Does the Rising Use of Complementary and Alternative Medicine Change the Rules for Informed Consent?

Gwen Mayes, JD, MMSc


June 30, 2004

The cover story for the June issue of HEALTH magazine, a popular consumer magazine for women, speaks volumes about today's expectations of healthcare consumers: "Feel Great Naturally – 16 Alternative Remedies That Really Work!"

Study after study indicates that increasingly, Americans are turning to alternative forms of therapies to treat everything from the common cold to depression. According to a new nationwide survey,[1] approximately one third of US adults aged 18 years or older use some form of CAM. Defined as a group of diverse medical and healthcare systems, practices, and products that are not presently considered part of conventional medicine, CAM includes therapies, such as acupuncture and yoga, and supplements, such as plant derivatives and minerals.

Although the study did not address the efficacy and safety of CAM use, it does represent the largest and most comprehensive study to date of the magnitude of its use among American adults. Administered to more than 31,000 representative US adults as part of the Centers for Disease Control and Prevention's (CDC) 2002 National Health Interview Survey, the survey included questions on 27 types of CAM therapies commonly used in the United States. These included 10 types of provider-based therapies, such as acupuncture and chiropractic use, and 17 other therapies that do not require a provider, such as the use of natural products (herbs and botanicals), special diets, yoga, and megavitamin use.

"Despite differences in survey design with prior studies, the study does seem to be indicative of a increase use of CAM in the United States," said Stephen E. Straus, MD, Director of the National Center for Complementary and Alternative Medicine (NCCAM), a component of the National Institutes of Health (telephone briefing, May 27, 2004).

Americans' use of CAM was first highlighted in a 1993 JAMA report by David Eisenberg, MD, from the Harvard School of Medicine. Eisenberg estimated that Americans made approximately 425 million visits to alternative therapy providers during 1990 and that expenditures associated with these therapies were comparable to nonreimbursed expenses incurred for all hospitalizations.[2]

Perhaps not surprising, more women than men use CAM. Although the new CDC survey did not specifically address the correlation between CAM use and the onset of menopause, researchers are interested in exploring the correlation.

"We are particularly interested in knowing, for example, how findings from the Women's Health Initiative [relating to the use of hormone therapy] have influenced women's use of CAM," said Richard L. Nahin, PhD, MPH, Senior Advisor for Scientific Coordination and Outreach at NCCAM and the report's primary author (telephone interview, May 27, 2004). "We hope to further look at that next year."

Other factors that correlate with frequent CAM use higher education, hospitalization within the past year, and former smokers.

Alternative medical systems have been built upon complete systems of theory and practice, which have evolved, for the most part, separately from and earlier than conventional medicine practice in the United States. The use of complementary and alternative medicine represents a trend toward addressing one's own personal illness, pain, and sickness rather than relying totally upon a health provider who practices only conventional medicine. According to the survey, CAM was most often used to treat back pain, colds, neck pain or problems, joint pain and stiffness, and anxiety or depression.

Of the top 10 uses of CAM ( Table ), 3 relate to prayer and its potential benefit to the respondent. When prayer specifically for health reasons was included in the definition of CAM, the percentage of US adults using some form of CAM in the past year rises to 62%.

It's doubtful that physicians will adopt the approach that patients should "say two prayers and call me in the morning," but the increasing use of CAM should persuade physicians to routinely inquire about its use. To date, there has been very little research on physician comfort levels and attitudes toward discussing CAM; however, it is presumed to vary considerably. More than 50% of physicians responding in a study of 751 physicians in Denver, Colorado, did not have a positive attitude about CAM when talking to their patients and were not comfortable during the discussion.[3]

What may prompt physicians to discuss CAM more often is the growing trend to use CAM for medicinal purposes and not simply because it's a popular thing to do or because it peaks the patient's interest. According to the CDC survey, approximately 28% of adults use CAM because they believe conventional medical treatments will not fix the problem. This in contrast to previous studies that found CAM users are not, in general, dissatisfied with conventional medicine. Furthermore, 26% of adults surveyed used CAM specifically because a conventional medical professional suggested they try it.

With the increasing use of CAM and its potential convergence with conventional medicine, physicians need to consider what, if any, implications it might have for their patients when obtaining informed consent for a new treatment or procedure. Today's well-established foundation of informed consent for medical treatment dates to the late 1700s, when a British court held that "it is reasonable that a patient be told what is about to be done to him, that he may take courage and put himself in such a situation as to enable him to undergo the operation."[4] Physicians know that where customary and approved practice is being applied, the duty includes disclosure to warn a patient of (1) the material hazards, (2) possible complications expected, (3) unexpected risks of the proposed intervention, (4) its reasonable alternatives and the risks and comparative benefits of each, and, in most cases, (5) the effects of nontreatment.[5]

At the heart of informed consent is good physician-patient communication. (For an excellent discussion of avoiding malpractice claims through the use of good communication and interpersonal skills see: "Minimizing the Risk of Malpractice Claims."[6]) Despite the legal requirements for proper informed consent, it is not a 1-way street. Having thorough knowledge of the patient's past medical history, pertinent family medical history, and current treatment course is paramount to assessing the risks involved with new treatment choices and the possible alternatives that may apply. This is where knowledge of a patient's use of CAM will become increasingly more important.

Although a patient's medical history will contain pertinent information for the physician to consider, patients often do not disclose their use of alternative therapies either because they do not believe it is necessary or because they do not believe it is important.

"Healthcare providers should question their patients about CAM used," said Dr. Nahin. "Most people make the assumption that because something is natural it is safe. Yet, we know that there are a number of studies which show that the use of natural products can be harmful if used inappropriately."

For example, in the United States, herbal and other dietary supplements are regulated by the US Food and Drug Administration (FDA) as foods. This means that they do not have to meet the same standards as drugs and over-the-counter medications for safety, effectiveness and what the FDA calls "good manufacturing practices." Furthermore, the active ingredient(s) in many herbs and herbal supplements are not known.

"We were surprised to find such high use of kava kava," said Nahin. "Especially considering FDA warnings last year that is may be linked to liver damage."

Ultimately, considerably more information is needed about the efficacy of CAM therapies before its use is considered on par with conventional therapies necessitating a full disclosure of their use and associated risks as part of the informed consent process. At a minimum, however, its increased use among Americans should prompt physicians to inquire about its use on a regular basis.


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