Wednesday, May 18, 2005

Statistically Significant

As one of our regular readers , you know that I explore and discuss complementary and alternative medicine right along with what is coming down the mainstream medical pipeline, since achieving optimum health sometimes - indeed often - requires traveling several paths. Although modern medicine thankfully offers us a great deal in both acute and chronic care, the practitioners of naturopathy and other alternative therapies also have many ways to treat and teach. Their drugs are born not in pharmaceutical houses, but through research of nature's effective tonics and medicines over the course of many centuries. The big question I hear frequently from readers is about the validity of the naturopathic practitioners' claims and advice. They want to know: Where's the evidence? There aren't any big studies on this "stuff." Before I address this question, here is a brief reminder about the safety of prescription medications: As we all know, pharmaceutical manufacturers put their drugs to the test through the gold standard of drug testing -- lengthy controlled clinical trials. In spite of these measures, how many headlines have we seen in just the last six or eight months that reversed the drug safety these trials had supposedly established? Vioxx anyone? How about Celebrex? In late February, the manufacturer of the just-released drug Tysabri (natalizumab), intended to reduce multiple sclerosis relapses, withdrew it from the marketplace. The reason? Several patients taking it developed a rare neurological disease -- one patient with fatal results. My purpose is not to say that prescription drugs are bad -- far from it. Rather, it is to point out that even rigorous testing of the most promising drugs can't and doesn't prove absolute safety over the long term. And what gets reported to the public is not necessarily the entire truth, which is why the FDA is now revising regulations on full disclosure of research results. Which brings me to natural products and the level of safety and efficacy consumers can assume for them. To help me out on this, I called Michael Traub, ND, past president of the American Association of Naturopathic Physicians (AANP), chair of the AANP's Scientific Affairs Committee as well as director of the Lokahi Health Center of integrated care. When I explained the readers' concern, Dr. Traub responded that he applauds questioning of medications in general, whether prescription or natural. He feels it is always good to have heightened awareness about any medication you might take. For example, a few years ago, in spite of years of successful use of the kava herb, some people in Europe developed liver problems while using it. Dr. Traub and other practitioners used their concern to energize further investigation. In time they discovered that these patients had preexisting conditions or were taking additional medications that challenged the liver, so the additional work of processing the kava "overloaded" it. Furthermore, the research showed that the patients were ingesting parts of the kava plant not traditionally used. Dr. Traub's and others' suspicions about the plant paid off by seeing to it that kava was used as originally -- and safely -- intended. Dr. Traub says that there are two important points to be made about drug testing. The first concerns prescription drugs and the dangerous side effects that don't necessarily show up in clinical trials. The reason, he says, is that even though testing involves large numbers of people, certain side effects will not show up until many more people -- even millions -- are taking the drug in question. With the number of users having expanded exponentially, any potentially dangerous side effects a drug may have are bound to eventually surface. The second point concerns complementary, or traditional, medications. Dr. Traub says that when people assume there isn't much scientific evidence backing these medications, they are flat-out wrong. The problem is that most doctors -- and people in the media who report on medical studies -- generally read the high-profile medical journals, such as New England Journal of Medicine (NEJM) and Journal of the American Medical Association (JAMA). Doctors often also read one or two journals that are specific to their own specialty. However, most studies of natural medications do not appear in these well-read publications. Rather, they appear in lesser-known specialty medical journals targeted to the naturopathic specialists, rendering the studies virtually unknown to the general public and mainstream doctors. This holds true even though they are peer reviewed in the same way as the more visible studies... and despite the reams and reams of well-designed and well-conducted research. Although most studies on natural materials do not have the huge sample size paid for by the pharmaceutical companies, many are indeed similar in size to a lot of mainstream studies. Remember, too, that these studies are in addition to the large quantity of anecdotal and observed evidence of natural medications that has accumulated over many, many years of product use. Where, then, does this leave you as a concerned health-care consumer? Dr. Traub's reminder is to be both wary and careful. He points out that no medication is harmless -- even over-the-counter products of all types can have serious side effects when used improperly. Most importantly, Dr. Traub recommends that you always choose health-care practitioners who have sophisticated understanding of your specific medical condition(s) and needs and how the medication in question works. Be confident of your right to question the information available to you... as well as your right to seek out and create a team of knowledgeable professionals in both mainstream and traditional medicines who can work together to find out what is right for you.

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