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Mainstreaming CAM

The unconventional cancer therapy boom challenges researchers to

improve studies

By Steve Bunk

in The Scientist 15[24]:1, Dec. 10, 2001

 

In biomedical research, is the " gold standard " of controlled studies

that analyze individual therapies the only way to get trustworthy

results? That question is central to what has arguably become

America's most profound public health development: the boom in

complementary and alternative medicine (CAM).

 

That question also was pondered frequently at the fourth annual

Comprehensive Cancer Care Conference recently in Arlington, Va.

Cosponsored by the nonprofit Center for Mind-Body Medicine in

Washington, D.C., and the University of Texas Medical School at

Houston, the meeting drew an audience of more than 1,200 to hear

about the inroads CAM is forging, and the roadblocks it is

encountering, en route to the goal of acceptance by mainstream

science.

 

" The reason there is as much interest in complementary medicine as

there is, is not because of the science, " according to James S.

Gordon, a professor of psychiatry and family medicine at Georgetown

University and founding director of the Center for Mind-Body

Medicine. " The moving force has been us. " He means the general

public and practitioners have led the push. In terms of government-

funded CAM research, Gordon believes that cancer is where the best

progress has been made to date.

 

CAM's popularity is widespread, according to most estimates. For

example, an oft-cited paper based on a national telephone survey of

2,055 adult Americans places CAM use at 42 percent.1 This

extrapolates to 83 million people, who spend $27 billion out-of-

pocket on such therapies. However, at least one large survey

disputes such figures. A paper based on a written national survey of

16,068 adults shows that only about 8 percent use unconventional

therapies.2 Regarding cancer, a survey of 453 outpatients reveals

that 69 percent used CAM treatments, excluding spiritual practices

and psychotherapy.3

 

Despite the generally strong evidence of public demand, CAM

practitioners are aware that the skepticism of mainstream medical

science is far from overcome. Harvard University medicine professor

David S. Rosenthal wryly recalls the comment of a colleague upon

hearing that he would be heading the Zakim Center for Integrated

Therapies at the Dana Farber Cancer Institute in Boston: " Oh,

Rosenthal. So now you're going to be giving antioxidants and

enemas. " By the same token, he remembers attending an American

Cancer Society (ACS) meeting on " quackery. " In following years, the

meeting was titled " questionable methods, " then it became " unproven

therapies, " before ACS finally adopted " CAM, " with its emphasis on

treatments that either complement or are alternatives to

conventional ones. Now, he observes, a popular term is " integrated

therapies " that are combined with mainstream modalities.

 

Burden of Proof

A major obstacle to integration of CAM into medical science is the

burden of proof. CAM advocates seem to disagree on whether to focus

on standard trials that test one intervention at a time, or to

emphasize new trial designs that begin with " best case " scenarios

taken from practices that use mainstream and CAM methods in

combination. In the best case format, the effectiveness of certain

modalities used together is first determined in the clinic, then

tested in controlled trials as a group of treatments rather than

singly. " CAM research can be just as good as non-CAM research,

whether we study shark cartilage or [natural] angiogenesis

inhibitors, " Rosenthal declares.

 

Stanford University School of Medicine psychiatry and behavioral

sciences professor David Spiegel affirms, " If we're going to be

accepted by mainstream medicine, we have to use the tools of

mainstream medicine, which is science. " Spiegel, whose work concerns

the effects of psychosocial treatment on cancer survival, adds that

although all the answers won't be delivered by using conventional

trial design, the established way of doing research must be

respected.

 

Gordon agrees, but he also argues that the reductive study of

isolated therapies is too slow and is irrelevant because CAM

treatments are administered in combination. Research must be

conducted on integrated approaches, as well as on treatments that

are individualized, such as Chinese herbs prepared for a particular

patient's needs. " This is crucial, " he insists. " This may represent

one of the most profound shifts. ... We're talking about a

fundamental sea change in the way we look at medicine and health

care. "

 

" I don't think you can do evidence-based practice without doing

effectiveness studies, " comments Ian D. Coulter, principal

investigator of the Southern California Evidence-Based Practice

Center CAM project. It's one of 12 centers nationally that develop

CAM " evidence reports " for the government. He conducts extensive

patient records analysis, including interviews with clinicians,

aimed at identifying best case models that warrant further study

because of treatment results achieved. " We shouldn't be too

apologetic that there are other ways of doing research, " Coulter

muses.

 

He advocates increased effort toward understanding what works in CAM

practices, for what kinds of patients, and the qualities of

effective physicians. Relatively few practitioners have participated

since the best case series began in 1997, he acknowledges. Political

factors are at stake, such as licensing issues, fear of prosecution,

or ridicule by peers. Coulter, who was trained in economics and

political science before embarking on a long career in CAM research,

notes that the social sciences faced criticisms of lack of

scientific rigor and responded with an array of methodologies and

measures. He believes all science is, in part, political. " I think

you have to build trust, " he says of reluctant CAM therapists. " It's

not the only issue, though. I think the other issue is that the

magnitude of the task overwhelms them. "

 

Jeffrey D. White, director of the National Cancer Institute's office

of cancer complementary and alternative medicine, is working with

NCCAM director Stephen E. Straus to uncover anecdotal evidence of

useful CAM therapies and move them into clinical trials. " We're

trying to develop a real dialogue with CAM practitioners, " White

declares.

 

Mary Ann Richardson, a program director at NCCAM, points out that

the center has funded integrative medicine programs, but there's a

catch: " You really need to show evidence [of effectiveness]. And

it's difficult when you have a whole group of things. " The trials

that NCCAM funds extend from the preclinical phase to full-scale

Phase III efforts, she adds. (See " CAM Cancer Research Grows " ).

 

Commission Highlights Self-Care

Gordon, who chairs the White House Commission on Complementary and

Alternative Medicine Policy, decries the " homeopathic level " of

funding for disease prevention. He says that wellness or self-care

has become a major focus of the commission's work. Established last

year by former President Bill Clinton, the commission issued a

progress report in September and is charged with filing its final

report by March 7, 2002. Recommendations are still being formulated,

but Gordon says the commission is operating on principles that

include: an emphasis on health promotion and a belief that self-care

should be integral to the nation's health care system; respect for

the body's self-healing capacities; attention to physical, mental,

emotional, environmental, and spiritual impacts on health; and an

appreciation of each patient's unique needs.

 

He also says the commission advocates increased information in lay

language about CAM research findings. " The ultimate goal is to

educate ourselves and other people, so we can discriminate between

what makes sense and what doesn't. " He adds, " We believe very

strongly that there should be large-scale demonstration projects of

CAM services, particularly for people of low income in community

health center settings. " Ultimately, he concludes, " We're talking

about giving power back to the people who come for their health

care. "

 

 

References

1. D.M. Eisenberg et al., " Trends in alternative medicine use in the

United States, 1990-1997: results of a follow-up national survey, "

Journal of the American Medical Association, 280:1569-75, 1998.

 

2. B.G. Druss and R.A. Rosenheck, " Association between use of

unconventional therapies and conventional medical services, " Journal

of the American Medical Association, 282:651-6, 1999.

 

3. M.A. Richardson et al., " Complementary/alternative medicine use

in a comprehensive cancer center and the implications for oncology, "

Journal of Clinical Oncology, 18:2505-14, 2000.

 

 

For More Information

National Center for Complementary and Alternative Medicine

nccam.nih.gov

 

White House Commission on Complementary and Alternative Medicine

Policy

whccamp.hhs.gov

 

 

CAM Cancer Research Grows

In 2001, the National Institutes of Health plans to fund more than

$220 million in CAM research and training. The lead agency, the

National Center for Complementary and Alternative Medicine (NCCAM),

has a $89 million budget that will top $100 million next year. It is

currently funding more than 50 CAM projects on cancer treatment.

Most involve biologics, which are roughly halved between herbal and

pharmacological remedies. Among substances being studied are plant

estrogens, skull cap for skin cancer, and ginkgo biloba for brain

cancer.

At the University of Hawaii, a fruit extract from the Indian

mulberry (Morinda citifolia) is in a Phase I trial to treat

incurable, late-stage cancers. The extract, called noni, is a

popular food supplement among native Hawaiians and other Pacific

Island and Asian cultures. At Stanford University, soy isoflavones

are being studied to treat prostate, breast, and bone cancer. At

Columbia Presbyterian Medical Center in New York, a trial is being

conducted of a complex nutritional regimen that includes coffee

enemas to treat pancreatic cancer.

 

Other studies funded by NCCAM embrace work on " alternative systems, "

including massage therapy, various forms of energy healing, music

therapy, and mind-body interventions such as guided imagery and

meditation. One example is a trial at Dana Farber Cancer Institute

in Boston, assessing acupuncture's ability to ease pain and nausea

while improving quality of life in about 40 patients with advanced

ovarian cancer.

 

Two free-standing specialty research centers, at Johns Hopkins

University and the University of Pennsylvania, have been funded for

a total of $8 million over five years to study CAM cancer therapies.

The National Cancer Institute and NCCAM have also jointly funded

five leading American cancer centers to study CAM treatments.

 

--Steve Bunk