By Judy Steeh
U-M News and Information Services

Come on, 'fess up. During your last visit to the doctor, did you mention the echinacea you take to ward off colds, or the St. John's Wort that helps you maintain mental equilibrium, or the ginger tea you're drinking to calm your tummy? Probably not. According to U-M anesthesiologist Dr. Michael O'Reilly, a survey reported that almost half of adults in the United States regularly take at least one vitamin, herb, mineral or over-the-counter supplement, but most of them don't tell their physicians. "They felt their doctors would know little or nothing about the supplements and might be biased against them," says O'Reilly, an anesthesiologist at the U-M Medical School.

If there's a reluctance to mention over-the-counter supplements, people are even less likely to talk about more unconventional treatments, like hypnosis, magnetic devices, relaxation techniques or various massage therapies. But in the last year, Americans spent some $35 billion on drugs or procedures that the medical establishment labels "complementary or alternative medicine" (CAM), and use of these alternatives has grown steadily over recent decades.

The area covered by that blanket term, CAM, is huge. The National Institutes of Health divides alternative medicine systems into a number of categories:

Homeopathy, in which practitioners treat disease using drugs which, given to a healthy person in minute doses, would produce symptoms similar to those of the disease.

Naturopathy and traditional folk-based, which view disease as a disruption in the process by which the body naturally heals itself. Practitioners use a variety of techniques aimed at restoring health rather than treating disease. Includes approaches such as qigong (pronounced chi-gong) in China, or reiki (ray-key) in Japan.

Body-based, such as chiropractic, acupuncture or massage.

Mind-body systems like hypnosis, biofeedback and meditation.

Biologically based pharmacological, herbal and/or nutritional regimes, including commercial diets, used to prevent or control illness as well as to promote health. Also unconventional medications like chelation, bee venom, shark cartilage, etc.

Bioelectromagnetic (use of magnets or delivery of electromagnetic currents).

After decades of denouncing most unconventional treatments as quackery, the allopathic medical establishment (see box below) is slowly but surely coming to terms with CAM.

CAM medicine is "complementary and alternative" to allopathic medicine. Allopathy is the modern Western approach to medicine, based on scientific testing and reporting. It arose early in the 20th century as a system of "fighting" the agents of the disease being treated with countering remedies, as distinct from homeopathy a system of treating diseases with minute amounts of agents similar to the ones causing the disease. What we think of as "medicine" today—the surgical, radiological, anesthetic, epidemiological, imaging, pharmacological and other therapies—derived from allopathic medicine. Homeopathy, by contrast, became associated with what are often termed "natural healing" practices.

Photo by Bill Wood, U-M Photo Services
Validation is the key to use of any alternative medical therapies at U-M Health System, say Drs. Warber (left) and Bolling, co-directors of the Complementary and Alternative Medicine Research Center.

In 1993. the Office of Alternative Medicine was established, and in 1998 Congress elevated it to the National Center for Complementary and Alternative Medicine at the National Institutes of Health (NIH). That year saw 75 out of 117 medical schools in the United States offer elective courses in CAM or include CAM topics in required courses. And 1998 also marked the establishment-with NIH funds that went to only a few other such units nationwide-of the U-M Complementary and Alternative Medicine Research Center by the U-M Health System. Dr. Steven Bolling, professor of cardiac surgery, heads the center with co-director Dr. Sara Warber, lecturer in family medicine, and their departments share its administration.

Is this sudden interest in CAM generated by that $35 billion in consumer spending? "Of course," Bolling says. "This is America, and money is a great motivator. If it was a $350-a-year industry, no one would pay any attention at all."

But Bolling is quick to point out another reason why that $35 billion is important. "It reflects the huge population that has embraced CAM in one form or another. Most of our patients are using some alternative therapies or medications, and many won't tell us about them," he says. "Maybe they're afraid they'll be laughed at, or argued with. Maybe they just forget to mention them. Whatever the reason, we can't treat them effectively if we don't know what they're doing, and especially if we don't know how what they're doing might affect the more conventional therapies we're prescribing."

Photo by Bill Wood, U-M Photo Services
'Read my lips: herbs are drugs!' says Paul, former dean of the College of Pharmacy.

The problem that concerns many in the medical and nursing professions is that no one has studied most alternative medical practices and supplements in detail. But where once there was scarcely any, there is now a growing body of scientific evidence about the efficacy of some alternative treatments and their interaction with treatments prescribed by a physician. One person who worries about possible conflicts between herbal medicines and traditional treatments is Ara G. Paul, dean emeritus of the College of Pharmacy. Paul began teaching a class in natural products in 1957, long before CAM became popular. "The chemistry of natural products has always intrigued me," he says. His course looks at natural products in a scientific way, using herbal remedies that are on the market as examples and relating them back to prescription drugs. "We also talk about ethnopharmacology, getting students from different countries or backgrounds to talk about what they or their grandparents use in their homes," Paul says.

A big question about many "natural herbal" supplements now flooding the market is, what is their quality? With no controls on their preparation (Congress classified them as dietary supplements in 1994 rather than medicines, thereby removing them from regulatory oversight), the amount of active ingredients they contain can vary widely. In fact, many supplements don't contain what they say they do or not in the amounts claimed. In addition, patients may overdose, because with no guidance they believe that more must be better and that "natural" automatically means safe.

Quite the contrary, says Paul, who believes strongly that herbs should be standardized and regulated as drugs, just as other prescription and over-the-counter remedies are. If there's one message he wants people to have, it's that "there's no line you can draw between herbs and drugs. Read my lips: Herbs are drugs! They have side effects, they interact with food, other drugs and each other, and some of those interactions can have serious consequences. Many people are aware of this, but many more aren't, and I'm afraid that includes too many health care practitioners."

Warber said the NIH funded CAM centers specifically to address these and similar concerns. "The goal was to generate interest in CAM in the research community and begin to establish baseline research on some of the CAM therapies," she says. The U-M center was established with a five-year, $6.7 million grant to investigate CAM therapies that might help prevent, manage and treat cardiovascular disease and its associated conditions. Other funding comes from the American Academy of Family Practice and the Women's Health Division of the Food and Drug Administration.

Three tests against placebos
"There is a tremendous opportunity to improve a patient's quality of life and save money using validated CAM therapies," says Warber, who is also a lecturer in family medicine. But, she notes, validation is the key. "It's essential to use scientifically rigorous research methods to assess these therapies, in order to determine their effectiveness and safety," she says. "Our goal is to bring people together to create the intellectual trust fund necessary to complete the tasks we've set ourselves."

Bolling agrees. "In the Orient they say, 'We've been doing [qigong] for five thousand years and it works, so just get on with it.' But in the West we need the whole range of research trials with rigorous controls. Right now, acceptance of CAM therapies is low in the medical community. That's exactly as it should be, because we have no idea about most of those therapies-whether they help, hurt or are neutral for our patients."

The U-M center is conducting three randomized, blind, placebo-controlled clinical trials in cooperation with a number of departments within the Medical School (Cardiac Surgery, Family Medicine, Endocrinology and Cardiology) and across campus (including Psychology, Biology and the schools of Nursing, Pharmacy and Public Health), as well as with community practitioners.

Hawthorn and the heart
The herb hawthorn, with active constituents that include flavonoid pigments and procyanidin pigments in its flowers, berries and leaves, is said to lower blood pressure and cholesterol. The CAM hawthorn study, the "most scientific" of the three, according to Bolling, examines a dietary supplement extracted from the flowers and leaves of the hawthorn tree as a treatment for congestive heart failure. Headed by Dr. Keith Aaronson, assistant professor of internal medicine, and Suzanne Zick, a research investigator in the Department of Family Medicine, the project involves researchers ranging from world-renowned scholars to undergraduates from the U-M Health System, the College of Pharmacy, and LS&A (Biology).

Photo by Bill Wood, U-M Photo Services
If hawthorn's circulatory benefits are proven and controllable, Kaufmann envisages 'growing hawthorn plants in urban environments, with robots tending the crops on rooftops.' He has great hopes for the invasive kudzu weed as well.

Biology Professor Emeritus Peter Kaufmann explains that the hawthorn project is a double-blind, randomized, controlled trial of patients with congestive heart failure. (In a blind study, patients don't know whether they are taking the test drug or a placebo. In a double-blind study, the researchers don't know either.) "We've got 72 patients now and hope to get 120," Kaufmann says. Patients who are taking digoxin (a standard commercial preparation) are excluded. Patients are interviewed to obtain their medical histories and given several tests-a six-minute walk test, blood tests, an electrocardiogram and an exercise test.

In another phase of the study Kaufmann and his team, which includes a number of undergraduates, are analyzing hawthorn caplets from a company in Germany, where the drug is taken much more than in the United States. Their aim is to establish a consistent standard and also to compare the German product to hawthorn preparations available here. In addition they are testing to identify which, if any, of the 150 active ingredients in hawthorn may be effective in lowering blood pressure and cholesterol, and using chromatography to measure varying amounts of those constituents in the plant's flowers, leaves and fruits.

According to Warber, the researchers will complete data collection in 2002 and analyze their data the following year.