As a practicing physician, I would enthusiastically welcome any complementary or alternative product or practice that is proven to be effective.
As you have heard or will hear from other members of the panel, the major problems with CAM are well recognized: Most CAM products and practices are either untested or their use is based on unreliable research. Nonetheless, they are aggressively promoted, usually with guarantees of success. Yet any experienced physician knows that no treatment or procedure is always effective. These promotions and promises mean that patients may not only waste money on unproven measures, but also fail to seek medical attention and obtain effective medications or procedures for illnesses that may have serious consequences.
People are urged to use CAM products because they are "natural," apparently forgetting that poison ivy, floods, hurricanes and tornadoes prove that natural isn't necessarily good. Because CAM products are unregulated, patients can be subjected to serious risks. Studies have shown that a number of herbal products contain toxic constituents or contaminants.
One example of CAM is chelation therapy, which involves a course of 2 to 3 weekly, 2-hour long intravenous infusions of EDTA for a total of 30 treatments. Originally, chelation was said to improve atherosclerosis by removing calcium from plaques in the arterial wall. Now, chelation therapy is reputed to improve angina and painful peripheral vascular disease by binding heavy metals that cause damage by enhancing the oxidation of tissues and blood proteins.
However, there is no data to support either theoretical benefit and no properly controlled study supports the effectiveness of chelation therapy. By contrast, in two randomized, blinded studies, done in Scandinavia and New Zealand on patients with peripheral vascular disease, researchers injected either EDTA or saline alone in a control group. After treatment, there were no differences between the EDTA group and the control group in how long they could walk on a treadmill before developing leg pain. A recent Canadian study of 80 angina patients, reported this March at a meeting of the American College of Cardiology, found no differences between the EDTA and control groups in how long they could walk on a treadmill before developing ischemic changes on an electrocardiogram.
In all three studies, patients in both the EDTA and control groups had modest improvements in how long they could walk before developing leg pain or angina. These findings emphasize the critical importance of a control group in studies of chelation, or any other CAM product or procedure.
In the Canadian study, at the end of one year of follow-up, there were no deaths and one heart attack in subjects from each group. Nine patients from the EDTA group and six from the control group had been hospitalized for treatment of angina. On questionnaires, patients in both groups reported similar improvements in angina and a better quality of life after the treatments. Chelation patients often feel they were improved by the treatment; but I suspect that anyone in this audience would tell their doctors they were better, and indeed believe they were improved, after they underwent 30 intravenous infusions and spent about $5000 out-of-pocket.
Most distressing to me is the statement made in response to the Canadian study by a past president of the American College for Advancement in Medicine, who is quoted as saying, "I've been doing it for 18 years and have seen some dramatic differences. I've been really impressed with it." He also said that 75% of his patients respond and are able to walk farther and have less chest pain.
His reaction raises the concern that CAM practitioners will not accept the negative results of scientifically valid studies and alter their practices accordingly. If that is true, properly conducted research by either CAM investigators or NIH-supported investigators at academic institutions will only be a waste of time and money.
Quite frankly, I cannot believe how any practitioner who is truly interested in the welfare of his or her patients can continue to practice chelation therapy.
A second question we were asked to address is: How can valid research study the complex issues inherent in CAM research? An editorial in JAMA stated: "advocates of alternative medicine argue that many alternative therapies cannot be subjected to the standard scientific methods, and thus, instead must rely on anecdotes, beliefs, theories, testimonials, and opinions to support effectiveness and justify continued use."
I disagree completely with this argument. The problems associated with CAM research are inherently no different than those faced in other areas of clinical research. What is needed is some ingenuity, the design of carefully controlled studies, and the willingness of investigators to roll up their sleeves and do the work.
CAM research requires large well-controlled studies which provide
scientific evidence that either supports or rejects the value
of all CAM products, such as herbs and vitamins, as well as procedures,
like chelation and therapeutic touch. Such studies on safety and
efficacy must be done before marketing and promotion of
products because it would exorbitantly expensive for government
agencies to fund such studies on every product or procedure that
imaginative and entreprenurial people can think of to sell to
gullible members of the public. I have heard, for example, that
the NIH may feel compelled to use taxpayer money to fund yet another
study on chelation therapy despite the lack of any evidence to
support it and the completion of three studies showing no benefit.
The health-food industry is doing well and can afford to do such studies before products and procedures are promoted or marketed. The failure to carry out such studies means that the public will lose out on two scores:
The Commission should urge Congress to revise the Dietary Supplement and Health Education Act of 1994 so that the FDA has some control over CAM products and procedures.
The Commission and CAM practitioners must accept and act appropriately when the results of sound studies prove that a CAM product or practice is ineffective or dangerous.
Dr. Margolis is Professor of Medicine and Biological Chemistry at Johns Hopkins School of Medicine.