Complementary and Alternative Medicine Therapies' Role in Health Care a Subject of Intense Debate
Cover Story — October 2016
By Joey Berlin
Tex Med. 2016;112(10):24-31.
Thirteen years practicing in a traditional family medicine model led Julie Reardon, MD, to pursue something new, something that aligned more with the reason she went into medicine.
"I felt like I was putting Band-Aids on things and not really looking at the root of issues for my patients, and not necessarily able to look at the whole person and all the aspects of their lifestyle in the way that I wanted to," Dr. Reardon said.
She says her thinking changed, and she sought more education and training. Gradually, Dr. Reardon says she came to embrace the idea of integrative medicine: The "whole-person" approach to integrative medicine augments science with complementary and alternative medicine (CAM) therapies to treat a patient's collective mind, body, and spirit. Today, she has her own integrative family medicine practice in Austin and says she can see the wisdom in some CAM practices, which she says lead to "true physiological changes and better clinical outcomes."
Dr. Reardon says each of her patients receives a plan incorporating diet, exercise, mindfulness, sleep, and other modalities as applicable. A patient with anxiety and irritable bowel syndrome might get electrostimulation or acupuncture incorporated in his or her plan, along with pharmaceutical-grade probiotics and herbs, she explains. In another instance, she says, a patient with hypertension might come in because his or her regular physician wants to prescribe yet another pharmaceutical, and the patient would like another opinion. She says the first step involves learning about the patient's lifestyle.
"We look at their daily habit with eating, how much coffee are they really drinking, what's their stomach like, and how much ibuprofen are they actually using," Dr. Reardon said. "And then we look at other things that [might] aggravate the issue and start taking away some things. … And then we look at ways to tweak those lifestyle issues, but in a way that's established within the doctor-patient relationship in that conversation, so it's not just me saying, 'Do this, this, and this.' And then we build off of that on what they're motivated for."
Depending on which therapy you're talking about, CAM modalities can be a revelation for some physicians and a source of scorn for others. In many cases, the therapies that fall under the general category of CAM are treatments that have gained currency across different ages and cultures, such as yoga and tai chi. And in many cases, CAM therapies — such as many supplements patients can buy for themselves on any given trip to the grocery store — carry shaky supporting evidence and minimal regulation.
Some physicians, such as Houston pathologist Leslie Haber, MD, say CAM lacks the scientific credibility to have any role in medicine and laments that patients and the federal government are spending money on CAM therapies.
"It's appalling, and we as physicians have an obligation to distill science for our patients," Dr. Haber said. "And in my opinion, anything less than a physician coming out and arguing against this stuff is a violation of our patients' trust."
As the debate over CAM's place in medicine continues, Texas Medical Association policy recommends physicians stay on top of evidence-based studies of complementary and alternative therapies and routinely ask patients about their use of CAM products and therapies.
TMA Says: Ask Questions
Generally, the term "complementary" refers to therapies patients use in conjunction with Western medicine, while "alternative" refers to therapies patients are using in place of conventional medicine. Surveys show a wide breadth of approaches has attracted a large number of patients.
The 2012 edition of the National Health Interview Survey found 33 percent of U.S. adults and 12 percent of children use complementary health approaches. Among adults, "natural products," such as fish oil, vitamins, and melatonin, were the most popular. (See "Complementary Health.")
A study in the December 2008 edition of the Southern Medical Journal titled "Complementary and Alternative Medicine Use Among Primary Care Patients in West Texas" looked at a sample of patients from nine clinics serving low-income populations. Out of 1,731 patients, 52 percent reported current or past use of CAM. The most popular CAM practitioners among survey respondents were chiropractors (42.7 percent), massage therapists (33.3 percent), herbalists (8.3 percent), and acupuncturists (7.1 percent).
The integrative medicine movement began gaining steam during the 1990s. During that decade, the federal government established what's now known as the National Center for Complementary and Integrative Health (NCCIH), which conducts research on CAM therapies. The proliferation of supplements on the market exploded during the same decade following the 1994 passage of the Dietary Supplement Health and Education Act, which established less stringent regulations of dietary supplements than for pharmaceuticals. Federal law, the Food and Drug Administration (FDA) notes on its website, doesn't require dietary supplements to meet an FDA standard of safety or for manufacturers to prove to the FDA that claims made on their supplement labels are truthful.
In 2015, after referral by the TMA House of Delegates, TMA's Council on Science and Public Health (CSPH) produced a report calling for TMA to encourage physicians to routinely ask patients about their use of CAM therapies, to be informed about the scientific base for those therapies, and to encourage medical schools to educate students about patients' use of those therapies. The TMA House of Delegates subsequently adopted the report’s recommendations in 2015.
In the report, CSPH made several recommendations, including that TMA:
- Advocate stronger federal oversight and support more high-quality studies of CAM;
- Encourage physicians to register with the FDA to receive updates on suspected tainted products (visit the FDA website to sign up for those updates);
- Monitor and share evidence-based studies of CAM-related topics to serve as a resource for physicians; and
- Advise patients using nonprescribed dietary supplements that those products are unregulated and that their quality, effectiveness, and safety haven't been established.
TMA's report noted laws on credentialing and licensure of CAM practitioners vary widely among states. Texas' Medical Practice Act requires licensure of acupuncturists and chiropractors, and the Texas Department of State Health Services licenses massage therapists. Naturopathic practitioners are not licensed in Texas but can be licensed in 17 other states.
Houston neurologist William Gilmer, MD, a member of the CSPH who helped study CAM and produce the report, says he was unaware how widespread CAM was before studying it. He stresses the importance of physicians finding out what their patients are using for complementary therapies.
"People spend more than $30 billion a year on it, so it's something that we really have to be aware that patients are using it and doing it," Dr. Gilmer said. "They don't automatically think that it impacts what their physicians are doing, so they don't necessarily think that they need to talk about it with their doctor. The problem with that is that supplements by themselves might be helping one thing, but they've got lots of drug interactions that people aren't aware of and really haven't even been studied very well.
"We just find out about them almost accidentally … a complaint or a problem or a death or a visit to the ER, and then somebody looks and says, 'Oh, you were taking this much of that supplement, and you're on blood thinners and antidepressants and other medicines; it's no wonder you have a problem.' But we don't think about it routinely enough."
The Integrative Approach
Integrative medicine physician Shelly Sethi, DO, opened her practice in Austin this year after working for about a decade in a conventional osteopathy practice at Austin Regional Clinic. Dr. Sethi's interest in CAM stretches back more than two decades, when she read books by such well-known holistic and alternative medicine advocates as Andrew Weil, MD. She later studied under Dr. Weil in a fellowship at the integrative medicine program at the University of Arizona, a fellowship program in which Dr. Reardon also participated.
"Integrative medicine is truly the integration of the best modalities: the essential medicine along with the best modalities of our healing traditions, and it's really relationship-centered," she said. "That's important [to realize] because I think sometimes there's this misunderstanding of people still thinking that practitioners who are doing integrative or holistic medicine [are] opposed to conventional medicine and not integrating medications and therapies and all that stuff, as well."
Dr. Sethi says she usually enters into a conversation with patients about integrative medicine with what she says is its most commonly accepted modality: proper nutrition.
"Most people can at least accept that what we eat affects us," she said. "Even if nothing else, we can at least address that, and I think that's doing a lot for a lot of people. And then once you get in there and it starts working and you become kind of a trusted source, you can start to really help them look at some of the other concepts, like how the state of your mind affects how your body feels. This is not a new concept, but sometimes people don't necessarily make that connection for themselves.
"That may at one time have been called New Age or out-there or alternative. But many of these therapies, like meditation, now that we can actually do really intense fMRIs and PET scans and things like that, we can look at what's occurring in the brain and in the body when we are doing these age-old therapies."
Some therapies under the CAM header have research backing their effectiveness. For example, in 2011, NCCIH released the results of a study that looked at MRI images of the brains of 16 participants two weeks before and two weeks after their participation in a meditation program, along with a control group of non-meditators over a similar time frame. Brain-image changes in the meditation group led researchers to conclude their findings "may represent an underlying brain mechanism associated with mindfulness-based improvements in mental health."
Among complementary therapies that can be ingested, Dr. Sethi says research has linked omega-3 fatty acids to eased symptoms in inflammatory conditions, such as arthritis. Recent research has also shed new light on probiotics, she says.
"We originally thought that probiotics could change the gut flora, but in fact they don't necessarily change the gut flora, but they kind of hold space with the good bacteria while you're taking the probiotics so you can change your gut flora by changing your diet and reducing stress and increasing your exercise," Dr. Sethi said.
The FDA notes folic acid and the crystalline form of vitamin B12 are supplements that have shown benefits for certain health conditions. Women of childbearing age who use folic acid can reduce the risk of some birth defects, the FDA says, while vitamin B12 can be beneficial for people over age 50, who often have a reduced ability to absorb B12 that occurs naturally.
Efficacious or not, use of CAM may have an effect on whether patients initiate chemotherapy. In May, the Journal of the American Medical Association (JAMA) published the results of a study attempting to determine whether CAM use decreased initiation of chemotherapy in breast cancer patients. The study looked at 685 women younger than 70 years with nonmetastatic invasive breast cancer, with 45 percent of the participants clinically indicated to receive chemotherapy. Researchers interviewed participants on their use of five CAM modalities, including vitamins/minerals, herbs/botanicals, other natural products, mind-body self-practice, and mind-body practitioner-based practice.
The study found a link between dietary supplement use and a lower number of participants who initiated chemotherapy. The results didn't link mind-body practices to lower chemotherapy initiation, but it did find participants with greater use of the five modalities overall had a lower rate of chemotherapy initiation.
The report cited a previous study in which cancer patients who took dietary supplements said they did so because "it was something they could do to help themselves."
"Distinguishing these motivations for use may explain our findings," the JAMA report said. "To date, in the breast oncology setting, the majority of dietary supplement interventions have not proven beneficial, whereas mind-body practices have a stronger evidence base for improving treatment-related adverse effects, psychological conditions, and quality of life."
Eighty-seven percent of the women in the study reported baseline use of CAM.
Austin breast surgeon Owen Winsett, MD, a member of the Texas Medicine Editorial Board, says the JAMA study illustrates that physicians could avoid delays in initiation of chemotherapy if they knew more about CAM. The Susan G. Komen Foundation notes pooled data analyses have linked carotenoids — the orange-red food pigments found in such plant foods as sweet potatoes and carrots — to lower risks of certain breast cancers, although they don't appear to have an effect on overall breast cancer risk.
Dr. Winsett says physicians who don't recognize the benefit of high-quality supplements are doing harm to their patients. Physicians need to know enough about those therapies to discuss with patients which ones might be beneficial, he said.
"I'm not saying we shouldn't do [pharmaceuticals like] Crestor or whatever," Dr. Winsett said. "But I am saying that to encourage healthy lifestyles, fruits and vegetables, and even supplements that have been proven to improve the measure of carotenoids, which have been associated with fewer breast cancers in multiple studies, is actually how we can care for our patients better. That's what I spend more than 50 percent of my time doing."
Dr. Haber and retired MD Anderson radiologist Joel Dunnington, MD, both strong skeptics of CAM treatments, say complementary and alternative medicine that works is simply called "medicine." The rest of it, they say, represents misleading and even dangerous ground.
"I fully realize that many of the medications we use today in medicine originally came from plants, and some of those are useful," Dr. Dunnington said. "But when you take the whole plant, there's often useful stuff, and there's also bad stuff."
Despite its wide acceptance, even acupuncture, Dr. Haber says, is among a group of therapies that have shown "no evidence whatsoever they could ever possibly work." The effects of acupuncture in studies, she says, disappear if a study includes a properly designed placebo arm.
Dr. Haber references a 2011 New England Journal of Medicine study that divided 46 asthma patients into four treatment groups: treatment with an albuterol inhaler, treatment with a placebo inhaler, treatment with sham acupuncture, and no intervention at all.
Thirty-nine patients completed the study. The albuterol treatment increased patients' forced expiratory volume (FEV1) by 20 percent, which was the only statistically significant difference among the treatment groups, according to the study. The placebo, sham-acupuncture, and no-intervention groups all improved their FEV1 by about 7 percent. The patients' self-reports, however, told a different story than the science did. The placebo group and the sham-acupuncture group both reported improvements at rates close to the 50-percent improvement rate patients in the albuterol group reported. The patients in the no-intervention group reported 21-percent improvement.
"Here's the problem with these CAM therapies: They make patients feel better because their practitioners are very good at placebo effect," Dr. Haber said. "You put somebody in a room, you do something to them, [and] they feel like they've had something done. But they're not solving the problem."
Dr. Dunnington says he encountered many patients at MD Anderson who might still be alive, or at least would have lived considerably longer, if they hadn't pursued alternative medicine treatments before coming to the renowned cancer center.
"Most of this stuff is just total[ly] bogus. …The large studies, which have been done on some of these things in a controlled way, scientifically have shown that almost all of them don't do any good," Dr. Dunnington said.
Supplements are often targets of scientific and legal fire for unsupported efficacy and supplement makers deceiving consumers about what's in the bottles. FDA notes some supplements are recalled because of microbiological, pesticide, and heavy-metal contamination; absence of an ingredient the product claims it has; and/or the presence of more or less of an ingredient than advertised.
In September 2015, the New York Attorney General's Office announced it had sent cease-and-desist letters to 13 manufacturers of dietary supplements to stop their sale, distribution, and marketing of herbal devil's claw supplements, which manufacturers market as a treatment for arthritis. Devil's claw is an herb in the sesame family native to southern Africa. Testing of the manufacturers' products showed they contained "a cheaper related species that is considered less desirable," the attorney general's office said in a statement.
"When a scientific study tests numerous herbal supplements manufactured by more than a dozen companies and finds the wrong plant in just about every one, it raises more troubling questions about whether people who buy dietary supplements are getting what they pay for," state Attorney General Eric Schneiderman said in a release.
Dr. Dunnington says supplements should have full FDA regulation, and testing for their efficacy should be a requirement. "If they don't have efficacy in studies," he said, "then they should be pulled."
Dr. Sethi agrees supplement regulation needs a greater standard.
"Let's assume that we would have more quality supplements available, because certainly it's hard to know what you're buying off the shelf when nobody's regulating that," she said. "And we've seen time and time again where '20/20' goes in undercover and gets all these supplements … and they're not ... what they're claiming to be."
It's difficult to tackle the problem because pulling every supplement from every store shelf would be a daunting and expensive task, she says, and finding funding sources for studies on readily available supplements would be difficult.
Dr. Dunnington says some CAM therapies are acceptable to recommend, but practitioners shouldn't give patients the wrong idea about their effectiveness.
"If you want to do a little tai chi, if you want to do a little yoga to relax your mind, fine," he said. "Don't sell it as, 'This yoga is going to cure your diabetes.'"
Trying to Fill a Void
Physicians on both sides of the CAM debate say CAM therapies and the field of integrative medicine are attempts to fill gaps traditional medical treatment leaves in patient care.
Dr. Haber says she sees the integrative medicine movement as "sort of a pushback against the very high-tech, sterile hospital environment." She says for cancer patients, such professionals as counselors and massage therapists might serve to improve that environment. Getting patients to exercise at the hospital could be beneficial too, she says, because exercise can reduce patients' fatigue.
"I don't think there's anything wrong with trying to make patients feel more comfortable when they're in the medical community," she said. "You get a patient who just got diagnosed with cancer, and they're suddenly just overwhelmed by this 'Go here; stand there; do this; get that done.' And the idea of bringing in something more touchy-feely into the system is not a bad one in general. But if we do it by giving currency to things that don't work and can't possibly work, we're not doing patients any favors."
Dr. Sethi says a large gap exists between what patients are already doing and the therapies physicians are sometimes willing to use in their practice.
"I don't think it's because physicians and health care providers feel that there's no validity there or value," she said. "I think it's because there just hasn't been enough education happening in the traditional form of medical school as there could be.
"It's changing, and I do think we're going to see a whole new generation of physicians coming out really understanding those connections between the mind, body, and spirit, and how if we don't access that and address that with our patients, we're not going to see improvements in the type of chronic disease that we're seeing in America, and the illness and … unhappiness that we're seeing here."
TMA's 2015 CSPH report did not call for a curricular mandate on CAM for medical students or residents or mandated continuing medical education on CAM for practicing physicians.
"However, physician awareness of patient interest in CAM calls for physicians to be better-informed about both the potential risks and the potential benefits of many products and therapies," the CSPH report said. "This presents an opportunity for the physician … to provide information while supporting patients who seek a greater sense of control of their health and to help manage symptoms they are experiencing."
The report notes several national organizations working to advance research and education on CAM. (See "CAM-Related Organizations.")
Dr. Reardon says while it's not smart for patients to "get all their advice from the clerk at the health food store," supplements are selling because "people are screaming for help" and trying to make up for imbalances in the typical American diet.
"I think that the fact that supplements are so popular illustrates that people aren't getting what they need," she said. "People are looking for an answer, and so they're going out of the regular model because the regular model isn't working for them."
Overall, she says her goal would be for all physicians to have some level of comfort with and knowledge of CAM therapies to be the best advocates they can be for patients.
"Different people can get us across the street in different ways," she said. "We tend to sometimes, in allopathic medicine, just see things our way. But we have to step back and look and realize that there are other ways we may not totally understand. And as the research evolves and changes, our opinion may change about it."
Joey Berlin can be reached by phone at (800) 880-1300, ext. 1393, or (512) 370-1393; by fax at (512) 370-1629; or by email.
History of Botanicals Exhibit
In early 2017, TMA's History of Medicine Committee will present an exhibit on the history of botanical medicine and pharmacology in the Robert G. Mickey History of Medicine Gallery, located on the first floor of the TMA building at 401 W. 15th Street in Austin.
The exhibit will trace the earliest known uses of plants to treat disease and promote health, and examine the development of modern drugs and pharmacology. For more information about the upcoming exhibit, please contact Casey Newbegin at (512) 370-1552 or Claire Duncan at (512) 370-1544.
National Cancer Institute, Office of Cancer Complementary and Alternative Medicine (CAM): Identifies gaps in existing cancer research on CAM; creates funding opportunities for more high-quality studies on CAM; encourages collaboration between cancer researchers and CAM practitioners; and provides expert review of CAM content.
U.S. Health Resources and Services Administration, National Coordinating Center for Integrative Medicine: Funds integrative medicine programs (IMPs) and provides technical assistance at entities that earn IMP grants, such as medical schools.
Academic Consortium for Integrative Medicine and Health: A group of more than 60 academic health centers and medical schools, including MD Anderson Cancer Center, Texas Tech University Health Sciences Center, and The University of Texas Medical Branch. Supports and disseminates information on integrative health care education and research.
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