Medicine focuses on the whole patient.

Silymarin

Milk thistle(Silybum marianum), the CAM compound most commonly used for liver disease, has been used for many disorders, including alcohol-associated liver disease, chronic viral hepatitis, drug-induced hepatitis, and as standard of care for acute mushroom poisoning fromAmanita phalloides in Europe.138 Silymarin, the active ingredient, is derived from the milk thistle plant. Its mechanism of action is not defined fully but appears to be multifaceted: it is thought to act as an antioxidant to prevent glutathione depletion149; it has anti-inflammatory activity and decreases formation of leukotrienes, prostaglandins, and TNF-α150 in animal studies; and it has been shown to block proliferation of hepatic stellate cells and production of procollagen III, suggesting a role to slow fibrosis in chronic liver disease.151

Silymarin has been evaluated in several trials of alcohol-associated liver disease. Ferenci and colleagues,152 in an RCT of cirrhotic patients treated with 140 mg of silymarin or placebo, demonstrated an improved 4-year survival in the treatment group compared with the placebo-treated group. Patients with alcohol-associated liver disease and early cirrhosis (Child-Turcotte-Pugh class A) were more likely to benefit than were those with Child-Turcotte-Pugh class B or C. This trial, however, did not confirm a clear benefit of silymarin, because patients were not randomized properly: the placebo group contained patients with more advanced cirrhosis (Child-Turcotte-Pugh class C) than did the treatment group. In addition, the degree of abstinence from alcohol among the study participants was not followed, and the dropout rate was high. A larger, more rigorously defined study by Pares and colleagues153 failed to demonstrate a survival benefit in alcoholic cirrhotic patients treated with 150 mg 3 times daily of daily silymarin compared with a group treated with placebo.

The Hepatitis C Antiviral Long-term Treatment against Cirrhosis Trial was designed to determine whether maintenance interferon therapy could slow disease progression in patients in whom prior interferon treatment had failed to eradicate HCV. Seeff and colleagues154 examined the use and potential effects of silymarin in the Hepatitis C Antiviral Long-term Treatment against Cirrhosis patient population. Among all participants, 67% had never used silymarin, 16% used it in the past, and 17% used it at baseline. Silymarin use varied widely with gender and ethnicity; men were more frequent users than women; non-Hispanic whites were more frequent users than African Americans and Hispanics. Silymarin use correlated strongly with higher education. No beneficial effect of silymarin was found on serum ALT or HCV RNA levels. Univariate analysis showed significantly fewer liver-related symptoms and better QoL parameters in users than nonusers.

Conclusion

Integrative medicine recognizes all of the potential influences on one's health. It is the study of the human ecology that includes the physical and nonphysical factors of how humans interact with their environment. Care is applied through relationships that provide insight into each individual's unique situation and needs. Evidence and research will continue to help us understand which therapies (e.g., pharmaceuticals, botanicals, acupuncture, meditation) will help the body heal. For patients with prostate cancer, this treatment involves much more than a surgical and pharmaceutical intervention. Our partnership with our male patients will help empower them to seek an understanding of how they can be active participants in their care, resulting in a more successful treatment outcome and quality of life for all involved.

Natural Products

Natural products encompass vitamins and minerals, herbs (also known as botanicals), and probiotics. These products are often sold as dietary supplements. Although many of these products have anecdotal support and some have stood the test of time by being recommended for hundreds of years, there is limited evidence of efficacy from well-designed, rigorous studies for most of these products. Natural products are currently regulated in the United States under the Dietary Supplement Health and Education Act (DSHEA), which was enacted in 1994. Under DSHEA, dietary supplements are considered to be food, and supplement manufacturers do not need to obtain Food and Drug Administration (FDA) approval before marketing any supplement that was already marketed before 1994 (“grandfathered status”). New dietary ingredients introduced after 1994 require reasonable evidence of their safety, which must be reviewed before marketing.

Under this system, the FDA is responsible for taking action against an unsafe product after it has reached the market, but manufacturers are not required to prove safety or efficacy of “grandfathered” natural products before marketing. Critics have raised concerns that there are limited protections for consumers to ensure that dietary supplements contain active ingredients in the amounts specified and do not contain other substances to which people may have allergies or other forms of intolerance. Concerns have also been raised that there are limited resources for the FDA to assess whether a supplement may be responsible for serious adverse events. Using nationally representative surveillance data from 63 emergency departments (ED) in the United States from 2004 through 2013, it was estimated that 23,000 ED visits every year are attributed to adverse events related to dietary supplements.10 One of the developments that spurred increased attention to safety issues was controversy over ephedrine alkaloids, which were included in several dietary supplements but were found to be associated with cardiovascular events. In response to concerns such as this, the Dietary Supplement and Nonprescription Drug Consumer Protection Act was passed by Congress in 2006. Of note for physicians, this act requires that a “responsible person” submit to the FDA all reports of a “serious adverse event” associated with a dietary supplement. Although this law is particularly aimed at supplement manufacturers, the reporting process can be initiated by health professionals, using a form available on the FDA website (MedWatch Form 3500A).

Two sources of information that may be useful for obtaining the current research status of different natural products are the NCCIH website, which has updated reports on research on individual herbs (https://nccih.nih.gov/health/herbsataglance.htm), and the National Institutes of Health Office of Dietary Supplements, which has additional information on different dietary supplements (https://ods.od.nih.gov/factsheets/list-all/). Moreover, the first of five comprehensive review articles investigating the >50,000 dietary supplements, including herbs, currently entered in the U.S. Office of Dietary Supplements’ “Dietary Supplement Label Database” was recently published and provides an overview of efficacy, safety, and government regulations in the United States.11 Although much of the research has not found evidence that clearly supports the use of different nutritional supplements, there are intriguing exceptions. An example is turmeric, which has historically been used in Ayurvedic medicine (traditional medicine from the Indian subcontinent). Turmeric is high in curcumin, a curcuminoid that has substantial biologic activity, including anti-inflammatory and antioxidant properties. A randomized, double-blind, placebo-controlled trial found that a curcuminoid preparation was more effective than placebo for decreasing the intensity of pain and its related interference with function in participants with knee osteoarthritis.A10 Another example isMucuna pruriens, a levodopa-containing tropical leguminous plant used as an alternative source of levodopa for indigent individuals who cannot afford medications for Parkinson disease.A10b

Integrative Mental Health

Integrative medicine has increasingly become recognized as a valid and effective approach to healthcare and is gaining increasing acceptance among both the general population and among allopathic physicians and healthcare delivery systems. The establishment of the National Center for Complementary and Integrative Health (NCCIH; formerly the National Center for Complementary and Alternative Medicine exemplifies this trend. In addition, the emergence of integrative medicine departments in leading academic medical centers and the establishment of specialty training and board certification for allopathic physicians in Integrative Medicine, as well as the creation of a Consortium of Academic Health Centers for Integrative Medicine, emphasizes this growth, acceptance and possibly moving from marginal to mainstream.

Despite the steady acceptance of integrative medicine for physical conditions, integrative approaches to mental healthcare have only recently begun to receive more attention (Sarris et al., 2014). However, given the factors described below, IMH is likely to receive increasing attention and application over the next decade.

Dietary Supplement Safety

Dietary supplements may have safety issues in children, but toxicity is much less common with nonprescription dietary supplements than with prescription medications (Table 78.2). Toxicity depends on dose, use of other therapies, and the child's underlying medical condition. Current use of a dietary supplement (e.g., ephedra for weight loss) may not reflect its traditional use (e.g., ephedra as a component of a traditional Chinese medicine tea in small doses to improve allergic or respiratory symptoms). Moreover, herbs that are apparently safe for most adults may be more hazardous in specific conditions (e.g., newborns, patients with impaired renal or hepatic function), under special circumstances (e.g., after organ transplantation or other surgery), or when combined with prescription medications. Some natural products are toxic in and of themselves. Even when a product is safe when used correctly, it can cause mild or severe toxicity when used incorrectly. For example, although peppermint is a commonly used and usually benign gastrointestinal spasmolytic included in after-dinner mints, it can exacerbate gastroesophageal reflux.

Although there are good manufacturing practices for dietary supplements in the United States, dietary supplement labels might not accurately reflect the contents or concentrations of ingredients. Because of natural variability, variations of 10-1,000–fold have been reported for several popular herbs, even across lots produced by the same manufacturer. Herbal products may be contaminated with pesticides, microbial agents or products, or the wrong herb misidentified during harvesting. Products from developing countries (e.g., Ayurvedic products from South Asia) might contain toxic levels of mercury, cadmium, arsenic, or lead, either from unintentional contamination during manufacturing or from intentional additions by producers who believe that these metals have therapeutic value. Approximately 30–40% of Asian patent medicines include potent pharmaceuticals, such as analgesics, antibiotics, hypoglycemic agents, or corticosteroids; typically the labels for these products are not written in English and do not note the inclusion of pharmaceutical agents. Even conventional mineral supplements, such as calcium, have been contaminated with lead or had significant problems with product variability.

Many families use supplements concurrently with medications, posing hazards of interactions (Table 78.3). Using the same principles of drug-drug interactions can help determine if a supplement-drug interaction is a concern. For example, St. John's wort induces CYP3A4 activity of the cytochrome P450 enzyme system and thus can enhance elimination of most drugs that use this pathway, including digoxin, cyclosporine, protease inhibitors, oral contraceptives, and numerous antibiotics, leading to subtherapeutic serum levels.

Integrative Medicine: Overview

Integrative medicine is a philosophy of care that integrates conventional allopathic medical therapies with modalities not typically included in conventional care and addresses the physical, emotional, and spiritual needs of the patient. This field of medicine is sometimes referred to as complementary medicine or complementary and alternative medicine (CAM). However, these terms refer more precisely to modalities such as acupuncture, meditation, nutritional supplements, and massage, all of which may be included in the integrative medicine “tool box.” In 2005 the Consortium of Academic Health Centers for Integrative Medicine defined integrative medicine as follows:

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, health-care professionals and disciplines to achieve optimal health and healing.

The use of complementary medicine modalities in the United States is increasing. One study found that 62% of adults had used some form of complementary therapy in the previous 12 months.1 The most commonly used CAM therapies were prayer for the improvement of health, natural products, deep-breathing exercises, meditation, chiropractic care, yoga, massage, and diet-based therapies. It is estimated that in 1997, between $36 and $47 billion was spent on CAM therapies in the United States.2

Pain syndromes, such as chronic back pain, appear to be increasing and are associated with significant health care costs.3 Unresolved pain has a wide-reaching impact in that it affects physical, emotional, and spiritual wellness and has a negative impact on social and occupational functioning. Integrative medicine, which adopts a mind-body approach to the treatment of pain and uses multiple effective CAM modalities, is well suited to address chronic pain syndromes. In 2002, 6% of the U.S. population used complementary medicine modalities for the treatment of back pain and 60% of respondents who used CAM for back pain perceived a "great deal" of benefit.4

Introduction

Integrative medicine most often involves provision of high-cost one-on-one consultation. Delivery models now exist that allow dramatic cost reduction, making the challenge of providing this care to underserved populations less daunting. Linked and group visits support financial sustainability even in today’s revenue-based health care systems. As the shift toward capitated payment and improved health outcomes continues, other models will become highly valued, particularly for the many issues not well addressed by conventional medicine. Characteristics of integrative medicine make it especially effective in working with the underserved, a group largely living in poverty. It should also be noted that nearly a third of the poor are already using complementary medicine, typically without any real guidance.1 The time seems right to bring integrative medicine to the underserved! In this chapter we will address the following:

Discuss factors suggesting how to approach this population

Provide specific examples of low-cost, effective integrative approaches

Discuss the challenges inherent in providing these services

Share current delivery models that meet those challenges

Briefly address the issues of provider self-care versus burnout

Integration

Integrative medicine involves using the best possible treatments from both CAM and allopathic medicine based on the patient’s individual needs and condition. This selection should be based on good science and neither rejects conventional medicine nor uncritically accepts alternative practices. It integrates successes from both worlds and is tailored to the patient’s needs using the safest, least invasive, most cost-effective approach while incorporating a holistic understanding of the individual.

CAM is not synonymous with integrative medicine. CAM is a collection of therapies, many of which have a similar holistic philosophy. Unfortunately, the Western system views these therapies as tools that are simply added on to the current model, one that attempts to understand healing by studying tools in the toolbox. David Reilly said it well in an editorial in Clinical Evidence: “We are the artists hoping to emulate Michelangelo’s David only by studying the chisels that made it. Meantime, our statue is alive and struggling to get out of the stone.”32

Integration involves a larger mission that calls for a restoration of the focus on health and healing based on the provider–patient relationship.

Integrative Medicine

Integrative medicine is healing oriented and emphasizes the centrality of the physician-patient relationship. It focuses on the least invasive, least toxic, and least costly methods to help facilitate health by integrating both allopathic and complementary therapies. These therapies are recommended based on an understanding of the physical, emotional, psychological, and spiritual aspects of the individual (Table 1-2).

The goal of integrative medicine is to facilitate health within complex systems, from the individual to the communities and environment in which all things live.

Conclusion

Integrative medicine includes all health and wellness practices that best serve each individual. Future research may continue to explore the mechanisms of these approaches and the effectiveness of their application for diverse conditions (eSlide 18.11).

Clinical Pearls

Spinal manipulation, most often provided by chiropractors, is beneficial for low back pain. Its contraindications include severe osteoporosis, spinal epidural infection, and spinal metastasis. The most common side effect is local discomfort. The risk of death or permanent neurologic sequelae from stroke after cervical spine manipulation is 1 in 1,000,000 (eSlide 18.12).

Reiki involves the manipulation of energy fields using specific hand positions. It can be performed at a distance and does not require focused attention by the patient.

The Dietary Supplement Health and Education Act of 1994 exempts manufacturers from having to prove the safety or efficacy of their herbal products.

Studies have suggested the following indications for complementary and alternative medicine in integrative rehabilitation:

Pain management: osteopathy, acupuncture (needle shock typically occurs during the first treatment), massage, qigong, tai chi, yoga, meditation, reflexology (based on the principle of microsystem), vitamin D, NAC, and fish oil

Arthritis: acupuncture, tai chi, SAM-E, glucosamine and chondroitin (full effects can take up to 2 to 4 months), MSM, strontium ranelate, fish oil, cat’s claw, devil’s claw

Cardiorespiratory fitness enhancement, balance improvement, and fall prevention: movement therapies

Relaxation or stress reduction: massage, meditation, qigong, tai chi, yoga