Sorting Claims from Facts About CAM

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If you are a health care provider, your patients are likely asking you questions about the use of complementary and alternative medicine. How can you advise them and help them distinguish between CAM therapies that have good-quality research on effectiveness and safety, and those with claims that may be attractive but are not evidence-based? What should you consider when you counsel patients about CAM? In this article we discuss CAM and cancer, but the information resources apply to many other conditions.

Case in Point: Cancer and CAM

CAM use for cancer is substantial, although estimates vary widely. A large 2002 national survey on CAM found that about 40 percent of the respondents with a cancer diagnosis reported using CAM. The National Cancer Institute (NCI) and NCCAM both support large programs of research intended to build an evidence base that will inform this use. Two ways health care providers can be most helpful to their patients are to encourage open communication about CAM therapies and to find out where to turn for reliable, evidence-based information.

Encouraging Open Communication

"It is very important for health care providers to create an environment, as well as a relationship with their patients, in which they can talk freely about all treatment options, whether CAM or conventional," says Josephine P. Briggs, M.D., Director of NCCAM. "I also believe that health care providers need to convey their understanding of the evidence and advise patients accordingly, even if they are not always in agreement."

Questions To Consider

Patrick J. Mansky, M.D., who is trained both in medical and pediatric oncology and in selected CAM therapies, was the first Director of NCCAM's Complementary and Integrative Medicine Consult Service at the NIH Clinical Center before he joined the Cancer Team at Bellin Health in February 2009.

Resource Tip

"About Herbs, Botanicals, and Other Products" is an evidence-based, searchable database of the Memorial Sloan-Kettering Cancer Center Integrative Medicine Service, at www.mskcc.org/mskcc/html/11570.cfm. NCCAM's Center for Botanical Immunomodulators, a research center, is located at this institution. Partnering institutions on the center are Memorial Sloan-Kettering, Weill Medical College of Cornell University, The Rockefeller University, and the Institute of Chinese Medicine at the Chinese University of Hong Kong.

When he has a patient who is interested in CAM therapies, Dr. Mansky asks the following questions:

Doctor and patient
Dr. Mansky examines a patient at the NIH Clinical Center

What does the therapy consist of?
Why is the patient interested in trying a CAM therapy? Does she think that her current care is adequate? Does she want to add a treatment or make a switch? Is it an issue of side effects?
Where did the patient hear about the therapy—on the Internet, for example, or from another health care practitioner, a family member or friend, an advocacy organization, etc.?
Has there been any research published on it? If there are study results, who sponsored the study or studies, are the results freely available, and where were they published (in a peer-reviewed journal or not)?

"It is very important for health care providers to create an environment, as well as a relationship with their patients, in which they can talk freely about all treatment options."
—Dr. Josephine P. Briggs

Is There Evidence?

"No health care provider can be knowledgeable about every CAM therapy and claim out there," Dr. Mansky says. "Sometimes my answer to patients is that I need to do some research and get back to them. For cancer patients, I turn first to NIH Web sites—including those of NCCAM, the National Cancer Institute, the Office of Dietary Supplements, and the National Library of Medicine's PubMed database. There are also large cancer centers that are affiliated with teaching hospitals [e.g., see box at left] and have developed and posted information. "Many or even most CAM treatments that people hear about or get excited about, however, have not yet been studied for effectiveness and safety," he continues. "Even if there is only a preliminary study or two, it might be at least somewhat helpful. In these cases I offer an honest assessment of the evidence and make the best recommendation I can, making sure that I provide the very best evidence-based care available and keeping the patient's safety a top priority."

Considering Safety

Herbal and other dietary supplements are an area in which safety needs to be looked at carefully. "While many beneficial drugs have been made from plants," Dr. Mansky says, "there are other plants or plant parts that are poisonous or potentially harmful. Many botanicals are pharmacologically active and can interact with conventional drugs or each other. 'Natural' does not equal 'safe.' "

Another major concern is about the use of CAM delaying or interfering with proven, beneficial treatments. For example, some herbs can enhance the blood-thinning effects of drugs such as aspirin or Coumadin. That could increase the risk of bleeding in a patient who is undergoing surgery or receiving chemotherapy that reduces platelet count. High doses of vitamins can significantly interact with chemotherapy and radiation.

Herbal and other dietary supplements are an area in which safety needs to be looked at carefully.

The bottom line, Dr. Mansky says, is that "when I am consulted about CAM, I try to make sure that my patients know that they can talk with me about it. I will do my best to put what is known about the therapy into perspective, help my patients to understand whether the claims are founded, and advise on whether I think it is in their best interests to use it."

FDA and FTC Act on Unsupported Claims

There are many reasons to be concerned about unsupported or even fraudulent therapeutic claims in the field of cancer. The U.S. Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) have major initiatives to address these concerns.

In September 2008, the FDA announced that it had issued warning letters to 28 U.S. companies and 2 foreign individuals to stop them from selling what it calls "fake cancer 'cures.'" It also warned consumers to stop using them. The 187 products listed include tablets, teas, tonics, black salves (a type of corrosive ointment), and creams that have been sold under various names on the Internet. Because they have not been shown to be safe and effective for their labeled use to cure, treat, mitigate, or prevent disease, the FDA says, they are being marketed as unapproved new drugs and thus are violating the law.

Also in September, the FTC announced an initiative called "Operation False Cures." The agency pursued 11 law enforcement actions against companies, some of which it said were also falsely claiming clinical or scientific proof for their product(s) marketed to treat cancer. These consisted of some Essiac teas and other herbal mixtures, laetrile, black salves, and some mushroom extracts.

For More Information

NCCAM

Thinking About Complementary and Alternative Medicine: A Guide for People with Cancer (coproduced with the National Cancer Institute): www.cancer.gov/cancertopics/thinking-about-CAM
Time to Talk educational campaign (free toolkits available): nccam.nih.gov/timetotalk
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