise healthy Americans aged 75 and up in a multi-year, randomized placebo-controlled trial, using very powerful brain imaging and neuropsychological testing measures to verify slippage of intellectual So we study herbal products. We look for its mechanisms of action and not just its clinical benefits. If the ginkgo study proved to be beneficial in slowing decline as we age, we would want to know why. Rather than wait for the end of that study, we have investigators at several universities taking apart ginkgo, examining its molecular activities. We also have a little menu of publications and good journals beginning to outline the exact biochemical pathways by which this product may work. We have a large study that was published a year ago. I’ve given much too much advertising to the Journal of the American Medical Association, but it’s at least a household term as a fairly credible venue. Our grantees published a report of 336 individuals with major depression of moderate severity, and said contrary to the claims of Complementary and Alternative Medicine Online Continuing Education Series NCCAM several articles, primarily from Western Europe in the 1990s, that St. John’s wort was not more effective than placebo. Now for mild depression, if you saw that chart earlier, we are doing additional studies. But in more severe forms of depression, there could be public health risks if you fail to place yourselves in the hands of an experienced mental health practitioner, make a good diagnosis, and use good therapies. So the issue of what you’re giving up is important. Part of the reason we started this study with the more serious side of depression, is because the cost of missing effective therapy would be great. But we’ve proven in this study that it is not as beneficial as we imagined. But again, as I said earlier, as long as it doesn’t have side effects, people are willing to hedge But here’s a cost that we hadn’t predicted. A colleague who is here at the NIH, Steve Piscatelli, a research pharmacologist, and my collaborators and colleagues in the Allergy and Infectious Disease Institute AIDS Clinic, Dr. Judy Faloon and her colleagues, noted that many of our AIDS patients take dietary supplements. They wanted to know whether dietary supplements could interfere with the activity of their AIDS drugs— drugs that we know have prolonged and extended their lives. And in the British journal, The Lancet, in February 2000, they published this data. Let me just go over this graphic for you. This bar is the level of an important AIDS drug known as Indinavir that you would get if you took the standard dose of that drug. This is the level of that same drug if in addition to the drug Indinavir, you take, every day, the dose of St. John’s wort used in our depression study. We have funded other investigators who have actually worked out the mechanism, the exact enzyme in the intestine and the liver, and the genetic pathway by which a single chemical known as hyperforin in St. John’s wort upregulates this. It turns out that St. John’s wort affects the metabolism of approximately 50% of all prescription drugs used


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