ARLINGTON, VaThe 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 guidanceparticularly 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,
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. Johns wort (hypericum), a
dietary supplement used as an antidepressant.
A study in the British Medical Journal showed that St.
Johns 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. Johns wort also reduced the action
of certain protease inhibitors, immunosuppressive drugs, and birth
If were 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 cant 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 NCCAMs 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.
NCCAMs 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 womens 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. Johns 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