Straus, Director of NCCAM, Outlines Research Priorities

ARLINGTON, Va—The National Center for Complementary and Alternative Medicine (NCCAM), a division of the National Institutes of Health, has undertaken the task of making a science out of complementary and alternative medicine (CAM).

“Our job is to take a movement and change it to a discipline,” Stephen E. Straus, MD, director of NCCAM, said at the Comprehensive Cancer Care 2000 conference. Dr. Straus pointed to studies showing that 40% of all Americans and 80% of those diagnosed with cancer have an interest in CAM approaches.

“Some of these practices are beneficial and some are not,” he said. “Some are safe and some may not be. The American people are tired of being without competent guidance—particularly when faced with a challenging moment like a new diagnosis of cancer. That is the point at which you need competent information, and NIH is trying to provide it.”

Dr. Straus, who has worked as a research internist and infectious disease immunologist at NIH, said that he brings to the office “not a knowledge of the thousands of CAM approaches but an understanding of how to look at an emerging area in a cohesive, organized way to obtain rigorous data.”

He noted that most CAM practices and their application to cancer are adjunctive to conventional care. Only a minority of CAM uses, he said, serve as an alternative to conventional care. For many patients, CAM provides hope for wellness and the relief of symptoms, he noted.

But Dr. Straus is concerned that, at present, CAM too often lacks the breadth and depth of the scientific underpinnings of conventional medicine. He cited the example of St. John’s wort (hypericum), a dietary supplement used as an antidepressant.

A study in the British Medical Journal showed that St. John’s wort had efficacy similar to imipramine and was better than a placebo. However, another study released 3 months later in The Lancet showed that St. John’s wort also reduced the action of certain protease inhibitors, immunosuppressive drugs, and birth control pills.

“If we’re going to take natural products seriously, we have to understand what else they do in a comprehensive way,” Dr. Straus said. “Any biologically active product affects the basic chemistry of the body and so may also have adverse effects that were previously unknown. People can’t assume that just because something is natural that it must be safe and good for you, and that more is better.”

Determining just which CAM options are “good for you” is the focus of NCCAM’s research agenda, he said. Currently, his office is funding studies into the effects of magnetic fields on cancer cell growth and the effectiveness of traditional Chinese medicine on uterine fibroids and breast cancer, for example.

NCCAM has also provided $1.4 million for a 5-year clinical study by Nicholas Gonzalez, MD, using enzymes, dietary supplements, and coffee enemas to treat advanced pancreatic cancer.

Dr. Straus said that the same hierarchy of evidence that applies to conventional medical studies should be used in any CAM research. While anecdotal evidence or observational studies might suggest research directions, he said, large, randomized controlled trials ultimately must be performed to test efficacy.

NCCAM’s research priorities are developed by looking first at the most credible preliminary data, then considering the opportunity to learn new science and the public health implications.

Simpler study designs that could be carried out at reasonable cost would also be considered favorably, he said.

NCCAM provides funding to 11 centers to evaluate CAM treatments for addictions, aging and women’s health, arthritis, cardiovascular disease, cardiovascular disease and aging in the black population, chiropractic, craniofacial disorders, neurological disorders, pediatrics, as well as two botanical centers.

Why CAM Trials Are Difficult

A number of issues make studying CAM therapies more difficult than studying conventional therapies, Dr. Straus said. Many CAM treatments are individualized to each patient and involve a variety of substances, not just a single herb. Test materials in CAM may be highly variable in composition, and consistency among practitioners is often variable, too. Thus, treatment approaches considered for study must be ones that can be taught and used widely. Finally, controls are often difficult to arrange. “How do you placebo massage?” he asked.

Dr. Straus commented that “people buy botanicals like they buy wine. If it has a fancy label and costs more, it must be good. But many products lack purity, stability, and bioavailability. They are not standardized or made with good manufacturing practices. We need investigative new drug exemptions from the FDA just to study them.”

NCCAM is working with other NIH institutes and centers to fund studies of St. John’s wort for depression, gingko biloba for dementia, acupuncture for pain relief in osteoarthritis, glucosamine/chondroitin sulfate for osteoarthritis, and shark cartilage for lung cancer.

Dr. Straus noted that HMOs often provide CAM services because of payer demand or state mandates, not for good public policy reasons: “Only 8% do so because they are persuaded that these methods are clinically effective.”