Integrative Medicine Gains a Mainstream Foothold

Responding to a grassroots demand from an increasingly culturally diverse US population, physicians, medical schools, and hospitals are taking a closer look at incorporating integrative medicine into routine teaching and practice. The concept of integrative medicine is derived from the popularity of complementary and alternative medicine (CAM), with the emphasis on "complementary," not "instead of" conventional modern medicine. And neurologists are being advised to learn more about this expanding field.

"The paradigm shift has begun, and it's an exciting thing to see," affirmed neurologist Allen C. Bowling, MD, PhD, in a recent interview with Applied Neurology. Bowling is medical director of the Rocky Mountain Multiple Sclerosis Center and its CAM program. He has written books and various articles for the neurologist, as well as the patient, on CAM therapies for multiple sclerosis.^1,2 "There is a lot of interest and excitement in how these therapies can be applied, but we still need the hard evidence to really have them be completely integrated. We have to see evidence that they actually work. There may be bits and pieces of these complementary therapies we incorporate, and it may be that for some we find no use at all. And on the conventional side, we may find some of our therapies are not as good as we thought."

CAM includes just about everything that relates to health and healing that is outside the conventional mainstream and historically has not been taught in the traditional medical schools or been readily available in community hospitals. From the ancient herbs of Ayurvedic medicine to Native American botanicals, Chinese acupuncture, biofeedback, electromagnetic waves, deep breathing and meditation, massage and bodywork, T'ai Chi, vitamins, yoga, and prayer, the modalities are as varied as they are numerous. Although many CAM modalities may offer symptomatic relief, the emphasis overall is less on treating symptoms and more on treating the whole body to achieve optimal health and prevent disease.

According to neurologist Alexander Mauskop, MD, director of the New York Headache Clinic, physicians "have no choice" but to become informed about integrative medicine for the simple reason that not being in the loop can have an adverse impact on their practices. "All the major medical schools are getting involved because that's what the demand is from the patients," said Mauskop, who also is a certified acupuncturist.

"Neurologists have to be able to answer intelligent questions from intelligent people and from not-so- intelligent people," added neurologist Barry S. Oken MD, founder and director of the Oregon Center for Complementary and Alternative Medicine in Neurological Disorders (ORCCAMIND), at Oregon Health & Science University (OHSU). "Neurologists can't just say that 'I don't believe in chiropractic,' or 'I don't believe in acupuncture.' They really need to have [a] better handle on these other therapies these days. Actually, some neurologists are finding themselves educating the consumer because this [CAM] is non-regulated--people can basically do what they want."

BROAD APPROACH, BROAD BASE

For many people, the appeal of CAM and integrative medicine lies in the new approach it offers, one where physicians and various practitioners are working in collaboration with the patient on a strategy to achieve and maintain optimal health. It's an approach that "brings back the humanistic aspect of medicine that was lost in medical school," said Randy Horwitz, MD, PhD medical director of the University of Arizona Program in Integrative Medicine. It also means more time for the average practicing physician. "But if you want to work with your patient and develop a therapeutic alliance, you need to know not just about what aspect of disease you as a physician or neurologist [are] treating, but what else is going on in this patient's life, which could be impacting their overall outcomes--like stress, for example," pointed out Michael Irwin, vice chair of the steering committee of the Collaborative Centers for Integrative Medicine at the University of California, Los Angeles (UCLA).

According to a nationwide government survey that was released in May 2004, 36% of American adults are using some form of CAM, and if megavitamin therapy and prayer specifically for health reasons are included, the number rises to 62%.³ Another report earlier this year from the Institute of Medicine (IOM) pointed out that the total visits Americans make to CAM providers each year now exceeds those to primary care physicians, which all adds up to annual out-of-pocket costs estimated to exceed $27 billion.⁴ A published survey conducted by the American Hospital Association in 2001-2002 indicated that 23% of American hospitals offered hospital-based CAM services at that time.⁵

A series of various events coalesced in the 1990s to raise the profile of CAM. In 1991, the US Congress created the Office of Alternative Medicine (OAM). That same year, the University of Maryland became the first academic center to study and offer clinical treatment with CAM in its Program in Alternative Medicine.

By 1995, Andrew Weil, MD, the Harvard-educated physician who had already gained literary and television renown for promoting a more natural path to health, had convinced the medical director and medical dean at the University of Arizona to offer a 2-year in-residence fellowship in integrative medicine for physicians and PhDs, the first such degree offered by an academic institution. About that time, some other major academic research institutions and hospitals across the country began adding integrative units. In 1998, the OAM became the National Center for Complementary and Alternative Medicine (NCCAM), and Congress granted it a budget for sponsoring re- search (www.nccam.nih.gov). In 1999, OHSU created ORCCAMIND (www.ohsu.edu/orccamind) with funds from NCCAM.

The Consortium of Academic Health Centers for Integrative Medicine--a collective of major institutions including some of the most prestigious medical schools in the country--met for the first time in 1999, then later incorporated in 2002. Its mission, according to its Web site (www.imconsortium.org) is "to help transform medicine and healthcare through rigorous scientific studies, new models of clinical care, and innovative educational programs." The consortium updated its definition of integrative medicine earlier this year: "the practice of medicine that reaffirms the importance of the relationship between practitioner and patient, focuses on the whole person, is informed by evidence, and makes use of all appropriate therapeutic approaches, healthcare professionals and disciplines to achieve optimal health and healing."

A significant trend in public attitude is that "people are thinking more about prevention now," said integrative neurologist Shri Mishra, MD, MS, ABMS, a professor of clinical neurology at the Keck School of Medicine at the University of Southern California, in an interview with Applied Neurology.

You would expect early adoption of change in Southern California, but consider this: "We found, even here in Minnesota, that we were serving an increasingly diverse population, increasingly caring for patients that were Hmong, southeast Asian, Tibetan, and Somali immigrants. As our culture becomes more diverse, there's a much broader cry for care that is more attentive to culturally based healing," said Mary Jo Kreitzer, PhD, RN, founder and director of the University of Minnesota Center for Spirituality and Healing and vice chair of the Consortium of Academic Health Centers for Integrative Medicine. "We recognized back in 1995 that people were really looking for broader options in healthcare."

HOW DO YOU KNOW?

Researchers and clinicians around the country have been tapping into their local communities for direction in both treatment and research. "In the southern California community, we recognized that a large number of people are engaged in T'ai Chi, yoga, and mindful meditation for stress management, and [we] thought it very appropriate to test whether these treatments are in fact efficacious, and if so, what are the mechanisms of their efficacy?" explained Irwin, who also is director of UCLA's Cousins Center for Psychoneuroimmunology at the Semel Institute for Neuroscience and Human Behavior. "What's going on locally parallels the mission of NCCAM, which is driven by the demand from the consumer that we know whether these treatments are effective and also determine if they are safe," added Irwin, who serves on the NCCAM advisory council.

The long-term future of integrative medicine rests with the evidence from research that is beyond reproach. The randomized controlled studies need to be done, case studies must be observed, and meta-analyses must be completed. "Evidence-based--that should be the goal," stressed Mishra. "Ayurveda has been used for 5000 years, and it does well in many conditions. What we need to do is use modern medicine's research methodology and to study it, and that's my crusade: Proveit.

"Modern medicine, for someone with an acute illness or situation, is still the backbone," added Mishra, who has degrees in Ayurveda and yoga from Banaras Hindu University in India as well as in neurology from the University of Toronto. "If you're having a stroke, I'm not going to give you yoga therapy, but many of the complementary and alternative modalities have a great deal to offer in health promotion and disease prevention, and the very important role they play is to complement. For many illnesses that feature rehabilitative problems, there is a real need for complementary and alternative modalities, which really are usually about lifestyle, healthy living."

Issues in designing studies for many of the CAM modalities complicate current research efforts, as does lack of funding, but where there is a will, there is a way, insisted Mishra. "There are ways we can look at these things. It doesn't always have to be double blind and randomized. We can do controlled trials, case studies." The studies are being done, and positive, negative, or no-impact results are coming in. The realm of CAM is still young, and tweaking of study design and protocols will continue as the research continues.

Irwin is optimistic about the progress already being made: "We now have randomized control designs. We're using clearly defined a priori primary outcomes. The literature is becoming much stronger, and we are going to have answers about efficacy for many of these treatments in the next few years."

THE SNICKER FACTOR

By its very nature, CAM can be a murky area--practitioners are often not licensed or are licensed in different ways and by different requirements in different states, and "prescriptions" of botanicals, megavitamins, supplements, and herbs are almost always not tested for interactions and are not regulated at the manufacturing level. The realm does attract its share of fabulists, conmen, and wannabe doctors, and sometimes the mere mention of anything alternative or complementary causes snickers to erupt. "Not everybody has bought into this, and it is a challenge," Mishra confirmed. "I come across academic medicine people, department chairs, and those who are old-timers, who say there is nothing there. My approach is, 'Have an open eye. Look at it from an academic perspective,'" he said.

In many ways, the snickers reflect a stronghold of resistance to all this change. "The skeptic will say that people don't know what they're getting in the bottle, and many times they're right," Oken pointed out. "Right now, this whole nutritional dietary supplement area is not regulated at all. The FDA is in the process of doing this under its good manufacturing practices, standards, and quantification. It won't be proving efficacy, but the consumer can know that they are buying what's actually on the label. Still, there needs to be some kind of other entity besides prescription drug and food."

Even with data on efficacy, acceptance of complementary or alternative therapies has not necessarily followed. "Some of these therapies have already been proved effective, and neurologists are slow in accepting them," Oken said.

"In 1997, I gave a lecture at the American Headache Society meeting in San Francisco," Mauskop recounted. In his presentation at the meeting, Mauskop, who has coauthored 2 books promoting magnesium and other CAM therapies for headache relief,^6,7 specifically discussed his work with magnesium.^8,9 "Somebody came up to me after the lecture and said, 'You're very, very brave.' Some physicians will not believe the data even if they are faced with the facts. When I give my lectures, I show all the double-blind studies and the science behind the magnesium work, and they say 'yes, yes.' When I ask, 'Do you give patients magnesium?' They say: 'No, not usually--maybe if everything else fails, then maybe.' That's the typical response."

Resistance also exists in the patient population--people who are loathe to exert any effort to control their diet or commit to exercising or changing any of their bad habits. "Many people would rather take a pill than change a lifestyle or behavior," Horwitz said, "and many CAM therapies require lifestyle changes."

In any case, "A batch of knowledge [is] out there that needs to get communicated to neurologists and there are 2 ways to do it. You can hit them in medical schools. The other is just getting to neurologists," said Oken, who wrote a book¹⁰ to do just that.

Attitudes continue to shift as the evidence comes in. "Now that NCCAM has existed as long as it has and is funding research, we're seeing attitudes change," said Kreitzer. "And as more physicians have personal experiences, attitudes will continue to shift."

TSUNAMI OR JUST A TIDAL WAVE?

Whether CAM has the impact of a tsunami or a short, quick tidal wave lies in the research."Conventional medicine is at the edge of accepting, but increased acceptance is going to be dependent on more evidence coming out," Bowling said. That means, for a while, it will be a rough sea to sail. "In the meantime, it's important that physicians, and especially neurologists, just think about what we do in terms of conventional medicine, and how often we guess what a diagnosis is and make an educated guess about what therapy might work. In my rigorous practice of conventional medicine, there are many times during the day where I can't fall back on an FDA-approved trial to justify why I am recommending a particular therapy to a patient," he said.

"There is an incorrect assumption out there of conventional medicine being proven therapies and unconventional medicine being unproven," Bowling continued. "The truth is, there is a gray area for conventional medicine and a gray area for unconventional medicine. As conventional medical providers, we are quite comfortable going into the gray areas in conventional medicine and using therapies where we have limited evidence, especially with things that seem fairly benign. Now a lot of our patients want to see what's in the gray zone on the unconventional side, and most physicians don't yet have a good sense for how to talk about that."

Chances are your patients are already taking 1 or more CAM therapies. According to an IOM report,⁴ an estimated 15 million American adults take herbal remedies or high-dose vitamins along with prescription drugs, and fewer than 40% of those disclosed such use to a physician. The need to know what your patients are taking is critical, and the reason is obvious. "Many herbal treatments will impact the pharmacology and the pharmacokinetics of active drugs that the clinicians and physicians are administering," Irwin explained. "We also know that patients engaging in non-herbal treatments or mind-body interventions may be engaging in practices that might not be safe, so we need to be able to advise our patients about what treatments are safe and what treatments might not be safe."

"What makes this challenging for practicing neurologists, as well as consumers, is, when do you know?" said Kreitzer. "How do you know when you know? How do you know what you know? Sometimes you know from experience, sometimes from anecdotal evidence, and empirical research other times--but when do you know enough to say 'I feel comfortable moving forward'?"

Most of those in the integrative field do what common sense would suggest: weigh the risk, benefit, and the evidence. "For some of these treatments, the risk may be low, the benefit low, unknown, or high--we don't know, and the evidence may be none, little, or a great amount. People behave differently if the risk is low, even if the evidence is low," Kreitzer pointed out. To treat a patient with acupuncture for a migraine headache is low risk, with a range of possible benefit. So if all other treatments have failed, it may be a very reasonable thing to pursue acupuncture."

The bottom line is the patient, and everything else you need to know is in the Hippocratic Oath you took. "People should get the best possible solution for the least possible risk," summed up Mary Hardy, MD, chief of the integrative unit at Cedars Sinai Hospital in Los Angeles. *

For references to this article, go to www.appneurology.com. REFERENCES

1. Bowling AC, Stewart TM. Dietary Supplements and Multiple Sclerosis: A Health Professionals Guide. New York: Demos Medical Publishing; 2004.

2. Bowling AC. Alternative Medicine and Multiple Sclerosis. New York: Demos Medical Publishing; 2001.

3. Barnes P, Powell-Griner E, McFann K, Nahin R. CDC Advance Data Report #343, Complementary and alternative medicine use among adults; United States, 2002. May 27, 2004. Available at: www.nccam.nih.gov/news/ camsurvey. Accessed September 19, 2005.

4. Committee on the use of complementary and alternative medicine by the American public, Institute of Medicine of the National Academies. Complementary and alternative medicine in the United States. Washington, DC: National Academies Press; 2005.

5. Ananth S. Health Forum/AHA 2000-2001 Complementary and Alternative Medicine Survey. Available at: www.aha.org/aha/resource_center/content/ CAM%20Article%20sept02.pdf. Accessed September 19, 2005.

6. Mauskop A, Brill MA. The Headache Alternative: A Neurologist's Guide to Drug-Free Relief. New York: Dell; 1997.

7. Mauskop A, Fox B. What Your Doctor May Not Tell You About Migraines. New York: Warner Books; 2001.

8. Mauskop A, Altura BM. Role of magnesium in the pathogenesis and treatment of migraines. Clin Neurosci. 1998;5:24-27.

9. Mauskop A, Altura BT, Cracco RQ, Altura BM. Intravenous magnesium sulfate rapidly alleviates headaches of various types. Headache. 1996;36:154-160.

10. Oken BS. Complementary Therapies in Neurology: An Evidence Based Approach. New York: Parthenon; 2004.

The Legal Aspects of Complementary and Alternative Medicine

Regarding the intersection of complementary and alternative medicine (CAM) and conventional modern medicine, the legal issues are already in the dialogue--perhaps as strong an indicator as any that CAM has its foothold. "The field is growing and interest is growing," said Michael H. Cohen, JD, MBA, assistant professor of medicine at Harvard Medical School, a principal in his own law firm, and author of 2 books on the legal implications of CAM.

"The fact that there are now 29 academic medical centers with integrative medicine programs tells you that this is an expanding phenomenon and that there are credible people in legitimate medical centers," he continued. "Even the diehards who still say this is all bunk are being forced to confront these issues, because if patients are using these therapies, then a responsible clinician has to know how to converse intelligently, dispassionately, neutrally, and in a way that is mindful of legal and ethical obligations."

In terms of practical guidance for the clinician, a starting point, according to Cohen, is the test for informed consent in conventional medicine: would a reasonable patient, in a similar situation, find the information regarding the complementary and alternative therapy to be material to the decision to use or forgo that therapy?

"My position has been that the same principles from health law that apply to conventional medicine can be applied across the board--whether you label a therapy conventional or complementary," said Cohen. "So the obligation of informed consent is the obligation to disclose and discuss with patients all material treatment possibilities."

What if a physician doesn't know about the alternatives? "Ignorance is no excuse," Cohen said. "To disclose and discuss all material treatment alternatives--now what's material? States interpret that differently. Some states say 'material' is what a reasonable MD in that position would consider significant, and half of the states say that it is what a reasonable patient would consider significant."

Is there room for argument? "There's room for argument on what is a reasonable physician," Cohen responded. "Certainly, if your patient is taking an herb or dietary supplement and you do not inquire about it, I would say there is arguable failure to do due diligence there. The ostrich approach is probably not to be recommended," he said.