Chapter 8 The use of complementary and alternative medicine (CAM) has been increasing every year in the United States. In 1993, Dr. David Eisenberg of Harvard Medical School released a landmark study in The New England Journal of Medicine that showed one third of Americans were using unconventional medicine such as aromatherapy, acupuncture, and therapeutic touch. In May 2004, the National Center for Complementary and Alternative Medicine (NCCAM) and the National Center for Health Statistics (NCHS; part of the Centers for Disease Control and Prevention) released the results of the 2002 National Health Interview Survey (NHIS). This comprehensive report on the use of CAM in the United States concluded that as many as 62% of adults 18 years of age and older use some form of CAM. The most commonly used CAM modality in 2002 was herbal therapy (18.6%, representing more than 38 million U.S. adults), which was followed in frequency by relaxation techniques (14.2%, representing 29 million U.S. adults) and chiropractic medicine (7.4%, representing 15 million U.S. adults). Among CAM users, 41% had used two or more CAM therapies during the prior year. Factors associated with highest rates of CAM use were patients aged 40 to 64 years, female gender, nonblack/non-Hispanic race, and annual income of $65,000 or higher (Tindle et al, 2005). This trend continues. Complementary, alternative, nontraditional, unconventional, and “Eastern” medicine are terms that are used interchangeably to describe diverse medical and health care practices considered outside the realm of conventional or allopathic medical therapies that have yet to be validated by scientific methods (Straus, 2002). The term complementary describes therapy used to supplement more traditional medical care, and the term alternative suggests that therapy has taken the place of usual medical therapy. Complementary or alternative medicine is the term most frequently seen in the lay literature. Integrative medicine is a term that is used to describe the appropriate use of conventional and alternative methods to facilitate the body’s innate healing response. Integrative medicine shifts the orientation of medicine to one of healing rather than disease and uses an approach that engages the body, mind, spirit, and community. It has also been defined as “the evidence-based combination of conventional with CAM for assuring the maximum therapeutic benefit for patients and practitioners” (Pelletier, 2007a). The NIH National Center for Complementary and Alternative Medicine (http://nccam.nih.gov) has identified five broad categories of CAM and integrative medicine for which a growing and substantial body of evidence about these techniques is based on research and clinical practice. The current literature describes the following (Pelletier, 2007a): • Mind-body medicine: Research about these approaches constitutes the largest body of CAM research. This research documents the efficacy of these types of interventions for the largest number of conditions for the greatest number of patients (Pelletier, 2004). • Acupuncture: The Cochrane Library (www.cochrane.org) has 16 systematic reviews regarding the efficacy of this approach in conditions such as back pain, Bell’s palsy, depression, dysmenorrhea, arthritis of the knee, and fibromyalgia (Kim, 2005; Martin et al, 2006). • Herbal medicine: Information on herbal interventions (www.herbalgram.org) and drug–herb interactions (www.herbmed.org; www.healthyroads.com) is becoming increasingly sophisticated. • Traditional Chinese medicine (TCM): This way of approaching diagnosis and treatment using ancient lore is now under study by several international NCCAM Centers of Excellence. Studies include research on irritable bowel syndrome, side effects of cancer treatment, and allergic asthma (AARP, 2007). • The National Institute of Health–NCCAM annually has about 50 ongoing research studies (http://nccam.nih.gov). Among the many diverse areas under study are dietary practices and supplements, chiropractic, homeopathy, naturopathy, and electromagnetic effects, as well as Ayurvedic medicine, chelation, and spiritual healing (Kaptchuk & Miller, 2005; Merrell, 2006). In a report by the American Association of Pediatrics on CAM, the task force says the following: A poster presentation at a Sigma Theta Tau International conference discussed research showing 74% of the APRNs reported asking their patients about over-the-counter use, but only 35% inquired about herbal product use. The most commonly discussed herbal products were ginseng (15%), glucosamine and chondroitin (14%), echinacea (13%), St. John’s wort (9%), and ginkgo biloba (9%). Seventy-five percent of the APRNs rated their knowledge of OTCs as good to excellent, while 86% believed they had only a fair to poor understanding of herbal products (Waszak, 2004). A growing body of knowledge is available to inform practitioners. Integrative medicine is part of a rapidly evolving face of health care that ushers in an era of genomics, international medicine, and evidence-based approaches (www.nap.edu/catalog/11182.html). Lack of knowledge about these techniques has caused practitioners to acknowledge and address the need for an adequate “evidence-based” foundation in conventional, CAM, and integrative medicine. The goal is to provide evidence-based standards by which all medicine should be judged and that will help both providers and patients as they consider new approaches to the treatment of old problems. A good first approach regarding patient-initiated and controlled therapy is to obtain a thorough medication history because many patient-initiated alternative treatment remedies are purchased over the counter and patients often neglect to tell their providers about them. More than 70% of patients who use complementary therapies do not tell their providers of the use. Although easy availability of herbal and over-the-counter products makes many Americans consider these products safe, the fact is that not all herbal therapies are safe for all patients. General knowledge about patient-initiated products enables providers to evaluate specific regimens that their patients report taking; this decreases the potential for negative outcomes when products that may be harmful are used. (Kennedy, 2005). • Are you using any over-the-counter vitamins, herbs, or supplements? • Why are you taking the product? • How long have you been taking the medicine? • Have you experienced any side effects? • Are you being treated by an alternative therapist—that is, a herbalist, acupuncturist, naturopathic practitioner, or chiropractor? • Patients seek products that will maintain health, prevent disease, or provide treatment for existing health problems. • They have tried conventional therapeutic options without success. • Conventional therapies had undesirable side effects. • No known therapy will relieve their problem. • Other respected family or community members may have recommended the product. • Conventional approaches have disregarded their religious or spiritual beliefs. • Patients may be dissatisfied with the fragmentation of care provided by multiple medical specialties. • Media reports and advertising promote alternative and complementary therapies as being more “natural” and therefore safe. • Using complementary and alternative modalities gives patients’ power in controlling their treatment. • Many complementary and alternative modalities focus on emotional and spiritual well-being. • Complementary and alternative therapists generally provide three elements that often are not provided by conventional medicine: touch, talk, and time. • Medical liability is an important issue as providers integrate complementary primary care practices or refer patients for alternative therapies. Standards of care for complementary and integrative therapies are developing as research and evidence-based guidelines are formulated. Providers who integrate CAM therapies into conventional care should determine whether evidence in the scientific and medical literature (1) supports both safety and efficacy, (2) supports safety but efficacy evidence is inconclusive, (3) supports efficacy but safety evidence is inconclusive, or (4) indicates serious risk or inefficacy. • Strategies should be used to decrease the risk for potential malpractice liability when care providers counsel about or offer CAM therapies and when they refer patients to other CAM providers (Cohen & Eisenberg, 2002). When counseling or offering CAM therapies, a provider should (1) determine clinical risk level by assessing evidence of safety and efficacy, (2) document literature that supports the therapeutic choice in the medical record and include a file of literature that supports the safety and efficacy of the treatment, (3) provide adequate informed consent by discussing the risks and benefits of CAM therapy, including what is not known or cannot be evaluated, and (4) obtain written consent to use CAM treatment (or obtain written consent for the use of CAM treatment). • When patients are referred to other CAM providers, similar strategies should be implemented: (1) Closely monitor the clinical risk level of the treatment that is being provided, (2) document the literature that supports the decision to refer, (3) provide adequate informed consent by discussing benefits and risks based on available medical literature, (4) document the patient’s decision to visit a CAM provider, thereby establishing the patient’s agreement to treatment, (5) continue to monitor the patient, and (6) inquire about the competence of the CAM provider by reviewing the licensing and scope of practice of the provider, understanding the care that is delivered, and inquiring about the provider’s history of disciplinary action or malpractice litigation. There is increasing information in the literature about the legal liability associated with not informing patients about the risk of using CAM and for patients who do not disclose to providers the CAM products they are using. Of great concern is the high risk of drug–drug interactions between CAM products and traditional medicines. The known potential for drug–drug interactions is included where known in the relevant chapters in this text. Clinicians should make every effort to learn the most recent information available about any herbal preparations the patient is taking and evaluate for possible drug interactions. Complementary and alternative therapies in general have been somewhat mysterious, and the scientific basis for their therapeutic action is often uncertain. Over the past several years, as research and interest in this area have increased, more universities and medical schools are incorporating the use and teaching of complementary/alternative modalities, and many are conducting research in this area. In 2000, 64% of medical schools were offering courses that addressed complementary and alternative therapies. The number of CAM practitioners in the United States is projected to increase by 88% between 1994 and 2010, and the number of conventional physicians who incorporate CAM into their practices will increase by 16% (Breuner, 2006). Because of the widespread use of complementary therapies, interest in the scientific study of various products is growing. In 1991, the Office of Alternative Medicine (OAM) was established within the NIH, and an Alternative Medicine Advisory Council was established in 1993. In November 1995, the NIH established the Office of Dietary Supplements to promote the scientific study of dietary supplements. In October 1998, Congress mandated the establishment of the OAM NIH center—the National Center for Complementary and Alternative Medicine. In February 1999, a charter creating NCCAM was signed, making it the twenty-fifth independent component of the NIH. In October 1999, NCCAM and the NIH Office of Dietary Supplements established the first Dietary Supplements Research Center, with an emphasis on botanical medicine. Since its inception, NCCAM has funded multiple studies, which are summarized on their website. Particular evaluation of herbal products is also available through NCCAM (http://nccam.nih.gov/health/herbsataglance.htm). Energy therapies involve use of the following two types of energy fields: 1. Biofield therapies affect energy fields that purportedly surround and penetrate the human body. The existence of such fields has not yet been scientifically proven. Some forms of energy therapy, such as therapeutic touch, Reiki, and qi gong, manipulate biofields by applying pressure and/or manipulating the body by placing the hands in, or through, these fields. 2. Bioelectromagnetically based therapies involve the unconventional use of electromagnetic fields, such as magnetic fields, pulsed fields, and alternating current or direct current fields. Biologically based therapies use substances that are found in nature to treat various conditions or to maintain health. Examples include botanical or herbal therapy, dietary supplements, orthomolecular medicine, and other “natural” therapies, which have yet to be scientifically proven (e.g., shark cartilage to treat lung cancer). Nonherbal biologics are discussed in Table 8-1. TABLE 8-1 Natural Remedies (Not Herbs or Vitamins)
Complementary and Alternative Therapies
Defining Complementary and Alternative Therapies
Primary Care Providers and Complementary and Alternative Therapies
Complementary Therapies and Herbal Medicine
Common Complementary and Alternative Practices
Energy Therapies
Biologically Based Therapies
Name
Source
Common Uses
Safety and Efficacy/Dosage
Drug Interactions
Chondroitin
Cattle cartilage
Eases aches and pains, protects and rebuilds cartilage
Safe and effective; 200-400 mg po bid-tid; 1000-1200 mg po daily
Antiplatelets, anticoagulants, ASA, NSAIDs
Coenzyme Q10
Produced in the body and formulated in soybean oil
Mitochondrial cytopathies, CHF, cardiovascular disorders, post-MI cardiac risk reduction, Alzheimer’s, Parkinson’s
Safe; dosage varies with use
Diabetes medications—hypoglycemic agents, insulins, warfarin, statins, β-blockers
Creatine
Muscle tissue or synthetic
Improving exercise performance and increasing muscle mass; ALS, CHF
Possibly unsafe in high doses 20 g/day for 5 days followed by a maintenance dose of 2 g or more per day
Gallium nitrate, aminoglycosides, nephrotoxic agents, tacrolimus
Glucosamine
Crab shells
Eases aches and pains, protects and rebuilds cartilage osteoarthritis, rheumatoid arthritis
Safe and effective if shells are not from polluted water; 500 mg po tid; 1500 mg po daily
Antiplatelets, anticoagulants, ASA, NSAIDs
DHEA
Androgen hormone synthesized from wild yams
Alleviates cancer, heart disease, and autoimmune disease; antiaging remedy
Believed to be safe, but all side effects not known
Toxic to liver in sufficient quantities
Efficacy not proven
Aromatase inhibitors, fulvestrant, tamoxifen
Melatonin
Hormone
If from natural sources, it comes from the pineal glands of cattle
Cure for jet lag, helps the body’s clock, sleep aid
Antiaging
May inhibit sex drive in men
0.3-5 mg po every night (insomnia)
5 mg po every night × 7 days (for jet lag); start 3 days prior to flight
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Complementary and Alternative Therapies
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