Interest in complementary and alternative medicine continues to grow

More than one-third of US adults report widespread use of complementary and alternative medicine, and they spend more than $30 billion out-of-pocket on these products and practices, according to statistics from the NIH. As interest in complementary and alternative medicine continues to grow, physicians who care for patients with endocrine disorders are reminded to carefully evaluate the risks and rewards associated with each treatment.

“Many patients who utilize complementary and alternative medicine products underreport them,” JoAnn V. Pinkerton, MD, professor of obstetrics and gynecology at the University of Virginia and director of Midlife Health, said in an interview. “It is up to providers to ask about these therapies and be knowledgeable about potential risks and benefits.”

Experts who spoke with Endocrine Today expressed a mix of hesitation, acceptance and hope about patient usage of complementary and alternative medicine, which is commonly referred to as CAM.

Jeffrey I. Mechanick, MD, director of metabolic support and clinical professor of medicine in the division of endocrinology, diabetes and bone disease at Mount Sinai School of Medicine, said he is reluctant to recommend some forms of CAM because of a lack of data on efficacy and safety, but acknowledged that the field is always changing.

Josephine P. Briggs

In April, the National Center for Complementary and Alternative Medicine (NCCAM) at the NIH unveiled a new online resource designed to give health care providers easy access to evidence-based information on CAM. The tool, which is available on the NCCAM website, links physicians to relevant clinical practice guidelines and systematic reviews, provides safety and efficacy information, summarizes research information, and includes tools for patients such as fact sheets and communication tips.

“As a physician, I understand the need to have easily accessible and accurate information on all health practices,” Josephine P. Briggs, MD, director of NCCAM, said in an NIH press release.

Trends in use

Regardless of the scientific evidence available, or the lack thereof, patients appear to continue to explore CAM and its practices.

In a study of more than 23,000 Americans, 38% reported using some form of CAM, according to data from the 2007 National Health Interview Survey. This represented a small but important 2% increase from 2002. Researchers at the NCCAM and CDC National Center for Health Statistics also found that CAM use was more common in women and in those with a higher income and education level.

“People who have graduated from college are more likely to use these health approaches than people who didn’t, and people with graduate degrees are even more likely,” Briggs told Endocrine Today. “Physicians are often surprised by that, but it is the highly educated consumers who are turning to these practices — sometimes with evidence, sometimes without it.”

American Indian or Alaska Native (50.3%) and white (43.1%) adults were also found most likely to use CAM compared with black and Asian adults. Briggs said many factors contribute to these trends, including cultural influences, geography and the distribution of providers. For instance, CAM use is particularly prevalent in the West, where natural remedies are popular. Similarly, chiropractic care tends to be more widely used in the Midwest. In smaller communities, chiropractors may be the most available health care providers.

Older adults aged 50 to 59 years are the primary users of CAM, with 44% reporting use during 2007.

Stephanie L. Lee

In a study restricted to patients with thyroid cancer, Stephanie L. Lee, MD, and Jennifer E. Rosen, MD, both from Boston University Medical Center, found that 80% of 1,300 patients surveyed used some type of CAM therapy. About 70% used CAM for treatment of their thyroid cancer symptoms and 31% reported using it as part of their cancer treatment. In this group, prayer and multivitamins were the most commonly used forms of CAM; patients also reported using massage therapy, chiropraxy, yoga, meditation, acupuncture, herbal tea, special diets, homeopathy and ginger.

“Patients with thyroid cancer used CAM therapies twice as often as the general American population [in our study]. Physicians who treat patients with thyroid cancer should be aware of these data to further assist in their assessment and care,” Rosen said while presenting the aforementioned results during a presentation at the International Thyroid Congress in September 2010.

Lack of communication

Despite the high use of CAM, many Americans do not discuss it with their health care providers.

In a 2010 survey conducted by the NCCAM and the AARP, 53% of adults aged 50 and older reported using CAM at some point in their lives; however, only 58% of those discussed CAM with their health care provider.

The two main reasons that patients gave for a lack of discussion are that the provider never asked (42%) and the patients did not know whether they should bring it up (30%).

The survey of older adults also revealed that if CAM is discussed at a medical appointment, it was most likely brought up by the patient. Respondents were twice as likely to say they raised the topic rather than their health care provider.

The dialogue is important because, although CAM is a part of health and wellness for many Americans, some CAM products can interact unfavorably with conventional medicine.

Cost considerations

With increasing use comes increasing costs associated with CAM use. More data from the National Health Interview Survey reveal that total estimated out-of-pocket costs for CAM reached $33.9 billion in the US in 2007. An estimated $22 billion of these expenditures went toward self-care purchases, classes and materials, although most was spent on nonvitamin, nonmineral, natural products ($14.8 billion).

The researchers also found that approximately 38.1 million adults mad more than 354 million visits to CAM practitioners — all of which accounted for $11.9 million of the estimated total out-of-pocket costs.

“These expenditures, although a small fraction of total health care spending in the US, constitute a substantial part of out-of-pocket health care costs and are comparable to out-of-pocket costs for conventional physician services and prescription drug use,” Richard L. Nahin, PhD, MPH, of the NIH, and colleagues concluded in their study published in National Health Statistics Reports in 2009.

Sarah L. Berga, MD

In their study of patients with thyroid cancer, Lee and colleagues found that half spent more than $20 per month on CAM therapies and 12.5% spent more than $100 per month. Interestingly, only two-thirds said they believed that CAM was helpful, whereas 31% said it had no effect and 1.3% said it had an adverse reaction. Despite these impressions, most reported CAM use more than 10 times during a 1-year period.

“Sometimes, people end up spending $800 a month on vitamin pills and a lot of money on unproven therapies,” Sarah L. Berga, MD, reproductive endocrinologist and professor at Emory University School of Medicine, told Endocrine Today. “Oftentimes, people think if a little is good, then a lot would be better.”

Questioning the benefits

Perhaps resulting from the growing emphasis placed on disease prevention and promotion of general health, more people are gravitating toward dietary supplements and nutraceuticals.

“What people don’t like about the ‘medical establishment’ is that they’re typically ailing when they visit a doctor,” Nanette Santoro, MD, professor and chair of obstetrics and gynecology at the University of Colorado in Denver, said in an interview. “What they like about CAM is that it takes a wellness approach to medical care.”

In 2003, the American Association of Clinical Endocrinologists published guidelines for use of dietary supplements and nutraceuticals. Mechanick, who was chair of the task force charged with writing the guidelines, said the panel did not characterize these products as alternative care. Rather, the task force categorized treatments as unproven or proven, based on a substantial body of scientific research.

This division into proven vs. unproven does not mean that all CAM products are ineffective, Mechanick said, noting that some natural treatments meet the burden of proof for recommendation.

“There are a host of vitamins and minerals used in clinical medicine that, in fact, do reach the threshold of sufficient scientific substantiation demonstrating benefit greater than risk,” he said. “One example might be using vitamin D and calcium to treat metabolic bone disease. Another might be folic acid to prevent neural tube defects.”

Although several dietary supplements are touted as beneficial in the management of diabetes, none have a clear-cut role in treating the disease, yet. For example, several small studies implicate oral chromium in improving glucose control; however, the design of the studies has been criticized. Moreover, chromium may cause glucose levels to drop when used in conjunction with conventional therapies, therefore putting a patient at risk for a hypoglycemic episode. Research is also lacking on the use of alpha-lipoic acid and polyphenols for treatment of diabetes.

One popular supplement surrounded by positive data is omega-3 fatty acids, which have been shown to improve triglyceride levels and are not associated with major safety concerns, according to Briggs. When more long-term data become available, omega-3 fatty acids may have a role as a supplement to conventional therapy for diabetes, she said.

Many patients also consider thyroid dysfunction when using dietary supplements and nutraceuticals. Amino acids such as tyrosine and carnitine have demonstrated no effect in several studies, but emerging data suggest that selenium and its ability to reduce autoimmune functions may help treat thyroid disease, according to Mechanick.

Many women continue to seek relief from symptoms of menopause, often turning to natural products. Pinkerton said black cohosh is popular among her patients. Although some claim black cohosh resolves mild-to-moderate hot flashes, several trials indicate that it has no benefit. Yet, Pinkerton said as long as a patient achieves success and the product can be used safely, she does not discourage its use. Santoro said many of her perimenopausal patients take isoflavones to mediate menopausal symptoms and to boost bone density.

A call for regulation

Conflicting data may be one reason why physicians do not fully support dietary supplement use, but a lack of regulation further complicates the matter.

“[Dietary supplements and herbal products] are not regulated by the FDA, so there is no one overseeing the quality and safety of these products,” Pinkerton said. “Some products may not be giving what they are purported to be giving, and some may actually contain contaminants that could be harmful.”

In addition, because these products do not need to meet requirements set by the FDA, information on long-term effects, dosing, contraindications and drug interactions is completely lacking, Pinkerton said.

This can be an especially troubling issue with certain products, such as those used for weight loss, according to Briggs.

“The contaminants of concern with dietary supplements for weight loss are either stimulant drugs or potent diuretics, similar to furosemide, that cause loss of potassium from the body,” Briggs said. Furthermore, physicians worry that overweight and obese patients hoping to amplify weight loss may exceed the recommended dosages and unwittingly ingest larger amounts of potentially dangerous contaminants.

Wallace Sampson, MD, clinical professor of emeritus medicine at Stanford University, takes particular issue with the terms used to describe CAM.

“The CAM field is a confection, the terms ‘holistic,’ ‘alternative,’ ‘complementary,’ ‘integrative’ having been appropriated over the past 3 to 4 decades to include known effective, discarded and dubious folkway methods,” he told Endocrine Today. “The terms have been used for socio-political acceptance and marketing purposes. The methods are ineffective, inadequate or scientifically unsound.”

In an interview with Endocrine Today, Marc R. Blackman, MD, said a recent Institute of Medicine report concluded that CAM modalities should be subject to the same requirements of evidence and proof as to their effectiveness and safety as conventional medicines and other therapeutic interventions.

“Nevertheless, we should remain open minded,” Blackman, associate chief of staff for research and development at the VA Medical Center in Washington, D.C., and professor of medicine at Georgetown University and George Washington University Schools of Medicine, said. “Although we should be cautious with our recommendations and advocacy of CAM modalities, as with any other treatment, if a robust body of high-quality evidence indicates an intervention’s safety and efficacy we should consider it carefully and seriously as a potential therapeutic option. Hopefully the emerging field of comparative effectiveness research will further refine our knowledge regarding the more promising CAM modalities.”

Sampson said the advertising and marketing that instill false hope and do not accurately represent a product or practice are a major problem.

“Physicians realize that most CAM products and practices do not alter the course of a disease. Occasionally, CAM products and methods are misbranded and advocates market them in this manner. This is when CAM can become dangerous,” Sampson said. “It is the physician’s job to educate patients, as well as other health care practitioners, about these issues so that patients do not lose money on false hope.”

Alternative practices

Recently, mind-body exercises such as tai chi, yoga, massage therapy and acupuncture have garnered attention from patients and researchers. Although data are still conflicting about the overall efficacy of these practices, many physicians acknowledge that even if they confer no benefits, the risks are low.

Potential advantages of engaging in activities such as tai chi or yoga include improved pain management, relaxation, introduction to new exercise options, and improving balance and fall prevention.

Body manipulation techniques, including massage therapy, chiropraxy and acupuncture, may also harbor benefits for certain patients. Massage, meditation or deep breathing may aid patients in dealing with diabetes-related pain, and acupuncture could help relieve hot flashes in perimenopausal women.

In the realm of mind-body practices, Berga said CAM may help improve fertility by reducing stress. In a study published in 2003 in Fertility and Sterility, Berga and colleagues found that cognitive behavioral therapy decreased stress and restored ovulation in women with functional hypothalamic amenorrhea. Berga largely attributes their success to fully involving the patient.

“The crux of the matter is you’ve got to get people engaged in their own recovery,” she said. “While some might liken it to a “placebo effect” in the sense that, by instilling hope or by managing stress or by improving muscular strength or causing physiologic relaxation through breathing, you may be reprogramming the brain in the same way.”

With any practices, Lee said a physician and the patient must ensure that he or she is physically capable of participating before proceeding. Patients with thyroid cancer, for example, many develop changes in their head and neck anatomy that make certain yoga positions, chiropraxy or deep massage dangerous.

Broaching the subject

Many physicians agree that the key to safely monitoring all types of treatment in patients is communication. Because patients may not realize that they are using CAM or because they feel embarrassed, physicians should always ask about exercise and supplement use.

“In my practice, we keep a very open policy,” Pinkerton said. “We know that women are taking and trying things, but we actually ask about them and ask people to bring in what they are taking, so even if we can’t tell them that it is safe or efficacious, at least we can tell them what we know.”

Although difficult at times, it is also important to remain even-handed, Berga said. When discussing CAM, she collects information on what a patient is using; explores a patient’s attitudes toward CAM, conventional medicine and the treatment in question; and tries to ensure that a patient has a reasonable sense of why he or she is pursuing this therapy. If the treatment poses a problem, rather than alienate the patient, Berga said she attempts to help the patient weigh the risks and benefits.

Mechanick said health care providers should stay up-to-date regarding information about alternative therapies.

“There are always new data emerging, and it is incumbent upon clinicians to read the literature and be aware of it,” he said. “Additionally, if the patient is interested and provides literature to the physician, then the physician should take it seriously and read it.”

Berga said each new piece of information has the potential to shift physicians’ approaches to treatment.

“You should evaluate your own beliefs and what the information says on a regular basis,” she said. “The reason CAM is very important is that, no matter what we say, patients do it. At the very least, we can figure out what practices or preparations are harmful and what practices or preparations may be helpful.” – by Melissa Foster

For more information:

• For more information on NCCAM, visit http://nccam.nih.gov/.
• Barnes PM. Natl Health Stat Report. 2008;12:1-23.
• Berga SL. Fertil Steril. 2003;80:976-981.
• Mechanick JI. Endocr Pract. 2003;9:417-470.
• Nahin RL. Natl Health Stat Report. 2009;18:1-14.

Disclosures: Drs. Berga, Blackman, Briggs, Lee and Santoro and Sampson report no relevant financial disclosures. Dr. Mechanick reports receiving a speaker honorary from Abbott Nutrition. Dr. Pinkerton reports no relevant disclosures. She consults (fees to UVA) for NovoNordisk, Pfizer, DepoMed, Teva, Amgen, BI and participates in multicenter clinical trials for Pfizer, DepoMed and Endoceutics.

Is CAM harmful or useful in diabetes?

Can be useful, with proper education

Laura Shane-McWhorter

CAM therapies and modalities may be useful — as long as patients are aware of potential side effects and drug interactions. It is the health care professional’s duty to promote safe use and to inform patients that they should not abandon traditional treatments since these modalities may only help a bit, and evidence is scanty.

CAM use is prevalent in diabetes. Different studies have shed light, such as one survey that revealed patients with diabetes are 1.6 times more likely to use CAM. Some therapies and modalities have been shown to benefit patients with diabetes. For example, cinnamon has been shown to increase insulin sensitivity and cell/tissue glucose uptake and have an effect on glycogen synthesis. However, cinnamon has also been associated with several side effects, such as topical allergic reactions and possible drug interactions, including if combined with glucose-lowering agents or anticoagulants such as coumadin. Other issues have been identified with CAM use, including stopping diabetes medications, contamination of products and dosage issues.

There is little evidence for long-term CAM use and no evidence for decreased morbidity or mortality. But, it is clear that patients are continuing to use CAM products and practices. It is important for the health care provider to discuss with patients which products they are using or are planning to use. It is also beneficial to monitor everything possible, including blood glucose, HbA1c, blood pressure, lipids, weight, and renal and hepatic function.

Laura Shane-McWhorter, PharmD, BCPS, BC-ADM, CDE, is a professor of pharmacotherapy at the University of Utah College of Pharmacy.

Disclosure: Shane-McWhorter reports no relevant financial disclosures.

Can be potentially harmful

June Felice Johnson

I lean toward being skeptical about CAM use in patients with diabetes. Many patients are taking CAM products such as cinnamon, ginseng and chromium on their own, with no discussion or potential drug interaction screening by their health care provider.

The reasons patients use CAM are manyfold. They may be worried about side effects associated with their approved diabetes drugs or may hear the word “natural” used to describe a CAM product and think that it is automatically safe. The expense of diabetes drugs, especially out-of-pocket costs for the unemployed or underinsured in the current economy, may make cheaper CAM products more appealing. Additionally, many patients do not see their provider aside from an annual visit, further decreasing their opportunities for discussion about CAM use. The worst-case scenario is when a patient has decided to substitute proven therapies with CAM.

It is important to respect a patient’s health belief system. Because of their cultural background, some patients believe in CAM and natural products used by their families. Be willing to go where the patient’s health belief system will go. You can’t be completely black and white or you won’t get patients to do what you believe is best for him or her.

Reasons for use aside, there are many limitations on the available “science” behind CAM products and practices. Often, the research is coupled by a flawed study design, small number of subjects and short-term duration. No large, randomized controlled trials, such as those that form the basis for consensus statements by the American Diabetes Association and other expert organizations, are available. The NIH and NCCAM are working to infuse some rigor into the science behind the use of CAM products. Additionally, because these products are not regulated for safety or efficacy by the FDA, we do not know how safe or effective they really are. Companies that manufacture CAM products and supplements are not required adhere to Good Manufacturing Practices (GMP). The USP-verified seal can be stamped on the product, but this only accounts for a small percentage of the total CAM manufacturers out there. Additionally, there are often issues with product purity, potency and adulteration. The FDA frequently issues notices via the MedWatch program. Many consumers are misled by people and companies that want to sell a specific product. “Caveat emptor” — let the buyer beware — is what I tell my patients who discuss CAM use with me.

June Felice Johnson, PharmD, is associate professor and chair of the department of clinical sciences at Drake University College of Pharmacy and Health Sciences, Des Moines, Iowa.

Disclosure: Johnson reports no relevant financial disclosures.